Interdisciplinary Assessment of Personal Health Monitoring

INTERDISCIPLINARY ASSESSMENT OF
PERSONAL HEALTH MONITORING

Studies in Health Technology and
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ISSN 0926-9630 (print)

ISSN 1879-8365 (online)
Interd
discipllinary Asses
A smentt
o Perssonal Health
of H h Mon nitoringg
y
Edited by
Sillke Schm
midt
D
Department of Health and
d Prevention,, University of Greifswalld,
Greif
ifswald, Germ
many
and
Ottto Rienh
hoff
Institute of Mediccal Informattics, Göttingeen Universityy Medical Ceenter,
Götttingen, Germmany
Amstterdam • Berrlin • Tokyo • Washington, DC

© 2013 The authors and IOS Press.
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or transmitted, in any form or by any means, without prior written permission from the publisher.
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Interdisciplinary Assessment of Personal Health Monitoring v
S. Schmidt and O. Rienhoff (Eds.)
IOS Press, 2013
© 2013 The authors and IOS Press. All rights reserved.
Foreword
Pēteris ZILGALVIS1 and Céline DESWARTE
Directorate General, DG Communications Networks,
Content and Technology, European Commission Brussels
Introduction
We welcome this book, which presents selected contributions to the pre-conference

symposium on Personal Health Monitoring (PHM) and Ethics and future areas of Per-
sonal Health Monitoring, held in Rotterdam, prior to the 11th World Congress of Bio-
ethics. The majority of papers present the outcomes of the European PHM-Ethics pro-
ject. In addition, some further invited contributions deal with important issues strongly
related to the project’s primary objectives and outcomes. Therefore, the contributions
in this book cover a broad spectrum, ranging from the technical set-up of PHM systems
to ethical issues raised by PHM applications, and will be of interest to all those con-
cerned with improving the provision of healthcare worldwide.
1. Towards Smart and Sustainable Healthcare in Europe
In Europe we are facing a paradox: while governments try to curb public spending, the
demands on our healthcare systems continue to rise.
The smart use of technologies and innovation can help to address the challenges
healthcare systems are facing today, such as an ageing population, a shortage of
healthcare professionals and a lack of financial resources.
Information and Communication Technologies (ICT) have already made a strong
contribution to these goals, but much more remains to be done. eHealth technologies
such as personal health monitoring devices enable the delivery of higher quality and
more efficient services to European citizens, irrespective of where they are, for the
convenience of both patients and practitioners. This is made possible by granting online
access to personal health information, by supporting personalised therapies and by im-
plementing innovative telemedicine services.
The Digital Agenda for Europe, adopted by the European Commission in 2010,
has defined a number of objectives, including the implementation of interoperable elec-
tronic patient records – which can be safely accessed and exchanged across the EU as
well as the widespread deployment of telemedicine by 2020. To reach these objectives,
the eHealth Network, which is composed of Member States’ representatives, will coop-
erate to ensure wider use of eHealth including EU wide interoperability of electronic
patient summaries.
1
Corresponding Author.
vi
Yet regardless of increasing evidence of the benefits technology can bring, the
healthcare sector has been hesitant to embrace the digital revolution. Instead, it has
stuck to its traditional methods and models.
2. A New eHealth Action Plan
In this context, the Commission launched a new eHealth Action Plan on 6 December
2012, which will provide a roadmap for 2012–2020 and is designed to bring the bene-
fits of digital solutions into healthcare systems and lift the barriers that are preventing
Europe from providing smarter, safer, patient-centred health services. It will also sup-
port Member States in bringing forward interoperable eHealth services within and be-
tween national healthcare systems.
In practical terms the eHealth Action Plan contains actions to give patients and key
healthcare workers in the field, such as nurses, carers and doctors, the skills and confi-
dence to use these new technologies, thus leading to more meaningful time between
doctors and patients and less unnecessary appointments, thanks to the better use,
among others, of ePrescription and telemonitoring. For patients, this means spending
less time, effort and money on unnecessary hospital or GP visits while allowing them
to take a more pro-active role in the management of their health. The plan also focuses
on:
• Linking up the devices and technologies so that they can communicate with
each other and spread the benefits of digital healthcare throughout the system,
thus avoiding waste and repetition;
• Investing in research towards the personalised medicine of the future, so that
future generations can benefit from even more patient-centric care;
• Giving small businesses a helping hand when starting up on this complex
landscape by providing funding opportunities and visibility;
• Providing clarity where there is legal uncertainty: this is particularly the case
for new technologies such as apps where issues such as safety, quality and
transparency remain grey areas.
Health apps could prove to be an enormously important tool to promote consumer
and patient empowerment and self-care. They represent an important technological tool
to help inform and support patients and consumers in the self-management of their
health. They bring valuable health information to our fingertips. The best of these apps
enable us to act swiftly and decisively on self-care issues.
But as more and more citizens start to compile and to take control of their own
health data using apps and other devices it is essential to ensure user confidence in the-
se services and establish appropriate safeguards. Effective data protection is vital for
building trust in eHealth, in particular in respect to the use of cloud computing infra-
structures and services for health and wellbeing data processing.
Ethical issues need to be built into eHealth solutions, ranging from apps to remote
monitoring, utilising a user-centric and user-driven innovation process. The ethical
considerations that should be observed or taken into account in this domain can be de-
duced from binding instruments like the Charter of Fundamental Rights and the Con-
vention on Human Rights and Biomedicine, as well as from opinions such as those of
national ethics committees and the European Group on Ethics. The European Group on
vii
Ethics issued an Opinion in 1999 on the ethics of healthcare in the Information Society,
emphasising the principles of privacy, confidentiality, “legitimate purpose”, consent,
security, transparency, participation, and education. It is one of the points of guidance
that has stood the test of time and is still relevant for those developing or deploying
new technologies today. We intend to discuss issues in ethics, the law, data protection,
and the internal market relevant to eHealth innovation at the eHealth Ministerial and
Week in Dublin in 2013 and hope to engage with stakeholders.
The Action Plan provides a new focus on mobile health (mHealth). Building on the
recommendations of the eHealth Task Force, the Commission will examine a range of
issues, including quality and transparency, in this fast-moving and developing area.
To increase further legal clarity and support the wider deployment of eHealth, the
plan is supported by a legal overview of how current EU legislation applies to cross
border telemedicine. This overview takes the form of a Staff Working Paper, which
provides responses to the main issues a healthcare practitioner would face when seek-
ing to provide telemedicine services across-border:
• Does s/he also need to be licensed/registered in the Member State of the pa-
tient?
• What are the conditions for the legitimate processing of health data?
• Will the telemedicine act be reimbursed?
• What is the liability regime applicable in case damage arises as well as what
are the relevant jurisdiction and law?
This Action Plan marks above all a commitment to change in order to better target
the challenges Europe is increasingly facing. This need to change is already reflected in
the European Innovation Partnership on Active and Healthy Ageing as 3000 stakehold-
ers have committed to improve the quality of life of 4 million European senior citizens
between now and 2015. This includes 20 regions of Europe which will deploy
telemonitoring programmes for chronic disease management and integrated care that
meet the needs of older persons and enhance system efficiency.
To do this, they are learning from the experience of others and adapting it to their
own circumstances. This means that they can save time and money and avoid making
expensive mistakes. As a result, thousands of people with chronic conditions and multi-
morbidity (but also their carers) will not have to travel back and forth between doctors,
hospitals and care institutions and will be able to monitor and self-manage their own
condition and health care choices.
This grass roots approach shows that even in a time of crisis, we can make smart
investments towards a sustainable future. It is our responsibility to take the changes to
the next level for the benefit of today’s citizens and future generations.
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ix
Summary
Helpful technology enters every sector of our private life, our home or even our clothes.
Data streams of our personal behaviour originate from cars and from our gym trainers.
Sensors monitor our body temperature in airports and urine parameters in the toilette.
There are uncountable ways to monitor personal health and hundreds of approaches to
use systems and data for this purpose.
This book is addressing the ethical aspects of personal health monitoring from an
interdisciplinary perspective. It is based on the European project “PHM-Ethics”, a pro-
ject conducting interdisciplinary analyses of emerging Personal Health Monitoring
(PHM) applications. Thus, the primary intention of this volume is to present the out-
comes of the PHM-Ethics project. Moreover, several invited contributions had been
added to broaden the scope on PHM, covering aspects of PHM that are strongly related
to those questions investigated within the PHM-Ethics project.
As Pēteris Zilgalvis and Céline Deswarte point out in their foreword to this volume,
the outcomes of the PHM-Ethics project are strongly associated with a new eHealth
Action Plan currently launched by the European Commission in December 2012,
“which will provide a roadmap for 2012–2020 and is designed to bring the benefits of
digital solutions into healthcare systems”.
The Project “PHM-Ethics”
The aim of the collaborative PHM-Ethics research project has been to conduct scien-
tific interdisciplinary research to analyse the dependencies between ethical, legal and
psychosocial aspects of Personal Health Monitoring (PHM) in relation to the major
types and steps of this very dynamic part of IT-development from a European perspec-
tive. An integrated European approach to the assessment of ethical, legal and psycho-
social issues in PHM applications has been developed.
The coordinating centre of the PHM-Ethics Consortium was located on the Uni-
versity of Greifswald in Germany and had its project partners at the Centre for Applied
Ethics at the Linköping University in Sweden, the Centre for Computing and Social
Responsibility at the De Montfort University in Great Britain, Callens Law Firm in
Brussels in Belgium as well as the Institute of Medical Informatics at the University
Medical Center of Göttingen in Germany and the International Ethics Office (IN-
SERM) in France as well as the Institute of Ethics of the University of Utrecht in the
Netherlands.
Introduction to PHM
The first chapter of the book provides an introduction to Personal Health Monitoring as
well as an overview on the PHM-Ethics project and its outcomes.
Otto Rienhoff from the University Medical Center Göttingen (Germany), partner
of the international PHM-Ethics project, describes the historical roots of monitoring in
x
health care in his contribution “From Intensive Care Monitoring to Personal Health
Monitoring to Ambient Intelligence”. It shows that since the 1970ies monitoring has
been spreading in more and more domains of health and even public health. Today one
can observe a ubiquitous monitoring of persons in many environments and regarding
widely different questions. It also emphasises why ethical and data protection questions
are an absolute must in most monitoring activities today.
Following that, Silke Schmidt from the University of Greifswald (Germany) as
well as Marcel Verweij from the University of Utrecht (Netherlands) briefly introduce
the PHM-Ethics project and the PHM methodology. Within the PHM-Ethics project, a
set of tools and modules had been developed that may assist in the assessment and
evaluation of new technologies for personal health monitoring, referred to as “PHM
methodology” or “PHM toolbox”. An overview on this interdisciplinary methodology
and its comprising modules is provided, areas of application and intended target groups
are indicated.
Perspectives on PHM
In their “Technical Literature Review” Gunnar Nußbeck and Murat Gök from the Uni-
versity Medical Center Göttingen (Germany) give a comprehensive overview on the
technical perspective of PHM. The increasing number of publications that are pub-
lished per year shows that the field of PHM is of growing interest in the research com-
munity. Most publications deal with telemonitoring, thus forming the core technologi-
cal application in this field. It also provides an outlook on information and communica-
tion technology that foster the integration possibilities of PHM into decision making
and remote monitoring of individual people’s health.
Holger Muehlan and Silke Schmidt from the Department of Health and Prevention
at the University of Greifswald (Germany) coordinated the international PHM-Ethics
project. They provide a descriptive literature review of psycho-social aspects of PHM.
Both core questions addressed within this review are: What is the impact of PHM on
intended psycho-social and health-related outcomes? And which psycho-social issues
affected by or related to PHM have already been investigated?
Stefaan Callens and Adrien Galot from Callens Law Firm (Belgium) as well as
Eugenia Lamas from the French National Institute of Health and Medical Research
(INSERM) located in Paris (France) give an insight into legal aspects of PHM in their
contribution. Firstly, it analyses the short term actions that are needed at the European
level to allow PHM in respect of the interests and rights of patients such as the need to
have more harmonised medical liability rules at the level of the European Union. Intro-
ducing PHM also implies legal actions at the level of the European Union on the long
run, which are related to e.g. the way in which hospitals are organised in their relation
with healthcare professionals and with other hospitals or healthcare actors. Finally,
health monitoring projects may change the traditional (non-)relationship between pa-
tients and pharmaceutical/medical device industry and may require new legal rules.
Assessment of PHM
PHM-Ethics project partners Murat Gök, Xia Teng, Gunnar Nußbeck and Otto Rien-
hoff from the University Medical Center Göttingen (Germany) present a taxonomy of
xi
PHM. It is needed in order to provide a systematic basis for communication in trans-

disciplinary research projects. The taxonomy is based on a systematic literature review
and an iterative adaption process with transdisciplinary partners.
The contribution from Simon Rogerson, Sara Wilford and Ben Fairweather from
the DeMontfort University in Leicester (England) discusses the research undertaken in
developing a comprehensive dependencies map for PHM applications. Included is a
discussion of the underlying research approach adopted and how this was operational-
ized. A new dependencies mapping method has been developed and is hence described
in detail. Illustrations of the derived tools are given using the PHM analysis undertaken.
A summary of the analysis outcomes and the resulting recommendations are discussed.
The chapter concludes with some suggestions of ways in which this type of data set can
be used in practice to deliver fit-for-purpose PHM systems.
Holger Muehlan, Dieter Rhode and Silke Schmidt from the University of Greif-
swald (Germany) introduce a psycho-social module for health technology assessment
on PHM applications. It covers important aspects that should be taken into account for
conducting a health technology assessment from a psycho-social perspective. As it
could be used in addition to other tools within the PHM-Ethics approach it is consid-
ered as a module of the interdisciplinary methodology.
Elin Palm, Anders Nordgren, Marcel Verweij as well as Göran Collste are re-
searchers from Linköping University (Sweden) and Utrecht University (Netherlands).
Starting out from a social constructivist theory of technology, an interactive ethical
assessment-model is offered in their contribution. The suggested model supplements a
traditional analysis based on normative ethical theory (top-down approach) with inter-
views including relevant stakeholders (bottom-up approach).
Broadened Perspectives on PHM
Chapter four extends the perspectives on Personal Health Monitoring, starting with
“PHM-Ethics and ETICA: Complementary Approaches to Ethical Assessment” written
by Brent Mittelstadt, Bernd Stahl and Ben Fairweather from De Montfort University in
Leicester (England), who had conducted the PHM-Ethics “sister” project “ETICA”. A
comparison is undertaken, which concerns different approaches to the ethical assess-
ment of novel technologies by looking at both research projects – PHM Ethics and
ETICA. The aims, methods, outcomes and recommendations of ETICA are compared
to those of PHM-Ethics, with identification of linkages and similar findings.
According to Irene Maucher and Wolfgang Weyand from T-Systems International,
developing and implementing PHM systems require a different approach than typical
application development processes. Based on a practical example, it is described how
ethical and legal aspects will be considered during the development process. The result
is cohesion and adoption of different methods with defined interaction points to reiter-
ate the solution design by legal and ethical aspects.
Thomas Norgall and Reiner Wichert from the Fraunhofer Ambient Assisted Living
Alliance in Darmstadt in Germany consider the personalised use of information and
communications technology (ICT), describe concepts from telemonitoring to ambient
assisted living and discuss users’ needs.
xiii
Résumé
Les technologies innovantes dérivées des champs de l’information et de la
communication se retrouvent dans tous les domaines de notre vie privée, dans notre
maison et même dans nos vêtements. Le flux de données sur notre comportement
personnel est obtenu à la fois à partir des appareils dans nos voitures et des activités
d’entraînement sportif. Les capteurs de la température de notre corps dans les aéroports
et les paramètres sur l’urine dans les toilettes. Il y des nombreuses façons de mettre en
œuvre le monitoring personnalisé en santé et une centaine d’approches pour
l’utilisation des systèmes et de données à ce propos.
Cet ouvrage traite les aspects éthiques du monitoring personnalisé en santé. Il est
basé sur un projet européen intitulé « PHM-Ethics » dont l’objectif a été de réaliser une
analyse interdisciplinaire sur les applications dérivées du monitoring personnalisé en
santé. Dans ce contexte, le premier but de ce livre est de présenter les résultats obtenus
au cours de ce projet PHMethics. De plus, plusieurs personnes ont été invités à
participer et leurs contributions ont été incluses dans ce livre et ceci afin d’élargir les
descriptions de domaines d’application du monitoring personnalisé en santé. Elles
recouvrent des aspects du PHM fortement liés aux questions étudiées au cours du projet
PHMethics.
Ainsi, Petris Zilgavis et Céline Deswarte soulignent dans la préface de cet ouvrage
que les résultats obtenus dans le cadre du projet PHMethics sont grandement associés
au nouvel e-Santé Plan D’action qui a été lancé par la Commission Européenne en
Décembre 2012, “lequel fourni la feuille de route pour 2012–2020 et il a été conçu ten-
ant compte de tous les bénéfices apportés par les solutions numériques dans les
systèmes de santé”.
Le projet PHMethics
Le but du projet de recherche PHMethics a été d’entreprendre une recherche

interdisciplinaire pour analyser les relations entre l’éthique, le droit et les sciences
psychosociales dans le PHMethics. Et ceci en relation aux différents types et diverses
étapes dans système très dynamique du développement de technologies de
l’information et de la communication dans une perspective européenne. Une approche
européenne intégrée a été développé pour évaluer les enjeux éthico-légaux et
psychosociaux soulevés par les applications du PHMethics.
Le coordinateur du Consortium PHMethics a été l’Université de Greinwvald en
Allemagne et les partenaires du projet sont : Centre d’éthique appliquée de l’Université
de Linköping en Suède, le Centre d’informatique et responsabilité sociale à
l’Université de Montfort au Royaume Uni, le Cabinet d’avocats Callens à Bruxelles en
Belgique, l’Institut d’informatique médicale à l’université de Göttingen en Allemagne
et l’Institut nationale de la santé et de la recherche médicale à Paris en France et
l’Institut d’éthique de l’Université d’Utrecht au Pays Bas.
xiv
Introduction au PHM
Le premier chapitre comprend une introduction du monitoring personnalisé en santé et

les objectifs et résultats du projet PHMethics.
Otto Rienhoff de Université Médical Center Göttingen (Germany), partenaire du
projet PHM-Ethics décrit les racines historiques du monitoring personnalisé en santé
dans “From Intensive Care Monitoring to Personal Health Monitoring to Ambient In-
telligence”. Il montre que depuis les années 70 le monitoring personnalisé s’est répandu
de plus en plus dans le domaine de la santé y compris dans le champ de la santé
publique. Aujourd’hui, on observe le monitoring des personnes présentent dans
différents environnements et traitant des questions très différentes. Il décrit quel sont
les raisons pour lesquelles la plupart des activités de monitoring soulèvent de nouveaux
enjeux d’éthiques tel que, par exemple, la question de la protection de données de santé.
Ensuite, Silke Schmidt de l’Université de Greifswald (Allemagne) et Marcel
Verweij de l’Université de Utrecht (Pays Bas) présentement brièvement le projet
PHMethics et la méthodologie utilisée. Ainsi, une série d’outils et modules ont été
développés afin de réaliser une évaluation des nouvelles technologies pour le monitor-
ing personnalisé en santé. Ils sont intitulés “PHM méthodologie” ou PHM boîte à outils.
Une vue d’ensemble de cette méthodologie interdisciplinaire et ses modules sont
présentés. Sont indiqués également les domaines d’application et les groupes cibles.
Perspectives du PHM
Dans la “Revue de Littérature Technique” Gunnar Nußbeck et Murat Gök du Centre

médical de l’Université de Göttingen (Allemagne) passent en revue l’ensemble tous les
aspects techniques du PHM. L’augmentation importante en termes de publications par
année dans ce domaine montre l’intérêt grandissant de la communauté scientifique dans
ce domaine. La plupart des ces publications concernent le telemonitoring, elles forment
ainsi le cœur des applications technologiques dans ce domaine. Ils incluent une per-
spective sur l’information et communication de ce type de technologique laquelle
renforce les possibilités d’intégration du PHM dans l’aide à la décision médicale et au
monitoring de santé individuel à distance.
Holger Muehlan, Dieter Rhode et Silke Schmidt du Département de Santé et
Prévention de l’Université de Greifswald (Allemagne) coordinateur du projet PHM-
ethics. Ils présentent une revue descriptive de la littérature sur les aspects
psychosociaux du PHM. Ils tentent de répondre aux questions suivantes : Quel es
l’impact du PHM sur les expectatives en termes de la santé (amélioration de la qualité
des soins) et des aspects psychosociaux? Quels sont les enjeux psychosociaux en
relation avec les PHM qui ont été déjà étudiés?
Stefaan Callens, Adrien Galot de Callens Law Firm (Belgique) et Eugenia Lamas
de l’Institut national de santé et recherche médicale (INSERM) à Paris (France)
présentent les aspects légaux soulevés par le PHM. D’abord, ils analysent quelles sont
les actions à court terme nécessaires pour permettre que le monitoring personnalisé se
réalise dans le respect d’intérêts et de droits de patients comme par exemple, mettre en
place une harmonisation de régulations de responsabilité médicale au niveau de
l’Union Européenne. Puis, ils décrivent quelles sont les implications légales quant à
l’introduction du PHM dans le cadre de l’institution hospitalière et leur organisation
interne avec le personnel de santé et toutes les parties prenantes. Finalement, ils
xv
soulèvent le changement qui entraîne le PHM dans la relation traditionnelle entre les
patients et l’industrie pharmaceutique/médicale qui fabrique les dispositifs. Ce nouveau
changement nécessite des nouvelles règles juridiques.
Evaluation du PHM
Les partenaires du projet PHM-Ethics Murat Gök, Xia Teng, Gunnar Nußbeck and
Otto Rienhoff du centre médical de l’Université de Göttingen (Allemagne)
présentement la taxonomie du PHM laquelle est indispensable pour établir de bases
systématiques pour la communication dans les projets de recherche transdisciplinaires.
La taxonomie est basée à la fois sur une recherche systématique de la littérature et un
modèle d’analyse d’approche systémique réalisée avec nos partenaires.
La contribution de Simon Rogerson, Sara Wilford et Ben Fairweather de
l’Université de DeMontfort à Leicester (Royaume Uni) porte sur la recherche qu’ils
sont développée d’une carte comprenant toutes les relations de dépendance des
applications du PHM. Ils décrivent l’approche méthodologique utilisée pour cette re-
cherche et la façon de comment elle est opérationnelle. Des illustrations des outils
dérivés de cette recherche sont montrées. Un résumé a été également élaboré avec les
principaux résultats et un certain nombre de recommandations sur les différents
chemins possibles pour l’utilisation de set de données pour qu’elles soient adaptées à
l'usage prévu.
Holger Muehlan, Dieter Rhode et Silke Schmidt de l’Université de Greifswald
(Allemagne) introduisent un module psychosocial afin dévaluer les applications du
PHM dans le domaine de la santé. Ce travail recouvre des aspects qu’il faut tenir
compte pour réaliser une évaluation technologique à partir d’une perspective
psychosociale. Ce module peut être utilisé en plus d’autres outils qui ont été élaboré
dans cette méthodo-logie interdisciplinaire.
Elin Palm, Anders Nordgren, Göran Collste et Marcel Verweij des chercheurs de
l’Université de Linköping (Suède) et de l’Université Utrecht (Pays Bas) partenaires du
projet PHMethics. Ils sont construit un modèle interactif d’éthique d’évaluation à partir
de la théorie sociale constructiviste pour les technologies. Cette approche est
complémentaire de l’analyse traditionnelle basée sur la théorie d’éthique normative
(top-down approach). Des entretiens à des parties prenantes ont été réalisés dans le
cadre de cette approche (bottom-up approach).
Perspectives élargies sur le PHM
Dans le quatrième chapitre les perspectives élargies du PHM sont abordées. Cela com-
mence par la description d’une approche complémentaire de l’évaluation éthique à
partir de deux projets de recherche : PHMethics et ETICA écrit par Brent Mittelstadt,
Bernard Stahl et Ben Fairweather de l’Université DeMontfort, partenaires du projet
ETICA. Une étude comparative de l’évaluation éthique de ces nouvelles technologies a
été entreprise sur les deux approches utilisées dans ces deux projets.
Selon Irene Maucher et Wolfgang Weyand de l’enterprise T-Systems International,
ce travail rend compte des similarités et des divergences de résultats entre ces deux
projets. En effet, le développement des systèmes du PHM nécessite des approches
xvi
complémentaires. Des aspects éthiques et légaux du PHM ont été décrits à partir des
exemples concrets.
Thomas Norgall et Reiner Wichert de Fraunhofer Ambient Assisted Living Alli-
ance in Darmstadten en Allemagne décrivent les concepts impliqués dans le
telemonitoring dans le domaine de l’assistance à l’autonomie à domicile et les besoins
des usagers.
xvii
Zusammenfassung
Assistive Technologien dringen in jeden Bereich unseres Privatlebens vor, in unser
Zuhause, selbst in unsere Kleidung. Datenströme unseres persönlichen Verhaltens
kommen aus unseren Autos und von unseren Fitnesstrainern. Sensoren überwachen
unsere Körpertemperatur an Flughäfen und messen Urinparameter in der Toilette. Es
gibt unzählige Wege die persönliche Gesundheit zu kontrollieren und Hunderte von
Ansätzen, Systeme und Daten dafür zu nutzen.
Das vorliegende Buch thematisiert ethische Aspekte von Personal Health
Monitoring aus interdisziplinärer Perspektive. Es basiert auf dem europäischen Projekt
„PHM-Ethics“, das interdisziplinäre Analysen zu neuen Anwendungen im Bereich des
Personal Health Monitoring (PHM) durchgeführt hat. Daher besteht die Hauptintention
dieses Buches darin, die Ergebnisse des PHM-Ethics-Projektes zu präsentieren. Um
den Blick auf PHM zu erweitern, wurden einige eingeladene Beiträge hinzugefügt, die
Aspekte von PHM behandeln, die in engem Zusammenhang mit jenen Fragestellungen
stehen, die im Rahmen des PHM-Ethics-Projektes untersucht wurden.
Pēteris Zilgalvis und Céline Deswarte weisen in ihrem Vorwort zu diesem Buch
darauf hin, dass die Ergebnisse des PHM-Ethics-Projektes stark mit einem neuen
„eHealth Action Plan“ der Europäischen Kommission assoziiert sind. Dieser wurde
im Dezember 2012 präsentiert, „stellt einen Fahrplan für 2012 bis 2020 bereit
und wurde dafür gestaltet, die Vorteile digitaler Lösungen in die Systeme der
Gesundheitsversorgung zu bringen“.
Das Projekt „PHM-Ethics“
Das Ziel des europäischen Verbund-Projektes „PHM-Ethics“ bestand darin,

interdisziplinäre Forschung durchzuführen um die Zusammenhänge zwischen Ethik,
Recht und psychosozialen Wissenschaften im Hinblick auf Personal Health Monitoring
(PHM) zu analysieren und dies – aus europäischer Perspektive – in Relation zu den
wesentlichen Typen und Schritten dieses äußerst dynamischen Bereichs der IT-
Entwicklung zu bringen. Entwickelt wurde ein integrierter europäischer Ansatz zur
Beurteilung ethischer, rechtlicher und psychosozialer Aspekte im Hinblick auf PHM-
Anwendungen.
Das Koordinationszentrum des Konsortiums von „PHM-Ethics“ war an der
Universität von Greifswald in Deutschland verortet und hatte seine Projektpartner am
Zentrum für Angewandte Ethik an der Linköping Universität in Schweden, am
Zentrum für „Computing and Social Responsibility“ an der DeMontfort Universität
in Großbritannien, der Anwaltskanzlei von Stefaan Callens in Brüssel (Belgien),
am Institut für Medizinische Informatik der Universitätsmedizin Göttingen in
Deutschland, am Nationalinstitut für Gesundheit und medizinische Forschung
(INSERM) in Paris (Frankreich) sowie am Ethik-Institut der Universität von Utrecht in
den Niederlanden.
xviii
Vorstellung von PHM
Das erste Kapitel des Buches gibt eine Einführung zu Personal Health Monitoring
sowie einen Überblick zum PHM-Ethics-Projekt und der Projekt-Ergebnisse.
Otto Rienhoff vom Universitätsklinikum Göttingen (Deutschland) beschreibt die
historischen Wurzeln des Monitorings im Gesundheitswesen in seinem Beitrag “From
Intensive Care Monitoring to Personal Health Monitoring to Ambient Intelligence”. Es
zeigt sich, dass sich Monitoring-Anwendungen seit den 1970ern in immer mehr
Gesundheitsbereichen und auch der öffentlichen Gesundheit ausgebreitet haben.
Heutzutage kann man allgegenwärtiges Monitoring von Personen in vielen
Umgebungen und hinsichtlich sehr unterschiedlicher Fragestellungen beobachten.
Zudem hebt der Beitrag hervor, warum heutzutage die Auseinandersetzung mit
ethischen Fragestellungen und dem Thema Datenschutz bei den meisten Monitoring-
Anwendungen unverzichtbar ist.
Daran anknüpfend stellen Silke Schmidt von der Universität Greifswald
(Deutschland) und Marcel Verweij von der Universität Utrecht (Niederlande) das
PHM-Ethics-Projekt und die PHM-Methodologie kurz vor. Innerhalb des PHM-Ethics-
Projektes wurde eine Reihe von Instrumenten und Modulen entwickelt, die die
Beurteilung und Evaluation neuer Technologien des Personal Health Monitorings
unterstützen können und als „PHM Methodologie“ oder „PHM Toolbox“ bezeichnet
werden. Ein Überblick dieser interdisziplinären Methodologie und der integrierten
Module wird gegeben und auf Anwendungsbereiche und intendierte Zielgruppen
hingewiesen.
Perspektiven auf PHM
In ihrem „Technical Literature Review“ geben Gunnar Nußbeck und Murat Gök vom
Universitätsklinikum Göttingen (Deutschland) einen umfassenden Überblick zu PHM
aus technischer Perspektive. Die steigende Zahl der jährlichen Veröffentlichungen
zeigt, dass der Bereich von PHM wachsendes Interesse in der Forschungsgemeinschaft
erfährt. Die meisten Publikationen beschäftigen sich mit Telemonitoring, was damit die
zentrale technologische Anwendung in diesem Bereich repräsentiert. Außerdem gibt
der Beitrag einen Ausblick auf solche Informations- und Kommunikationstechnologien,
welche die Integrationsmöglichkeiten von PHM für die Entscheidungsfindung und das
Gesundheitsmonitoring von Individuen aus der Distanz voranbringen.
Holger Muehlan und Silke Schmidt vom Lehrstuhl für Gesundheit und Prävention
der Universität Greifswald (Deutschland) koordinierten das internationale PHM-Ethics-
Projekt. In dem Beitrag stellen die Autor/innen einen deskriptiven Literaturüberblick zu
den psychosozialen Aspekten von PHM bereit. Darin werden folgende beiden zentralen
Fragenstellungen thematisiert: Welchen Einfluss hat PHM auf die intendierten
psychosozialen und gesundheitsbezogenen Zielkriterien? Und: Welche psychosozialen
Probleme, die durch PHM beeinflusst werden oder damit in Beziehung stehen, wurden
bisher untersucht?
Der Beitrag von Stefaan Callens und Adrien Galot von der Anwaltskanzlei Callens
aus Brüssel (Belgien) sowie von Eugenia Lamas vom französischen Nationalinstitut für
Gesundheit und medizinische Forschung (INSERM) in Paris (Frankreich) gibt einen
Einblick in rechtliche Aspekte von PHM-Anwendungen. Zunächst analysieren die
xix
Autoren die kurzfristigen Aktivitäten, die auf europäischer Ebene nötig sind, um die
Interessen und Rechte der Patienten im Hinblick auf Anwendungen des Personal
Health Monitoring zu gewähren, wie z.B. das Bedürfnis nach einheitlichen
medizinischen Haftungsrichtlinien auf der Ebene der Europäischen Union. Die
Einführung von PHM-Anwendungen impliziert zudem rechtliche Aktivitäten auf
Ebene der Europäischen Union in langfristiger Perspektive, was z.B. in Verbindung
damit steht wie Krankenhäuser in ihrer Beziehung zu medizinischem Personal, anderen
Krankenhäusern oder sonstigen Akteuren im Gesundheitswesen organisiert sind.
Schließlich könnten Gesundheitsmonitoring-Projekte die traditionelle (Nicht)-
Beziehung zwischen Patienten und der pharmazeutischen/medizinischen
Geräteindustrie verändern und neue rechtliche Richtlinien erforderlich machen.
Beurteilung von PHM
Die PHM-Ethics-Projektpartner Murat Gök, Xia Teng, Gunnar Nußbeck und Otto
Rienhoff vom Universitätsklinikum Göttingen (Deutschland) präsentieren eine
Taxonomie von PHM. Diese ist notwendig, um eine strukturierte Grundlage für die
Kommunikation in transdisziplinären Forschungsprojekten zu schaffen. Die
Taxonomie basiert auf einem systematischen Literaturüberblick und einem iterativen
Adaptionsprozess mit Forschungspartnern aus unterschiedlichen Disziplinen.
Der von Simon Rogerson, Sara Wilford und Ben Fairweather von der DeMontford
Universität in Leicester (England) verfasste Beitrag präsentiert die Forschungsarbeit
zur Entwicklung einer umfassenden „Dependencies Map“ für PHM-Anwendungen.
Eine neue Methode zur Darstellung von Abhängigkeiten bei PHM-Anwendungen
wurde entwickelt und wird im Detail beschrieben. Illustrationen zu dem neuen
Instrument werden unter Einbezug einer PHM-Anwendungsanalyse präsentiert. Die
Zusammenfassung der Analyseergebnisse sowie die resultierenden Empfehlungen
werden diskutiert. Der Beitrag schließt mit einigen Vorschlägen für Ansätze, wie diese
Daten praktisch genutzt werden können, um zweckdienliche PHM-Systeme zu
entwickeln.
Holger Muehlan, Dieter Rhode und Silke Schmidt von der Universität Greifswald
(Deutschland) stellen ein psychosoziales Modul für die Technikfolgenbeurteilung
(„Health Technology Assessment“) von PHM-Anwendungen vor. Es deckt wichtige
Aspekte ab, die bei der Durchführung von Technikfolgenabschätzungen aus
psychosozialer Sicht beachtet werden sollten. Da es ergänzend zu anderen
Instrumenten im Rahmen des PHM-Ethics-Ansatzes angewendet werden kann, ist
dieses Instrument als ein Modul der interdisziplinären Methodologie zu verstehen.
Elin Palm, Anders Nordgren, Marcel Verweij sowie Göran Collste, Forscher von
der Linköping Universität (Schweden) und der Utrecht Universität (Niederlande),
waren ebenfalls Partner des PHM-Ethics-Projektes. Ausgehend von einer sozial-
konstruktivistischen Perspektive auf Technologie stellen sie in ihrem Beitrag ein
interaktives ethisches Bewertungsmodell vor. Das vorgeschlagene Modell ergänzt
die auf der normativ-ethischen Theorie basierende traditionelle Analyse (top-down
Herangehensweise) um Interviews mit den relevanten Akteuren und
Entscheidungsträgern (bottom-up Herangehensweise).
xx
Erweiterte Perspektiven auf PHM
Kapitel vier erweitert die Perspektiven auf Personal Health Monitoring, beginnend mit
dem Beitrag “PHM-Ethics and ETICA: Complementary Approaches to Ethical
Assessment”, verfasst von Brent Mittelstadt, Bernd Stahl und Ben Fairweather von der
DeMontfort Universität in Leicester (England), die das PHM-Ethics-Schwesterprojekt
„ETICA“ koordiniert hatten. Für den vorliegenden Beitrag wurde ein Vergleich der
verschiedenen Ansätze zur ethischen Beurteilung neuartiger Technologien
durchgeführt, unter Betrachtung der beiden Forschungsprojekte PHM-Ethics und
ETICA. Die Ziele, Methoden, Ergebnisse und Empfehlungen von ETICA wurden mit
denen von PHM-Ethics verglichen, wobei Verbindungen und ähnliche Befunde
identifiziert werden konnten.
Nach Irene Maucher und Wolfgang Weyand von T-Systems International GmbH
erfordert die Entwicklung und Implementierung von PHM-Systemen einen anderen
Ansatz als typische Prozesse sonstiger Anwendungsentwicklungen. Anhand eines
praktischen Beispiels wird beschrieben, wie ethische und rechtliche Aspekte im
Entwicklungsprozess berücksichtigt werden. Das Ergebnis ist die Zusammenführung
und Anpassung unterschiedlicher Methoden durch definierte Interaktionspunkte zur
iterativen Entwicklung des finalen Designs unter Berücksichtigung ethischer und
rechtlicher Aspekte.
Thomas Norgall und Reiner Wichert von der Fraunhofer Ambient Assisted Living
Alliance in Darmstadt (Deutschland) betrachten den personalisierten Gebrauch von
Informations- und Kommunikationstechnologien (ICT), beschreiben unterschiedliche
Konzepte von Telemonitoring bis zu Ambient Assisted Living und diskutieren die
Bedürfnisse der Anwender.
xxi
Contents
Foreword v
Pēteris Zilgalvis and Céline Deswarte
Summary ix
Résumé xiii
Zusammenfassung xvii
I. Introduction to Personal Health Monitoring
From Intensive Care Monitoring to Personal Health Monitoring to Ambient

Intelligence 3
Otto Rienhoff
The PHM-Ethics Methodology: Interdisciplinary Technology Assessment
of Personal Health Monitoring 13
Silke Schmidt and Marcel Verweij
II. Perspectives on Personal Health Monitoring
Technical Literature Review 23

Gunnar Nußbeck and Murat Gök
Psycho-Social Aspects of Personal Health Monitoring: A Descriptive Literature
Review 41
Holger Muehlan and Silke Schmidt
Legal Aspects of Personal Health Monitoring 55
Stefaan Callens, Adrien Galot and Eugenia Lamas
III. Assessment of Personal Health Monitoring
Setting the Scene: Taxonomy of Personal Health Monitoring 67

Murat Gök, Xia Teng, Gunnar Nußbeck and Otto Rienhoff
A Dependencies Mapping Method for Personal Health Monitoring 79
Simon Rogerson, Sara Wilford and Ben Fairweather
A Module for Psycho-Social Assessment of Personal Health Monitoring 95
Holger Muehlan, Dieter Rhode and Silke Schmidt
Ethically Sound Technology? Guidelines for Interactive Ethical Assessment
of Personal Health Monitoring 105
Elin Palm, Anders Nordgren, Marcel Verweij and Göran Collste
xxii
IV. Broadened Perspectives on Personal Health Monitoring
PHM-Ethics and ETICA: Complementary Approaches to Ethical Assessment 117

Brent Mittelstadt, Bernd Stahl and Ben Fairweather
Development of a Personal Health Monitoring System – The IT-Systems
Industry View 137
Irene Maucher and Wolfgang Weyand
Personalized Use of ICT – From Telemonitoring to Ambient Assisted Living 145
Thomas Norgall and Reiner Wichert
Appendix
About the Editors 155

List of Authors 159
Subject Index 163
Author Index 165
I
Introduction to Personal Health Monitoring
Interdisciplinary Assessment of Personal Health Monitoring 3
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-3
From Intensive Care Monitoring

to Personal Health Monitoring
to Ambient Intelligence
Otto RIENHOFF
Institute of Medical Informatics,
Göttingen University Medical Center
Abstract. The historical roots of IT-based monitoring in health care are described.
Since the 1970ies monitoring has been spreading to more and more domains of
health care and public health. Today one can observe monitoring of persons in
many environments and regarding widely different questions. While these
monitoring applications have been introduced ethical questions have been raised to
balance the possible positive and negative outcomes of the approaches. Today IT-
technology is entering many parts of our life – IT eventually became what had
been coined already in the last century by IBM as “electronic dust” which one can
find in every part of our environment. As most of these “dust-particles” are able to
observe something one can also understand this development as a development
into ubiquitous monitoring of nearly everything at any time. The foreseen ambient
intelligence worlds are also spaces of ambient monitoring. This article describes
this historical development. It emphasizes why ethical and data protection
questions are an absolute must in most IT activities today.
Keywords. Intensive care systems, monitoring, monitoring devices, ubiquitous

monitoring, ambient intelligence, ethics, privacy
1. Roots of Monitoring Physiological Parameters
Surgery fought for generations against shock, infections, and pain. Its major
breakthroughs were only possible after these non-surgical problems could be handled.
Shock stood for the collapse of circulation due to different reasons one of which was an
acute bleeding after operation. The latter could be handled if noticed instantly. In the
1960ies heart operations became more daring year by year. In 1967 Christian Barnard
managed the first heart transplantation at Groote Schuur Hospital in Cape Town. In the
1970ies progress in surgery depended more and more on how well postoperative
monitoring of critical parameters could be performed. At that time, computers in
medicine were at the end of their second decade of development and a new generation
of systems allowed local monitoring of physiological parameters with small non-
mainframe-machines. In the midst of the seventies Francis Robicsek from Charlotte,
North Carolina, developed and published the first “closed loop monitoring system”.
This type of system – in contrast to the plain monitoring systems which controlled
heart and lung functions – measured the complete fluid balance and decided by itself on
whether to apply more fluid or even drugs for circulation management. The system was
also imported to Europe by an Israelian company who marketed it as an advanced
4 O. Rienhoff / From Intensive Care Monitoring to Personal Health Monitoring to Ambient Intelligence
monitoring system. In Germany the Medical Schools in Düsseldorf and Hannover

bought it and ran it for several decades.
This type of monitoring systems gained ethical interest: the closed loop systems
made interventions (actions) on patients possible without human decision. Closed-loop-
monitoring systems never reached a general breakthrough as they could not prove to be
substantially better than other systems – instead open-loop medical monitoring systems
became more and more sophisticated and entered every niche of medical treatment –
just telemonitoring and training systems for incontinent persons shall be mentioned.
The seventies also were the decade during which data protection laws made their way
into the legislations of many industrialized countries following the Swedish example.
Thus more than 30 years ago – one generation – ethical boundaries of monitoring were
theoretically and legally apparent and had to be considered in designing, developing,
running, and maintaining such technology. Monitoring systems have never left the
sphere of skeptical ethical considerations.
2. Definitions
“Monitoring systems” in medicine are defined as technical solutions which allow

longitudinal measurements of parameters of human individuals, their storage, and
analysis with the aim to monitor performance of patients. Wikipedia formulates
(http://en.wikipedia.org/wiki/Monitoring_(medicine), 2.2.13): “In medicine,
monitoring is the observation of a disease, condition or one or several medical
parameters over time….”. “Monitoring” as such describes in general the observation of
interested parameters by a process – human, technical or else.
The definition of “Personal Health Monitoring” (PHM) is somewhat fuzzy as the
term “health” is more and more used in different fields to describe a well-functioning
status of any system, e.g. an airplane. Further, in several languages “health” and
“medicine” are disjunct: medicine being very much focused on the physician driven
intervention and health much more on all other aspects of personal wellbeing in the
sense of the definition by the World Health Organization. This book understands health
in the WHO definition.
Many countries distinguish legally between “medical devices” and else – with the
medical devices strictly legally regulated regarding testing and operations. As the
focus of the EU-project “Ethics of Personal Health Monitoring” has been clearly the
ethical issues in new monitoring approaches beyond the current applications, we
neglect possible legal differences of sensors and systems due to this aspect.
In the history of computing (Fig.1) the term “ambient intelligence” has been used to
describe a world which has intelligent devices everywhere and may use such devices
for monitoring personal activities in order to react to results of the monitoring process.
Wikipedia nicely summarizes this thinking (http://en.wikipedia.org/wiki/Ambient_
intelligencecomputing, 2.2.13) as “ambient intelligence (AmI) refers to electronic
environments that are sensitive and responsive to the presence of people...” [1].
O. Rienhoff / From Intensive Care Monitoring to Personal Health Monitoring to Ambient Intelligence 5
Figure 1. Schematic drawing of the development from a few big computer systems to many small systems
distributed everywhere in our world. Still today the sustainable power supply for small systems everywhere
is a technical challenge. Nevertheless, the figure shows that the development is accelerating. Derived and
modified from: Waldner, J.B.: Nano-informatique et intelligence ambiente. London 2007 – documented
under Wikipedia: Ambient intelligence, 02.02.2013
3. Early Observations and New Questions
Introducing monitoring approaches into health care yielded some experience which has
remained true since the early days:
• The acceptance of systems has never been in doubt by patients supported by the
systems.
• Ethical and data protection aspects are vigorously discussed by observers of system
usage.
• Persons with monitoring experience tend to a very pragmatic use of such systems
including switching them off.
Meanwhile, ubiquitous networking and especially social media have enabled very
different types of monitoring in our industrialized societies. Many of these applications
can be summarized as “personal health monitoring” e.g. applications for fitness training,
ambient assisted living etc. Since social media have spread globally there are some
observations that young users may be much less critical to being observed or monitored
(Fig.2). However, there are no valid evaluations available addressing the issue of health
data.
An important aspect relates to monitoring systems which trigger actions: liability
aspects add to the already complex legal and ethical consideration... Another dimension
of general monitoring is unintended secondary use of data e.g. for health-analyses: e.g.
an automotive safety system that monitors the drivers performance in a car and at the
same time monitors the surrounding of the driven car may allow quite different health
related analyses:
• How is the actual driver’s readiness (…also a kind of personal health monitoring)?
• How does he observe the surrounding?
• Are there medical symptoms which compromise the ability to drive a car?
• Does the driver act responsible? Etc.
Over the decades it has been interesting to observe that some monitoring systems
cause little discussions e.g. cardiac devices whilst others cause major concerns e.g.
closed-loop-monitoring systems or monitor based robotic support for handicapped
persons. We can learn from the development during the last four decades that the
perception of ethical and legal impacts is depending on the subjective advantage of the
monitored individual at a given point of time. This makes it difficult to formulate very
general rules and regulations.
A major problem in all these developments and corresponding projects,
publications and discussions has been a very vague use of terms. Therefor the PHM-
Ethics project specified a taxonomy used in all its subprojects.
As already described, monitoring systems for health purposes have been developed
in many directions. From roots in intensive care the concept has spread to aero-space-
medicine, diving, and many other arenas with dangerous condition for human health.
The last 15 years the concepts have been applied to normal living conditions of elderly
and handicapped persons to safeguard them from falling and other traumatic impacts
on health and life (next chapter).
The fields mentioned are characterized by an ambiguity paradigm: most systems
have not explicitly been developed for health but handle monitoring data which can (as
secondary use) be utilized for health aspects or analyses of healthiness. This issue gains
even more momentum, when data can be linked to locations or movements – as it is
more and more precisely possible through different technological gadgets.
Another technical development is currently taking place: companies which drive the
technical developments are trying to integrate sensors into our private space in a way
that they are not recognizable e.g. many sensors in so-called intelligent homes become
part of the electrical wiring of the apartment. On the contrary protagonists of privacy
and ethics require sensors to be seen and systems to show their presence or activity. It
looks as if it is necessary that a clearly visible element allows off/on switching in a user
appropriate and easily recognizable form.
A few other aspects of the theme personal health monitoring shall be mentioned in
the following:
In recent years another application scenario has emerged: telemedical monitoring of
parameters for the optimization of therapies. A good example is the monitoring of high
blood pressure and its individual treatment. The latter case is of major importance,
because it could be observed that the day by day behavior of many patients differs
substantially from the measured behavior at reporting intervals in clinical trials. This
fact has very much raised research interest in continuous measurements or monitoring
of parameters to get to better and more valid research results. This has been pushing the
issue of personal health monitoring applications.
Because of this one can observe spreading interest in so-called patient reported
outcome measurements. These do not only include the patient’s perspective but also
possibly more relevant monitoring approaches to physiological parameters.
Implanted systems will become much more common than currently. Most devices,
which have been developed so far, are functioning remotely – however this may be
changed easily to improve systems maintenance or parameterization. As such devices
can also monitor health parameters they may become another source of monitoring data
in the field of personal health assessment.
The downgrading of the powerful approaches in intensive care 40 years ago to
everyday situations has moved monitoring out of highly concealed environments in
medicine or space into the everyday life situation and made it ubiquitous. With this
change ethical questions became much more urgent than in the original domains.
Figure 2. The black and white copy of a piece of art in the Frankfort Schirn Museum depicts the change of
cultural attitudes in perceiving private and public spaces as e.g. described by H. Arendt in 1958.The woman
who is presenting herself via her mobile smart phone has totally different apperceptions than the post war
generation which pushed the development of privacy laws in the late sixtieth. Source: E. Baden, Colour
Fotografy `Èmily´, Exhibition `Privat`, 1.11.12 – 3.2.13, Kunsthalle Schirn, Frankfurt.
4. Ambient Assisted Living (AAL)
Already in the late nineties of the last century several research groups started to design
monitoring techniques for the sake of elderly persons – especially regarding fall-
detection and recognition of emergency situations. Much later the term Ambient
Assisted Living (AAL) was coined in Europe to summarize different methodological
approaches to this challenge. MEDINFO 2004 hosted the first evaluator work shop
internationally in San Francisco. The workshop made clear that AAL is facing the same
methodological problems as intensive care monitoring before: success depends on
whether one can drive the system in a way that it nearly has no false negatives and very
few false positives. Linkages between AAL and Ambient Intelligence are e.g. presented
in the volumes of the corresponding IOS-series [2].
As this is difficult to achieve, two directions were subsequently followed:
• Robust devices
• Multi-sensor networks.
Especially the latter quickly gave rise to many ethical questions – especially when
such systems were intended to be used in patients with limited awareness or intellectual
capabilities. Also, privacy issues have been addressed [3].
The last five years in many countries hundreds of such systems were installed for
research or as early commercial products in field testing. An international
interoperability forum was established: the Continua Health Alliance. In the meantime
it became apparent that from the many acceptance questions raised only few seem to be
relevant:
• The false positive/negative relation
• Privacy and
• The acceptance by non-managing nursing staff.
Even in ethically very sensitive nations like Germany, which still reflects its Nazi-
past, philosophers and social researchers are not any more fighting the assistive
systems approach but rather focus their thoughts on the questions of generally existing
ambient intelligence and the essence of human nature in such environments. The most
general discussion of such issues is found under philosophical papers labeled
“cybernetic anthropology” – discussing human live in the context of information and
IT-Systems everywhere.
The AAL-concept has widened considerably in the context of understanding the
private home as the “3. health care location” besides physicians’ offices (2) and
hospitals (1) [4]. There are some observations in AAL applications which may
generally be true for personal health monitoring in general: Individuals relate very
differently to such aspects:
• If sensors (e.g. a hearing aid) may sense physical impairment or weakness, many
persons want to hide assistive technology.
• If monitoring systems activate false alarms users become very reluctant to use them.
• If false alarms lead to publicly observable reactions (e.g. ambulance coming) the
system acceptance runs down to zero.
• If monitoring systems change working processes, roles, and/or liability.
• At least in the German population older citizens distrust sensors and their abilities
in general.
There are some opinions that these reactions relate to age, social strata, education, and
many other factors. Some researchers suppose that differences exist between urban and
non-urban areas as well as between culturally different regions (e.g. North versus South
Germany). Besides these observations metalevel studies are not available.
5. Ethical Questions Accompanying Monitoring Developments
The ethical aspects of sensible data stemming from personal health monitoring are
rarely addressed in the literature compared to thousands of technically driven articles
and discussions. Examples are the recently published book on Tele-rehabilitation in
which various ethical problems are discussed – without addressing the fact that more
and more data comes into existence giving details on personal health conditions [5].
The same is true for more commercially orientated brochures as e.g. from the
Asklepios Hospital Group in Germany [6]. Recent very helpful editions from the
Springer Series on Health Informatics address systematically many issues of IT-
innovation in Healthcare – however do not mention possible ethical questions because
of the data distribution [7], [8].
Ethical questions in the context of monitoring systems have changed. During the
first phases of monitoring systems – especially with closed loop reaction – a key issue
had been how to make sure that systems did not harm patients physically. Another
question was whether it is ethically acceptable that decision-support programs would
interfere with the treatment of an unconscious patient without the consent of neither the
patient nor his legal representatives.
However, these systems failed regarding user acceptance and not because of the
ethical issues: doctors hesitated to follow advice of reasoning programs if it was
difficult to control and especially to understand why a decision was taken in a specific
way.
The next major step was the wide spread of video monitoring especially after
´September 11th´. Video monitoring became technically easy to handle and was
immediately incorporated into different health approaches. The spectrum of usage has
been very wide: from public health surveillance to use in diagnostic niches like
detection of pre-clamptic phases in patients with convulsive diseases. Also, AAL-
systems incorporated video scans for fall detection and other monitoring purposes.
The reaction of different national societies or social groups has been quite
confusing. A general experience is that video observation/monitoring is the more
accepted the more its purpose is to help a patient to survive in a dangerous situation.
Recently the video monitoring approach in personal health monitoring has taken two
different directions: (1) limited to clear emergency situations and (2) reduced to
symbolic graphs of a human being. The latter is inspired by new versions of whole
body scanners at airports.
In summary the historical spread of monitoring equipment has been perceived
differently in different societies and parts of society. So far the technology has been
able to mirror many ethical considerations by re-engineering details. A good example is
AAL-Systems that monitor individual mobility at home and do not transmit data
streams but rather agglomerated status reports which had been consented by the
monitored individual before.
Despite the changes of perception regarding the public and private spaces there
seems to be a growing concern in most political parties of industrialized societies
regarding the ubiquitous monitoring situation. The concern is reflecting the fact that a
composition of data sources from different monitoring systems may enable individual
pattern analyses – also of health related issues. A good example for this are the above
mentioned links between data gathered by cars on behalf of measuring the awakeness
of the driver with other data e.g. from spatial location by a mobile phone. This type of
data linkage cannot be counterbalanced by engineering: only legal regulations can stop
abuse such linkages.
When legally addressing this issue a key concept has been identified to safeguard
individual freedom despite ubiquitous monitoring: a private space has to be well
defined out of which no data is allowed to leave without consent of the individual. This
legal concept is simple enough to become part of our culture – however it will need
many years to move from the general idea to an accepted and absolutely defended legal
principle.
The consequence of these developments is to distinguish between generalized
monitoring (e.g. video monitoring of spaces) and individualized monitoring (e.g. blood
pressure telemonitoring). The two directions have different ethical impacts: generalized
monitoring has more evaluative options and is less easy to control for an individual
person while individualized monitoring is much easier to control for persons and is
more efficiently protected by privacy regulations in many countries. Personal health
monitoring is usually taking place in the private sphere of an individual and is closer to
the live management of each of us.
As mentioned above, a related issue to the spreading of monitoring functions and
their social acceptance and thus ethical valuation has been a change of perception
regarding public and private space. On the one side more and more elements of the
private space have been turned public during the last 30 years (Fig.2). On the other
hand, privacy officers have more and more intensely defended the remaining private
space against intrusion of non-perceivable, non-controllable, and non-stoppable IT-
infrastructures which may be turned into monitoring devices. A good example for this
thinking is the report of one of the most prominent German state-privacy-
commissioners (Th. Weichert) and his institution after evaluating various AAL
approaches (ULD, 2010).
If someone accepts being monitored for variable good reasons and in the best
personal interest of an individual other means have to be established in society to
hinder misuse of such systems or data collected in such systems [9]. This asks for
investigation PHM in a wider context. If it is possible to safeguard monitoring systems
and monitored individuals in an effective way with measurable intrusion risks, it is also
possible to compare the risks of the monitoring approach with the risks of not-
monitoring on a personal basis. This would give the individual the power of decision
back – a similar historical process as with other new revolutionizing technologies in
history (e.g. motorcars).
Personal Health Monitoring is just one aspect of the change into a “digital society”.
The impact of this change has been discussed vividly and probably over- und
underestimated in many ways. However, the change is not any more theoretical but has
reached every person’s life. The impact of digital technology is so massive that we are
not any more scientifically analyzing a new technical gadget in a well-defined society
and culture but that societal rules and cultural habits are changing too.
A good example for the different cultural perceptions is the acceptance of humanoid
robots in the care process in Asian countries – specifically Japan and in Western
civilizations. This difference was markedly strong at the beginning of the new
millennium. In the meantime there are some indications that the strong cultural
antagonism specifically in Germany against such technical systems is fading quickly.
Research on PHM and its ethical and legal regulations is therefore research on a
moving target. Different research groups in various countries may observe the
praenomen differently. Therefore it has been a major step in the PHM-project to build
up and utilize taxonomy to standardize communication and limit ambiguities. A special
problem in this (and many other contexts) is to find adequate regulation for persons
who are not able to estimate the impact of monitoring systems on their lives. This may
apply to children and senior citizens but especially to handicapped persons, for whom
some monitoring systems may be of real value, e.g. young adults with epilepsy.
6. Conclusion
The historical evolution of medical monitoring with computer/IT tools has a 50 years
history. On one hand, ethical aspects have only played a minor part of all
corresponding publications and studies – besides the usual privacy niche. Nevertheless,
one can observe that especially the niche discussions led to more awareness of ethical
constraints especially in respect to individualized or personal monitoring. This book on
personal-health-monitoring is a good example of the latter.
On the other hand many ethical issues are discussed since there are many examples
of how more and more IT-components invade everyday life, are able to monitor
persons and can interpret behavior – especially if linked with other data sources. The
negative and positive aspects of this development – more in the general health than in
the medical arena - are broadly discussed in many ethics groups and some
philosophical corners. These discussions are focusing on the question how human
beings live and interact with “intelligent” environments and how a private sphere can
be safeguarded.
In this area of generalized health monitoring there are many links to public
monitoring under public health or safety regulations. At this point public and political
opinions regarding ethical questions vary from country to country. It seems to be very
unclear into which direction the debate is moving: some groups are addressing
traditional data protection issues others see ethical and privacy issues compromised by
e.g. security needs. The rise of social media in the last decade has even raised the
question of whether some parts of the society do not perceive monitoring as evil. There
is a mountain of open ethical questions linked to this development. Another code word
for new questions is ambient intelligence. Although this aspect is not addressed in this
book, the discussions on personal health monitoring may also give some hints
regarding related ethical thesis.
As described and illustrated with the art piece from Frankfort the ethics of personal
health monitoring are nothing static. The whole societal framework of values is moving
– partly driven by information technology. Thus the ethical assessment can be only
valid in relation to a defined point of time. Reassessment of the framework is as
necessary as reassessment of the object of study.
The ethical-legal aspect, especially privacy, is also affected by this development –
which runs at different speed and into slightly different direction in various
industrialized countries. In all these countries the legal system has set up complex laws.
However, we need to formulate ethical and cultural norms which are so simple, that
everyone can use them for guidance without being knowledgeable about regulations
and laws. Solutions may be to keep the private space of an individual closed to any
monitoring approach as long as the individual him/herself or an emergency in the
community explicitly allows it.
7. Acknowledgements
The research leading to these results has received funding from the European
Community's Seventh Framework Programme (FP7/2007-2013) under grant agreement
no. 230602.
References
[1] S. Lingner, B. Lutterbeck, F. Pallas (eds.), Die Zukunft der Räume: Gesellschaftliche Fragen auf dem
Weg zur “Ambient Intelligence”, Graue Reihe, Nr. 50, Europäische Akademie, 2010
[2] J.C. Augustus, Ambient Intelligence and smart environments, ios-series, Amsterdam, Berlin, Tokyo,
Washington, since 2008
[3] ULD – Unabhängiges Landeszentrum für Datenschutz Schleswig-Holstein (eds.): Vorstudie - Juristische
Fragen im Bereich altersgerechter Assistenzsysteme, Kiel 2010
[4] U. Fachinger, K.-D. Henke (eds.): Der private Haushalt als Gesundheitsstandort: Theoretische und
empirische Analysen, Europäische Schriften zu Staat und Wirtschaft, Nomos: Baden-Baden 2010
[5] K.D. Seelmann, Health Information Management and Rehabilitation: Moving Toward an Adequate
Ethical Framework for Telerehabilitation, in: Kumar S., Chn; E.R. eds. Telerehabilitation, Springer,
Health Informatics, London 2013, 191-209
[6] AFH Alliance: Connecting Competence for eHealth Services, Alliance for Healthcare, Management
Perspectives, Vol. 04, 2010, 1-93
[7] B.R. Schatz, B.R. Berlin, Healthcare Infrastructure, Health Informatics, Springer, London 2011, 1-287
[8] L. Berkowitz, C. McCarthy, Innovation with Information Technologies in Healthcare, Health
Informatics, Springer, London 2013, 1-300
[9] A. Stahmann, M. Gök, Stärkung der Patientenrechte bei Telemonitoring-Anwendungen in
Onlineportalen durch Transparenz, in: Strausberg, J. et.al; Abstractvol. GMDS 2012, Schattauer:
Stuttgart 2012, 227-228
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-13
The PHM-Ethics Methodology:

Interdisciplinary Technology Assessment
of Personal Health Monitoring
Silke SCHMIDT a1 and Marcel VERWEIJ b
a
Department of Health and Prevention, University of Greifswald
b
Department of Ethics, Utrecht University
Abstract. The contribution briefly introduces the PHM Ethics project and the
PHM methodology. Within the PHM-Ethics project, a set of tools and modules
had been developed that may assist in the evaluation and assessment of new
technologies for personal health monitoring, referred to as “PHM methodology” or
“PHM toolbox”. An overview on this interdisciplinary methodology and its
comprising modules is provided, areas of application and intended target groups
are indicated.
Keywords. Personal health monitoring, health technology assessment,

methodology
Introduction
Nowadays it seems almost impossible to imagine a life without those technologies that
enable us to communicate, travel, play, produce the necessities of life, protect ourselves
against threats, or to diagnose and treat diseases. Technology helps people to gain
greater control over their lives and their surroundings, accomplish the things they want
to do, and stay away from the things they want to avoid. Paradoxically, at the same
time, advanced technologies may undermine our sense of control. Either because they
take over specific processes people used to perform ‘manually’ or because
technological processes obscure the way of working of how some result is created.
Some technological devices possess a greater skill in arriving at a desired result than
most human beings – in such cases it may be just more efficient to do away with
‘manual control’.
Information technology and medical engineering have entered a new phase of
integrating systems from different areas. After a long period of isolated development in
medical informatics and medical engineering, new developments incorporate a direct
integration of human physiology readouts and information technology parameters. The
interlinking of sensors, ICT and data banks is an innovation driver for technological
development. When compared to conventional technologies, interlinking,
customizability, and worldwide accessibility of formerly stand-alone systems add a
new dimension to technological evolution [1]. Single components, which do not have
any remarkable characteristic, might generate powerful performances or display far-
1
14 S. Schmidt and M. Verweij / The PHM-Ethics Methodology
reaching consequences if some of them team up and establish an interconnected system

of elements. Such systems could be also constructed for continuously assessing,
monitoring, processing, transmitting and storing health-related parameters and thereby
influence the health-status of their users.
1. Personal Health Monitoring
Personal health monitoring technology represents such a further step in technological

and societal evolution [2]. An increasing number of technologies are developed to
protect us from diseases and other health risks by monitoring our health and our
behaviour. This includes new health-related technologies, such as smart home solutions,
sensor-equipped assistive technologies, products for activity and weight monitoring,
direct measurement of health-related parameters such as ECG, blood pressure or blood
glucose levels etc. [3, 4]. To capture this diversity of health-related technological
applications the term “personalized health monitoring” (PHM) was introduced. PHM
includes „all technical systems collecting, processing, and storing data linked to a
person, allows monitoring parameters of that person and can lead to health related
information of that person“ [5]. The range applications that are collected under this
umbrella term starts with portable technologies which collect health-related data by
means of one single sensor up to complex smart home solutions in which multiple
sensors continuously generate health-related data.
In the short term, using such technologies, patients can be reminded, for instance to
take their medication on time, or to help physicians and nurses to monitor the health of
a patient without visits or travelling [6]. In the longer term, using health-monitoring
technologies it will be impossible for persons to drive a car or fly a jet for instance, in
case they suffer from specific health problems, when they are tired, or have consumed
alcohol, etc. Such technological developments have made our lives safer and healthier,
but also affected our humanity. After all, as human beings we see ourselves as having
the power to significantly direct and control our lives, and consequently, we hold
ourselves responsible for choices made. Technologies that monitor our physical and
mental condition and our competencies act on our lives and may partially take over
control of them, and, as a result they may undermine our sense of autonomy and feeling
of responsibility. The evaluation of these developments is a big challenge which raises
unique questions in the fields of ethics, law, and psychosocial impact of those new
technologies.
2. Objective and Methods
The European collaborative project PHM-Ethics has conceived a methodology for

interdisciplinary technology assessment of personalized health monitoring applications
[5]. Several modules have been developed that support the assessment and evaluation
of emerging and newly developed PHM applications.
The aim of the collaborative PHM-Ethics research project has been to conduct
scientific interdisciplinary research to analyse the dependencies between ethics, law
and psychosocial sciences in personalised health monitoring in relation to the major
types and steps of this very dynamic part of IT-development from a European
S. Schmidt and M. Verweij / The PHM-Ethics Methodology 15
perspective. An integrated European approach to the combined regulation of ethical,

philosophical, legal and psychosocial constraints has been developed.
In the first phase of the project a framework for the assessment of applications in
personal health monitoring has been developed. This includes a taxonomy for the
assessment of PHM technologies as well as a dependencies map to analyse the
embedment of technologies in a broad cultural perspective. The aims of the second
project phase have been to develop and test an interdisciplinary assessment
methodology that allows assessing PHM technologies in terms of psychosocial and
ethical implications. In addition a full analysis of the present legal context of PHM has
been conducted.
3. Risks and Chances
This combination of valuable opportunities and moral and societal concerns under-
scores the need for careful reflection on the ethical, legal and psycho-social aspects of
personal health monitoring technologies. Such analysis and reflection provide support
for policy making, facilitate and steer technology development, and overcome
problems that concern morals and public distrust [7, 8]. To this extent, such ethical
reflection is as important to governments and citizens, as it is to technology developers
and (future) users. PHM-Ethics is a project whose aim it is to develop tools for analysis
of the new ethical, legal and psycho-social issues that arise from personal health
monitoring practices.
With the PHM-Ethics methodology methods for analysis of ethical, legal and
psychosocial challenges have been developed that may arise with emerging
technological applications for personal health monitoring [5]. Such an approach takes
into account efforts and actions directed towards an increased consideration of ethical
and social issues in health technology assessment [9]. According to that, the Federal
Ministry of Education and Research in Germany already established a funding program
(“ELSA”), which is aimed to promote research on ethical, legal and social aspects of
modern life sciences and biotechnology. In addition, several approaches addressing
ethical issues in health technology assessment were published in recent years [10, 11].
Moreover, in the call for stronger involvement of patients and public in the HTA
process has been growing even louder. A report addressing this issue had been
published recently by the German HTA Agency [12].
4. Key Values and Principles
PHM-Ethics has indicated an initial set of key values and principles. These encompass
common values in bioethics and ICT ethics, but also cover issues regarding the quality
of those health care relationships that are especially relevant for intermediate users
[13]. Personal health monitoring technologies can promote as well as undermine or
violate these values. Any ethical reflection on a new device should include an overview
of how these values can be affected positively or negatively by the technology. Ideally,
PHM technologies:
• Protect and do not undermine a patient’s privacy,

• Respect a patient’s autonomy, i.e. respect her capacity as self-sufficient and
responsible; and promote autonomy in case a patient is incapacitated,
• Are not imposed upon patients; instead people should be offered a choice
between using PHM technology or opting for ‘traditional’ care if available,
• Promote and do not inhibit equal access to essential health care; actually both
benefits and burdens of technological innovations are distributed equitably
(justice),
• Promote the health and quality of life of patients, and do not expose them to
any risk of harm (to health or well-being),
• Enhance the quality of health care provision, both from the perspective of the
care giver and the care-receiver,
• Facilitate communication and interpersonal contact and cooperation, and not
merely substitute personal contact with technological monitoring
(interpersonal relationships).
It is essential to acknowledge that these values may enter into conflict, e.g. some
devices may indeed promote the quality of care and the well-being of a patient, how-
ever at the cost of invading her privacy [14, 15]. In such cases – as in any other area of
life – stakeholders need to weigh competing values, seek opportunities for compromise
and defend the course of action most reasonably acceptable to all involved. PHM-
Ethics includes tools (notably the psycho-social module and the interactive ethics
methodology) that may provide the data for such balancing.
5. The PHM Ethics’ Toolbox
PHM-Ethics has developed a set of basic tools that may assist in the evaluation and
assessment of new technologies for P. The modules can be used combined or
individually – depending on the needs of stakeholders. Combining different modules
however enhances the analysis.
The PHM-Ethics’ ‘toolbox’ has two important characteristics. First, being inter-
disciplinary, it combines insights taken from ethics, medical informatics, law, and
psycho-social sciences. Second, it views technological development as a series of
dynamic, on-going and open-ended processes. The tools begin by taking certain initial
concepts as starting points: an initial circumscription of PHM technology, an initial
idea of how technologies may affect society and the identification of moral values
needed to be taken into account in formulating ethically justified policies. However, all
tools are open for adjustment and revision.
The PHM-Ethics’ toolbox includes two descriptive modules: a taxonomy module
that helps understand the nature of a new technology using this interdisciplinary
approach, and a dependencies map that provides details both regarding inter-relations
between all stakeholders involved, as well as on the various ways on how the
introduction of technologies may have an impact on society. Another important tool is
the comparative analysis of ethical constraints contained in EU directives into the
national laws. Furthermore, this report shows current legal gaps at the European level
regarding PHM. Two other modules provide evaluative assessments: the assessment of
ethical aspects, and the assessment of the psycho-social impact. The five parts included
in the full methodology are described as follows:
• Taxonomy of personal health monitoring technologies: This tool provides

support for users in getting an overview of current and future PHM
technologies, hence the technologies can be appropriately classified and
located at the point where they cross boundaries [16]. Thus, this classification
system aims at categorizing PHM technologies and applications. It generates
groups with similar characteristics and allows to makes distinctions between
similar technologies. The taxonomy starts from a basic definition of PHM
technologies, providing an idea of what all technologies have in common and
offers an overview of the ways in which technologies can differ with respect
to relevant features that might be relevant from ethical and psycho-social
points of view. In this manner, the taxonomy helps to explore possibilities for
PHM in the future, as a basis for early assessment and evaluation [17].
• Dependencies map: PHM technologies may have impact on a wide variety of
values, aspects of life, and societal practices and institutions, which in turn
may influence each other. The dependencies map is a multi-layered, complex
network of relationships that illustrates dependencies between parties involved
in PHM. As a result, the dependencies map offers a comprehensive overview
of these relationships, and thus keeps stock of the possible ways of how a new
technology impacts society.
• Interactive ethics methodology: The interactive ethics module [13] aims at
bridging the gap between general values as endorsed and explained in ethical
theories and methods, and specific experiences and moral judgement of stake-
holders (notably patients, caregivers, family members). This module allows
evaluating existing and upcoming PHM technologies from an ethical point of
view. Ethical values and principles are put into perspective with Personalised
Health Monitoring. The module presents an initial list of questions for
interviews to clarify ethical experiences of stakeholders. These questions
pertain to the fields of privacy, autonomy, freedom of choice, justice, and
further content relevant in PHM ethical assessment. The results of the
interviews are to be used to amend and specify the core values of PHM-Ethics,
and to help formulate specific ethical criteria for specific PHM technologies.
• Psychosocial module: A core concern for new technologies is its impact on
human well-being as well as its effect on how people generally evaluate
technology [18]. The psycho-social module is an integrated tool for psycho-
social health technology assessment that covers various domains of
technology perception and psychosocial outcome criteria. It is based on a map
highlighting selective psycho-social issues of relevance when applying a PHM
system. The module involves two methods, a list of evaluation criteria and an
assessment method comprising a range of questions for specific target groups
and broader populations. The method is to be used to evaluate (expected)
psychosocial impact and describe people’s (evaluative) attitudes and
judgements towards PHM technology.
• Legal framework: A comprehensive legal report that describes the legislation
at the European level, regarding telemedicine and/or health monitoring. It
takes into account the consequences of recent decisions by the European Court
of Justice important for the project, dealing with privacy and reimbursement
of monitoring systems.
These tools have been developed on the basis of reviews of technology, reviews of
ethical and legal guidelines, and reviews of ethical [19] and psychosocial literature
[20]. Moreover, the results obtained by applying one tool can provide information on
the use of another. For example, it is useful to explore how a specific technology can
be “staged” within the taxonomy in order to reveal the novel features of the technology
that may ultimately serve as input for ethical assessment or become a topic for a
psychosocial survey.
6. Target Groups
Since reflection on novel or future personal health monitoring technologies is relevant

for all stakeholders and persons involved in technology development, the European
PHM-Ethics Group will publish a book (see annex), including a manual of the PHM
methodology. The PHM methodology addresses diverse target groups and can be of
benefit to them e.g.:
• Technology developers often only focus on the potential benefits of
technology. They therefore may also gain a more focused perspective on
possible drawbacks, risks, and user acceptance. This can lead to more
sophisticated technology concepts and advanced products on the market.
• HTA experts will benefit from applying this methodology in addition to their
established procedures, especially in case of PHM technology assessment.
Reviews
Technical Psycho-social Ethical

review review review
… ………… … …
Descriptive modules
Dependencies Report on legal and

Taxonomy
Map ethical constraints
Evaluative modules
Psycho-social Interaktive-ethical
module module
Figure 1. Overview on different parts of the PHM Ethics methodology for health technology assessment in
personal health monitoring applications
• Health care institutions and regulatory authorities in the healthcare sector need
to explore how PHM devices can truly enhance the quality of care, and not
impoverish the human dimensions of care.
• Health care professionals may be especially interested in issues such as: How
does the application of PHM technology fit within the professional ethics of
physicians, nurses and other health care workers?
• Governments will be able to explore how PHM devices fit within current legal
frameworks, or whether additional legislation is necessary by focusing on the
dependencies map integrated in the methodology (e.g. regarding liability
issues, cross-border health care, or reimbursement and health insurance). The
legal review provides a first indication, general but specific technologies may
require a context-sensitive legal analysis.
• Last but not least, patients and citizens will be concerned how the use of PHM
will affect their lives in positive and negative ways. The methodology also
covers the patient’s and public’s perspective on emerging PHM applications.
7. Conclusion and Outlook
The PHM-Ethics project developed a methodology which can be used modularly for
the assessment of various aspects regarding impact and features of PHM technologies.
The prospective, dynamic and multi-perspective HTA-approach focuses on depicting
and involving all of the participating actors and relevant decision makers. It also
considers a variety of dimensions and requires interdisciplinary corporation. The wide
scope of the PHM-Ethics methodology is able to support HTA-studies in whatever
phase of the “technical life cycle”.
Further work is indicated to establish the full potential of the concept in use with
various upcoming PHM applications and technologies. The PHM methodology will
take into account future developments and emergent technologies in the realm of PHM.
Thus, also the manual provided will continue to develop further. Moreover, further
studies using the PHM methodology and its modules will provide substantial feedback
for further refinement. Last but not least, applying the methodology within technology
assessment represents the most sufficient proof of its validity.
The usage of the PHM-Ethics methodology is not necessarily restricted to the
assessment of technology assessment of PHM applications even though this modular
HTA-System was genuinely designed therefor. In order to adequately implement
technologies in other areas, adoptions will be necessary. The superior methodological
approach may be used as an appropriate framework for HTA-conceptions in the field of
innovative or emerging technologies.
8. Acknowledgements
no. 230602.
References
[1] B. Chaudhry, J. Wang, S. Wu, et al., Systematic Review: Impact of Health Information Technology on
Quality, Efficiency, and Costs of Medical Care, Annals of Internal Medicine 144 (2006), 742–752.
[2] S. Rogerson, J. Haines, The way to healthy ICT, IMIS Journal 20 (2010), 35–36.
[3] S. Schmidt, S. Sheikzadeh, B. Beil, M. Patten, J. Stettin, Acceptance of Telemonitoring to Enhance
Medication Compliance in Patients with Chronic Heart Failure. Telemedicine and e-Health 14 (2008),
426–433.
[4] G. Paré, M. Jaana, C. Sicotte, Systematic Review of Home Telemonitoring for Chronic Diseases: The
Evidence Base, Journal of the American Medical Informatics Association 14 (2007), 269–277.
[5] S. Schmidt, O. Rienhoff, Interdiscilpinary Assessment of Personal Health Monitoring, IOS Series on
Health Technology and Informatics, IOS Press, Amsterdam, 2013.
[6] D. Rhode, Personal(ized) Health monitoring, Personalization and Personality, Journal of Technology in
Human Services 29 (2011), 83–100.
[7] A.D. Smith, D.R. Manna, Exploring the trust factor in e-medicine, Online Information Review 28 (2004),
346–355.
[8] D. Zweig, J. Webster, Personality as a moderator of monitoring acceptance, Computers in Human
Behavior 19 (2003), 479–493.
[9] S. Droste, A. Gerhardus, R. Kollek, Methoden zur Erfassung ethischer Aspekte und gesellschaftlicher
Wertvorstellungen in Kurz-HTA. Berichten – eine internationale Bestandsaufnahme, Schriftenreihe
Health Technology Assessment, Bd. 9. DIMDI, Köln, 2003.
[10] B. Hofmann, On value-judgements and ethics in health technology assessment, Poiesis & Praxis 3
(2005), 277–295.
[11] B. Skorupinski, K. Ott, Technology assessment and ethics, Poiesis & Praxis 1 (2002), 95–122.
[12] C. Brettschneider, D. Lühmann, H. Raspe, Der Stellenwert von Patient Reported Outcomes (PRO) im
Kontext von Health technology Assess-ment (HTA), Schriftenreihe Health Technology Assessment,
Bd. 109. DIMDI, Köln, 2011.
[13] E. Palm, An interactive ethical assessment of surveillance-capable software within the home-help
service sector, Journal of Information, Communication & Ethics in Society, submitted.
[14] A. Nordgren, Remote monitoring or close encounters? Ethical considerations in priority setting
regarding telecare, Health Care Analysis, doi: 10.1007/s10728-012-0218-z, (2012).
[15] E. Palm, Who cares? Moral obligations in formal and informal care provision in the light of ICT-based
home care, Health Care Analysis, doi: 10.1007/s10728-011-0199-3, (2011).
[16] G. Nußbeck, M. Gök, O. Rienhoff, Systematik Assistiver Systeme in Versorgung und Forschung, E-
Health-Com 4 (2010), 52–53.
[17] G. Nußbeck, Reduktion des Implementationsrisikos von Tele-monitoring durch eine Taxonomie-
gestützte Risikoanalyse, In: B. Böckmann, et al. (Hrsg.), 1. Nationaler Fachkongress Telemedizin
(pp. 14–20), TMF - Technologie- und Methodenplattform für die vernetzte medizinische Forschung
e.V., Berlin, 2010.
[18] D. Rhode, H. Muehlan, S. Schmidt, Personalisiertes Gesundheits-monitoring – psychosoziale Aspekte
und interindividuelle Unterschiede. In: F. Duesberg (Hrsg.), e-Health 2012. Informationstechnologien
und Telematik im Gesundheitswesen (pp. 253–256), Medical Future Verlag, Solingen, 2011.
[19] G. Collste, Under my Skin: The Ethics of Ambient Computing for Personal Health Monitoring, In: S.
Nagy & Hesse-Biber (Eds.), The Handbook of Emergent Technologies in Social Research (pp. 89–111).
University Press, Oxford, 2011.
[20] H. Muehlan, S. Schmidt, Psycho-Social Aspects of Personal Health Monitoring: A Descriptive
Literature Review, In: S. Schmidt & O. Rienhoff (Eds.), Interdisciplinary Assessment of Personal
Health Monitoring, IOS Press, Amsterdam, 2013.
II
Perspectives on Personal Health Monitoring
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-23
Technical Literature Review

Gunnar NUßBECK and Murat GÖK1
GöttingenUniversity Medical Cente
Abstract. This review gives a comprehensive overview on the technical perspec-

tive of personal health monitoring. It is designed to build a mutual basis for the
project partners of the PHM-Ethics project. A literature search was conducted to
screen pertinent literature databases for relevant publications. All review papers
that were retrieved were analyzed. The increasing number of publications that are
published per year shows that the field of personal health monitoring is of growing
interest in the research community. Most publications deal with telemonitoring,
thus forming the core technology of personal health monitoring. Measured param-
eters, fields of application, participants and stakeholders are described. Moreover
an outlook on information and communication technology that foster the integra-
tion possibilities of personal health monitoring into decision making and remote
monitoring of individual people’s health is provided. The removal of the techno-
logical barriers opens new perspectives in health and health care delivery using
home monitoring applications.
Keywords. Telemonitoring, personal health monitoring, health parameters
Introduction
This review on technological perspectives of personal health monitoring gives an over-

view on the medical technology components of personal health monitoring (PHM).
PHM comprises all technical systems collecting, processing, and storing data linked to
a person. It allows monitoring parameters of that person and can lead to health-related
information of that person. Moreover this review focuses on clinical aspects of the vast
field of personal health monitoring. A brief sketch of the historical development is
drawn.
The development of telemedicine drives the enforcement of telemonitoring in pa-
tients’ daily lives. In order to provide a comprehensive overview the review focuses on
clinical parameters and key technologies rather than getting lost in technological details.
1. Methods
To build the review database, the literature was retrieved searching both PubMed (US
National Library of Medicine, database: Medline) and DIMDI (German Institute of
Medical Documentation and Information, databases: CCMed, CDSR, AR96, ETH-
MED). The Reviews where read by two researchers and categorized according to the
field of application. To include additional perspectives of other disciplines, the project
1
24 G. Nußbeck and M. Gök / Technical Literature Review
partners were asked to provide case scenarios of PHM applications they pondered sig-
nificant for their respective field of research. The original work that is published re-
garding these scenarios was included into this review. In order to build up a compre-
hensive basis for the taxonomy, for each of the previously identified fields of applica-
tion that were not covered by the scenarios one prominent study has been chosen as an
example.
1.1. Databases
The Medline database holds documents of all medical fields published 1966 or later. It
comprises approximately 13 million documents.
1. CCMed (Current Contents Medicine) is a literature database by ZBMed (Ger-
man National Library of Medicine). It consists of articles of all medical fields
that are published in German language or in journals that are published in
Germany; approx. 300,000 documents.
2. CDSR (The Cochrane Database of Systematic Reviews) is a database of the
Cochrane Library, which encompasses structured reviews issued by a network
of international researchers and physicians. A structured review outlines all
relevant studies concerning a therapeutic issue; approx. 3,700 documents.
3. The AR96 database includes all documents linked to the German journal
“Deutsches Ärzteblatt”, dealing with medicine and health politics; approx
36,000 documents.
4. ETHMED is a database in the field of biomedical ethics with emphasis on eth-
ics in medicine. It contains mainly data from German speaking countries; ap-
prox. 10,500 documents.
1.2. Search Algorithm
All these databases were searched using the search terms “telemonitoring”, “personal
health monitoring”, “ambient assisted living”, “smart home”, and “pervasive health
care” consecutively to both PubMed and DIMDI. The DIMDI search only returned
distinct matches among all included DIMDI databases. A total of 553 hits were re-
turned (PubMed 413, DIMDI 140). The searches were conducted between July 1, 2009
and July 13, 2009.
Fifty articles that are not available in German or English were excluded (PubMed
22, DIMDI 28). French language articles were sent to the French project partners for
review. Three articles were identified as duplicates (either matched more than one
search term (in PubMed), or where indexed in more than one database (i.e. Medline
and one of DIMDI’s databases). This led to 500 articles (PubMed 391, DIMDI 109).In
order to compose a comprehensible yet sensitive review the selection of articles was
limited to reviews. The review is thus based on 85 reviews. The reviews are grouped by
their field (AAL and smart home (13 reviews), telemonitoring (45 reviews), personal
health monitoring (25 reviews), and pervasive health care (1 review).
G. Nußbeck and M. Gök / Technical Literature Review 25
1.3. Limits
The main limiting factor of the search algorithm is that it neglects work that has not yet
been reviewed by others. Furthermore the restriction to articles that are published in
English, French or German language might disregard some projects.
2. Results
At present a lot of research is conducted in the fields contributing to personal health

monitoring. Due to its early development, telemonitoring seems to be the most re-
searched of these fields. Ambient Assisted Living, as an approach to integrate telemon-
itoring and technical comfort and security systems, is still in a research phase without
widespread commercial use cases [1-3]. AAL is aimed at elderly people or people that
suffer from a chronic disease. The goal of AAL technologies is to allow people to live
in their homes despite their ailments.
Figure 1 gives a chronological overview of the number of reviews that were re-
trieved. It shows a continuous incline in numbers. The decline in 2009 is due to the fact
that the search was performed in mid-2009, one could extrapolate the number to be
around 30 in total for 2009. Figure 2 gives the same overview for publications that
review telemonitoring projects. Again, numbers rise continuously, and the decline in
2009 is explained with the date the search was performed on. Extrapolated the number
of reviews in 2009 is estimated around 15. Both graphs show that half of the reviews
retrieved deal with telemonitoring. The remaining papers spread mostly across ambient
assisted living and personal health monitoring related reviews.
2.1. General Overview of the Technical Perspective
The majority of projects stem from early telemedicine approaches. They concentrate on
clinical data. Starting with the electrocardiogram (ECG), early examples of transporting
ECG - data can be traced back to the beginning of 20th century [4, 5]. From these early
approaches of telemedicine (e.g. diagnosis from distance) the continuous telemonitor-
ing arose.
Review Articles Retrieved Telemonitoring Reviews per

20 per Year Year
10
15 8
6
10
4
5 2
0 0
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Figure 1. Number of reviews per year. This graph Figure 2. Number of telemonitoring reviews per year.
shows the number of reviews retrieved by the The graph shows that telemonitoring reviews form the
search. A continuous incline in publications is largest fraction of reviews retrieved.
observed.
26
Table 1. Evolutionary Steps of Measuring the Parameter “Body Temperature”
Digital thermometer
Mercury Digital Digital thermometer
with continuous Infrared camera Satellite
thermometer thermometer with data link
measurement
Measurement
Analogue Digital Digital Digital Digital Digital
procedure
Place of Body contact / Body /
Body contact Body contact Line-of-sight Environment
G. Nußbeck and M. Gök / Technical Literature Review

measurement near proximity near proximity
Period of
Discrete Discrete Discrete Continuous Continuous Continuous
measurement
Multiple parameters
Measured data Single parameter Single parameter Single parameter Single parameter Single parameter
(temp and location)
Intention Diagnosis Diagnosis Diagnosis Diagnosis Surveillance Surveillance
Consent Patient Patient Patient Patient Operator Operator
Sensitivity Single patient Single patient Single patient Single patient Group of people Population
Active participant Patient / operator Patient / operator Patient / operator Patient / operator Operator only Operator only
Data processing Manual Manual Automated Automated Automated Automated
History History (external record

Data storage External record Developing Developing Developing
(in device) and in device)
Transmission Line of sight Line of sight Bluetooth Bluetooth CCTV Satellite interlink
Bidirectional
Unidirectional Unidirectional Unidirectional Unidirectional Bidirectional
Data flow (camera <-> display /
(manual reading) (manual reading) (thermometer -> record) (thermometer -> record) (satellite <-> control centre)
storage / operator)
There are telemonitoring techniques where a nurse calls the patient in predeter-
mined schedule and ask for health parameters [6, 7]. One project focused on the spatial
independence for the health care professionals. This means that a physician is able to
access data from intensive care unit (ICU) patients through a web based portal; in the
ICU the patient communicate through a robot with the physician [8].
Another possible way of using telemonitoring for collecting ECG data is to equip a
person with sensors invasive or non-invasive. The recording of ECGs can be either
triggered manually by the patient in case he notices anomalies, or can be triggered
automatically in case of a critical cardiac event [9]. In the 1980s implanting of heart
defibrillators has started [10].
The body temperature for example can be measured in different ways (see Table 1).
On the low end side with plain reading of a mercury thermometer by only one person
taking a single parameter with a single sensor on the high end side monitoring many
individuals being measured without their awareness by infrared cameras. The pulse rate
can be measured via acoustic or electric signals. The measurement is usually non-
invasive. The devices for monitoring ranges from wrist-watches over chest straps to T-
shirts equipped with sensors for several health parameters. Persons with diabetics are
able to transfer their measured data into an electronic record where it can be discussed
with fellow patients or health professionals. There are also future scenarios for “smart
toilets” where sensors analyze the urine components for monitoring purposes [11].
Devices to collect information about a person’s mind range from polygraph (measure-
ment of vital signs: blood pressure, pulse, and breath) to lie detection via measuring the
brain stimulation with magnetic resonance tomography [12]. There are solutions (mo-
bile phones) which in emergency cases use the GPS signal to locate the person [9].
The transfer of the measurement setting from a clinical or doctor’s office setting
into a personal setting suggests grouping the parameters in a traditional way. This
would represent the fields of application in respect to the medical domain. After further
examination it emerged that this grouping would not be consistent, and the lines drawn
between the groups would be blurry. Multiple parameters are used in several fields of
applications and some fields of application solely rely on combinations of parameters
and deduce their specific readings from these combinations. A variety of combinations
is anticipated in respect to the purpose of measurement. Another possibility would be
to categorize the parameters by permanently measured vs. discretely measured, or ac-
tively (with interaction of a person (either the person self or a third party) and passively
measured (automatically without any user interaction). Those categorization approach-
es also seem to be prone to bias. However, this review gives an overview of technolo-
gies that are in use now or are reasonably foreseeable in future applications. Therefore
an approach was chosen that is not subject to bias or arbitrary grouping of parameters
but rather depends on the physical or technical method that leads to parameter readings.
Thus the results of the review are structured in a very low level hierarchy, relying on
the parameters that are measured. These can be grouped into parameters that can direct-
ly be measured and parameters that rely on the interpretation of multiple parameters.
With direct parameters we refer to parameters that can be directly measured by
sensors, in contrast to indirect parameters which rely on the reading of different sensors
for different source parameters.
2.1.1. Direct Parameters

Direct parameters in our sense comprise all traditional clinical physiological parameters
like heart rate, blood pressure, electrocardiogram, oxygen saturation, breath air flow,
breath peak flow, breathing rate, blood glucose level, body weight, body temperature
and some not so common like tonometry (measuring intraocular pressure). The line-up
of these parameters resembles the parameters typically monitored in intensive care
monitoring. Some parameters cannot easily be monitored outside a hospital environ-
ment for safety or comfort reason (e.g. invasive blood pressure measurement, balancing
of liquid intake and excretion), or for lack of technical feasibility or accuracy of read-
ings (e.g. electroencephalograms (EEG’s)). The following paragraphs give an overview
of direct parameters. The list is intended to give an understanding on what parameters
are measured, and how they are measured. The list does not include all possible param-
eters, as it seems neither feasible nor helpful for gaining a comprehensive understand-
ing. Thus the list comprises the most prevalent parameters.
Electrocardiogram (ECG): Cardiovascular diseases form major death causes in the
western world. With the help of electrodes placed on the skin the electric stimulus of
the heart can be visualized and abnormalities can be diagnosed. Electrocardiography as
we know it today is based on the work of W. Einthoven. Einthoven successfully exper-
imented already in 1906 with transfer of ECG signals over telephone leads[13]. Elec-
trocardiography plays an important role in medical diagnostics. It ranges from monitor-
ing of heart rate and heart beat in intensive care units to diagnosis of cardiac problems
in medical examinations. ECG electrodes that are placed on the skin usually have a gel
layer that enhances the conduction of electric signals. They can be fixed on the skin
with elastic straps or belts, with adhesive foil or clamps. New dry electrodes that can be
integrated into garments allow permanent ECG monitoring with minimum comfort
restrictions[14, 15]. Devices used for ECG monitoring also can assess ECGs and send
alarms together with the ECG signals or give feedback as soon as a medical emergency
is detected using mobile communication devices like smart phones[16].
Heart Rate (HR): The heart rate can be calculated directly from the ECG or meas-
ured with simpler methods that either monitor electric action (e.g. thorax belt) or pulse.
Blood Pressure (BP): Blood pressure is also one of the most common measured
parameters. Common devices use a high pressure cuff that is typically placed around
the arm or the wrist of a patient (larger cuffs that fit thighs are also available). For BP
monitoring, the cuff is placed around the arm (or wrist/thigh) in set intervals and the
measurement conducted. The cuff based monitoring of BP over a long time requires the
patients to strictly follow a schedule. This approach faces problems in the patient ad-
herence [17]. Cuff-less, light-weight, and small sized alternatives which can monitor
the BP unobtrusive are researched [18-20].
Respiratory Rate: Various methods to measure breathing rate of a person exist.
They rely on thorax movement, blood gas analysis (see oximetry section below) or air
flow measurement (see spirometry section below)[21].
Oximetry (SpO2): Pulse oximetry can be done with devices that optically measure
the oxygen saturation of the blood. Common are devices that have finger clips. The
patient puts a finger inside the clip and both pulse rate and oxygen saturation can be
measured. The parameter allows estimating the effectiveness of oxygenation of eryth-
rocytes in the lungs. Small, handy devices are widespread available, there exists a vast
variety of devices capable of wireless and wired communication. Additionally, most
oximeters also measure the peripheral pulse beat. Other blood gas analysis methods
measure CO2 concentration.
Spirometry (Air Flow and Peak Flow): The parameters air flow and peak flow are
measured to analyse the quality of breathing. It measures the volume per breath and the
peak flow per breath. To measure both parameters the patient has to blow through a
little tube on a spirometer. Inside the tube, a little propeller is propelled by the breath.
Thus, the spirometer can calculate both breath volume and peak flow. The readings are
used to calculate the amount of drugs the patient administers using an inhaler. Recent-
ly, integration of a telemedicine capable spirometer into an inhaler has been designed
by Sendsor GmbH 2 , München, Germany. Spirometry can be easily performed by
trained persons without supervision of a health professional [22]. Nevertheless the
quality of readings generated by persons without professional supervision depends on
the accuracy the instructions is followed.
Blood Glucose Level: The measurement of the blood glucose level is a widespread
method used in diabetes patients. Some diabetes patients need to adjust their insulin
intake to their actual glucose level, depending on nutrition and activity. Hence, affected
patients are familiar with self-measuring [23-25].There are a number of glucose meters
with built in memory or computer links. Some also have built in graph functionalities
to display trends[26]. Glucose level sensors also play a role in insulin pumps – im-
planted devices that administer insulin automatically and adjusted to demand [27].
Body Weight: Many home monitoring device set ups include scales. Weighing is
one of the best established instances of clinical parameter measuring. Bathroom scales
can be found in almost every household. Scales used for telemonitoring are mostly
connected with the system and readings are transferred automatically.
Body Temperature: Body Temperature is probably the simplest parameter that can
be monitored. Thermal sensors can be place in, on, or near the body. Even high distant
sensing of the body temperature is possible.
Self-Tonometry (Intra Ocular Pressure): Projects introduced possibilities of tele-
medical applications of intra-ocular pressure measurement in ophthalmology [28, 29].
Patients are trained to conduct the measurements in their homes in a telemonitoring
service provided by the University Hospital in Greifswald3 [30].
2.1.2. Indirect Parameters

Indirect parameters comprise outcomes of sensor-systems that measure different varia-
bles in order to deduce the current reading. These systems can be quite simple formu-
las, like the body-mass-index (BMI), which relies solely on body height and body
weight, or can require complex algorithms to detect falls or behavioural abnormalities.
Other indirect parameters are parameters that require assessment of health professionals
like assessing wound healing with the use of pictures taken at the patient’s homes.
Some of the parameters are, in contrast to direct parameters, used for various applica-
tions that do not only monitor health per se, but broaden the scope of monitoring to e.g.
coping, general activity, or symptomatic behaviour. Some of these parameters are inte-
grated into ambient assisted living systems. These systems collect a vast amount of
data from very different types of sensors. The acquired data is then analysed. With the
evolution of high speed internet and the dropping prices for data storage, huge data
collections become affordable. These data collections allow later analysis for retrospec-
2
http://www.sendsor.de/Englisch/Products/Produkte.htm
3
http://www.teleaugendienst.de/TTMV.html page in German, last retrieved 29.01.2010
tive methods, or can be source for new methods that were previously unknown. The
following paragraphs give an idea on what parameters are measured, and how they are
measured.
Body Mass Index (BMI): BMI is a simple example of an indirect parameter calcu-
lated using body height and weight (body weight in Kg divided by the square of the
height in meters [kg/m2]). It indicates overweight or underweight if the BMI is above
or below a certain threshold. Of course, it seems not very helpful to monitor the param-
eter permanently. However, it might be interesting to have a long term record of the
BMI for patients with weight problems that are still in their growth phase.
Behaviour [31]: Behaviour is one of the aspects monitored in patients with demen-
tia. A low level approach of behavioural monitoring would be location tracking or
detecting of breach of pre-defined boarders to detect wandering. A more complex
method is used to measure agitation. The monitoring of Sleep/Wake Cycle (circadian
rhythm) allows carers to help people with dementia finding back to a natural rhythm.
Monitoring of the circadian rhythm also facilitates detection of other abnormalities like
sleep apnoea or nightly strangury. The measuring of the sleep-wake rhythm itself does
not allow the diagnosis of the latter two, but it can be used as an indicator for a need of
further investigation in a sleep laboratory.
Wound Healing: Chronic wounds are a major problem for patients. The regenera-
tion of the skin is often very slow and the risk of infections is high. In a low level ap-
proach patients take pictures of their wounds with a digital camera and email them to a
wound care specialist. The pictures allow experts to diagnose and evaluate the chronic
wounds from a distance periodically [32]. A possible approach of giving feedback is
responding via email or conducting a video conference. A high level approach is the
WOUNDMONITOR project (funded by the EU). The consortium develops a sensor
device which is able to detect harmful bacteria in the air that signal the first signs of
infection [33].
Environmental Monitoring (Data received from Home Awareness Tech) [1-3, 34]:
The increase of home automation and the merging of personal health technologies have
formed the field of ambient assisted living (AAL). The context aware environment can
monitor various parameters in a person’s environment. These are not only primary
medical parameters, but parameters that allow a deduction of information about a per-
son’s status. For example, motion sensor can be used for automatic lighting, as a source
for a burglar alarm, or allow tracking of a person’s movement or variation of habits
(e.g. nightly wandering) and detect falls or non-typical lack of movements for example
a person is not getting out of bed in the morning, or was registered going to the bath-
room at night, but not returning. This could trigger alarms or notifications of next of
kin or professional helpers.
2.1.3. Field of Application

Personal health monitoring is applied in many fields. One could try to classify these
fields into three main categories: “Medical Care / Health Care”, “Occupational Health
Monitoring”, “Recreational Health Monitoring”, and “Public Health Monitoring”. Be-
cause of the broadness of this field, a limitation to the scope of “Medical Care / Health
Care” is adequate. This can be broken down to the traditional fields “preventive”,
“treatment related”, and “assistive/rehabilitation”. This is necessary to focus on the
main topic and in order to cover the scope as extensive as possible. It would just not be
feasible for example to outline the whole legal implication without limiting the scope.
Personal health monitoring in medical applications is used to keep track of health

related issues. It can be used to allow early diagnosis of certain conditions, for example
cognitive decline, and allows commencing a therapy as soon as possible thus enhancing
the outcome. Monitoring of persons with dementia (wandering, sleeping behaviour)
and their environment (e.g. monitoring the cooker, turning off water taps when not
needed, monitoring environmental temperature) improves the persons’ autonomy and
reduces the carer’s burden [31]. In this scenario personal health monitoring can be
understood as an add-on feature to traditional home care.
In internal medicine, especially in cardiology, telemedicine is used as a diagnostic
tool as well as a therapeutic aid that contributes directly to clinical decision making.
The goal is to achieve a prompt intervention by using telemedicine applications. Fur-
thermore telemedicine allows a longitudinal measurement of health related data. It
allowed documenting palpitations, which patients reported for a long time, but that
could not be registered by diagnostic means before. Telemedicine also allows recording
ECGs associated with palpitation in an unprecedented, adequate quality [9].
Another aspect is long term monitoring of the course of a person’s medical condi-
tion. This forms the base for adjusting therapeutic measures to individual needs. Diabe-
tes patients, for one, can monitor their glucose level at home. If the levels are alarming,
a suggestion to adapt their insulin intake or to take other measures can be either gener-
ated by a decision support system, or by feedback of a physician [35, 36]. Asthma
patients for example can enter the output of a spirometer self-test into a web based
entry system. This allows patients to conduct the test in their own homes whenever
they want, without the need of visiting a physician’s office [37, 38]. Another example
is monitoring of high-risk pregnancies [39]. Women are monitored during gestation to
foresee complications that are life threatening for mother or child.
The third aspect is to detect events that endanger a person’s health, like falls,
strokes, heart attacks and such. The detection of events allows a rapid response which
again has an impact to outcome. Fall detection is one of the researched events because
it is an important factor for elderly persons to feel secure in their homes. Once a person
has experienced the serious consequences of a fall, the fear to fall again worries people
a lot. Knowing that a fall will be promptly detected, they regain confidence [40].
2.1.4. Target Group

The use of personal health monitoring is manifold. It is not only targeted to persons
with a medical condition who suffer a permanent reduction of their health status or
wish to keep themselves informed about their well-being. These are typically persons
who wish to live their life as normal as possible despite any ailments, like elderly per-
sons, disabled persons, and persons with cognitive impairment. Through monitoring,
deviances from usual habits as well as abnormal clinical parameters which indicate a
decline, can be detected [41]. Monitoring of drug intake can help to improve the com-
pliance of patients with cognitive impairment [34].
In addition to persons with chronic or permanent condition it is also targeted at
persons in need of medical attendance who are situated in a distance to appropriate
medical support (e.g. persons living in rural areas). Rehab patients for example can
receive appropriate treatment through telemedicine without the need to travel long
distances. This allows the patient to save valuable time without cut backs in the quality
of medical care [42].
But personal health monitoring is also used in other settings. It can be used by per-
sons who are still in perfect health, but still want to be informed about their well-being
as a preventive measure. Furthermore it is used to detect events that may happen with-
out any augury, like sudden infant death syndrome[43].
2.1.5. Active Participants

With the entrance of clinical data collection and assessment into everyday life of peo-
ple, secure management and handling of sensitive clinical data plays an important role.
The circle of people who have access to data has been broadened. On one hand, these
are people dealing with the data as a service provider (e.g. physicians, emergency med-
ical technicians, call centre workers, home care nurses, ICT technicians, data control-
lers), on the other hand lay carers are embedded in the caring workflow process and are
integrated at least into part of the data flow (e.g. alerts in case of adverse events). Final-
ly, the monitored persons themselves are active participants and can get immediate
feedback concerning their health status [1, 44, 45]. Others might involuntarily be ex-
posed to personalized health monitoring systems e.g. visitors or other health profes-
sionals like locum physicians or paramedics on an emergency calls. There is also the
possibility to partly monitor medical action taken by persons on house calls; this is
especially the case for the latter mentioned emergency services personnel.
2.1.6. Stakeholders
Besides the active participants mentioned in the section above there is a set of stake-
holders that may play a prominent role in future.
As for now, in Germany for example, statutory health insurers all have the same
fees by law. Most of their reimbursement is regulated by law as well. Insurers strive to
outstand by offering special programs. Personalized health monitoring could be part of
one of these additional features. (BARMER for example offers a personal health record
based on lifesensor, a interComponentWare product 4 , Techniker Krankenkasse
launched the “Telemedizin fürs Herz”5 (Telemedicine for the heart) programme where
subscribers are given a bathroom scale and a blood pressure cuff which transmit meas-
ured data via mobile phone to a telemedicine centre).
Insurance companies might also make personal health monitoring mandatory for
certain policies or discounts. Data acquired from monitoring might be collected by
insurers to calculate personal risk factors.
Service provider such as large telecommunication companies might see personal
health monitoring as a future market they want to serve as an end-to-end service pro-
vider. Microsoft6 and Google7 offer personal health records as a service, just to name a
few examples.
2.1.7. Used Technology

There are a great many of sensors and sensor systems for measuring almost every pa-
rameter which is measureable. The majority of telemonitoring projects target at the four
primary vital signs: body temperature, blood pressure, pulse, and respiratory rate. There
4
https://www.lifesensor.com/de/barmer (German)
5
http://www.tk-online.de/tk/behandlungsangebote/telemedizin/herz/9784 (German)
6
https://www.healthvault.com
7
https://www.google.com/health
are a number of Projects which have invasive and no invasive sensors. An example for
an invasive sensor is the measurement of blood pressure through intra-arterial catheters.
A non-invasive technique is a beat-by-beat blood pressure measurement on the finger
[20]. Some projects measure the environment of the person. Examples are sensors on
the floor which measure whether some is standing or lying on the floor. For mobile
environments like cars projects exist for example to recognize if someone is tired or
not.
These sensors or system of sensors can be a simple single value measurements or
even a very complex multi-value measurement based on more than one sensor tech-
nique. Most systems of sensors require a sophisticated design and extensive testing to
assure interoperability, security and safety of the whole composition. It is necessary to
consider the higher fault risks, e.g. loss of links or faulty links between sensors, higher
risk of intrusion or other manipulation – deliberate or not. Therefore, higher infor-
mation overhead is needed in order to monitor the health status of the system. This
information overhead includes for example information about the sensors themselves
like for example battery status, firmware status, link status, physical information, de-
tected spoofing attempts, just to name a few.
Table 2. Escalation steps in sensor setup for sensors used in PHM.
Escalation Step Example Explanation of Example

1a Sensor not designed for medical Sliding door Sensor detects variation in surrounding tem-
application sensor perature
1b System of sensors not designed for Burglar alarm Various sensors detect intrusion into a house
medical application
2a Single sensor for one single health Clinical Sensor used to diagnose body temperature at
parameter, discrete measurement thermometer time of use
2b System of sensors for one single Stress ECG System of sensors used to diagnose ability of
health parameter, discrete meas- cardiopulmonary system
urement
2c Sensor with monitoring capability ECG Sensor used to monitor cardiac activity
for single health parameter
2d System of sensors with monitoring EEG System of sensors used to monitor cerebral
capability for one single health activity
parameter
3a Sensor to detect multiple health Respiratory air Air flow, peak flow, inspirational volume,
parameters flow meter residual volume, expiration volume can be
measured
3b System of sensors to detect multi-
ple health parameters
3c Sensor with monitoring capability Pulse oximeter Infrared sensor used in pulse oximeters is
for multiple health parameters capable of sensing both SpO2 and pulse fre-
quency
3d System of sensors with monitoring ICU monitor Intensive care unit monitors monitor various
capability for multiple health signals
parameters
4a Sensor to detect wilful act of a Pedometer Sensor detecting shocks related to footsteps
person
4b System of sensors to detect wilful Geo-tracker Geo trackers allow tempo spatial tracing
act of a person
4c Sensor with monitoring capability ‘Pill Box’ The Pill Box monitors the compliance of a
for wilful acts of a person person to a drug subscription
Escalation Step Example Explanation of Example

4d System of sensors with monitoring Activities of Can monitor if a person successfully com-
capability for wilful acts of a Daily Living pletes tasks of daily living. E.g. having baths,
person monitoring cooking, walking.
5a Sensor to detect unconscious act Fall detection Accelerometers can detect sudden movements
of a person sensor of a person
5b System of sensors to detect uncon- Fall detection Accelerometers, gyrometers and microphones
scious act of a person system correlate the movement and the thud of a
person hitting the ground
5c Sensor with monitoring capability Micro sleep Sensors monitor the driver of a car to diminish
for unconscious acts of a person sensor the danger of micro sleep related accidents
5d System of sensors with monitoring ‘InBed’ (sleep Multiple sensors monitor a sleeping person’s
capability for unconscious acts of monitoring) movements, and detect convulsions etc.
a person
6a Sensor replacing body function Cochlear In certain cases of deafness, an electrode can
implant be implanted to stimulate the hearing nerve
6b System of sensors replacing body Prosthesis
function
6c Sensor replacing body function Insulin pump A sensor monitors blood glucose level and the
(with monitoring) device administers insulin accordingly
6d System of sensors replacing body Neuroprosthe- Various sensors give haptic feedback to
function (with monitoring) sis prosthesis wearer
7a Sensor enhancing body function Night vision The user’s sight is enhanced by an infrared
goggle sensor
7b System of sensors enhancing body G-Suit Fighter-plane pilots wear G-Suits to be able to
function withstand G-forces without passing out.
7c Senor enhancing body function Night vision The user’s sight is enhanced by an infrared
(with monitoring) camera sensor
7d System of sensors enhancing body Powered Future Force Warrior: Soldiers wear an exo-
function (with monitoring) exoskeleton skeleton and can carry heavy loads easily
8a Sensor to detect single environ- Radiation Radiation badges monitor the dose of radia-
mental parameter badge tion a person is exposed to
8b System of sensors to detect single Drinking Analysis of quality of drinking water supply
environmental parameter water analysis
8c Sensor with monitoring capability Room ther- Warns when room temperature is too high or
for single environmental parame- mometer too low to be safe.
ter
8d System of sensors with monitoring Breathing System that can sample the air a person is
capability for single environmen- zone sampling breathing –the sensor is situated close to the
tal parameter mouth/nose region of wearer
9a Sensor to detect multiple envi- Traffic count Counting of traffic for statistical investigation
ronmental parameters
9b System of sensors to detect multi- Neighbour- E.g. rotten-neighbor.com – online rating
ple environmental parameters hood rating platform for neighbourhoods
system
9c Sensor with monitoring capability Traffic density Monitors air pollution, noise etc. generated by
for multiple environmental param- monitoring traffic
eters
9d System of sensors with monitoring Weather Monitoring of temperature, humidity, atmos-
capability for multiple environ- station pheric pressure, precipitation
mental parameters
10a Sequencing of genome 23andMe.com Full sequencing of a person’s genome –
service offered for individuals
10b Detection of genetic predisposi- Microarray Rapid, high throughput testing of genetic
tion SNP testing morphism (Single Nucleotide Polymorphism)
In the literature one can see many signs that a pre-processing of data should be done
by the sensor system prior to the transfer over a medium to the data storage. Consider-
ing the measured data, the quality of data and the accuracy are important for the later
evaluation and interpretation process. The accuracy of self-measured data is different
than measurements by implants. As transport medium some projects use radio, others
wired connections. The dataflow is sometimes unidirectional sometimes bi-directional
which means that one can react to measured and transferred data, and manipulate the
sensor system from a distance. Telemonitoring can also be classified as a synchronous
(real-time) or asynchronous application [36]. Synchronous or real-time applications
process data within a very short time frame. In addition the point of time of data trans-
mission is predictable. This allows prompt reactions to sensor readings. Asynchronous
or delayed data processing refers to delayed transfer of data e.g. stored on a flash drive
and imported onto the target system at the next opportunity.
2.1.8. Measurement Techniques

The evolution of sensor setup closely depends on the actual measurement. With the
advances in miniaturization a variety of sensors becomes available for personal use at
an affordable cost. These sensors are small enough yet powerful enough to unobtru-
sively monitor parameters continuously in almost any environment. Together with the
advances in ICT, especially wireless communication, inter-sensor communication as
well as bi-directional communication of sensors with a central processing unit is feasi-
ble [46]. Sensors can be implanted into a person’s body (e.g. an implanted cardioverter-
defibrillator (ICD) with audible alert function by Medtronic Inc., Minneapolis, MN,
USA), placed on a person’s body (e.g. blood pressure cuff, ECG-electrodes etc.), or
monitor persons from a distance (e.g. motion detector, infrared thermometers, etc.).
Some sensors need to be used manually, like spirometers (devices to meter the respira-
tion air flow), or weight scales. Through the mentioned feasibility of communication
and data processing, in combination with powerful home computing and high band-
width internet connections, it is possible to store and communicate large amounts of
measurement data, thus creating a very dense clinical course. Complex algorithms
allow event detection in a series of measurements (e.g. fall detection using acceleration
sensors [47]). Bi-directional communication allows triggering of measurements, for
example if a person with dementia is to be located, or transmission of measured data
from remote spots, for example during a face-to-face visit in a physician’s office.
2.1.9. Information and Communication Technology

Data transfer rates have been increasing in the recent years. Not long ago data com-
pression was necessary in order to compensate the bottleneck of transfer speed. This
has changed in recent years. Broadband internet has become available not only in urban
areas, but also in most rural areas. With the abolition of the data transfer bottleneck
remote services have become available for many applications like online data storing,
online photo management or even online television in high definition quality. Key
infrastructures and the anticipated evolution are described in the next sections.
Broadband Internet: Currently, broadband landline internet connections are availa-
ble with bandwidth of up to 100 Mbit/s downstream (data transfer from the internet to
the customer). The upstream (transfer from customer to the internet) is artificially lim-
ited for market reasons, though 100 Mbit/s are feasible using VDSL2 (VDSL2, ITU-T
G.993.2). 1 Gbit/s DSL links have been achieved under lab conditions [48]. To exem-
plify the speed: current hard disk drives personal computers are typically equipped with
can achieve a data transfer rate of up to 150 MB/s (≈1.4 Gbit/s); of course new models
of build-in data storage, solid state discs (SSD) achieve up to 500MB/s. The key point
of this comparison is that data transfer rates over a long distance will be fast enough to
transfer huge amounts of data in real-time.
Mobile wireless networks: Current mobile wireless networks are third generation
networks (3G) of the global system for mobile communications (GSM). Using updates
to the specifications such as High-Speed Downlink Packet Access (HSDPA, HSDPA+)
applied to the provider’s networks, data rates of up to 14 Mbit/s can be achieved. The
International Telecommunication Union (ITU) targets to bandwidths of up to 1 Gbit/s
for low mobility applications (moving at pedestrian speed) and 100 Mbit/s for high
mobility applications (moving at speeds up to 350 km/h) for advanced 3G/4G networks
[49]. First fourth generation (4G) networks are already deployed in Sweden and Nor-
way[50]. The vast increase in mobile communication bandwidth removes the bottle-
neck of data transfer for mobile devices.
Wireless Personal Area Networks: In the field of wireless personal area networks
(WPAN), two technologies (Bluetooth and ZigBee) play an important role. Personal
area networks allow devices to exchange data within a short range (up to 100m for
Bluetooth, 75m for ZigBee). Bluetooth and ZigBee can be integrated both in stationary
devices as well as into mobile devices. Bluetooth (ratified as IEEE 802.15.1) was in-
troduced by the Bluetooth Special Interest Group (SIG) in 1994. It is a widespread
technology for wireless personal area networking. Its bandwidth is expected to increase
from initially 1 Mbit/s (Bluetooth 1.0) over currently 3 Mbit/s (Bluetooth 2.0 + EDR)
up to 24Mbit/s (Bluetooth 3.0 + HS) in the near future. With low power, low band-
width (Bluetooth 4.0) specifications, the SIG is targeting at integration of Bluetooth
technology into small, mobile devices. Bluetooth is an open standard, but registration
with the SIG is necessary in order to get access to the specifications [51]. ZigBee
(IEEE 802.15.4) is designed as a personal area network technology. It is similar to
Bluetooth but intended to be less complex and therefore cheaper than Bluetooth. It
features lower data rates (250 kbit/s per channel) but higher battery life and secure
networking. Home health monitoring is one of the markets the ZigBee Alliance focuses
on. ZigBee is an open standard and free of charge for non-commercial use. Commercial
applications require membership in the ZigBee Alliance [52].
3. Discussion
This review provides an overview on the technical background of personal health mon-
itoring technology. The complete field of PHM is very broad and complex. The devel-
opment of PHM is influenced by and closely interwoven with many different medical
and technical disciplines. Almost all projects that exceed the transfer of established
clinical measurements to the homes seem to be technology driven. The setup of meas-
ured parameters is rather static. It occurs that more parameters can be monitored simul-
taneously and close meshed. This is fostered by developments of advanced sensors that
provide more accurate readings, consume less power and are smaller in size. Sensors
can communicate with one another to give a complete impression of measurements of a
subject. The combination of parameters monitored (both medical and non-medical)
leads to new possibilities. The enhancement of technology shifts the assessment of
feasibility of monitoring from technical barriers to ethical, socio-psychological or legal

challenges. Data is aggregated in virtually all fields of a person’s life (e.g. communica-
tion, banking, travel bookings, groceries through customer appreciation cards, and
movement profiles through mobile phones). The German customer appreciation pro-
gramme Payback8 jointly operated by various nationwide retailers includes also phar-
macies. This exemplifies a low-key combination of medical and non-medical data
sources.
The review provides no statement about quality of measured data and no statement
about medical effectiveness of methods. The overview on ICT focuses on key technol-
ogies in the field of data transfer.
With the overview of the technological perspective on PHM an insight to the devel-
opment trajectory is given. This builds a basis for further investigation by other disci-
plines within the PHM-ethics project.
References
[1] M. Chan, D. Esteve, C. Escriba, E. Campo, A review of smart homes- present state and future challenges,
Computer Methods and Programs in Biomedicine 91 (2008), 55–81.
[2] G. Demiris, B.K. Hensel, Technologies for an aging society: a systematic review of "smart home"
applications, IMIA Yearbook 2008: Access to Health Information (2008), 33–40.
[3] T. Norgall, Fit und selbstständig im Alter durch Technik [Fit and independent in the aging population
using technology. From concept to reality?], Bundesgesundheitsblatt Gesundheitsforschung
Gesundheitsschutz 52 (2009), 297–305.
[4] M. Oeff, A. Muller, J. Neuzner, S. Sack, J.O. Schwab, D. Pfeiffer, C. Zugck, ECG telemonitoring,
Herzschrittmacherther Elektrophysiol 19 (2008), 137–145.
[5] S. Meystre, The current state of telemonitoring: a comment on the literature, Telemedicine Journal and e-
Health 11 (2005), 63–69.
[6] S.I. Chaudhry, C.O. Phillips, S.S. Stewart, B. Riegel, J.A. Mattera, A.F. Jerant, H.M. Krumholz,
Telemonitoring for patients with chronic heart failure: a systematic review, Journal of Cardiac Failure
13 (2007), 56–62.
[7] J.L. Roglieri, R. Futterman, K.L. McDonough, G. Malya, K.R. Karwath, D. Bowman, J. Skelly, S.W.
Warburton Jr., Disease management interventions to improve outcomes in congestive heart failure,
American Journal of Managed Care 3 (1997), 1831–1839.
[8] P.M. Vespa, Multimodality monitoring and telemonitoring in neurocritical care: from microdialysis to
robotic telepresence, Current Opinion in Critical Care 11 (2005), 133–138.
[9] J.O. Schwab, A. Muller, M. Oeff, J. Neuzner, S. Sack, D. Pfeiffer, C. Zugck, Nucleus der Arbeitsgruppe
Telemonitoring der Deutschen Gesellschaft für Kardiologie, Herz- und Kreislaufforschung,
Telemedizin in der Kardiologie – Relevanz für die Praxis?! [Latest proceedings: remote medicine -
ready for clinical practice?!], Herz 33 (2008), 420–430.
[10] A. Muller, T.M. Helms, J. Neuzner, J. Schweizer, H. Korb, Schrittmacher und interne Defibrillatoren
mit kardiotelemedizinischer Unterstützung [Pacemaker and implantable defibrillators with telemedical
support], Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 52 (2009), 306–315.
[11] VDE, Intelligente Assistenz-Systeme im Dienste für eine reife Gesellschaft. VDE Positionspapier,
Verband der Elektrotechnik Elektronik Informationstechnik e.V., Frankfurt am Main, 2008.
[12] S. Schleim, Gedankenlesen – Pionierarbeit der Hirnforschung, Access date: 02.09.2009, Available
from: http://www.heise.de/tp/r4/artikel/26/26759/1.html.
[13] W. Einthoven, The telecardiogram, American Heart Journal 53 (1957), 602–615.
[14] K. Hoffmann, R. Ruff, Flexible dry surface-electrodes for ECG long-term monitoring, Conference
Proceedings - IEEE Engineering in Medicine and Biology Society (2007), 5740–5743.
[15] L. Beckmann, C. Neuhaus, G. Medrano, N. Jungbecker, M. Walter, T. Gries, S. Leonhardt,
Characterization of textile electrodes and conductors using standardized measurement setups,
Physiological Measurement 31 (2010), 233–247.
8
http://www.payback.de
[16] P. Leijdekkers, V. Gay, A self-test to detect a heart attack using a mobile phone and wearable sensors,
21st IEEE International Symposium on Computer-Based Medical Systems (2008), 93–98.
[17] N.V. van der Hoeven, B.J.H. van den Born, M. Cammenga, G.A. van Montfrans, Poor adherence to
home blood pressure measurement schedule, Journal of Hypertension 27 (2009), 275–279.
[18] S. Deb, C. Nanda, D. Goswami, J. Mukhopadhyay, S. Chakrabarti, Cuff-Less Estimation of Blood
Pressure Using Pulse Transit Time and Pre-ejection Period. Proceedings of the 2007 International
Conference on Convergence Information Technology: IEEE Computer Society, (2007), 941–944.
[19] M. Wong, C. Poon, Y.T. Zhang, An Evaluation of the Cuffless Blood Pressure Estimation Based on
Pulse Transit Time Technique: a Half Year Study on Normotensive Subjects, Cardiovascular
Engineering 9 (2009), 32–38.
[20] G. Parati, P. de Leeuw, M. Illyes, S. Julius, I. Kuwajima, J.M. Mallion, K. Ohtsuka, Y. Imai, Blood
pressure measurement in research, Blood Pressure Monitoring 7 (2002), 83–87.
[21] M. Folke, L. Cernerud, M. Ekström, B. Hök, Critical review of non-invasive respiratory monitoring in
medical care, Medical and Biological Engineering and Computing 41 (2003), 377–383.
[22] M. Jaana, G. Pare, C. Sicotte, Home telemonitoring for respiratory conditions: a systematic review,
[23] S. Seereiner, K. Neeser, C. Weber, K. Schreiber, W. Habacher, I. Rakovac, P. Beck, L. Schmidt, T.R.
Pieber, Attitudes Towards Insulin Pump Therapy Among Adolescents and Young People, Diabetes
Technology & Therapeutics 12 (2010), 89–94.
[24] C. Fritschi, L. Quinn, S. Penckofer, P.M. Surdyk, Continuous Glucose Monitoring: The Experience of
Women With Type 2 Diabetes, The Diabetes Educator 36 (2009), 250–257.
[25] S. Skeie, G.B. Kristensen, S. Carlsen, S. Sandberg, Self-Monitoring of Blood Glucose in Type 1
Diabetes Patients with Insufficient Metabolic Control: Focused Self-Monitoring of Blood Glucose
Intervention Can Lower Glycated Hemoglobin A1C. J Diabetes Sci Technol 3 (2009), 83-88.
[26] O. Ajai, A. Tiwari, J.R. Alcock, Evaluation of the state-of-the-art in informatics in glucometers.
Informatics for Health and Social Care 34 (2009), 171-179.
[27] E. Renard, J. Place, M. Cantwell, H. Chevassus, C.C. Palerm, Closed-Loop Insulin Delivery Using a
Subcutaneous Glucose Sensor and Intraperitoneal Insulin Delivery. Diabetes Care 33 121-127.
[28] G. Labiris, M. Fanariotis, C. Christoulakis, A. Petounis, G. Kitsos, M. Aspiotis, et al., Tele-
ophthalmology and conventional ophthalmology using a mobile medical unit in remote Greece. J
Telemed Telecare 9 (2003), 296-299.
[29] G. Michelson, W. Striebel, W. Prihoda, V. Schmidt, Telemedicine in the control of intra-ocular
pressure. J Telemed Telecare 6 Suppl 1 (2000), 126-128.
[30] C. Jürgens, R. Grossjohann, J. Meiering, C. Meinke, S. Antal, F. Tost, Home-monitoring in
ophthalmology--prerequisites for an improvement in quality of life: conclusions from the management
research study Teletonometry Mecklenburg-Vorpommern. Klinische Monatsblätter für Augenheilkunde
226 (2009), 459.
[31] S. Lauriks, A. Reinersmann, H.G. Van der Roest, F.J. Meiland, R.J. Davies, F. Moelaert, et al., Review
of ICT-based services for identified unmet needs in people with dementia. Ageing Res Rev 6 (2007),
223-246.
[32] C. Chanussot-Deprez, J. Contreras-Ruiz, Telemedicine in wound care. International Wound Journal 5
(2008), 651-654.
[33] K. Persaud, A Nose for Infection. Wound Repair and Regeneration 15 (2007), 115.
[34] P. Cheek, L. Nikpour, H.D. Nowlin, Aging well with smart technology. Nurs Adm Q 29 (2005), 329-
338.
[35] F. Verhoeven, L. van Gemert-Pijnen, K. Dijkstra, N. Nijland, E. Seydel, M. Steehouder, The
contribution of teleconsultation and videoconferencing to diabetes care: a systematic literature review. J
Med Internet Res 9 (2007), 37.
[36] J. Polisena, K. Tran, K. Cimon, B. Hutton, S. McGill, K. Palmer, Home telehealth for diabetes
management: a systematic review and meta-analysis. Diabetes Obes Metab (2009).
[37] J. Finkelstein, G. Hripcsak, M.R. Cabrera, Patients' acceptance of Internet-based home asthma
telemonitoring. Proc AMIA Symp (1998), 336-340.
[38] J. Finkelstein, M.R. Cabrera, G. Hripcsak, Internet-based home asthma telemonitoring: can patients
handle the technology? Chest 117 (2000), 148-155.
[39] H. Buysse, G. De Moor, G. Van Maele, E. Baert, G. Thienpont, M. Temmerman, Cost-effectiveness of
telemonitoring for high-risk pregnant women. International Journal of Medical Informatics 77 (2008),
470-6.
[40] N. Noury, A. Fleury, P. Rumeau, A.K. Bourke, G.O. Laighin, V. Rialle, et al., Fall detection--principles
and methods. Conf Proc IEEE Eng Med Biol Soc 2007 (2007), 1663-1666.
[41] J. Demongeot, G. Virone, F. Duchene, G. Benchetrit, T. Herve, N. Noury, et al., Multi-sensors

acquisition, data fusion, knowledge mining and alarm triggering in health smart homes for elderly
people. C R Biol 325 (2002), 673-82.
[42] M. Sung, C. Marci, A. Pentland, Wearable feedback systems for rehabilitation. J Neuroeng Rehabil 2
(2005), 17.
[43] J. Weber, D. Blanc, A. Dittmar, B. Comet, C. Corroy, N. Noury, et al., Telemonitoring of vital
parameters with newly designed biomedical clothing. Stud Health Technol Inform 108 (2004), 260-5.
[44] M.N. Boulos, A. Rocha, A. Martins, M.E. Vicente, A. Bolz, R. Feld, et al., CAALYX: a new
generation of location-based services in healthcare. Int J Health Geogr 6 (2007), 9.
[45] V. Rialle, F. Duchene, N. Noury, L. Bajolle, J. Demongeot, Health "Smart" home: information
technology for patients at home. Telemed J E Health 8 (2002), 395-409.
[46] O. Aziz, B. Lo, J. Pansiot, L. Atallah, G.Z. Yang, A. Darzi, From computers to ubiquitous computing
by 2010: health care. Philos Transact A Math Phys Eng Sci 366 (2008), 3805-11.
[47] C. Ni Scanaill, S. Carew, P. Barralon, N. Noury, D. Lyons, G.M. Lyons, A review of approaches to
mobility telemonitoring of the elderly in their living environment. Ann Biomed Eng 34 (2006), 547-63.
[48] B. Lee, J.M. Cioffi, S. Jagannathan, M. Mohseni, Gigabit DSL. IEEE Transactions on Communications
55 (September 2007), 1689 - 92.
[49] Report ITU-R M.2134. Requirements related to technical performance for IMT-Advanced radio
interface(s): International Telecommunication Union2008 Contract No.: M.2134.
[50] TeliaSonera. TeliaSonera has selected 4G vendors. Access date: 28.01.2010. Press Release]. Available
from: http://www.teliasonera.com/press/pressreleases/item.page?prs.itemId=466640.
[51] Specification of the Bluetooth System Version 4.0.
http://www.bluetooth.com/Bluetooth/Technology/Building/Specifications/: Bluetooth SIG, Inc.; 2009.
[52] ZigBee Specifications. http://www.zigbee.org: ZigBee Alliance, Inc.; 2007.
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-41
Psycho-Social Aspects of
Personal Health Monitoring:
A Descriptive Literature Review
Holger MUEHLAN1 and Silke SCHMIDT
Department of Health and Prevention,
Ernst-Moritz-Arndt University of Greifswald
Abstract. We aimed at providing a short review on already published studies

addressing psycho-social issues of personal health monitoring (PHM). Both core
questions addressed within this review are: What is the impact of PHM on
intended psycho-social and health-related outcomes? And which psycho-social
issues affected by or related to PHM have already been investigated? This
descriptive review based on a literature search using various databases (Psycinfo,
Psyndex, Pubmed, SSCI). Resulting 428 abstracts were coded regarding their
psycho-social content. Inspection of results was carried out along the relevance of
the papers regarding psycho-social issues. Research in PHM focuses on
telemonitoring and smart home applications: Tele-monitoring studies are directed
to outcome-related questions, smart home studies to feasibility issues. Despite of
technological matters, comparability of both systems in psycho-social issues is
lacking. Tele-monitoring has been proven for impact on patient groups with
chronic diseases, yet smart home still lacks evidence in health-related and psycho-
social matters. Smart home applications have been investigated with respect to
attitudes, perceptions and concerns of end-users, telemonitoring regarding
acceptance and adherence.
Keywords. Personal health monitoring, telemonitoring
Introduction
Our research group initiate literature search to identify relevant psycho-social issues in
terms of psychological and social impact and outcomes regarding the implementation
of PHM applications in health care settings or for health-related purposes. This paper
will give a general outline of the results.
As “Personal Health Monitoring” (hereafter PHM) has not widely established as a
key word or a technical term for a specific group or collection of technologies or
technical systems there was a need on fixing what the term “PHM” refers to. Thus, for
reasons of clarification, a preliminary working definition of what is referred to as PHM
was developed within the European PHM-Ethics Group: “Personal Health Monitoring
comprises all technical systems processing, collecting, and storing data linked to a
person. It allows monitoring parameters of that person, and leads to health-related
information of that person”. This working definition serves as a detector for addressing
PHM in past, present, and future, as it has been established on an abstract level to keep
1
42 H. Muehlan and S. Schmidt / Psycho-Social Aspects of Personal Health Monitoring
the scope broadened and the inclusion criteria not too restricted to be flexible enough
for future developments within the rapidly emerging field of PHM technology
evolution. Given the case of “smart homes” this progression itself had also been subject
to a study, analysing the dynamics of technical configurations in general [1].
As the previously outlined working definition does not include discrete PHM
technologies or technical systems, our project partner from the Department of Medical
Informatics of the University Hospital of Goettingen (Germany), namely Murat Gök,
Gunnar Nußbeck, and Otto Rienhoff (Head of Department), were providing us with all
information about technology-related information necessary for this review. Thus, their
contribution supports us to fix an initial collection of PHM related key words for our
literature search (“ambient assisted living”, “smart home”, “personal health
monitoring”, “pervasive health care”, and “telemonitoring”).
1. Method
1.1. Specific objectives
In general, the objective of this literature review addresses psycho-social issues of

PHM applications. More specifically, this review is directed to answering two
questions: What is the impact of PHM on intended psycho-social and health-related
outcomes (e.g. satisfaction, quality of life, hospitalization, mortality)? And which
psycho-social issues affected by or related to PHM (e.g. perceptions, attitudes,
acceptance, adherence) have already been investigated?
1.2. Databases
For our review we screened relevant databases, storing publications on PHM with
special emphasis on psycho-social issues. Literature review included the following
databases:
• MEDLINE (PUBMED): Database from the American Medical Association
(AMA), that holds publication entries from all medical areas published since
1966.
• PSYCINFO: The PsycINFO database, the American Psychological
Association’s (APA) renowned resource for documents, is the largest resource
devoted to peer-reviewed literature in behavioral science and mental health. It
contains nearly 3 million documents dating as far back as the 1600s. Journal
coverage, which spans from the 1800s to the present, includes international
material selected from more than 2,400 periodicals in nearly 30 languages.
• PSYNDEX: PSYNDEX is the most comprehensive abstract database of
psychological documents from the German-speaking countries. PSYNDEX
contains two database segments: PSYNDEX Literature and Audiovisual
Media with records of psychological publications, audiovisual media, and
descriptions of intervention programs; PSYNDEX Tests with extensive
descriptions of tests.
• SSCI (Social Science Citation Index): SSCI is an abstract database including
approximately 2.500 social sciences journals as well as 3.500 of the scientific
and technical journals.
H. Muehlan and S. Schmidt / Psycho-Social Aspects of Personal Health Monitoring 43
1.3. Search Algorithm
As the databases chosen for literature search represents a selection with respect to the
targeted subject, we decided to apply terms directly addressing technical systems
representing or dealing with PHM technologies; after running the initial literature
search, we selected further terms by reviewing the resulting literature and the search
was done once again. Finally, the following lists of terms was used for running the
literature search: “ambient assisted living”, “smart home”, “personal health
monitoring”, “pervasive health care”, “telemonitoring”, “remote health monitoring”,
and “remote health assessment”. The latter two terms are added to the initial collection
provided by our project partner. As some of the database records were exclusively
available in German language (PSYNDEX), the term list was added with the German
translation of the terms, as far as a German term had been established so far, as most of
the terms are used in German in their English original wording too. The search was
restricted for all sources published until 2009. After running the search, 517 articles
returned. After the removal of duplicates (89) 428 articles still remain.
1.4. Preparation
Initially, abstracts were rated regarding their psycho-social relevance (0=”not relevant”,
1=”less relevant”, 2=”medium relevant”, 3=”most relevant”). Coding was realized
from a trained psychologist and sociologist, supervised by the Project Manager.
Initially, to increase reliability, 15 randomly chosen abstracts were independently rated
by a second judge after the initial agreement on the principal scoring procedure. After
the initial double-scoring both judges checked and discussed differences in the ratings,
resulting in a refined and more reliable rating procedure. Remaining papers were
assessed by one judge only. After the coding was completed, we first focus on papers
with psycho-social relevance, with a focus on papers rated as “most” or at least
“medium” relevant. At the same time, abstracts were analysed and information was
prepared and transferred into an Excel-spreadsheet with respect to various criteria
(main objective, methods used, target group/participants, and results/conclusion). With
respect to methodological considerations, we also put our focus on descriptive reviews
and systematic meta-analysis as well as randomized control trials for outcome
evaluation. Regarding psycho-social issues, we also highlight qualitative studies. As
literature search had been initially arranged very broadly, many papers return just
dealing with technological issues – even if stored in databases of social sciences.
2. Results
2.1. General Results
A first look on the results returning provides an initial impression about the frequency
of psycho-social issues addressed in PHM-related scientific documents: As compared
to the final bulk of publications, the minority of papers has been listed within genuine
psychological or social scientific databases (Pycinfo, Psyndex, SSCI: 102 documents).
The majority of results returned from browsing the MEDLINE database (415
documents).
As the results in terms of frequency of publications, psycho-social content, main

objective or methods used, strongly vary between different PHM applications
addressed within this review, we decided to outline the results in a more “logical”
order. Thus, results are presented in line with the respective PHM application or under
the heading of the corresponding technical term used for literature search respectively.
Thus we go on from those terms located on a “higher” or abstract level to even more
discrete terms referring to already established applications such as “telemonitoring”.
“ambient assisted living” applications and “smart home” systems are not grouped
together as “assistive technologies”. Although both technologies are strongly related in
terms of shared purposes and target groups, we neglected this classification as
“assistive technologies” to provide information on existing research specific to each
application.
2.2. Specific Results
2.2.1. Personal Health Monitoring – PHM

Documents without psycho-social relevance: For “personal health monitoring” (PHM)
a total of 11 hits return. Focusing on literature dealing at least to some part with
psycho-social issues, just 5 papers remain according to the ratings. Other 6 papers
remain primarily addressing technological innovations in PHM, such as system-on-a-
chip devices, intrabody communication, wearable health systems, ECG analysers for
mobiles, personal recognition using head-top images, and the use of microsystem
technical sensors.
Documents with psycho-social relevance: The 5 papers dealing with psycho-social
issues at least on a minor level are published between 1985 and 2005. The both most
recent papers are from the same working group, addressing the impact of PHM on the
health care system, especially regarding the transformation of professional culture
resulting from the implementation of PHM [2, 3]. One paper is dealing with potentials
of PHM for managing community health nursing, that is for assessing, monitoring, and
planning the distribution of public health nursing resources at the community level [4].
Another paper focuses on cost reduction in public health care systems by the use of
information technologies for PHM [5]. The last remaining paper reports on the use of
PHM for air monitoring, estimating personal exposures to air pollutants in a
community-based study of health effects in asthmatics [6].
Conclusions: Despite of the sparse literature including the term “PHM”, some
statements and conclusions could be derived. PHM has not been established as a key
term, it is rather referred to as a process using various technologies for different
processes in several settings monitoring selected target groups. PHM fails
technological and terminological uniqueness; it’s a term used for a variety of
technologies allowing for monitoring persons regarding health-related parameters.
Thus, literature is very heterogeneous. Comparing the frequency of documents
published dealing with psycho-social issues of PHM with the range of years these
documents have been published, it appears that PHM has not been established as a
discrete term. There is one common issue in all papers outlined: All studies stress the
impact of PHM on health-related social systems (health care system, medical/health
professions etc.) rather than the impact on persons monitored by PHM applications.
2.2.2. Remote Health Monitoring / Remote Health Assessment – RHM / RHA

Documents without psycho-social relevance: Screening for “remote health monitoring”
(RHM), a total of 21 results (excluding duplicates) return. Focusing on literature
dealing at least to some part with psycho-social issues, 10 results remain. Excluded
papers are mostly dealing exclusively with issues of technical innovation, such as wire-
less body-area networks, energy consumption of mobile phones, fish-eye cameras, or
algorithms for activity monitoring in smart homes, wearable non-invasive monitoring
systems, and data access architectures for home monitoring. One study was directed to
health monitoring in animals. The studies on “remote health assessment” (RHA)
investigating RHA to detect forest health, RHA for human health risks from blooms of
potentially toxic cyanobacteria or technical issues of RHA.
Documents with psycho-social relevance: Most of the papers that address psycho-
social issues are dealing with RHM in (smart) home environments for the elderly [7-
10] or in rehabilitation [11]. More specific studies on RHM are investigating the use of
bio-behavioral monitoring [12], or applications for patients with chronic heart diseases
[13]. One study investigated the implementation of a community-based intervention
[14]. Another study aimed at understanding how tele-health can provide support to
health professionals under challenging conditions in developing countries and
potentially provide access to resources (RHA). A more general study was undertaken
evaluating the impact of RHM on health outcomes in rural areas [15].
Conclusions: Similar to “personal health monitoring”, the terms “remote health
assessment” or “remote health monitoring“ are uncommon in the respective literature.
Both are generic terms, emphasizing the fact of acquiring health-related data from a
distance of the data source. The objective of investigations varies according to techno-
logy used and target group addressed. Moreover, it turns out that RHM/RHA is not
necessarily linked to monitoring issues, as RHM/RHA could also be an integral part of
more complex e-health or tele-health systems.
2.2.3. Pervasive Health Care – PHC

Documents without psycho-social relevance: For “pervasive health care” (PHC) a total
of 5 results return. Limiting the results to literature dealing at least to some part with
psycho-social issues, 4 papers remain. The other paper investigated the impact of
alcohol-related medical emergencies on health care utilization in an inner city hospital
medical intensive care unit.
issues at least on a minor level are published between 2008 and 2009, thus the rare
output has been published within the last 2 years. Regarding methodological
considerations neither a review on randomized control trials, nor a single randomized
control trial could be identified. The remaining group of papers address the relevance
of PHM technologies regarding different levels of generality, that is the role of PHM
technologies in general [16, 17], in providing more efficient health care in special [18],
or with respect to the question how PHM technologies could lead to new ways of living
and new ways of health care [19].
Related issues – “pervasive computing in health care” (PCHC): As PCHC is
strongly associated with PHC we also screened one generic review that aims at
providing an overview on literature on PCHC [20]. This review includes a paragraph
on “deployment issues”, including organizational and personnel issues, privacy and
security issues as well as financial issues. With respect to these “deployment issues”,
authors conclude that “although these issues are crucial for the success of pervasive
computing in health care, they are rarely addressed in literature. Hence, no quantitative
analysis of these topics was possible” (ibid., p. 12f.).
Conclusions: For PHC, some of the conclusions derived for PHM and RHM/RHC
hold true even stronger. As only a few documents have been identified explicitly using
this term, we assume that there is no “body of research” on PHC so far. Moreover, as
all documents of psycho-social relevance have been published within the last 2 years,
PHC seems to be an upcoming issue. All papers at least have two things in common: all
addressing the relevance of PHC and thus, PHM technologies, and all documents
retrieved have been published very recently. While broadening the scope from PHC to
PCHC trying to answer the question regarding psycho-social issues of relevance “in
advance”, there is also a lack of research on this topic in this area.
2.2.4. Ambient Assisted Living – AAL

Documents without psycho-social relevance: Searching for “ambient assisted living”
(AAL), a total of 14 results return. Focusing on literature dealing at least to some part
with psycho-social issues, 8 papers remain, whereas the other 6 papers primarily
address technological innovations in AAL.
issues at least on a minor level are published between 2007 and 2009, thus indicating
that AAL is an upcoming topic and empirical studies are still rare. As AAL
technologies within health monitoring contexts primarily aiming at enhancing quality
of live for older and disabled people, the majority of studies included elderly persons or
targeted on older people [21-27]. One out of these publications outlines several
psychological models regarding user acceptance and motivation directed to applying
“assistive technologies” such as AAL or SH technologies, respectively [23]. One solely
publication is directed to present a project on “emotional engineering” issues linked to
AAL [28].
Conclusions: AAL has mostly been investigated within the context of “assistive
technologies”, enabling older or disabled people to more comfortable living or improve
quality of life. Thus, core questions are directed to outcomes of implementing not AAL
specifically, but assistive technologies in general. Thus, AAL is also strongly linked to
smart home technologies. AAL is assumed to provide high potentials in improving
quality of life for older and disabled persons, although it has been rarely empirically
studied so far regarding outcome parameters or psycho-social issues. As the majority of
papers do not report original empirical data, no conclusions could be derived regarding
evidence for impact on psycho-social issues or clinical outcomes.
2.2.5. Smart Home – SH

Documents without psycho-social relevance: For “smart home” (SH) technologies, a
total of 84 results return. (Within a systematic review on SH technologies, 114
publications has been identified [29]. In order to provide a comprehensive review of
SH projects the authors conducted extensive searches across databases from a
multitude of disciplines and manually searched for relevant references in the retrieved
documents. ) Focusing on literature dealing at least to some part with psycho-social
issues, 44 papers remain, where-as the other 40 papers primarily addressing
technological innovations, most frequently published in the Conference Proceedings of
the IEEE English Medical and Biological Society (14 documents) or journals such as
“Studies in Health Technology & Informatics” (6 documents) and “Technology &

Health Care” (5 documents).
Documents with psycho-social relevance: The 44 papers that had been judged as
relevant regarding psycho-social issues are published between 1994 and 2009, with just
2 papers dating before 2001. Thus, the majority of literature has been published after
2000, indicating a growing interest of the SH as an emerging field of assistive
monitoring technologies. Given the bulk of publications finally matched the main
criteria (“smart home” and psycho-social relevance), it was decided to focus on
randomized controlled studies as well as already existing reviews for evaluating
outcome research in a first step. For analyzing psycho-social issues, we broaden the
scope by screening publications on further empirical investigations (e.g. case studies,
qualitative investigations, surveys, quasi-experimental designs) that had been rated as
average or most relevant with respect to their psycho-social content.
Methodological issues: As opposed to a lack of RCT-based outcome studies in the
area of smart home technology evaluation, a series of qualitative studies including
interviews and focus groups and multiple interview surveys primary addressing
psycho-social and outcome issues related to SH have been established within the last
years. In most cases, focus groups and interviews were used for data recruitment with
emphasis on perceptions and attitudes of elderly persons regarding smart home
technologies. Some papers reporting on case studies [30, 31].
Outcome research: Some reviews on smart home applications could be identified,
slightly differing regarding their main objective and more significantly regarding their
methodological approach. Besides one extensive review on smart home projects [29],
one selective review of smart home projects [32] and one descriptive review on the
“emerging concept” of health smart homes “and its potential through the use of tele-
medical information systems and communication technologies” [33] could be
identified. At least, one review especially regarding outcome evaluation had been
published [34]. Moreover, one RCT study [35] was identified. Given the outcome
review and the one RCT study, the results are ambivalent. As the review from
Cochrane’s Library seeks to include RCT studies, quasi-experimental studies,
controlled before and after studies and interrupted time series analyses, none of the
existing studies does fulfill the inclusion criteria of the review [34], the authors
conclude that this result “high-lights the current lack of empirical evidence to support
or refute the use of smart home technologies within health and social care”. The one
randomized control study [35] has already been published in 2007 but was not included
in the review from 2008. This RCT study initially indicated the use of smart home
technologies as well as their impact on outcome measures: The study included 46
treatment and 67 control home-based frail elders who lived alone. Participants
benefited from the SH technology, and 91% recommended its use by others Treatment
group maintained physical and cognitive status, control group declined significantly in
both [35]. On the background of these results, we have to conclude that much more
evaluation and outcome-related research is needed. This conclusion is also supported
by another review [31], that pro-vides a comprehensive overview of existing smart
home projects. Regarding the impact on clinical outcomes of the reviewed smart home
projects, authors stated that evidence is lacking.
Further issues: Several studies highlight positive attitudes of older people towards
SH technologies: Two studies investigating older people perceptions of and reactions
on a variety of different SH applications [36, 37]. In one out of those studies [36], the
majority of the participants responded most positively to the smart door and voice
activation [36]. As opposed to widely established assumptions on older people and

technology, most findings are contradictory, indicating a basically positive attitude on
SH technologies [36-38]. Nevertheless, barriers for accepting and adopting SH
technologies already exist, e.g. the inference of technology on daily routines or
concerns related to those technologies [39, 40]. Where concerns occur in participants,
they are related to issues of privacy, user-friendliness of the devices or a lack of human
response [39-42]. Depending on the SH environment, participants included as well as
the degree to which participants are involved in the respective study or SH
development, concerns regarding privacy vary. For instance, one study using a
participatory evaluation of an ongoing SH project [43], participants did not express
privacy concerns. Moreover, they reported a sense of control resulting from their active
involvement in the evaluation process. Obtrusiveness, as a specific construct associated
to questions of privacy has also been object of research for some studies on SH [44-
46]. The impact of implementing SH applications in organisations has been rarely
studied, one study explores the constituents of and challenges related to technological
innovations such as SH applications in the long-term homecare sector [47].
Conclusions: As SH technology is primarily directed to older and disabled people,
investigating the psycho-social impact of SH applications is almost confounded with
the “age-factor”, irrespective of which specific issue has been addressed. Therefore,
most of the studies are more strongly linked to issues of “ageing and technology”,
rather than to “personalized monitoring of health”. SH technologies – as for AAL – are
strongly focused as assistive technologies, enabling older or disabled people to more
comfortable living or improve quality of live. Core questions are directed to attitudes
on and perceptions of SH by (potential) end-users, especially older persons and the
impact of SH technologies on health-related outcomes. As opposed to AAL, studies on
SH technologies are increasing and span a wide range of issues, also including psycho-
social ones. Challenges in investigating and evaluating SH technologies are the
specificity of various configurations and the necessity of independent evaluation, as
research so far often has been undertaken by the provider or system developer.
Further reading: Most recommended paper for psycho-social issues on SH are the
comprehensive reviews on smart home projects [31, 32], providing a sufficient
introduction to the field and explicitly addressing psycho-social issues as well. More-
over, a working group from the University of Washington in Seattle (Head: George
Demiris) had published a bulk of publications addressing a variety of issues of psycho-
social relevance of SH technologies [22, 31, 37, 40-46, 48-52]. In addition, the
systematic review from the Cochrane Library on publications related to SH
technologies for health and social support [34] in combination with the sole RCT study
[35] are recommended for impact evaluation of SH.
2.2.6. Tele-Monitoring – TM
Out of 263 documents, 73 have been judged as not relevant, whereas just 9 papers have
been rated with “most relevant”. As opposed to other key terms reviewed, TM has been
widely researched so far. A bulk of papers returned including dozens of randomized
clinical trials and reviews. To handle the stuff we focus on systematic and descriptive
reviews. Within a further methodological inspection it turns out that there are just a few
qualitative studies, using interviews, focus groups or delphi studies, although they
appeared more frequently in the last years [38, 47, 53-57].
Outcome research: As opposed to research on SH applications, TM studies had

been strongly focused on outcomes and evaluation. Besides a battery of RCT studies,
selected systematic reviews on RCTs using TM as well as several descriptive reviews
on TM in various patient collectives have been identified. In the following, the
paragraph on „outcome research“ is subdivided with respect to various chronic
conditions.
Chronic diseases in general: One systematic review on outcomes of TM for four
types of conditions was conducted, including pulmonary conditions, diabetes,
hypertension, and cardiovascular diseases [58]. Evaluating the impact of TM on
outcomes (e.g. early detection of symptoms, reduced mortality) is ambiguous or in
terms of the authors “inconclusive”. Nevertheless, observed effects are more consistent
in pulmonary and cardiac studies than diabetes and hypertension. Moreover, patients
comply with TM applications and the use of these technologies in general, irrespective
of various socio-demographic indicators.
Chronic heart diseases: Mortality decreased for TM in chronic heart failures
patients, and several outcomes (e.g. related to hospitalization) have proofed to benefit
from TM [59]. Three out of 4 studies display economic advantages of TM. Regarding
psycho-social outcomes, results are inhomogeneous as just 3 out of 6 studies shows
TM to improve quality of life.
Hypertension: A descriptive review including 14 studies summarizes empirical
evidence on the impact of TM on hypertension patients. Evidence is reported for
positive impacts of TM on patients and their conditions (e.g. changes in patients'
lifestyle), although results of the studies reviewed ”should be considered with caution
due to the limitations of study designs” [60].
Diabetes: In one systematic review on diabetes patients [61] TM has shown a
positive effect on glycemic control, although results were deviant for telephone
support. Again, results indicate that TM had a positive impact on numerous health
services (number of patients hospitalized, hospitalization, days of care in bed).
Regarding psycho-social outcomes such as patient satisfaction and quality of life, TM
in diabetes patients was similar or favorable to conventional care. In addition several
descriptive reviews had been screened, addressing evaluation of TM in diabetes care
[62]. A further descriptive review on home telemonitoring of patients with diabetes
showed significant reduction in clinical parameters and complications, good
receptiveness by patients and patient empowerment and education [62]. Nevertheless,
authors stated that “the magnitude of effects remains debatable”.
Respiratory conditions: One descriptive review [63] had been published regarding
the impact of TM in patients with respiratory conditions such as asthma or chronic
obtrusive pulmonary disease (COPD). Although the positive impact on patient health-
related behavior had been shown consistently as this also holds true for patient’s
attitudes and receptiveness of TM, “little quantitative evidence exists about its effects
on patient medical conditions and utilization of health services”. For instance,
regarding socio-economic impact, just two studies analysed performing a detailed cost
analyses. Also a narrative review [64] points out, that, even while “many studies report
that staff and patients ‘liked” the technology”, results for the impact of TM on clinical
outcomes, quality of care or financial costs were “less obvious”. Thus, to sum up,
despite of some initial empirical support on the impact of TM in respiratory conditions,
results are preliminary and evidence is still lacking.
Further issues: As TM is directed to monitor patients at a distance from the
caregiver, it is assumed this technological innovation should have an impact on the
relationship between caregiver and patient, especially as there had been a huge
emphasis on the relevance of the doctor-patient-relationship in terms of trust etc. As
opposed to that, research on psycho-social issues of telemonitoring had been widely
focused on patient-related barriers of implementation (acceptance), determinants of
utilization related to patient behaviour (adherence, compliance) and clinical outcomes
as quality of life, satisfaction, mental health indicators etc. Less research has been
published addressing the impact on caregivers, the relationship between caregivers and
patient and the social systems affected by the implementation of telemonitoring
systems [57]. Although patient’s attitudes towards telemonitoring frequently have been
evaluated as positive [58, 60, 63, 64], similar data for provider and medical staff are
rare. Thus, the assessment of providers' acceptance and attitudes regarding
telemonitoring as well as evaluation of the impact on their workload remains necessary
[58, 60, 63].
Conclusions: Tele-monitoring is believed to have the potential to enhance health
care, quality of life, and prognosis of patients with chronic illness. The summarized
empirical scientific findings based on systematic and descriptive reviews including
various patient populations with chronic conditions. Numerous findings suggest that
telemonitoring in terms of monitoring by phone and by vital signs can improve quality
of care for patients with chronic heart failure by decreasing mortality. Findings
concerning the implementation of telemonitoring techniques to other chronic diseases
like diabetes or respiratory diseases are ambiguous with respect to clinical outcomes.
Evidence for the positive impact on patient-related outcomes (e.g., quality of life) is
ambiguous as well. On the other hand, patient's satisfaction with telemonitoring
techniques seems to be high. But it has to be noted that empirical approaches are
missing, and that especially the impact of different models of care on the interference
of the doctor-patient-relationship and on the medical occupation-role has not been
evaluated yet. In addition, less in evidence is provided regarding the attitudes of the
medical staff and the impact of telemonitoring on their workload.
3. Discussion
Research so far strongly focuses on telemonitoring and smart home applications.

Moreover, focus of research differs between different types of PHM: TM studies are
usually directed to outcome-related questions; smart home studies focus on feasibility
issues. Both applications strongly differ, as they are developed for different purposes.
Thus, despite of various technological issues, comparability of both systems regarding
psycho-social issues is lacking. Telemonitoring has been proven for impact on various
patient groups with chronic diseases, whereas smart home still lacks evidence on its
impact on health-related and psycho-social indicators, although some first studies have
been conducted. Psycho-social topics in smart home applications have been mainly
investigated with respect to attitudes, perceptions and concerns of end-users,
telemonitoring was more likely to be investigated regarding acceptance and adherence.
There is a need for more research regarding the impact of PHM devices on psycho-
social issues.
Our search is limited by neglecting ongoing and emerging technological
innovations, immediately changing the broad field of PHM and therefore our targeted
subject of interest [1]. Reconsidering this, our results are temporary and preliminary,
although the working definition on PHM from the PHM Ethics Group has been
established in order to keep track of innovation dynamics. Furthermore, the review is

limited by the final list of terms used in search and the selected databanks retrieved.
Thus, this review provides a more general overview but it is far from being exhaustive.
4. Acknowledgements
no. 230602.
References
[1] A. Peine, Understanding the dynamics of technological configurations: A conceptual framework and the
case of Smart Homes. Technological Forecasting and Social Change 76 (2009), 396–409.
[2] S. Bolsin, M. Colson, Making the case for personal professional monitoring in health care, International
Journal for Quality in Health Care 15 (2003), 1–2.
[3] S. Bolsin, A. Patrick, M. Colson, B. Creatie, L. Freestone, New technology to enable personal monitoring
and incident reporting can transform professional culture: the potential to favourably impact the future
of health care, Journal of Evaluation in Clinical Practice 11 (2005), 499–506.
[4] J.G. Kosidlak, K.B. Kerpelman, Managing community health nursing. A personal computer tool for
assessing, monitoring, and planning the distribution of public health nursing resources at the
community level, Computers in nursing 5 (1987), 175–180.
[5] C. Kunze, U. Grossmann, W. Stork, K.D. Müller-Glaser, Application of ubiquitous computing in
personal health monitoring systems, Biomedizinische Technik 47 (2002), 360–362.
[6] T.H. Stock, D.J. Kotchmar, C.F. Contant, P.A. Buffler, A.H. Holguin, B.M. Gehan, L.M. Noel, The
estimation of personal exposures to air pollutants for a community-based study of health effects in
asthmatics-design and results of air monitoring, Journal of the Air Pollution Control Association 35
(1985), 1266–1273.
[7] B.G. Celler, W. Earnshaw, E.D. Ilsar, L. Betbeder-Matibet, M.F. Harris, R. Clark, T. Hesketh, N.H.
Lovell, Remote monitoring of health status of the elderly at home. A multidisciplinary project on aging
at the University of New South Wales, International Journal of Bio-Medical Computing 40 (1995),
147–155.
[8] B.G. Celler, N.H. Lovell, T. Hesketh, E.D. Ilsar, W. Earnshaw, L. Betbeder-Matibet, Remote home
monitoring of health status of the elderly, Medinfo 8 (1995), 615–619.
[9] P.R. Liu, M.Q. Meng, P.X. Liu, F.F. Tong, X.J. Chen, A telemedicine system for remote health and
activity monitoring for the elderly, Telemedicine Journal and e-Health 12 (2006), 622–631.
[10] F.G. Miskelly, Assistive technology in elderly care, Age Ageing 30 (2001), 455–458.
[11] M. Cooper, D. Keating, Implications of the emerging home systems technologies for rehabilitation,
Medical Engineering and Physics 18 (1996), 176–80.
[12] M.K. Goldstein, G.H. Stein, D.M. Smolen, W.S. Perlini, Bio-behavioral monitoring: a method for
remote health measurement, Archives of Physical Medicine and Rehabilitation 57 (1976) 253–258.
[13] R. Ricci, L. Morichelli, M. Santini, Home monitoring remote control of pacemaker and implantable
cardioverter defibrillator patients in clinical practice: impact on medical management and health-care
resource utilization, Europace 10 (2008), 164–170.
[14] R. Harvey, M. Smith, N. Abraham, S. Hood, D. Tannenbaum, The Hurricane Choir: remote mental
health monitoring of participants in a community-based intervention in the post-Katrina period, Journal
of Health Care for the Poor and Underserved 18 (2007), 356–361.
[15] L.L. Hicks, D.A. Fleming, A. Desaulnier, The application of remote monitoring to improve health
outcomes to a rural area, Telemedicine Journal and e-Health 15 (2009), 664–671.
[16] R. Haux, M. Gietzelt, N. Hellrung, W. Ludwig, M. Marschollek, B. Song, K.H. Wolf, Health-enabling
technologies for pervasive health care: a pivotal field for future medical informatics research
education? Studies in Health Technology and Informatics 150 (2009), 14–16.
[17] S. Hussain, L.T. Yang, F. Laforest, Ch. Verdier, Pervasive health care services and technologies,
International Journal of Telemedicine and Applications Vol. 2008, Article ID 946082, 2 pages, 2008.
doi:10.1155/2008/946082.
[18] O. Aziz, B. Lo, J. Pansiot, L. Atallah, G.Z. Yang, A. Darzi, From computers to ubiquitous computing
by 2010: health care, Philosophical transactions. Series A, Mathematical, physical, and engineering
sciences 366 (2008), 3805–3811.
[19] R. Haux, J. Howe, M. Marschollek, M. Plischke, K.H. Wolf, Health-enabling technologies for
pervasive health care: on services and ICT architecture paradigms, Informatics for Health & Social
Care 33 (2008) 77–89.
[20] C. Orwat, A. Graefe, T. Faulwasser, Towards pervasive computing in health care - a literature review,
BMC Medical Informatics and Decision Making 8:26 (2008), doi: 10.1186/1472-6947-8-26.
[21] M.N. Boulos, A. Rocha, A. Martins, M.E. Vicente, A. Bolz, R. Feld, I. Tchoudovski, M. Braecklein,
J. Nelson, G.O. Laighin, C. Sdogati, F. Cesaroni, M. Antomarini, A. Jobes, M. Kinirons, CAALYX: a
new generation of location-based services in healthcare, International Journal of Health Geographics
6:9 (2007), doi:10.1186/1476-072X-6-9.
[22] G. Demiris, Smart homes and ambient assisted living in an aging society – New opportunities and
challenges for biomedical informatics, Methods of Information in Medicine 47 (2008), 56–57.
[23] I. Kryspin-Exner, C. Oppenauer, Wird die Gerontotechnik die Zukunft des Alterns veraendern?
Ethische Aspekte und psychologische Modelle zu Akzeptanz und Motivation technischer Innovationen.
[Will gerontotechnology change the future of aging? Ethical aspects of technical innovations and
psychological models of acceptance and motivation.] Psychopraxis 4 (2007), 20–26.
[24] I. Martinez, J. Escayola, M. Martinez-Espronceda, L. Serrano, J.D. Trigo, S. Led, J. Garcia,
Implementation experiences of ISO/IEEE11073 standard applied to new use cases for e-health
environments, Conference Proceedings - IEEE Engineering in Medicine and Biology Society (2009),
1679–1682.
[25] T. Norgall, Fit und selbstständig im Alter durch Technik [Fit and independent in the aging population
using technology. From concept to reality?], Bundesgesundheitsblatt Gesundheitsforschung
Gesundheitsschutz 52 (2009), 297–305.
[26] A. Sixsmith, M. Sonja, Ambient assisted living for older people: results from the EU-Soprano project,
Gerontologist 48 (2008), 376–377.
[27] G. Virone, A. Sixsmith, Monitoring activity patterns and trends of older adults, Conference
Proceedings - IEEE Engineering in Medicine and Biology Society (2008), 2071–2074.
[28] J.M. Belda-Lois, R. Poveda, R. Barberà, M.J. Such, J.R. Ruiz-Rodríguez, Emotional engineering
techniques for ambient assisted living, Gerontechnology 6 (2007), 178–180.
[29] G. Demiris, B.K. Hensel, Technologies for an aging society: a systematic review of "smart home"
applications, IMIA Yearbook 2008: Access to Health Information 1 (2008), 33–40.
[30] R.D. Davenport, H. Elzabadani, J.L. Johnson, A. Helal, W.C. Mann, Pilot live-in trial at the GatorTech
smarthouse. Topics in Geriatric Rehabilitation 23 (2007), 73–84.
[31] M. Edenius, The function of representation in a 'smart home context.', International Journal of
Technology and Human Interaction (IJTHI) 2 (2006), 1–15.
[32] M. Chan, D. Estève, Ch. Escriba, E. Campo, A review of smart homes - Present state and future
challenges, Computer Methods and Programs in Biomedicine 91 (2008), 55–81.
[33] V. Rialle, F. Duchene, N. Noury, L. Bajolle, J. Demongeot, Health 'Smart' Home: Information
Technology for Patients at Home, Telemedicine Journal and e-Health 8 (2002), 395–409.
[34] S. Martin, G. Kelly, W.G. Kernohan, B. McCreight, C. Nugent, Smart home technologies for health
and social care support, Cochrane Database of Systematic Reviews 4 (2008), CD006412.
[35] M.R. Tomita, W.C. Mann, K. Stanton, A.D. Tomita, Use of currently available smart home technology
by frail elders: process and outcomes, Topics in Geriatric Rehabilitation 23 (2007), 24–34.
[36] J.L. Johnson, R. Davenport, W.C. Mann, Consumer feedback on smart home applications, Topics in
Geriatric Rehabilitation 23 (2007), 60–72.
[37] G. Demiris, B.K. Hensel, M. Skubic, M. Rantz, Senior residents' perceived need of and preferences for
"smart home" sensor technologies, International Journal of Technology Assessment in Health Care 24
(2008), 120–124.
[38] A. Essen, The two facets of electronic care surveillance: An exploration of the views of older people
who live with monitoring devices, Social Science & Medicine 67 (2008), 128–136.
[39] K.L. Courtney, Privacy and senior willingness to adopt smart home information technology in
residential care facilities, Methods of Information in Medicine 47 (2008), 76–81.
[40] K.L. Courtney, G. Demiris, M. Rantz, M. Skubic, Needing smart home technologies: the perspectives
of older adults in continuing care retirement communities, Informatics in primary care 16 (2008), 195–
201.
[41] G. Demiris, M. Rantz, M. Aud, K. Marek, H. Tyrer, M. Skubic, A. Hussam, Older adults' attitudes
towards and perceptions of "smart home" technologies: a pilot study, Medical Informatics and the
Internet in Medicine 29 (2004), 87–94.
[42] G. Demiris, M.J. Rantz, M. Skubic, M.A. Aud, H.W. Jr. Tyrer, Home-based assistive technologies for
elderly: attitudes and perceptions, AMIA Annual Symposium Proceedings (2005), 935.
[43] G. Demiris, D.P. Oliver, G. Dickey, M. Skubic, M. Rantz, Findings from a participatory evaluation of a
smart home application for older adults, Technology and Health Care 16 (2008), 111–118.
[44] B.K. Hensel, G. Demiris, K.L. Courtney, Defining obtrusiveness in home telehealth technologies: A
conceptual framework, Journal of the American Medical Informatics Association 13 (2006), 428–431.
[45] K.L. Courtney, G. Demiris, B.K. Hensel, Obtrusiveness of information-based assistive technologies as
perceived by older adults in residential care facilities: A secondary analysis, Medical Informatics and
the Internet in Medicine 32 (2007), 241–249.
[46] G. Demiris, Privacy and social implications of distinct sensing approaches to implementing smart
homes for older adults, Conference Proceedings - IEEE Engineering in Medicine and Biology Society
(2009), 4311–4314.
[47] A. Essen, M. Conrick, New e-service development in the homecare sector: Beyond implementing a
radical technology, International Journal of Medical Informatics 77 (2008), 679–688.
[48] G. Demiris, Home based E-health applications, Studies in Health Technology and Informatics 106
(2004), 15–24.
[49] G. Demiris, Interdisciplinary innovations in biomedical and health informatics graduate education,
Methods of Information in Medicine 46 (2007), 63–66.
[50] G. Demiris, Independence and shared decision making: The role of smart home technology in
empowering older adults, Conference Proceedings - IEEE Engineering in Medicine and Biology
Society (2009), 6432–6436.
[51] G. Demiris, D.R. Parker Oliver, K.L. Courtney, D. Porock, Use of Technology as a Support Mechanism
for Caregivers of Hospice Patients, Journal of Palliative Care 21 (2005), 303–309.
[52] G. Demiris, M. Skubic, M.J. Rantz, K.L. Courtney, M.A. Aud, H.W. Tyrer, Z. He, J. Lee, Facilitating
interdisciplinary design specification of "smart" homes for aging in place, Studies in Health Technology
and Informatics 124 (2006), 45–50.
[53] R. Farzanfar, J. Finkelstein, R.H. Friedman, Using qualitative research methods to improve home
telemonitoring, AMIA Annual Symposium Proceedings (2001), 903–903.
[54] R.A. Clark, J.J. Yallop, L. Piterman, J. Croucher, A. Tonkin, S. Stewart, H. Krum, CHAT Study Team,
Adherence, adaptation and acceptance of elderly chronic heart failure patients to receiving healthcare
via telephone-monitoring, European Journal of Heart Failure 9 (2007), 1104–1111.
[55] K. Horton, Falls in older people: The place of telemonitoring in rehabilitation, Journal of Rehabilitation
Research and Development 45 (2008), 1183–1194.
[56] C. Thielscher, C.R. Doarn, Long-term future of telemedicine in Germany: the patient's, physician's, and
payer's perspective, Telemedicine Journal and e-Health 14 (2008), 701–706.
[57] J.Y. Chang, L.K. Chen, C.C. Chang, Perspectives and expectations for telemedicine opportunities from
families of nursing home residents and caregivers in nursing homes, International Journal of Medical
Informatics 78 (2009), 494–502.
[58] G. Pare, M. Jaana, C. Sicotte, Systematic review of home telemonitoring for chronic diseases: The
evidence base, Journal of the American Medical Informatics Association 14 (2007), 269–277.
[59] R.A. Clark, S.C. Inglis, F.A. McAlister, J.G. Cleland, S. Stewart, Telemonitoring or structured
telephone support programmes for patients with chronic heart failure: systematic review and meta-
analysis, BMJ 334 (2007), 942.
[60] M. Jaana, G. Pare, C. Sicotte, Hypertension home telemonitoring: Current evidence and
recommendations for future studies, Disease Management & Health Outcomes 15 (2007), 19–31.
[61] J. Polisena, K. Tran, K. Cimon, B. Hutton, S. McGill, K. Palmer, Home telehealth for diabetes
management: a systematic review and meta-analysis, Diabetes Obesity & Metabolism 11 (2009), 913–
930.
[62] M. Jaana, G. Pare, Home telemonitoring of patients with diabetes: a systematic assessment of observed
effects, Journal of Evaluation in Clinical Practice 13 (2007), 242–253.
[63] M. Jaana, G. Pare, C. Sicotte, Home Telemonitoring for Respiratory Conditions: A Systematic Review,
[64] S.M. Smith, S.L. Elkin, M.R. Partridge, Technology and its role in respiratory care, Primary Care
Respiratory Journal 18 (2009), 159–164.
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-55
Legal Aspects of
Personal Health Monitoring
Stefaan CALLENSa,1, Adrien GALOTb and Eugenia LAMASc
a
Lawyer at the Bar in Brussels, Professor of Health Law at the KU Leuven
b
LLM-program KC London 2012-2013, Masters in Law at the KU Leuven 2011-2012
c
Researcher Ethique / E-santé -Centre de Recherche des Cordeliers,
Institut national de la santé et de la recherche médicale (INSERM)
U872 Equipe 20, Paris, France
Abstract. Personal health monitoring (PHM) can be defined as comprising all

technical systems, processing, collecting, and storing of data linked to a person.
PHM involves several legal issues that are described in this paper. This article
analyses firstly the short term actions that are needed at the European level to
allow personal health monitoring in respect of the interests and rights of patients
such as the need to have more harmonised medical liability rules at the EU level.
Introducing PHM implies also legal action at the EU level on the long run. These
long-term actions are related to e.g. the way in which hospitals are organised in
their relation with healthcare professionals and with other hospitals or healthcare
actors. The paper analyses finally also how health monitoring projects may change
the traditional (non-) relationship between patients and pharmaceutical/medical
device industry. Today, the producers and distributors of medicinal products have
no specific contact with patients. This situation may change when applying
telemonitoring projects and may require new legal rules.
Keywords. Personalised health monitoring; legal aspects; European legislation
Introduction
Healthcare is confronted with two tendencies that are also visible in society, i.e.
globalisation of health care and individualisation of healthcare2. Globalisation is
obvious if one looks at the way the pharmaceutical industry is organised and at the
emerging networks of sickness funds and of hospital chains; Individualisation becomes
obvious with the increasing use of so-called personalised medicine. Personalised
medicine is not a topic limited to pharmacogenomics whereby the influence of
individual genetic constitution of a patient on the efficiency of a medicinal product is
important. Personalised medicine goes further and includes also treatment plans
whereby an individual is treated with own “manipulated cells”, i.e. by applying
Advanced Therapeutic Medicinal Products (ATMP). Personalised medicine includes
also the use of individual made implants to monitor patients at a distance. There are
indeed many applications whereby elderly or chronically ill patients can be followed to
1
2
This contribution is partly based on CALLENS, S., “Legal aspects of Personalized Health
Monitoring”, to be published in November in the European Journal of Health Law, 2012.
56 S. Callens et al. / Legal Aspects of Personal Health Monitoring
allow them to stay as long as possible in their own environment (so called Ambient
Assisted Living – tools). By following several parameters, by using sensors and
cameras at a distance and/or by using devices implanted in the patient or put on the
body or in the clothes of a patient, health data can be processed. In monitoring projects
like telecardiology projects, an implantable cardiac rhythm management device enables
the daily, remote, wireless, the patient-independent ambulatory monitoring of multiple
medical and technical data. The data may go to a service centre via cellular networks.
The aims of the cardio devices may be:
1. The monitoring of the patients’ clinical status;
2. The early detection of several heart diseases and heart failure;
3. Day-to-day monitoring that subsequently offers a means of confirming the
success of rate or rhythm control.
Personal health monitoring (PHM) compromises all technical systems, processing,
collecting, and storing of data linked to a person. PHM is very broad and it takes not
only place for treatment purposes (for example monitoring a patient who suffers from
diabetes or from cardiac arrhythmia from a distance), but also to prevent driving a car
after drinking too much alcohol by using an alcohol slot in a car, to check someone’s
temperature in the airport at his arrival from another country; etc. This paper deals
mainly with the medical devices, used in healthcare and with the (European) legal rules
that are already implemented to the use of these PHM-devices. However, the main
issue of the paper is related to the rules that have still to be enacted at the European
level in order to allow the introduction of PHM-projects in compliance with the
interests of all the parties involved.
Given the wide scope of the definition a lot of different legal regulations are
involved such as rules related to e-Health, data protection, liability, reimbursement etc.
1. PHM in the Context of Regulations
E-health has been and is still receiving a great deal of attention at the European level.
Over the last decades the European Commission has paid a lot of attention to the need
of having a legal framework for e-health.
In 1999, the European Commission launched the initiative ‘e-Europe – an
information society for all’ in order to ensure that the European Union would take into
account the changes brought about by the growing information society. A key part of
this initiative was the so-called ‘Health Online Action’ that reaffirmed the strategic
importance of fully exploiting new technology in health care. Moreover, the European
Commission invested in numerous research programs and, in 2004, enacted an Action
Plan for a European E-Health Area.
At European level, several legal binding documents are related to healthcare and are
of importance for PHM-projects.
Firstly, the Treaty on the Functioning of the European Union (TFUE) contains a
number of principles that are important when dealing with PHM, namely: the right to
the protection of personal data (art. 16 TFUE), the freedom to provide services within
the EU (art. 56 TFUE), and the competition rules (art. 101, 102 and 106 TFUE).
Moreover, article 168 TFUE defines the role of the European Union as complementing
national policies, sets out procedures by which the European Union institutions act in
the health field and delineates the types of measures that may be enacted.
S. Callens et al. / Legal Aspects of Personal Health Monitoring 57
Secondly, a whole range of Directives and Regulations are applicable to personal

health monitoring on European Level. These have a significant impact on healthcare
systems and play an important role in PHM-projects. We think inter alia of Directive
95/46/EC on the protection of individuals with regard to the processing of personal data
and on the free movement of such data (the Data Protection Directive), Directive 98/34
of 22 June 1998 laying down a procedure for the provision of information in the field
of technical standards and regulations and rules on Information Society services
(Transparency Directive), Directive 2002/58 on privacy and electronic
communications, Directive 200/31/EC on certain legal aspects of information society
services in the internal market (the so called ‘E-commerce Directive), the Medical
Device Directives, Directive 1997/7/EC on the protection of consumers in respect of
distance contracts, and to certain extent Directive 2005/36 on the recognition of
professional qualifications. Attention should also be paid in case of (European)
personalised medicine projects to the rules regarding the competent judge and the
applicable law, i.e. Regulation 44/2001 on jurisdiction and the recognition and
enforcement of judgments in civil and commercial matters, Regulation 593/2008 on the
law applicable to non-contractual obligations has to be taken into account (Rome I),
and Regulation 864/2007 on the law applicable to non-contractual obligations is
important, in case of tort (Rome II). Finally, Directive 2001/24/EU on the application
of patients’ rights in cross-border healthcare, will have an important impact on PHM.
Although the European Commission adopted several Directives and enacted many
rules related to health care, there are still important legal issues about e-health that need
to be clarified in order to allow the further development of PHM-projects. In other
words, the European Legal framework for e-health is not yet complete and legal actions
need to be taken.
Besides European Legislation on PHM it is also important to have a look at national
legislation when assessing PHM projects. Firstly, although the European Union is
competent to draft rules in certain domains, European Directives still needs to be
implemented by each Member State of the European Union into the law of the Member
State. It is to be noted that due to the European Data Protection Directive 95/46, every
Member State of the European Union has its own specific law or act about data
protection. Secondly, due to a lack of harmonisation at Community level, some issues
related to healthcare (including PHM) remain within the competence of the Member
States. Although all the Member States of the European Union have a general liability
system, only a few of them adopted specific rules for medical liability. Finally, in a
majority of the Member States of the European Union rules concerning the
reimbursement of PHM and telemedicine are lacking. Moreover, the few Member
States that offer reimbursement for PHM and telemedicine only do so under strict
conditions.
2. Short-Term Legal Action Is Needed
Some very important challenges for PHM are to ensure that it develops in a manner
that benefits patient care, that it ensures overall patient safety, and that it does not in
any way reduce the quality of healthcare provided to patients. To assure high quality in
patient care more urgent legal actions need to be taken. This will also lead to more
legal clarity. Some current weaknesses in the legislation have to be resolved in the
short term. These issues are related to e.g. liability, the practice of medicine through
PHM and informed consent. These topics are described below.
2.1. Towards More Common Liability Rules
Medical liability is an issue of increasing importance in Europe. It is important that

patient rights are always properly defended and that decisions related to quality of care
and patient rights are taken in a reasonable time period. PHM does imply, however,
several and often complex liability issues, for example: Who will be held liable when
something goes wrong during a monitoring session (The physician or healthcare
professional? The healthcare institution, the manufacturer of the device (liability for
defective products), the telephone company, the call centre?)? Which Member State of
the European Union has to supervise the physicians in case of cross boarder healthcare?
Which legislation is applicable in case of cross-border healthcare? etc. These days,
there exists no specific European legislation concerning liability and PHM.
Nevertheless, the general liability rules (Rome I and Rome II Treaties, see above) are
also applicable in case of healthcare and the Product Liability Directive and the
Directive on patient rights and cross border care may be applicable in case of damage
caused by PHM. It is, however, obvious that different medical liability legislation in
the Member States of the European Union (including the legislation concerning
compensation for damages caused by medical acts) may hinder the application of
PHM. A patient taking cross-border healthcare services may not necessarily always
remain under the scope of legal protection offered by his own legal system. Therefore,
the EU should also play a more important role with regard to the liability issues. Some
countries recently enacted so-called “legislation concerning compensation for damages
caused by medical acts”. This legislation does often introduce the no-fault standard
with regard to the treatment of patients by healthcare professionals. The Directive on
the application of patient rights in cross-border healthcare states that the EU Member
States have to ensure that there are mechanisms for patients in order for them to seek
redress and compensation if they suffer harm. If in a PHM project the physician
treating the patient is not residing in the Member State of the patient and if the patient
suffers harm because of the treatment/monitoring at a distance (from another Member
State), the no–fault legislation should ideally also be applicable for a patient who
suffers harm that is caused in the Member State of the physician which is another
Member State in which the patient lives. The no-fault legislation should not be limited
to harm caused in the Member State of the patient, as is still often the case.
2.2. Healthcare Profession – Towards a Need for a Specific License
Most healthcare professions are regulated professions and can only be exercised under
strict legal conditions (see e.g. Article 2, g) of the E-Commerce Directive). These
conditions diverge in the different Member States of the European Union. Every
Member State in the European Union has its own licensing system and in most cases,
the physician who wishes to exercise his profession in a Member State needs to apply
for a license in that specific Member State. Physicians, for example, need a personal
permission to practice as a physician. Physicians (and some other healthcare
professionals) have to be registered to practice as a qualified professional. Each
Member State has its own authority that regulates the practice of the healthcare
providers, such as the British Medical Council in the UK, the Bundesärztekammer in
Germany, the Conseil National de l’Ordre des Médecins in Belgium and the
Koninklijke Nederlandsche Maatschappij tot Bevordering der Geneeskunst in the
Netherlands. In some countries, there are also medical councils at the level of each
region. In Germany for example, there are 17 medical councils. In case of cross-border
PHM, the physician and the patient do not move from their own country but they use
ICT applications to contact each other in the other Member State. An important
question is then whether the physician who delivers healthcare at a distance (via
telephone, Internet …) has to obtain a license to practice medicine in the country where
the patient resides at the time of the monitoring session. The worst case scenario for a
physician is that he has to register with the authorities of (at least) 26 other Member
States of the European Union. There is a need for a regulatory framework for the
healthcare profession also working with PHM, so that healthcare professionals can
deliver cross-border monitoring activities without restrictions concerning cross-border
licensing. It would not be favorable for the Internal Market if healthcare professionals,
who are allowed to deliver healthcare (including PHM) in their own country (Member
State of the European Union), are not allowed to deliver the same services via PHM for
patients living in another Member State of the European Union. Directive 2005/36 on
the recognition of professional qualifications establishes the rules for the mutual
recognition among Member States of the European Union for a set of regulated
professions (including medical doctors and a number of medical specialties). The aims
of the directive are to ensure that the European Union Member States enact uniform,
transparent, and non-discriminatory rules recognizing professional qualifications and
experience to allow professionals to work temporarily or permanently throughout the
Union. However, in the case of (cross-border) PHM the Directive will not apply since
the health professional and the patient are not simultaneously present. Article 5(2) of
Directive 2005/36 states that Title II (dedicated to provision of service) shall “only”
apply where the service provider moves to the territory of the host Member State to
pursue, on a temporary and occasional basis, his/her profession. In case of
telemedicine, the health professional is not physically moving to the territory of another
Member State, only the “service” itself moves.
2.3. Informed Consent
If the PHM device is to function as an alert device, this should be clearly

communicated to the patient. The patient should be informed what action s/he has to
take and what s/he might expect of the actions to be taken by the treating physician.
The patient must be informed about the information flows and the categories of persons
who might have access to their data. The patients must also be informed about the
device, the working of the device and the treatment plan. The same patient (or his/her
representative) must consent to the treatment and the (further) processing of health data
for other purposes than treatment purposes. The globalisation of healthcare actors
requires more harmonised rules for health data processing, particularly as the exchange
of data between European e-health actors will not be limited to the treatment of patients
during monitoring sessions – the data may also be processed for evaluation, research or
statistical purposes. Currently, harmonised rules on this further use are lacking. Several
Member States have formulated strict rules for the processing of medical data for e.g.
purposes, while other Member States of the European Union have more flexible rules.
Article 8 of the Directive leaves too much room for different legislation in the Member
States of the European Union, which is not good for the establishment of an internal
market in which international quality review projects, epidemiological studies, clinical

trials etc. are emerging.
Moreover, these legislative differences between the Member States of the European
Union are detrimental to the establishment of an internal market, especially in the
actual context of globalisation of healthcare.
In other words, more European action is required in order to remedy the current
weakness of the Data Protection Directive. In this regard it is to be noted that the
European Commission adopted a proposal for a new Data Protection Regulation.
Generally speaking, a regulation has the advantage of being binding entirely and
directly applicable in the Member States enhancing thereby harmonisation. Directives
to the contrary allow Member States to interpret the ruling in different ways and may
lead to divergent legislations in different Member States.
The main purpose of the Regulation is to establish a single set of rules on data
protection, valid across the EU. The proposal of the new Data Protection Regulation
contains some innovative ideas such as “the right to be forgotten” in the online
environment or the right to deletion of personal data in such a way that any publicly
available or replications should be deleted. Other key features include the necessity to
give explicit consent for data processing rather than consent to be assumed.
3. Long-Term Action Is Also Needed
3.1. Challenges for the Healthcare Practitioners (Pro-Active Role) and Hospitals
For PHM to be successfully applied in healthcare, several legal actions on the long-
term are needed. Some of these actions are described below.
The role of different health professionals may change in view of developing PHM.
We think that nurses and medical assistants may play a growing role. Surveillance of
monitoring systems implies that there will be a shift from inpatient to outpatient
treatment. The role of the hospital will change and hospitals may eventually monitor
outpatients that are not physically admitted or not physically present in the hospital.
Because of the cross-border effect of PHM, some hospitals may become European-
wide referral centres through PHM. The use of monitoring devices in PHM-projects
will lead to changes in the way physicians and hospitals usually work. Physicians and
other healthcare professionals as well as hospitals will have to be always standby for
the patients they monitor in case of an emergency. This implies that they will have to
organise a guard duty, probably with many other healthcare professionals and hospitals
especially in view of the increasing shortage of physicians in several Member States.
The guard duty will have to take into account a huge increase of patients to follow in
case of application of telemonitoring services. Many of these patients may reside in
other regions than the region where the treating hospital is located; Personalised health
monitoring will simplify cross-border healthcare and reference centres will treat more
patients (from several countries) than in the past. So PHM will urge healthcare
personnel and hospitals to work together beyond the national boundaries to follow
patients through telemonitoring. This activity of telemonitoring leads to important
questions concerning the hospital legislation such as:
• Who will be responsible for the organisation of the safeguards?

• Who will have access to the information arriving in the hospitals?
• May a physician delegate the processing of the data to a non-physician?
• What is the status of a physician who is participating in a guard system for
telemonitoring organised by a hospital?
• Is this status different if the physician, who is monitoring a patient at a
distance, is working outside the hospital?
• May this physician participate in the “medical council” representing the
physicians in the hospital?
• Is the hospital still the central contact point if wrong information or if bad care
was given by the telephysician?
• Can a hospital that works with independent physicians at a distance be held
liable if one of these physicians causes harm to a patient?
3.2. Towards Reimbursement of PHM Projects
In the EU Member States, for a medical act to be legally recognised as such and to be
reimbursed, the presence of the patient and the health professional in the same place is
in principle required. This condition is not fulfilled in case of many PHM projects. The
question is whether the requirement of physical presence for the reimbursement forms
an obstacle to the free movements of services. New monitoring projects often end in
Member States due to a lack of financing structure. Although reimbursement is an issue
to be treated by the Member States, clear European rules on the criteria to be used in
reimbursement decisions might be useful at the EU-level, as was done in the past for
the reimbursement of medicinal products by Directive 89/105/EC. The rules of
reimbursement of cross-border care as provided in Directive 2011/24 of 9 March 2011
will be of importance for telemedicine. The Member State of affiliation has to ensure –
in principle – that the costs incurred by an insured person who receives cross-border
healthcare are reimbursed, if the healthcare in question is among the benefits to which
the insured person is entitled in the Member State of affiliation.
3.3. Relationship between Patient and Industry: Challenges Concerning Publicity,

Promotion and Competition
The role of the medical device and pharmaceutical industry will change if more PHM
projects are applied in healthcare. Delegates and employees from the medical device
industry may be in direct contact with the patients to, for example, implant a
monitoring device to give information about the functioning of the device, about the
health status of the patient etc. The data may be gathered in a data centre that will send
the information that the treating physician needs to the physician. As occurs today, the
industry only has contact with health professionals and distributors; there is in principle
no direct contact between the industry and patients. This situation will change when
applying PHM projects especially if the data centres are owned by the manufacturer of
the device or if the device is installed and/or followed up by the industry.
Specific rules at the European level will be needed to regulate the relation between
the healthcare industry and the patient in the monitoring sector, for example to avoid
illegal promotion, publicity, illegal overconsumption or unfair competition. If devices
or even data centres are made available to hospitals or health professionals free of
charge by the industry, this may be considered as an illegal advantage for the
healthcare professional/facility. These free products and/or services may also not be in
compliance with the competition rules if the free products/services are tied to the
selling of the implants. It is obvious and not necessarily bad that the industry will
become more involved in the treatment and follow up of the patient with a device,
provided however that there will be a rethinking of their role/function. More and more
custom-made devices adapted to the specific needs of the patients will be developed
and will come into use. Patients will need to be informed about the function of the
devices and will need to know what they have to do when something goes wrong.
However, healthcare professionals will no longer be the sole person to provide this
information nor are they the person who will deliver the devices. The devices will be
obtained from the manufacturer/supplier, and not necessarily from the (hospital)
pharmacist.
As stated above, nowadays there is usually no link between the patient and the
manufacturer/supplier of medicinal products. The manufacturer delivers the product to
the pharmacy and the pharmacist delivers the product to the patient, so there is no
direct link between the manufacturer and the patient. This will change if patient-
tailored devices or personalised monitoring devices begin to be used. Retailers,
consumer product companies and other players accustomed to marketing directly to
consumers may want to inform the patient directly and help them with the use of the
device data. It will be a challenge to make sure that there is a clear distinction in
practice between providing information and making publicity.
PHM leads also to the processing of data that can be used for several purposes. The
data gathered by the data centre and related to the implanted/used device in monitoring
projects and/or the patient may be processed by the industry before arriving in the
mailbox/pc of the treating health professional. The question is whether these data
centres can be owned by the companies who deliver the implant and which might make
it more difficult for hospitals to work with several types of implants (having
consequences with regard to competition law) or whether these data centres should be
run by new independent healthcare players.
Until now, there is no extensive European legislation concerning the publicity and
distribution of medical devices that can be used in PHM projects. If the industry gets
involved in the use of the monitoring devices by the patient and gets in direct touch
with the patient, more clear rules are needed at the EU-level related to the distinction
between providing information by the industry and making publicity, the issue of
promotion and the cost of data centres or nurses involved in PHM-projects, the
freedom of choice by the patient regarding the nurse who is assisting the patient with
regard to the use of the device, the use of data processed by the data centres, etc.
4. Conclusion
Many aspects regarding the monitoring of patients are already regulated at the EU
level. We think e.g. of the Data Protection Directive and the Directive on Patient Rights
in cross-border healthcare. However, more European action is needed to assure a high
quality of care of personalised health monitoring in the future. Besides legal action on
the short term, more complex legal actions will be required. We are referring to
hospital care and health care in general will be organised. Due to the shortage of health
care professionals in many Member States and due to the possibility that (chronically
ill) patients can be continuously monitored even if they are not hospitalised, the legal
status of these health care professionals will have to be made clear: which type of
monitoring activity can be carried out and by which type of health care professionals
(physician, nurse etc.)? What will be the status of physicians working outside the
hospital and who will be involved in a monitoring project of patients who are not
hospitalised?
The role of the data centres that collect the information retrieved by implanted
medical devices and process the data that are used by the treating physician/hospital
should be made clear. If public authorities do not (yet) finance the cost of these data
centres, one should make sure that data centres are not organised in a way that is in
contradiction with the competition rules. A distributor of implantable medical devices
cannot provide for free a data centre to his client, the hospital. Moreover, more detailed
EU rules regarding compliancy rules for medicinal devices like the rules provided for
medicinal products will be useful. There should be also more detailed EU rules on the
distribution of (implantable) devices, on the data centres processing the data retrieved
from the devices and on the promotion of (implantable) monitoring devices.
III
Assessment of Personal Health Monitoring
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-67
Setting the Scene: Taxonomy of

Personal Health Monitoring
Murat Gök1, Xia Teng, Gunnar Nußbeck and Otto Rienhoff
Göttingen University Medical Center
Abstract. In order to provide a systematic basis for communication in trans-

disciplinary research projects, there is a need for taxonomies and ontologies. Our
developed taxonomy of personal health monitoring (PHM) is based on a
systematic literature review and an iterative adaption process with trans-
disciplinary partners. The construction method of the taxonomy is an ongoing
process and need regularly updates.
Keywords. Taxonomy, personal health monitoring
Introduction
The diffusion of technology in a specific domain goes through different phases of its
hype and impact. In the first few stages of exploring how to solve problems from a
technological point of view many experiments, different methods, and technological
approaches are applied. In many cases this experimental phase results in an
unmanageable amount of less effective concepts, implementations, and products,
intermingled with useful and well tested concepts and products. In order to reach the
next phase of implementation, analyses from different disciplines are needed,
developing e.g. guidelines for the use of these new technologies. These analyses
require transfer of knowledge between domains, and often break new grounds in the
respective disciplines. Hence, to enable analyses in trans-disciplinary approaches, the
heterogeneous and unstructured area needs to be structured in a way that can be
understood from different perspectives like ethical, psycho-social, or epidemiological
ones. Neglecting this process of structuring a specific field when analyses start, there is
a potential risk of missing important aspects.
Personal health monitoring (PHM) and assistive technologies are an example of
such a new, unstructured domain. In order to enable other disciplines to conduct their
analyses, we systematically developed a taxonomy for PHM.
1
68 M. Gök et al. / Setting the Scene: Taxonomy of Personal Health Monitoring
1. Methods and Foundations
1.1. Development of the PHM Taxonomy
The taxonomy is based on an analysis of 85 reviews from the years 2000 through 2009.
The reviews were retrieved with the search terms ‘AAL and smart home’ (13 reviews),
‘telemonitoring’ (45 reviews), ‘personal health monitoring’ (25 reviews), and
‘pervasive health care’ (1 review).
The AAL and smart home reviews covered more than 70 systems, some of which
may have been reviewed in more than one paper. Thus, the set of unique systems is
probably much smaller, but the different perspectives of the reviewers may still deliver
valuable information. Telemonitoring reviews mainly dealt with cardiac diseases,
diabetes care, or home blood pressure monitoring, and cumulate to a total of 178
studies. Given the fact that most of the reviews were published within a rather short
period of time (44 of 85 in 2007 through mid-2009), and mostly deal with one of only
three fields of application, the number of unique PHM systems is most likely
significantly smaller. The reviews on personal health monitoring include more than 100
studies. In order to build the taxonomy, we extracted the relevant information
continuously and grouped them by functionality.
1.2. Definition of Personal Health Monitoring
Within the project we agreed to this definition of PHM:

Personal Health Monitoring (PHM) comprises all technical systems collecting,
processing, and storing data linked to a person. It allows monitoring parameters of that
person and can lead to health-related information of that person.
This definition is purposely kept general to ensure that no unforeseen system is exempt
from being considered as PHM.
1.3. Characteristics of Taxonomy
Taxonomy is a specific form of classification system. Like typologies, taxonomies

assign items into groups with similar characteristics. The vital difference is that
taxonomies build the groups posteriori, i.e. categories are deducted from empirical
analysis, whereas typologies have predefined categories. Classification groups of a
taxonomy should be exhaustive, mutually exclusive, and stable. Albeit its dynamic
creation, the classification criteria needs to be clearly verifiable so that grouping of
items remains the same irrespective of their classification order.
2. Current State of PHM and Assistive Technologies
To date more than 100 national and European research projects tackle the challenges of
the demographic change. The first German projects in this area started in 2004 and
were founded by the Robert-Bosch-Foundation. The European Ambient Assisted
Living (AAL) Joint Program as well as the Germany AAL initiative of the Federal
Ministry of Education and Research started to sponsor - mostly technology driven -
M. Gök et al. / Setting the Scene: Taxonomy of Personal Health Monitoring 69
projects in 2008. The majority of these AAL project results are currently in the phase
of laboratory tests and early field tests. The intersection of PHM and AAL lies in the
integration of assistive technologies and health parameters of PHM technology to
enable elderly people to live longer self-determined in their own homes.
The PHM projects have a longer history but are not yet wide spread implemented
into the health system. Most of the PHM projects derived from early telemedicine
approaches. These applications focused on clinical parameters that are commonly
monitored in intensive care settings. The early examples of transporting ECG - data can
be traced back to the beginning of 20th century [1, 2]. From these early approaches of
telemedicine (e.g. diagnosis from distance) the continuous telemonitoring arose. There
are simple telemonitoring techniques where a nurse calls the patient in predetermined
schedules and asks for health parameters [3, 4]. Other projects focused on
teleconsultation techniques. This means that a physician is able to access data from
intensive care unit (ICU) patients through a web based portal, and in the ICU the
patients communicate through a robot with the physician [5]. Another project aims at
adapting the medication dosage for high blood pressure patients via regularly sending
relevant parameters to a physician. Despite benefits for both the patient and the
physician, only few telemedicine products are currently available to the general public.
3. The Taxonomy of PHM
In order to analyze new technological domains, which could have an impact on the
health system, there is a need for a systematic view on it. These views provide the
analysts with the relevant information they need to draw their conclusions.
3.1. Escalation Steps of Personal Health Monitoring
The following enumeration provides a first overview of the field of PHM. The items
were collected in a brainstorming, and seem to be arbitrary. With a second look, one
can see that the level of complexity and the possible information retrieved, in
connection with knowledge of the person concerned, can lead to a higher degree of
information about that very person.
These steps are examples of how ethical concerns might arise with the development
or combination of existing technologies for use in PHM. Advance in technology and
new methods possibly change the ethical, legal, or socio-psychological implications of
a monitoring process. Modifications that change these implications are here referred to
as “escalation step”.
In Enumeration 1 all items are subdivided into “sensors”, “system of sensors” as well
as “without monitoring capability” and “with monitoring capability”. Systems of
sensors are regarded as a (smaller, side-) step because they change the technical
implications. Systems of sensors can be highly complex and are more prone to failure
and design errors than single sensor solutions. There is also a set of security and safety
issues that needs to be specially addressed within sensor networks. “With health
monitoring” and “without health monitoring” refers mainly to data processing and
information storing capabilities of these systems. A discrete measurement does not
necessarily allow drawing conclusions to overall health status or courses of a condition.
Monitoring capabilities refers to build-in methods to support this information storing,
processing and analysis.
Enumeration 1. Proposed escalation steps based on a twofold subdivision
1. No Medical Application
a. Sensor not designed for medical application
b. System of sensors not designed for medical application
2. Single health parameter
a. Single sensor – single health parameter – discrete measurement
b. System of sensors – single health parameter – discrete measurement
c. Sensor with monitoring capability for one single health parameter
d. System of sensors with monitoring capability for one single health parameter
3. Multiple health parameters
a. Sensor – multiple health parameters – discrete measurement
b. System of sensors – multiple health parameters – discrete measurement
c. Sensor with monitoring capability for multiple health parameter
d. System of sensors with monitoring capability for multiple health parameters
4. Wilful act
a. Sensor to detect wilful act of a person
b. System of sensors to detect wilful act of a person
c. Sensor with monitoring capability for wilful acts of a person
d. System of sensors with monitoring capability for wilful acts of a person
5. Unconscious act
a. Sensor to detect unconscious act of a person
b. System of sensors to detect unconscious act of a person
c. Sensor with monitoring capability for unconscious acts of a person
d. System of sensors with monitoring capability for unconscious acts of a person
6. Body function replacement
a. Sensor replacing body function
b. System of sensors replacing body function
c. Sensor replacing body function – with monitoring capability
d. System of sensors replacing body function – with monitoring capability
7. Body function enhancement
a. Sensor enhancing body function
b. System of sensors enhancing body function
c. Sensor enhancing body function – with monitoring capability
d. System of sensors enhancing body function – with monitoring capability
8. Environment – single parameter
a. Sensor to detect single environmental parameter
b. System of sensors to detect single environmental parameter
c. Sensor with monitoring capability for single environmental parameter
d. System of sensors with monitoring capability for single environmental parameter
9. Environment – multiple parameters
a. Sensor to detect multiple environmental parameters
b. System of sensors to detect multiple environmental parameters
c. Sensor with monitoring capability for multiple environmental parameters
d. System of sensors with monitoring capability for multiple environmental parameters
10. Genomics
a. Sequencing of a person’s genome
b. Detection of genetic predisposition
Item 10a and 10b are both related to genetics and do not fit into this scheme. The
genetic make-up of an individual is at least not constantly changing in its whole.
Detection of a mutation at the point of occurrence would therefore require monitoring
every single cell, which is not feasible.
To extend the scope and validate the list, a literature review is conducted in phase two.
Based on the review, the previously produced list could be integrated into a hierarchical
ordered map. Additionally, a more traditional perspective (locational, application, and
technological view using boxes) is produced as well.
3.2. Views
Generally spoken, there are different possible points of view, from which
systematization could start. We developed three different views. The first two views are
top down approaches: (1) locational view and (2) application view. The third view, the
technological view, arose from a bottom up approach.
3.2.1. Locational View

The locational view (Figure 1) describes the possible positions of a sensor or system of
sensors. There are for example systems for measuring accelerations with sensors in the
belt of a person [6], or the heart functions with the help of a sensor-shirt. In the mobile
personal space, e.g. within a car, there are sensors for measuring the vital signs of the
driver. Some approaches monitor the activity of a person via infra-red sensors in their
own homes, thus monitoring a stationary, static space. Currently there are some
projects which assist elderly people to manage their activities of daily living in the
public space.
3.2.2. Application View

The application view (Figure 2) structures the area of PHM from the traditional
medical perspective. It shows the possible application fields where PHM technologies
could be implemented.
Figure 1. Locational view of personal health monitoring technologies. Based on: [6]
Figure 2. Application view of personal health monitoring technologies. Based on [7]
The PHM health care application area consists of four main groups. PHM technologies
could also be implemented for public health services as well as for e.g. occupational
health applications.
3.2.3. Technological View

The technology view (Figure 3) consists of a hierarchical tree. It classifies the attributes
of a PHM technology into eight main categories. These categories are “Information and
communication technology”, “System”, “Workflow”, “Measurement”, “Participant”,
“Target Group”, “Field of Application”, and “Parameter”. The non-technical attributes
“Participant” and “Target Group” are included into the technological view because of
their importance in socio-technical system analysis.
Figure 3. Technological view of personal health monitoring technologies. Based on [7]

Further down in the classification tree, characteristic functional groups are formed. On
the lowest level (the leaf nodes), instances of PHM attributes of all preceding groups
are included, this concept is often refered to as inheritance. That is, all instances of
lower groups feature the characteristics of all preceding groups up to the root node (the
highest level node). The degree of detail (number of levels included in the tree) is not
limited, yet it is advisable to keep the number of levels as small as reasonable possible
in order to maintain a concise view. This view allows to make assumptions based on
the technological make-up of a PHM system. Analyses of specific traits can be
transferred along the main axes of the tree. Thus, changes in the set-up can be assedsed
easier by deducting rather than starting from scratch.
A highlevel classification supports a structured description of PHM technology. It
facilitates analyses from different perspectives like ethical, psycho-social or legal
points of view. Here, the challenge is bringing together the results of different ways of
thinking and analytic apporaches. A mutual understanding of a specific domain is a key
factor to solve this problem. Ease of use was one of the main concerns in the design of
the taxonomy. Hence, the examples are not exhaustive, nor exclusive.
Also, the structured representation massively supports development of use case
scenarios. Other project used similar mechanism, to describe integration patterns of
AAL-systems (see www.raali.de).
In the following paragraphs, major branches the taxonomy will be discussed. Often,
they are starting elements for further analysis.
Key aspects of the branch “parameters” are shown in Figure 4. They are subdivided
into “clinical”, “location” and “environment”. Clinical parameters include all
parameters that describe the clinical status of a subject.
Location includes parameters that allow statements about the whereabout of a
person, be it time-related (tracking) or at given points in time, or via “electronic
fencing”. Electronig fencing triggers a message or reaction as soon as a subject leaves a
predefined area. This might for example be helpful to allow persons with dementia to
roam around, but hinders undesired wandering, or entry into dangerous areas (e.g. deep
woods, highways etc.).
Environment includes parameters that reflect the surrounding of a subject. Thus,
these parameters generate implicit knowledge. For example the mental status of a
person can be assessed by assessing their interaction with their environment (e.g.
unattended stoves, illogical or unusual use of devices).
The implication of these categories is, that not only “traditional” clinical parameters
are important inidcators of the health status, but also previously unrecognized
paramters gain relevance. Thus, the legal, ethical and psycho-social framework needs
to be re-evaluated. The possibililty to deduce medical information from environmental
monitoring for example poses interesting questions in various areas, e.g. freedom of
information, self-determination, consent to sruveillance, just to name a few.
Figure 4. “Parameter” category of the PHM taxonomy. Based on [7]
In Figure 5 the “Field of Application” is described further. The application field can be
subdevided into three main fields: „Medical/Illness“ reflects traditional areas an
reaches from „Early Diagnosis“ to „Monitoring“ and finally to „Eventdetection“.
Early diagnosis includes parameters that can give hints to a medical condition even
before the condition itself is developed. These parameters may be genetic tests, early
signs of cognitive decline and such. Monitoring of ilnesses may be a 24h ecg
(temporary) or a permanent monitoring of a clinical parameter e.g. blood glucose level
in diabetics. Event detection can be broken down to emergencies (e.g. cardiac arrests,
high blood pressure, hyoglycaemia) or adverse events like accidents, falls, wandering
(for example in patients suffering from dementia).
Occupational health is the second branch, which can be broadened to preventive
measurements. Examples of this field are radiation exposure measurement via badges
that are worn by workers in hazardous areas, or stress monitoring.
The third area, “wellness / gadgets” comprises application fields that form one of the
driving forces behind the development of PHM. Many PHM devices that are available
on the market today fall into this category. These devices unify a life-style attitude and
a interest in personal health status of their users. Smart phones and wireless technology,
combined with miniaturization fuel the development in this area.
Key factors for this categorization are different legal, ethical and psycho-social
implciations. Technology, that is used by a person to monitor their personal behaviour,
or work-out performance has does not have to meet the same standards as devices that
are used in a professional medical setting.
Figure 5. “Field of Application” category of the PHM taxonomy. Based on [7]
On the other hand, devices that meet the standards of the medical devices act are not
necessarily honored by the health insurances, and reimbursement issues may hinder the
economic success of these devices in a professional setting. Occupational health is
ethically and psycho-socially and in that consequence also legally a highly senisble
field. Applications, that may be socially acceptable in a medical or personal setting
may be considered not suitable in an occupational setting.
The sensor setup (see Figure 6), which has also been described in enumeration 1, is
the key element of the system branch of the PHM taxonomy. The complexity of a
sensor setup plays an important role. The more information is gathered through one
system, the higher becomes the threat of technology misuse. Multivariable analysis
may generate additional, critical, information through concatenation of information that
is, regarded on its own, uncritical. Also, systems of sensors, i.e. the combination of
more than one sensor to generate one parameter, poses more risks of misreading, or
misinterpretation.
Figure 6. “System” category of the PHM taxonomy. Based on [7]

The way a measurement itself is conducted also plays an important role in the
assessment of PHM devices. The “measurement” category with the subcategories
technique, location, evolution, frequency, and actuator addresses the relevant aspects in
this area, as shown in Figure 7. The location of the measurement for example is
important with respect to the medical devices act. Devices that measure inside the
body, for example, must be tested thoroughly according to the medical devices act,
whereas devices that measure from a distance (peripheral) may only need an appraisal.
The evolution of a measurement specifies, wether a known parameter can be measured
in a novel way, or with a higher sensitivity, or wether a previously unknown parameter
is introduced. The introduction of new parameters does not necessarily mean that a
parameter is new per se. The use of a potentially well known and established parameter
in a different setting may also have to be re-evaluated, for example the dispersion of
genetic information in a direct-to-consumer context. Here, measurements that where
previously limited to laboratories in a professional medical setting now become
availale to lay persons with the advent of lab-on-a-chip technology or by companies
that offer genetic test results via internet. The challenge in this ist, that now lay persons
are confronted with information that they may not be able to interpret correctly. The
may find them selves with potentially devestating outcome based on statistics, which
meaning they cannot interpret without the help of a health care professional.
The frequency of a measurement may be important for questions like data security
or self-determination. Some people may feel limited in their freedom when they know
that they are monitored continuosly, whereas some may feel reassured by a continuous
monitoring. Triggered monitoring poses the question of who or what triggers the
monitoring, which leads to the last category “actuator”. A device that is used by a
person him or herself does not pose the same questions as a device that is triggered by a
third party. The act of self-measurement implies a consent of the person, whereas an
automated or third-party-triggered measurement calls for a well described operating
procedure and an informed consent ot the subject to be measured.
Figure 7. “Measurement” category of the PHM taxonomy. Based on [7]

3.3. Usage
The views of the taxonomy have proven to be a useful instrument in various settings in
which a systematic representation of knowledge enabled researchers to structure the
field of PHM and dissect relevant parts for their work. In early project phases, the
taxonomy was used to help describing scenarios that feature representative
characteristics of PHM which are of high interest in different research fields. The
technological view allowed the researchers to test their scenarios for completeness and
classify the field of application. Thus, the scenarios where not only focusing on
characteristics relevant to one discipline, but also included links to other fields. In some
cases, the links where rudimentary in the beginning, but could be developed and
refined in iterative design steps, leading to complex, feature-rich scenarios.
These scenarios have been analyzed by experts from different fields in the next
project phases. By linking the scenarios and the respective results, the taxonomy
allowed trans-disciplinary analyses.
4. Discussion and Outlook
The purpose of the systematic representation of the field of PHM from a technological
perspective was to provide a common discussion basis for the experts from different
disciplines who are involved in the assessment of PHM systems, which are highly
complex socio-technological systems in the first place. The main problem that needed
to be solved was to find a method to structure and represent the knowledge of the PHM
domain and lead the experts to a mutual understanding of the characteristics of PHM.
Early approaches towards a taxonomy of PHM showed that, albeit the same words
where used, the meaning of characteristics and their impact on research questions from
different disciplines remained unclear to outsiders of the respective subject areas. The
solely technological description of PHM needed improvement in order to fit its
purpose. This led to additional views that where created to account for the non-
technical aspects that highly impact the assessment of technological traits.
Although the major break-through of PHM devices is yet to be expected, the rapid
development of mobile technologies and ubiquitous access to personal data and
personalized information combined with the development of electronic health records
may be a key factor for the success of PHM.
References
[1] K. Bailey, Typologies and taxonomies: An introduction to classification techniques, Sage University
papers: Quantitative applications in the social sciences, Thousand Oaks, CA: Sage Publications, Inc,
1994.
[2] K.D. Fiedler, V. Grover, J.T.C. Teng, An Empirically Derived Taxonomy of Information Technology
Structure and Its Relationship to Organizational Structure, Journal of Management Information
Systems. 13, Number 1, 9-34, 1996.
[3] E. Mayr, P.D. Ashlock, Principles of Systematic Zoology, 2 ed, New York: McGraw-Hill, Inc., 1991.
[4] H. Fraser, Y. J. Kwon, M. Neuer, The future of connected health devices, in IBM Institute for
Business Value. Somers, NY: IBM Global Services, 2011.
[5] M. Swan, Emerging Patient-Driven Health Care Models: An Examination of Health Social Networks,
Consumer Personalized Medicine and Quantified Self-Tracking, Int J Environ Res Public Health,
Number 6, 492-525, 2009.
[6] M. Marschollek, A. Rehwald, K. H. Wolf, M. Gietzelt, G. Nemitz, H. Meyer Zu Schwabedissen, R.

Haux, Sensor-based fall risk assessment--an expert to go, Methods Inf Med, Bd. 50, Nr. 5, S. 420–426,
2011.
[7] G. Nußbeck, M. Gök, O. Rienhoff, Systematik Assistiver Systeme in Versorgung und Forschung,
EHEALTH-COM, Nr. 4, S. 52–53, 2010.
[8] G. Nußbeck, Taxonomy-Based Assessment of Personal Health Monitoring in Ambient Assisted
Living, Ambient Assisted Living, R. Wichert und B. Eberhardt, Hrsg. Berlin, Heidelberg: Springer
Berlin Heidelberg, S. 199–211, 2012.
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-79
A Dependencies Mapping Method

for Personal Health Monitoring
Simon ROGERSON,1 Sara WILFORD and Ben FAIRWEATHER
Centre for Computing and Social Responsibility,
De Montfort University Leicester
Abstract. This chapter discusses the research undertaken in developing a

comprehensive dependencies map for Personal Health Monitoring (PHM).
Included is a discussion of the underlying research approach adopted and how this
was operationalized. A new dependencies mapping method has been developed
and this is described in detail. Illustrations of the derived tools are given using the
PHM analysis undertaken. A summary of the analysis outcomes and the resulting
recommendations are discussed. The chapter concludes with some suggestions of
ways in which this type of data set can be used in practice to deliver fit-for-purpose
PHM systems.
Keywords. PHM-Ethics, ICT, personal health monitoring, heuristics, nominal

group technique; transdisciplinarity, ethics; complex systems; dependencies,
method
Introduction
Personal Health Monitoring (PHM) can be considered as a collective term for a range
of devices, processes and systems that are used to monitor personal health. As such they
can be distinguished from epidemiological monitoring (not personal), security
monitoring (not health), and traditional medical tests (not monitoring). However, there
can be overlaps with the neighbouring areas. Devices designed to monitor for intruders
can be used to check whether an elderly occupant has fallen, personal health monitoring
can include constant monitoring of blood sugar, and data from personal health
monitoring can be aggregated for epidemiological purposes as well as for purposes
related to the health of the individual. For our purposes, to count as monitoring, a
system must have the capability of communicating data with a health professional, carer,
or other third party independently of the individual patient, thus a glucometer that only
outputs to a display and accessed only by the individual patient is not within the scope
of PHM, but one which also alerts a carer in a remote location when thresholds are
reached, or routinely sent them the results, would be called a Personal Health
Monitoring device. To date most personal health monitoring has taken place within the
walls of a health care facility, but particularly when PHM takes place outside the health
care facility, ethical issues become more complex, with many more influences and
impacts and many stakeholders, all of which are situated in a complicated lattice of
dependencies. It can be very difficult to analyse PHM in a meaningful way which
1
Correspondence can be sent via e-mail to the first author at srog@dmu.ac.uk.
80 S. Rogerson et al. / A Dependencies Mapping Method for Personal Health Monitoring
provides insight for planners, developers, operators and users. It was felt that a new
holistic approach was needed to address this issue.
Therefore the PHM-Ethics project adopted an approach that utilized the multi-
faceted, non-orthogonal, and sometimes disparate influences and disciplines of the
project partners and was based on the concept of transdisciplinarity. It is suggested that
transdisciplinarity goes beyond simply drawing together concepts from the disciplines
and that it creates new frameworks that break down (transgress) the traditional
boundaries between disciplines [1], [2]. This transdisciplinary approach was used ‘to
derive a dependencies map that delineates the interrelationship between ethics, law,
psychosocial and medical sciences … [and] … to foresee necessary research and to
fasten product development by balancing it with early addressing non-technical issues’
[3, p.9].
Dependencies are identified as elements of a complex social system which include
social and psychological aspects as well as technical, medical and legal ones. Through
the identification of dependencies it was therefore possible to consider the impact of
PHM on a wide range of stakeholders and societal groups across the lifecycle of PHM
development and application, in a way that took into account the various influences and
factors that may affect it. A map of dependencies and associated tools were developed
to gain an understanding of these dependencies. Whilst the team could have developed
a static and simple map of standard influencing features, it was recognised that there
was a need for a dynamic and fluid map that would accommodate the complexity of
PHM dependencies, integrate ethical considerations with other influences,
accommodate the fast-moving nature of PHM technology and which ‘allows groups of
people to share a common understanding of a complex topic’ [4, p.74].
This chapter details the work undertaken in developing a comprehensive
dependencies map for PHM. The chapter opens with a discussion of the underlying
research approach adopted and how this was operationalized. Section 2 describes the
new dependencies mapping method that was developed and used during this research.
Illustrations of the tools are given using the PHM analysis undertaken. The rich data set
derived through the analysis is not included in total in this chapter but a summary of the
outcomes and the resulting recommendations are discussed in Section 3 and Section 4
respectively. The concluding section suggests ways in which this type of data set can be
used in practice to deliver fit-for-purpose PHM systems.
1. An Approach to Investigating PHM
A dependencies map provides a structured way for knowledge of ethical issues to be

identified and organised whereby ‘the dependent structure provides organisation for the
knowledge map and helps to identify clusters of knowledge’ [4, p.78]. A dependencies
mapping tool can also be utilised to raise awareness about the many external influences
and impacts resulting from the use of PHM ‘creating a visible framework for
knowledge that will facilitate its manageability’ [4, pp.77-78] and to be cognisant of the
cultural and social impact of both appropriate and inappropriate use of the information
gained by a PHM system.
To understand and evaluate properly the impact of PHM systems, research needs to
identify stakeholders [5] and consider the multiple spheres of influence that may impact
on the adoption and subsequent uses of PHM alongside the potential social and
psychological impact on stakeholders such as individuals, their carers, professionals
S. Rogerson et al. / A Dependencies Mapping Method for Personal Health Monitoring 81
and wider society. These stakeholders are amongst the structures that are appropriately
placed on a dependencies map, but since considerations about PHM must go beyond
describing stakeholder relationships, the dependencies mapping exercise conducted by
the authors went well beyond describing only stakeholder relationships. Dependencies
maps go beyond stakeholder relationships by covering multiple types of entities (such
as processes and artefacts), and multiple types of relationships. Transdisciplinarity
enables dependencies mapping to be undertaken without the constraints of a pre-defined
lens such a stakeholder, data or operation. It is an amalgam of perspectives which was
operationalized through heuristics and the nominal group technique.
Heuristics are widely used in virtually all forms of enquiry. The PHM research was
working in a field at the complex intersection of medicine, ethics, information systems,
and legal studies and so the heuristic approach was considered to be the only practical
solution to understanding such complexity. It was used here to facilitate an
understanding of the subtlety of PHM-Ethics and enabled us to consider that the
identification of dependencies may not be exhaustive and that, although many
dependencies may not always have a direct influence on implementation, they could
nonetheless, be highly important in individual contexts. This is because, “an heuristic is
a guided search widely used in practice but does not guarantee to find the optimal
solution. However, in most cases it works and produces high quality (satisfactory)
results’ [6, p.4].
Systems theory was relevant since PHM applications in use are systems, within the
work systems of particular professionals, which are in turn embedded in healthcare
systems, which are themselves part of a broader social care system. Thus there is a
boundary problem, since ‘all problem definitions, solution proposals, evaluations of
outcomes, and so on, depend on prior judgments about the relevant ‘whole system’ to
be looked at’ [7, p.1]. If applications, such as PHM, are to be useful and practical, they
need to be integrated into wider systems. Their manufacture, distribution, installation,
maintenance and disposal all involve further systems.
The combination of heuristics and systems theory led to Critical Systems Heuristics
(CSH) which was developed to ensure that value assumptions underlying decisions
were revealed [8]. It is relevant to our consideration of a field composed of interlocking
systems, in which values are intimately interwoven with the nature of the field of
research. The key realm in which value assumptions can be revealed by CSH is
precisely that of ‘boundary judgments’: the decisions about ‘which empirical
observations and value considerations count as relevant and which others are left out or
considered less important’ [7, p.2]. Within the boundaries, in order to be able to
understand and gain meaning from the dependencies map, its systemic nature was
identified and analysis undertaken utilising the systemic or a ‘social cybernetic’
approach of general systems theory [9, p.501]. Further, ‘systemics’ was considered
appropriate, as research utilising this approach provides the impetus to study systems
from a holistic point of view.
It was decided to use an adaptation of the ‘Nominal group technique’ [10] in
developing an understanding of dependencies. It is usual for nominal group technique
to be used in large group settings whereby voting is undertaken for the purposes of
achieving a majority view [11]. However, as our team was small, voting on issues was
not considered to be a useful way to reach agreement on issues. Therefore, consensus
was achieved through reasoned discourse, and based on the previous development work
undertaken by the individual team members before the sessions. In democratic theory,
consensus building is an alternative technique to voting for establishing a majority view
[12]. This adaptation was used throughout the development of the dependencies map,
whereby the research team met at regular intervals to conduct the discourse element of
the research. This gave a consistency of method that further reinforced the heuristic
approach, which was felt to be necessary to provide a sufficiently fluid and dynamic
contextual analysis of complex systems.
Figure 1. Flowchart showing steps taken in the development of the dependencies map
2. The Dependencies Mapping Method
It was necessary to develop a dependencies mapping method as no such method exists.

Through the adopted research approach it was possible to evolve this method in parallel
with the ongoing PHM analysis. Described here is the version of the method at the
conclusion of this research. It is not in its final form as this is work for the future and
beyond the scope of the PHM-Ethics project.
The flow chart in Figure 1 clearly shows how the dependencies map was built and
the steps taken to ensure consistency and sufficient granularity so that the dependencies
map is able to provide a comprehensive (but not necessarily exhaustive) and
meaningful set of relationships. The constituent parts of the developed method are
described in detail in the sections below.
2.1. Lexicon
A lexicon of 10 key words or phrases was developed to define the concepts of the
dependencies mapping method. These are briefly described here.
1. Map: A dependencies map is a graphical representation of information around key
areas. It shows how different areas are related to or impact on one another. Maps
produced in this context provide a snapshot of the dependencies by showing nodes
(defined below) and the interrelationships between them. A map could be
decomposed into sub-maps.
2. Node: Nodes identify the key areas between which dependencies are revealed.
Nodes at a given level are decomposed into maps of nodes at a lower level. The
influence of node areas on PHM-ethics is identified by the linkages between
dependencies within and between nodes.
3. Subject: This is a node which is the influence on an object.
4. Object: This is a node which is influenced by a subject node.
5. Type: Whilst nodes provide key points and identify specific areas of concern or
interest, the interrelationships between nodes needs to be more clearly defined. Five
types of node were identified as follows:
• State: A feeling or perception at a particular time
• Stakeholder: Those with a special interest or who may be affected by a system
• Attribute: A characteristic or that which defines or separates one from another
• Process: The way in which an operation is implemented
• Artefact: A physical manifestation of a tool or product
Therefore, as each node was identified, its type, which was related to its broader
context, was also considered. By placing nodes within a broader context, several
nodes were therefore allocated the same ‘type’.
6. Dependency: A dependency is a series connections, which identify a specific area of
concern or interest that may have an impact or effect on PHM. Dependencies are
between nodes, and are represented on the map by a line. Many show dependencies
that have an influence on several nodes. Arrows on the map indicate whether this
influence is one-way or two-way. Many nodes are linked to other nodes by the
dependencies which are identified through the use of verbs to aid in the analysis of
what dependencies might mean for the future of PHM.
7. Mutual Dependency: This is where a node is both influenced by and influences
another node. It is shown on the map through two arrows and provides clarity in
understanding the complex relationships between nodes, dependencies and potential

PHM system development. A mutual dependency may not always have an equal
distribution of influence in that a dependency may affect another more than the
other affects it. In some of these cases, it should be noted, only one arrow is shown.
8. Verb: These are used as a way to identify how nodes influence and are influenced
by each other. They describe the relationships between them, and as such provide
some information about the nature of the dependency between the nodes. The verb
set used to describe the relationships and impacts of PHM dependencies is shown in
Table 1.
9. Decomposition: This is the way in which the dependencies map elements are
identified. Nodes are decomposed within the maps to show further nodes and the
dependencies within or among them. Decomposition in this sense refers to the
identification of the dependencies within each node through each lower level.
10. Level: The dependencies map as presented comprises three levels in addition to the
outline map at level zero. Level one refers to primary nodes which also include their
own dedicated sub-maps. Level two nodes identify the important elements within
each level one sub-map and are where level three dependencies are outlined.
2.2. Graphical Tool
The lexicon provided the components with which to construct a graphical

representation of the complex PHM. In a typical dependencies or system diagram, the
link lines may often identify (but not necessarily explain) relationships between nodes
and is normally hierarchical in that ‘The control of large systems is always organized in
a distributed hierarchy’ [13, p.1]. The actual link lines used are likely to be a way of
joining one node to another or a direction of travel rather than attempting to offer an
explanation of relationships between the nodes.
However, in a complex analysis, the lines and links may also have meaning,
particularly where the diagram is trying to explain a social system.
Table 1. Verbs to describe relationships within PHM
affect(s) inform (s) facilitate(s) regulate(s)

collaborate(s) with interpret(s) fashion(s) require(s)
demand(s) lead(s) to impact(s) serve(s)
develop(s) mitigate(s) implement(s) to be(is)
drive(s) question(s) incorporate(s) use(s)
employ(s) raise(s) influence(s)
Nodes may contain descriptions and identify issues or denote relationships, but line
markers generally only show the links themselves without explaining the relationships
as shown in Figure 2.
Or they can show a series of steps towards an expected outcome as in a process
diagram shown in Figure 3.
However, the dependencies mapping exercise included maps that could be
decomposed into sub-maps, but these did not place greater or lesser importance on any
particular degree of decomposition and so were not hierarchical. It is possible to
describe the degree of decomposition as a ‘level’ (and indeed this is done in the
relationships table, see the next section), but this is purely descriptive. It is important to
avoid associating concepts like ‘importance’ with level: level three nodes can be just as
important as level two nodes, when deciding on priorities. The diagram in Figure 4
indicates how the use of verb descriptions for the link lines created an opportunity for
contextual understanding, while countering hierarchical assumptions.
In this map of Social Scientists and Philosophers used within the context of PHM-
Ethics, the coloured link lines indicate the relationships between nodes, and the verb
descriptors provide an aid to their meaning.
In this graphical representation, verb descriptions for link lines are presented in the
same colour font as the link lines they refer to so that the relationships can be easily
identified when viewing the graphical map for example the connections in blue which
indicate that Advisors ‘inform’ and influence’ policy makers. There are also connectors
that appear to be open ended. However, these lines directly link to other maps within
the system, and so indicate the relationships between maps, for example, Social
Scientists and Philosophers ‘influence’.
Parent Node
Child Node Child Node Child Node
Figure 2. Simple hierarchical diagram
Process 1
Followed by Process 2
Results in Outcome A
Figure 3. Simple process diagram

Figure 4. PHM ethics Dependencies Map of Social Scientists & Philosophers
2.3. Relationship Table
The method of verb use described above was complemented and strengthened by the
development of a relationship table. Within the map, even though the verbs enhance the
contextual understanding of the relationships, it is still highly complex and appears to
lack a systematic approach. Therefore, a relationships table was developed alongside
the maps so that nodes and relationships could be quickly identified and examined.
In the example in Table 2, if we consider the map of Social Scientists and Philosophers;
by reading across the grid from left to right, we reveal that: Policy Makers as
Stakeholders at level 2 serve Policy Makers: Government as a Stakeholder at level 1
with a strong relationship, which means that when considering dependencies and
relationships within the map of social scientists and philosophers, policy makers are
second level stakeholders who make decisions that serve to strongly reflect decisions
made by government policy makers at level one.
A second example further highlights the power of the tool in providing context and
understanding of the complex systems; Advisors as Stakeholders as level 2 incorporate
Advisors: Clinical as a Stakeholder at level 3 also with a strong relationship, which
means that when considering the map of social scientists and philosophers, advisors are
stakeholders at level two providing advice, guidance and information based on level
one policy. They include the advice from clinical advisors at level three (advice based
on experience from working practices delivered in accordance with level one and two
policy decisions). This relationship is strong as the influence of individual advisors at
level three is incorporated and strengthened by being incorporated into the expertise of
advisors at level two.
The table could be further populated and nodes deconstructed to derive greater
detail or deeper understanding. In fact, it was quickly understood that the table provided
a particularly powerful tool to understand context within complex systems, and that
whilst the maps were unable to fully represent the complexity, they could provide a
graphical overview of the system and its interrelationships.
Table 2. Relationship table

Social Social
Scientists Scientists Stake- Policy Stake-
As 1 influence As 2 m
and and holder Makers holder
Philosophers Philosophers
Social Social
Scientists Scientists Stake- collaborate Stake-
As 1 Academics As 2 s
and and holder with holder
Social Social
Scientists Scientists Stake- Stake-
As 1 influence Advisors As 2 m
and and holder holder
Social
Policy
Scientists Policy Stake- Stake-
As 2 serve Makers: As 1 s
and Makers holder holder
Government
Philosophers
Social Policy
Scientists Policy Stake- Makers: Stake-
As 2 fashion As 3 s
and Makers holder Medical holder
Philosophers Policy
Social
Scientists Stake- Academics: Stake-
Academics As 2 incorporate As 3 s
and holder Lecturers holder
Philosophers
Social
Scientists Stake- Academics: Stake-
Academics As 2 incorporate As 3 s
and holder Researchers holder
Philosophers
Social
Scientists Stake- Policy Stake-
Academics As 2 inform As 2 m
and holder Makers holder
Philosophers
Social
Scientists Stake- Advisors: Stake-
Advisors As 2 incorporate As 3 s
and holder Clinical holder
Philosophers
Social
and holder Financial holder
Philosophers
Social
and holder Sociological holder
Philosophers
Social
and holder Political holder
Philosophers
Social
and holder Theorists holder
Philosophers
Social
Advisors As 2 inform As 2 s
Philosophers
Social
Advisors As 2 influence As 2 m
Philosophers
The development of verb descriptions included in the links, helped to explain the
impact of the interactions. It allowed further links and influences to be observed across
and between the key areas of investigation. In this way, for example, a dependencies
map that is chiefly concerned with Politics and Governance related to PHM will supply
multiple links and impacts on a wide range of other maps within the same subject. The
inclusion of verb descriptors enabled the development of an understanding of the nature
of the impact alongside the ability to further expand understanding from the sub-maps
created. The multiple links between maps and nodes meant that each map could be
considered alone in the first instance so that the key issues can be examined in detail.
Then, the links and their relationship to other maps can be followed and other less
important but no less significant issues can be considered, based on their already
established impact on/from or between the earlier map/level/category.
The high level of complexity meant that without identifying the influencing factors
and links, it was difficult to see a clear picture or meaning derived from the
identification of issues. Further, the use of a table to identify the relationships meant
that direct links to maps could be seen quickly and specific analysis undertaken,
focusing on clear goals and objectives, without losing sight of the bigger and more
complex picture of the whole area for investigation. The use of verb descriptions,
complemented by a relationships table enabled complexity to be understood and
avoided missing areas of importance.
2.4. Narratives
The narrative descriptions of each of the dependencies maps provided rich contextual
insight into the meaning that the graphical and tabular tools revealed as ‘a focus on
narrative is valuable because it facilitates recognition of the extent to which interpretive
research involves the creation and ascription of meaning in ways that require authorial
reflexivity’ [14, p.1].
The use of narrative was a particularly important element in the PHM investigation.
Without explanation, the dependencies maps and associated relationship table merely
provide data without providing information. The narrative therefore, served to explain
the impact of dependencies by using examples and scenarios that would enable further
understanding and therefore aid decision makers and policy makers as well as
developers of complex systems. For example, here is an extract from the narrative for
Social Scientists and Philosophers.
“Within ethics, and especially the branches of medical ethics and computer
ethics/ICT ethics, the object for study is the impact of PHM- technologies on health
care values. So far however, there is not much research being conducted within this
field. The result of the research within social sciences and ethics can have different
kinds of impact on personal health monitoring. It can lead to knowledge about how
personal health monitoring is experienced by the users, i.e. patients and health care
providers. Furthermore, the results can influence politicians on different levels – from
regional health care providers to the EU commission - and hence political decisions can
affect the allocation of resources for personal health monitoring. It can also influence
the technicians that are developing the technique, the health care authorities that
introduce the technique and the attitudes of health care personnel. ”
3. Outcomes
The analysis using the dependencies mapping method revealed 11 interrelated maps.
These were PHM-Ethics Dependencies Map which was the Overview at level 0,
Society, Health Informaticians, Social Scientists and Philosophers, Healthiness, Law,
Government, PHM Instruments, Operation, Medics and Allied Professionals, and
finally, People. There were 297 dependencies identified intra-maps or inter-maps. Of
these 10 were at level zero, 73 were at level one, 177 were at level two and 37 were at
level three. The maps and tables are combined with a narrative which explained the
dependencies in detail. Thus the three elements of map, table and narrative provide a
comprehensive picture of PHM [15]. The detail of these outcomes is not described here
but the recommendations below represent the synthesis of this detailed analysis.
4. Recommendations
The culmination of the dependencies mapping analysis resulted in a set of

recommendations. These recommendations lay a foundation for PHM-Ethics and
indicate the challenges for stakeholders when considering or evaluating PHM
technologies. Much of what is included below reveals the need to emphasise an ethical
approach to PHM that appreciates the potential impact of dependencies and their
associated relationships, and which could directly influence current and future PHM
development.
4.1. Recognise the importance of the transdisciplinary approach which leads to deep
meaning and understanding of PHM and its context
A transdisciplinary approach enables the drawing together of concepts from the

disciplines to create frameworks and to break down barriers to co-operation and
understanding.
4.2. Use a common language of communication to ensure consistency of dialogue

across disciplines and between key players in rolling out PHM
A transdisciplinary approach requires that in order to ensure accurate communication

and understanding, a common language is adopted. A Lexicon has been provided to
standardise the meaning of key words used in this work. In future PHM development, a
standard or common language not only is important, but also ensures that all
stakeholders are able to understand, through the minimisation of discipline-specific
technical or overly-academic language.
4.3. Recognise that dependencies are not just between stakeholders
Dependencies may impact, or have an influence on, a wide range of areas. Whilst
directly affected stakeholders are probably the most important, dependencies are also
found that operate between organisations, physical artefacts (such as technical
equipment), Law, Governments and wider society. For example, Law as a process
facilitates business as a stakeholder. It is vital to take into account the rich diversity of
dependencies when planning, developing, implementing and using PHM.
4.4. Recognise the dynamic nature of dependencies and relationships over time and
through technological evolution
Technological evolution can often be predictable in many ways due to the largely
incremental nature of development but this is not always true. However, many of the
dependencies and associated relationships identified are dynamic in nature and subject
to change that is less predictable than technological change. This means that PHM
decision making cannot be static in the way that it is either derived or applied.
4.5. Recognise the complexity and variability of dependencies and relationships
The graphical maps provide limited snapshot views for PHM-Ethics. Through the
development of the relationships table, further depth and detail has been derived.
However, the complexity, variability and fluid nature of the dependencies and
relationships means that it is likely that new dependencies and relationships may be
discovered as new developments and changes occur within the field of influence on
PHM.
4.6. Contextualise PHM to improve the probability of successful PHM
PHM may be used in many different contexts and for a wide range of different health
conditions. Future use may also include general wellbeing and health monitoring as a
preventative rather than treatment option or even as a tool for social control. It is
essential therefore that the use for which the PHM system is developed, and the context
in which it is to be placed, should be considered alongside the practical application of
the system. This is likely to increase the probability of successful PHM implementation.
4.7. Prioritise the contextual issues surrounding PHM so that focus can be placed on
the key elements
It is understood that PHM-Ethics is a highly complex and dynamic area, and that there
are many dependencies that could have an impact on the success or failure of PHM.
Therefore, when developing PHM systems, it is important to prioritise those
dependencies and relationships that are likely to have the greatest impact, whilst being
aware of the potential impact that the other dependencies may have.
4.8. Understand the nature of relationships between dependencies
In order to be able to evaluate the impact of nodes and relationships, it is also necessary
to understand the nature of the relationships identified. Relationships are better
understood through an awareness of the context in which they are considered. Some
nodes and their relationships may be considerably stronger and more influential than
others, and so it is important to ensure that the cultural, social and political context is
understood. Relationships may also vary in strength according to the specific nodes
they are linked to and the context in which they are formed.
4.9. Make this complex system description accessible to all interested parties so that it
can be used as an analytical instrument and standards compliance model for
future PHM
PHM is complex and dynamic and due to this, the maps, table and verb-set descriptions
may not be useful analytical tools alone for PHM developers. A means is required to
turn this into a practical tool. This requires further work.
4.10. Address the key issues of the nature of PHM
There are several key issues of the nature of PHM that were identified during this work
and which would need to be addressed before a PHM system is implemented.
4.10.1. How can adequate privacy be maintained?

This would require that privacy and security protection was built into the original PHM
system. Further, strong and consistent use of data protection law would add some
protection. However, there is always the danger of malicious inappropriate behaviour of
individuals leading to a loss of privacy. Staff training, good security, and an ethos that
considers privacy a right, all help to maintain the privacy of the individual and their
data.
4.10.2. What regimes for informed consent are necessary for PHM to be both morally
appropriate and practical?
Informed consent by its nature cannot be considered to have been given without the
person being fully aware of what is being asked. Therefore, particularly with embedded,
long-term PHM, it is inappropriate for any changes in policy or procedure to be
introduced without the consent of those whose information may be used. Therefore, it
should be assumed that consent would not be given, and that a patient must be offered
information about what is intended during treatment (including who will see their
personal information), and information about alternatives. Only then can a patient give
their ‘informed’ consent.
4.10.3. Staff training is important, but cannot be sufficient: what can be done to
maximise the chance that staff behave in the way they have been trained?
Training in the use of technical equipment is not sufficient alone, it is just as important
that staffs are made aware of the impact that their behaviour may have on patients.
However, it is not possible to be sure that their motivations are honestly stated, and
trust plays a large part. Listening to patients to find out what their experiences are like,
would provide some opportunity to discover whether staff are operating the system in a
way that is most efficient and that also makes patients feel comfortable with using PHM
themselves.
4.10.4. To what extent can ethically and legally required constraints be designed into
the technologies?
To build ethical and legal constraints into technologies, developers first need to be
aware of their responsibilities to stakeholders in particular. A well formulated project
plan that considers these obligations from the outset is one way that these constraints
can be designed into the technologies. Further, if ethical and legal issues are identified
at the planning stage (through the use of ethical and risk analysis techniques) it is more
likely that the critical issues that could potentially lead to project failure can be
addressed at the design stage.
5. Conclusions
The comprehensive picture derived from the PHM analysis using the dependencies
mapping method can be used in a variety of ways. For example:
• Through interpretation, the key contextual areas of concern can be identified
providing an action plan for addressing the issue of ensuring fit for purpose PHM.
• The picture can be distilled into briefing papers for policy makers to assist informed
decision making regarding regulation and governance of PHM
• The derived rich data set can be used as direct input into existing software tools,
such as SoDIS Project Auditor [16], in the detailed work of technology specification
of specific PHM systems.
• The picture can be used as an invaluable resource in systems analysis activities in
general for any application system.
• As the picture can be updated as new knowledge is gleaned it will act as an early
warning of potential problems in a proposed PHM application development.
The planning, development and implement of PHM application systems is a highly
complex process involving many agencies and is beset by many complex issues. The
new insights offered through systematic dependencies mapping analysis should reduce
the risk of failure and increase the likelihood of fit-for-purpose PHM that is acceptable
and valuable to individuals as well as society at large.
6. Acknowledgements
no. 230602.
References
[1] B. Rosi, M. Mulej, The dialectical network thinking: a new systems theory concerned with management,
Kybernetes 35 (2006), 1165-1178.
[2] C. Francois, Transdisciplinary Unified Theory, Systems Research and Behavioural Science 23 (2006),
617-624.
[3] European Commission. PHM-Ethics, Annexe 1, Description of Work, Grant agreement no: 230602,
Seventh Framework Programme, Priority 10: Science and Society, (2009).
[4] J.L. Gordon, Creating knowledge maps by exploiting dependent relationships, Knowledge-Based Systems
13 (2000), 71–79.
[5] USDoH, U.S. Department of Health and Office of the National Coordinator for Health Information
Technology Human Services, Remote Monitoring, detailed use case document, (2008). (accessed
2010/01/28, substantive document unavailable. http://healthit.hhs.gov/portal/server.pt?open=512&mode
=2&cached=true&objID=1202&PageID=15669
[6] H. Abbass, R. Sarkar, C. Newton, Data Mining: A heuristic approach, Idea- Group Inc (IGI) (2002).
[7] W. Ulrich, A brief introduction to critical systems heuristics (CSH), ECOSENSUS project website, The
Open University, Milton Keynes, UK, (2005) http://projects.kmi.open.ac.uk/ecosensus/publications/
ulrich_csh_intro.pdf
[8] S. Carr, S. Oreszczyn, Critical Systems Heuristics: a tool for the inclusion of ethics and values in complex
policy decisions, Proceedings of the 4th Eursafe Congress, 20-22 March, Toulouse, France (2003)
[9] W. Lutterer, Systemics: the social aspects of cybernetics, Kybernetes 34 (2005), 497-507.
[10] A.L. Delbecq, A.H. VandeVen, D.H. Gustafson, Group techniques for program planning : a guide to
nominal group and Delphi processes, Scott Foresman and Company, Glenview, Illinois (1975).
[11] C. Brahm, B. Kleiner, B. Advantages and disadvantages of group decision-making approaches, Team
Performance Management 2 (1996), 30-35.
[12] A. Lijphart, Democracies: Patterns of majoritarian and consensus government in twenty-one countries,
Yale University Press, New Haven, CT (1984).
[13] P. Varaiya, A question about hierarchical systems. In: T. Djaferis, I. Schick (eds.) System Theory:
Modelling, Analysis and Control, Springer (2000).
[14] A.D. Brown, Narrative, Politics and Legitimacy in an IT Implementation, Journal of Management
Studies 35 (1998), 35-58.
[15] S. Rogerson, S Wilford, N.B. Fairweather, PHM-Ethics Deliverable D2.4-2b: Final version of
dependencies map De Montfort University, Leicester, 2010.
[16] D. Gotterbarn, S. Rogerson, Next generation software development: responsible risk analysis using
SoDIS, Communications of the Association for Information Systems 15 (2005), 730-750.
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-95
A Module for Psycho-Social Assessment

Holger MUEHLAN1, Dieter RHODE and Silke SCHMIDT
Department for Health and Prevention,
Ernst-Moritz-Arndt University of Greifswald
Abstract. This contribution to an interdisciplinary methodology on Personal

Health Monitoring (PHM) aims at developing a psycho-social module for health
technology assessment on PHM applications. It covers important aspects that
should be taken into account for conducting a health technology assessment from a
psycho-social perspective. As it could be used in addition to other tools within the
PHM-Ethics approach to health technology assessment it is considered as a
module of the interdisciplinary methodology. As a prerequisite, we provide a
conceptual framework on psycho-social issues of PHM applications. From that
framework we delineate an integrated module for psycho-social health technology
assessment for PHM applications, consisting of a map highlighting selective
psycho-social issues that may appear when applying a PHM system. This psycho-
social tool is at least twofold in its intention as a sole HTA tool on the one hand
and as an integral part of the interdisciplinary PHM methodology on the other
hand. It provides a quick overview on potential benefits and risks from the user’s
point of view.
Keywords: Personal health monitoring, psycho-social issues
Introduction
Over the last decade, there has been increased emphasis on (subjective) patient-repor-
ted outcomes (PRO) in health technology assessment (HTA). This was due to the fact
that the individual and social impact of emerging technologies had been of more in-
terest in the field of HTA.
1. Background and Concept
This contribution to the interdisciplinary methodology on Personal Health Monitoring

(PHM) aims to provide a psycho-social health technology assessment tool of PHM
applications. It covers important aspects that should be taken into account when con-
ducting a health technology assessment from a psycho-social perspective. The psycho-
social module is at least twofold in its intention as a sole HTA tool on one hand and as
an integral part of the interdisciplinary PHM methodology on the other. The module is
to be used to evaluate (expected) psycho-social impact and describe people’s attitudes
and judgments towards PHM technology.
1
96 H. Muehlan et al. / A Module for Psycho-Social Assessment of Personal Health Monitoring
The psycho-social assessment module was developed aiming to be: simple (instead
of complex); pragmatic (instead of scientific); useful (instead of theoretical); generic
(instead of specific); focused on users/laypersons (instead of stakeholders/ profess-
sionals); related to personal monitoring (instead of public surveillance); highlights
health monitoring (instead of health care).
Initially, a literature review [1] and expert interviews have been conducted to
establish a framework of relevant psycho-social issues in PHM. Based on that
framework on psycho-social issues (see Table 2), a module was delineated providing a
comprehensive overview on psycho-social issues to be considered and investigated in
case of assessing emerging PHM technologies. The aim of validating the psycho-social
module was to identify obstacles within the preliminary version and further improve
the performance of this module. The term validation refers to the process of evaluating
an instrument, measurement or assessment being under development. We applied a
combined approach to validate the psycho-social module, including conceptual analysis
as well as empirical.
The module provides tools for investigating psycho-social issues in health techno-
logy assessment for personal health monitoring applications at all stages of develop-
ment. The focus of the assessment is on the impact on (potential) users and the
assessment from the perspective of the (potential) users.
The psycho-social module is composed out of two different parts, a list of
evaluation criteria and an assessment method. The list of evaluation criteria provided
added value by briefly outlining intended purposes as well as unintended outcomes and
risks associated, an example is presented in Table 1. The survey instrument comprises a
range of questions for specific target groups and broader populations. Both instruments
are applicable without further training using the manual of the PHM methodology.
Table 1. An extract from the psycho-social module for PHM assessment
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H. Muehlan et al. / A Module for Psycho-Social Assessment of Personal Health Monitoring 97
Based on the framework on psycho-social issues, a module was delineated providing a

comprehensive overview on psycho-social issues to be considered and investigated in
case of assessing emerging PHM technologies. Added value is provided by briefly
outlining intended purposes as well as unintended outcomes and risks associated.
2. Methodological Dimensions
2.1. Impact
The dimension of impact refers to characteristics of the impact being under

consideration, according to the following three attributes: evaluation, intension and
attribution.
• Evaluation of impact (positive vs. negative): The impact of using a PHM
application should be assessed regarding positive as well as negative aspects. This
refers to the pros and cons of using the respective PHM application under suspicion.
Covering “both sides of the story” is urgently needed for several reasons: (i) Health
technology assessment is naturally directed to primarily cover negative impact,
detecting concerns, risks or hazards. In doing so, addressing or identifying positive
impact in terms of benefits is biased in this context. On the roundabouts, in outcome
research, target criteria are assessed, regularly addressing intended positive
outcomes using PHM applications (and therefore, outcome assessment is biased
against identifying negative impact). Moreover (ii) this module aims at addressing
positive and negative associated attitudes, experiences and evaluations in terms of
aspirations vs. concerns, risk vs. potentials, or benefits vs. constraints with respect
to the (intended) use of PHM applications. In addition, (iii) most psycho-social
attributes covered by the module could be labelled “positive” or “negative”,
depending on the respective subjective connotation, evaluation or judgment of the
user. Most aspects are not “positive” or “negative” by nature. One should also
consider (iv) the methodological obstacle caused by the direction of question
wording in terms of so-called pro-trait and con-trait items. That is, it could make a
difference in answering a question whether or not the wording of the item is in
“direction” of the construct of interest. Finally, (v) including pro- and con-trait
items allows investigating the dimensional nature of a construct under suspicion.
• Intension of impact (intended vs. unintended): It seems obvious – not to say self-
explaining – to distinguish between intended and unintended impact. But this
distinction adds up some value if considered while preparing an assessment because
PHM applications do implicate at least two directions of including unintended
effects despite of unintended effects as usual. First, (i) several monitoring
applications (especially from the area of ambient monitoring) could include persons
that are not intended to be monitored. Moreover, (ii) as every data could be linked,
a further noteworthy impact could be related to the natural unintended linkage of
data.
• Attribution of impact (related to application vs. not related to application): A
sometimes neglected, yet often quite difficult task is to distinguish between
different attributions of PHM impact. That is, whether or not a change in something
is attributed to the implementation of a PHM application or not. Whilst preparing
the assessment this distinction has to be kept in mind.
2.2. Assessment
The dimension of assessment itself refers to methodological attributes of the

assessment, such as focus, time point and perspective of assessment.
• Focus of assessment (technology-, monitoring-, or outcome-related): While
considering to assess the impact of PHM applications, one should bear in mind the
distinction between technology assessment and outcome assessment. Moreover, one
should distinguish between technology assessment and monitoring assessment.
Although both issues are strongly interdependent, it is valuable to draw a distinction
here, since a specific technological application is not necessarily limited to a
specific monitoring usage and vice versa. Moreover, concerns about technology are
primarily related to “intrusiveness” and “reliability”, whereas concerns about
monitoring are primarily directed to “privacy” and “data security”. Thus, before
conducting an assessment, the focus should be clarified, since depending on the
focus of the assessment, questions should be specified to device-related issues
(technology assessment), monitoring-related issues (monitoring assessment) or
health in terms of physical, mental, social and functional well-being (outcome
assessment).
• Time point of assessment (before, within, or after implementation): Not just from a
scientific point of view, it is important to note that the time point of the assessment
may have a huge impact on the issues under consideration. Obviously, this holds
true for studies to be conducted in the future, but one should not neglect to consider
this distinction with respect to PHM-related studies that had already been conducted.
It does make a difference if people are asked before, within or after experiencing
PHM on their own. Depending on the point of time of the monitoring
implementation, questions will be addressed to people’s attitudes (before),
experiences (within) or evaluations (after).
• Perspective of assessment (self-, proxy-report): In best case, one could implement a
wide range of perspectives and thus participants, although the single-perspective
trial will be the most widely used in reality. It is recommended to include the person
concerned (usually the user/patient/consumer) at least with self-report, since his or
her subjective experiences are of primary intent and these could not be achieved by
others. Thus, a proxy-report provided by a relative (e.g. family member) should
focus on user’s experiences instead of its own experiences.
3. Descriptive (“Content-Related”) Dimensions
Referring to the time point of assessment, psycho-social issues of PHM from the user’s
point of view are differentiated into three main domains: implementation, processing
and outcomes. Furthermore a separation between “intended purpose/target (inherent
benefit)” and “unintended outcome (risks associated)” was done across all domains,
according to the dimension “Intension of impact” (cf. Table 2).
3.1. Implementation
The first main domain “Implementation” subdivides into the domains implementation
“related to the potential user”, which is to be assessed via target group analysis, using
qualitative and/or quantitative approaches, and secondly, implementation “related to
implementing the technological application”, which is to be assessed via usability
studies and pilot trials. When considering the implementation of PHM related to
potential users, three issues are regarded: “perceived need”, “perceived relevance” and
“acceptance”. Considering the issue “perceived need”, the intended purpose is to match
the needs of a certain target population; whereas the associated risk is the failure to
match certain needs of the potential users (e.g. application does not address purposes or
target groups). Regarding “perceived relevance”, PHM’s intended purpose is to be
deemed necessary, important or more relevant compared to alternatives, whereas the
associated risk is that PHM may be obsolete to users (e.g. because of sufficient
alternatives). The intended purpose of PHM associated with “Acceptance” is the
intention to be used, as well as the adoption to the technology. Associated risks
regarding the issue of “Acceptance” are the rejection of technological applications (e.g.
because of unwillingness to adapt to new technologies).
When considering PHM related to implementing the technological application, the
issues from the user’s point of view are: “Affordability”, “Demand on Effort”, and
“Sustainability”. In terms of “Affordability”, PHM needs to be available at no or less
additional private costs for end-users to create an inherent benefit. The risk associated
is that PHM may not be affordable for those persons in need (e.g. no one pays for it).
Requiring no or less additional effort regarding time for the implementation would be
an intended purpose regarding the “demand on effort”, whereas the requirement of
(extensive) additional effort (e.g. extensive training) would be considered an
unintended outcome. A further issue when looking at the implementation of
technological applications is sustainability; its associated intended purpose would be
the orientation of the implementation of PHM towards sustainability, yet an associated
risk would be the lack of sustainability (e.g. high potential of technical obsolescence).
3.2. Processing
The second domain “Processing” is divided into technology-related processing, which

is to be assessed via usability studies and pilot trials, as well as monitoring-related
processing, meaning data transfer, which is to be assessed via ethical technology
assessment.
Technology-related issues are subdivided into seven sub-domains. The issues
concerning function are associated with the intended purpose to ensure high functional
performance and neglect functional limitations, yet the associated risks are the
malfunction or suboptimal performance, as well as functional limitations of PHM. In
terms of Reliability, the purpose is to ensure accuracy of the measurement, yet the risk
would be an inaccurate measurement (e.g. issue of false alarms). It needs to be ensured
that PHM applications have a user-friendly design, which would be perceived as an
inherent benefit; a failure in user-friendliness (e.g. design is not age-appropriate) would
form an unintended outcome of PHM. In terms of Usability-issues PHM is to ensure an
ease-of-use in order to constitute an inherent benefit. An associated risk from the user’s
point of view would be a technology that is hard to handle (e.g. requests reading an
extensive manual). Another technology-related issue is control. The user sees an

inherent benefit if a user intervention can be enabled if needed (regarding manual
interruption of automated processes). An associated risk in terms of control would be
the lack of user interruption if needed (e.g. in case of emergency). PHM should provide
sufficient possibilities for active user participation to build an inherent benefit
regarding participation-issues. However, if PHM does not provide possibilities for
active user participation (e.g. no options to customise settings) it would be seen as an
associated risk. Other issues that would form an intended benefit for the users would
be the guarantee to affect other people as little as possible (regarding spatial and
physical intrusiveness of the technological set-up). Other associated risks would be the
obtrusiveness to other people (e.g. retrofitting a flat for ambient-assisted purposes
requires comprehensive changes in living arrangements).
Monitoring-related processing, meaning Data transfer encompasses the following
issues: Privacy, Surveillance, Freedom of Choice, Trust, and Others. Privacy from the
user’s point of view forms a benefit if PHM is able to ensure privacy (regarding
informational, decisional, spatial and bodily aspects). An associated risk, however,
would be the intrusion of privacy. PHM needs to promote the monitoring technology as
a positive service and hinder feelings of being observed to form an inherent benefit. In
case the users feel observed (as in being under suspicion) an unintended outcome
would be attained. Considering freedom of choice when it comes to PHM, the enabling
of user participation regarding monitoring settings would be an inherent benefit, yet,
users see risks associated when users are not enabled to decide on monitoring settings
(e.g. decide which information is being monitored). Issues of trust would be beneficial
if PHM supported trust in technology and enhanced trust in professionals. Yet, it would
be associated with risks if PHM deteriorated trust in professionals due to technology
(e.g. due to lack of personal attendance at home). Other issues that form an inherent
benefit would be that other persons are not being monitored and accordingly an
associated risk if other persons are being monitored (e.g. in case of ambient sensors).
3.3. Outcomes
The Outcomes-section is subdivided into outcomes regarding quality of life related to

health and well-being, which is to be assessed initially via pilot trials using qualitative
approaches, finally via randomised control trials using standardised measures.
Secondly quality of life related to independent living, which is to be assessed initially
via pilot trials using qualitative approaches, finally via randomised control trials using
standardised measures. Thirdly quality of life related to comfortable living, which is to
be assessed initially via pilot trials using qualitative approaches, finally via randomised
control trials using standardised measures.
Quality of life related to health and well-being is further subdivided into six
domains. Regarding physical health, PHM would form a benefit if the user is to
maintain or enhance physical well-being, regarding physical integrity and performance.
In contrast to this, PHM would be associated with risk if PHM had no (additional)
positive impact on the respective target (outcome intended) or, if there was a negative
impact on the target due to a PHM application, e.g. skin irritations from electrodes. In
terms of mental health, PHM would form an inherent benefit if mental well-being
would be maintained or enhanced, with respect to mental performance. If there was no
(additional) positive impact on the respective target (outcome intended) or even a
negative impact on the target due to the PHM application, e.g. feelings of being under
suspicion, this would result in an unintended outcome. Social well-being would be

benefited if social well-being was maintained or enhanced, regarding social acceptance,
participation and integration. Associated risks would be the absence of (additional)
positive impacts on the respective target (outcome intended) as well as a negative
impact on the target due to the PHM application (e.g. visible PHM application could
result in stigmatisation). PHM would form an inherent benefit if functional health was
maintained or enhanced, regarding functional integrity and performance, yet an
unintended outcome would exist if no positive impact on the respective target was seen,
as outcome intended or, if there was a negative impact on the target due to the PHM
application, e.g. functional restrictions in mobility due to the PHM system.
In terms of role-expectations, users would see a benefit if PHM maintained or
enhanced role-functioning regarding work-life, family affairs, leisure time activities
and social life. On the other side, an unintended outcome would be no (additional)
positive impact on the respective target, as outcome intended, or even a negative
impact on the target due to the PHM application (e.g. if using the PHM system requires
additional time).
If the health status of the user is maintained or enhanced in general, the users will
see an inherent benefit, yet, if no (additional) positive impact on respective target
(outcome intended) can be seen or even a negative impact on the target due to PHM
application appears, e.g. rejection reactions after implementing an invasive device, a
risk will be associated with PHM.
Quality of life related to independent living splits up into autonomy and security.
PHM will be associated with an inherent benefit in terms of autonomy if independent
living (in all areas of daily living) is being maintained or enhanced. A risk will be
associated with PHM if there is no (additional) positive impact on the respective target
(intended outcome) or even a negative impact on the target due to PHM application
(e.g. dependency on technology). PHM is furthermore viewed as a benefit when safety
is maintained or enhanced at home, at work and elsewhere. Users will associate a risk
with PHM if there is no (additional) impact on the respective target (intended outcome)
or if there is even a negative impact on the target due to the PHM application, e.g. lack
of functioning or response in case of emergency.
Also the category “Quality of life” related to comfortable living is subdivided into
“convenience”, as well as “wellness”. From the user’s perspective, if the feelings of
comfort and convenience will be maintained or enhanced, it will form an inherent
benefit. In contrast to that, if there is no (additional) positive impact on the respective
target, as outcome intended, and even a negative impact on the target/user due to a
PHM application (e.g. if the technological systems generate noise), it will be seen as an
associated risk by the users. Regarding wellness, a benefit will be seen if wellness and
happiness are maintained or enhanced, yet, if no (additional) positive impact on the
respective target takes place, as outcome intended or PHM even having a negative
impact on the target due to the PHM application, the users will associate PHM with a
risk.
4. Areas of Application
The module is thought to be used by HTA experts with a general interest in the psycho-
social impact of emerging health monitoring applications as well as related patient/
client reported outcomes. A survey was conducted to investigate the performance of
the modu ule as a tool for exploring g subjective judgments on n emerging PH HM appli-
cations. Scenarios
S had d been prov vided by the PHM Ethiccs Group. W We used a
questionnaire providin ng informatio on on attitud des and emo otions relatedd to PHM
applications. This questionnaire waas derived fro om the frameework on psyycho-social
issues in PHM.
P Likert-llike scaling was
w applied forr answering th he majority off items and
criteria in
ncluded in thee assessment. All case scen narios were asssigned randoomly to the
survey resspondents fro om two differrent samples: a homogenous student saample (n =
450) and a heterogen neous populattion sample (n > 300). Survey resullts provide
quantitativve information n on general attitudes
a to tecchnology and the emotional impact of
PHM app plications. Vaarious scenarrios provoke specific resp ponses as inddicated by
different “profiles”
“ of psycho-sociaal dimensions assessing the anticipated impact of
PHM appllications on in ndividual and social level.
Figure 1. Comparing scenario specific profiles of psycho-social dimensions for different PHM applications
wledgements
5. Acknow
The reseaarch leading to these results has recceived fundin

ng from the European
Communiity's Seventh Framework
F Prrogramme (FPP7/2007-2013) under grant agreement
no. 23060
02.
Referencees
[1] H. Mueh
hlan, S. Schmidt, Psycho-Social Aspects
A of Person
nal Health Monito oring: A Descriptive Literature
Review
w, In: S. Schmiidt & O. Rienh hoff (Eds.), Interrdisciplinary Asssessment of Perssonal Health
oring, IOS Press, Amsterdam, 201
Monito 13.
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-105
Ethically Sound Technology? Guidelines

for Interactive Ethical Assessment
Elin PALMa,1, Anders NORDGRENa, Marcel VERWEIJb and Göran COLLSTEa
a
Centre for Applied Ethics, Linköping University
b
Department of Philosophy, Utrecht University
Abstract. Novel care-technologies possess a transformational potential. Future care

and support may be provided via monitoring technologies such as smart devices,
sensors, actors (robots) and Information and Communication Technologies. Such
technologies enable care provision outside traditional care institutions, for instance
in the homes of patients. Health monitoring may become ”personalized” i.e.
tailored to the needs of individual care recipients´ but may also alter relations
between care providers and care recipents, shape and form the care environment
and influence values central to health-care. Starting out from a social constructivist
theory of technology, an interactive ethical assessment-model is offered. The
suggested model supplements a traditional analysis based on normative ethical
theory (top-down approach) with interviews including relevant stakeholders (a
bottom-up approach). This method has been piloted by small-scale interviews
encircling stakeholder perspectives on three emerging technologies: (1) Careousel,
a smart medicine-management device, (2) Robot Giraff, an interactive and mobile
communication-device and (3) I-Care, a care-software that combines alarm and
register system. By incorporating stakeholder perspectives into the analysis, the
interactive ethical assessment model provides a richer understanding of the impact
of PHM-technologies on ethical values than a traditional top-down model. If the
assessment is conducted before the technology has reached the market - preferably
in close interaction with developers and users - ethically sound technologies may be
obtained.
Keywords. Care, Care Ethics, Health Care, Home Care, Interactive Ethical
Technology Assessment, Monitoring, Personalized Care Technology, Surveillance,
Stakeholders, Values.
Introduction
The starting point for an interactive ethical assessment of novel Personal Health
Monitoring-technologies is the question of how the technologies influence the
realization of values and ethical principles central to health care. Although check-lists
of values and ethical principles for novel technologies have been developed [1] and
provide important input, in order to achieve increased relevance of the ethical analysis
and a nuanced picture of how PHM-technologies influence different stakeholders, the
proposed interactive ethical assessment-model supplements a traditional top-down
1
106 E. Palm et al. / Guidelines for Interactive Ethical Assessment of Personal Health Monitoring
approach with a bottom-up approach. The bottom-up approach includes interviews with
relevant stakeholders – in particular health care personnel and patients.
The interactive ethical assessment methodology presupposes a social constructivist
theory of technology. In contrast to technological determinism, social constructivists
insist that new technology is the result of social interests, forces, and choices. The
theory is both descriptive and constructive. It informs us that technologies are not
neutral, but instead serve the interests of some institutions and social groups. The
model carries constructive and normative implications. If we are aware of the fact that
a technology is not set but may be shaped according to our needs and values,
technological development becomes an ethical challenge. The process of technological
construction is intimately connected to questions of what constitutes a good life and
which values we ought to realize and why.
Technological development is typically difficult to predict – especially long-term
consequences [1]. Hence, anticipation must be organized as a regular activity.
According to this methodology for ethical assessment, the stakeholders will be
involved in the assessment in a regular way. In an ethical assessment the questions
raised concern values, moral principles, and norms like autonomy and privacy. It is
constructive in the sense that it is integrated in the design and development of a new
technology and interactive means that it involves different categories of stakeholders [2,
3].
Within the PHM-project three piloting investigations have been performed: (1)
Careousel, a smart medicine management device [4], (2) Robot Giraff, an interactive
and mobile communication device originally developed as a tool for video-
conferencing [4, 5], and (3) I-Care, a care-software that combines alarm and register
system. Three small-scale interviews carried out within the PHM-project illustrate the
bottom-up approach. However, the investigations conducted are merely piloting an
interactive methodology. A full-scale interactive ethical assessment would better
represent the many different stakeholder categories, recurrent interviews and
continuous influence on the technology development.
In brief, the interactive ethical assessment model is a diptych model including a
bottom-up as well as top-down perspective that provides a richer understanding of the
impact of PHM-technologies on ethical values than a traditional top-down model.
1. Objectives
An interactive ethical technology assessment aims to evaluate emerging technologies

and to influence the development of technology at an early stage – preferably before
the artefacts have reached the market. If aspects in need of modification are pointed out
at the prototype stage, technology developers are more likely to alter the design than
later on in the developmental process when a change is more inconvenient and costly
[1].
Conducted at an early stage of technology development/implementation an
interactive ethical assessment can encircle concerned parties’ needs, interests and
opinions. Based on such results, technology developers and those responsible for the
introduction of certain technical solutions can adjust the technology, promote positive
aspects of the technology and avoid negative ones as far as possible. An interactive
ethical assessment can show who is affected by a technology and in what way, and may
contribute to a fair distribution of benefits and burdens, as well as allocating
E. Palm et al. / Guidelines for Interactive Ethical Assessment of Personal Health Monitoring 107
responsibility for dealing with risks and burdens. First and foremost, the aim of
interactive ethical assessment of health technologies is to reveal implications and
integrate health care values in emerging technologies. However, not only users benefit
from interactive ethical technology assessments but technology developers and care
providers as well. Negative impact may be costly in many respects, not only from an
economical perspective. Users´ well-being is central to any technology developer – and
perhaps particularly so regarding health care technology.
A core idea in all forms of Technology Assessment (TA) is that technology should
not be developed in isolation from the users. This model includes a broad range of
stakeholders and is interactive in the sense that the stakeholders´ opinions should be
considered throughout the development and implementation of technology that
concerns them. Ideally, an interactive ethical assessment would be part throughout the
whole chain of technology development and all concerned parties should have their say
and access to the opinions of others.
Importantly, the interactive empirical part of the ethical assessment does by no
means replace the ethical analysis of the new technology. First, an ethicist will identify
relevant values from the background of discussions in medical ethics and ICT-ethics,
for example. Values and principles that have proven to be relevant in relation to similar
technologies are most likely of relevance for PHM-technologies as well. For instance,
Privacy, Autonomy, Liberty and Justice have been identified as such core values in
relation to ICT [6]. Having encircled “classical” values and principles, the interactive
part can inform the ethicist of how stakeholders interpret the different values and
principles and how they see their relevance for the particular context.
The interactive part can provide the ethicist with information about which values
are more important and which are less for the specific assessment. Responses from
interviews can also give the ethicist new perspectives and insights for her ethical
analysis. Furthermore, the empirical part will also inform the ethicist on possible value
conflicts related to the introduction of a new PHM-technology. The task for the ethicist
is then to analyse the conflict and – when feasible – suggest a possible ways out.
2. Development Process
Guidelines suggested for interactive ethical assessment contain three parts: (1) a battery
of ethical questions, (2) an ethical matrix and (3) ethical reflection. In the first part a
battery of questions are presented. Those questions cover different ethical aspects and
possible ethical implications of new technologies for personal health monitoring. They
are anchored in values and principles that have proven to be of relevance to other –
similar – technologies such as autonomy, privacy, dignity and justice.
They can be directed at different stakeholders; technicians, politicians, health care
personnel and patients. The second part is an ethical matrix. In this graph the Y-axis
shows values of relevance for the ethical assessment and the X-axis possible
stakeholders. The third part consists of a general ethical reflection.
New technologies are developed through different stages. In order to maximally
influence the construction of a new technology, the interactive ethical assessment
should ideally start already at the stages of design and prototypes [1].
3. Users
Ideally, an interactive ethical assessment should involve all relevant stakeholders.

Regarding health care technologies this includes patients, relatives, health care
personnel, technology developers etc. It is vital that a person with ethical expertise is
involved, who, preferably, works together with the technology developers and health
care personnel concerned.
4. Methods
The methods used must be adjusted to the specific technology under assessment. The
same can be said regarding stakeholders involved. Both questionnaires and interviews
have been used within this project. Below some examples of questions in the three
small-scale assessments conducted within the PHM-project are described. Noticeably,
the questions are more or less relevant for different stakeholders.
5. Guidelines 1: Questionnaire for Ethical Assessment
Questions related to need and functionality
• What is the aim of the technology?

• What problem does technology X solve?
• Is the aim laudable/reasonable?
• Is the technology a good/the best means given that aim?
• What need does the technology correspond to?
• What need does the user have?
• Does the technology correspond to this need?
• How should the technology be designed/implemented in order to correspond
to the need?
• How is the technology marketed/launched?
Issues related to concepts and definitions
Questions pertaining to autonomy
• Have you been involved in the development and/or implementation of the

technology? If so, have you been able to influence the design/usage of the
technology? (Sufficiently so?) (Surveillance theory)
• Do you feel a need to adjust to the technology? Do you alter your behaviour
when under surveillance?
• Do you know what the system is doing and why?
• Do you know how to control the system in different usage situations?
• Does the technology enhance independence? If so, is this a desirable
development?
Questions pertaining to privacy
• What types of information, if any, do you considered intrusive? Why?

• Under what circumstances and why?
• Are certain ways of using the technology/applications considered privacy
sensitive/invasive? If so, what ways/applications and why?
• Are you aware of how your data is processed?
• Are you aware of which persons/institutions that have access to your data?
• Who has/should have access to the information generated by technology X
and why?
• Are there any aspects of using technology X that you consider embarrassing?
Questions pertaining to freedom of choice
• To what extent do you perceive the usage of technology X a voluntary action?

• What alternatives do you have to use technology X?
• How do you consider the alternatives to technology X?
• Does the technology have any impact on your freedom of choice with regard
to activities? (enable/restrict/enhance)
• Does the technology raise demands on you being “accessible at all times”?
Questions pertaining to informed consent
• How is the technology presented?

• In what way, if at all, did you consent to technology X?
• Were you sufficiently informed prior to your consent?
• Are you aware of how the technology functions?
• Are you aware of the consequences of your acceptance?
• Are there aspects of the technology/system that you are uncertain of/would
like more information about?
• Would you like reminders regarding a ubiquitous/continuously active system?
• Do you have the chance to opt out?
• Do you feel that you are forced to consent?
Questions pertaining to quality of life and quality of care
• Does the technology increase the quality of life?

• Does the technology enhance or diminish your sense of control?
• Does the technology enhance or diminish your sense of involvement in the
health care process?
• Does the technology enhance or diminish the quality of care?
• Does technology X reduce/enhance bad conscience among kin persons/
informal caregivers?
• Does technology X reduce/enhance stress among care personnel, kin persons/
informal caregivers?
Questions pertaining to trust, safety and security
• Do you feel safer with the technology than before it was implemented?
• Does the perceived safety correspond with the security/actual reliability?
• Is the reliability sufficient for the aim the technology should fill?
Questions pertaining to human contact patterns
• Does technology X make you feel isolated?

• Does the technology imply more frequent contacts (real/virtual)?
• Does the technology facilitate (real/virtual) contacts?
• What impact, if any, does the technology have on the relation care giver – care
recipient? (enhanced/diminished closeness/presence/isolation/trust)
• What kind of contact do you prefer – real/virtual?
• Does the technology increase isolation?
Questions pertaining to justice
• Can all citizens be granted equal access to technology X?

• To what extent is the technology distributed fairly?
• To what extent can the technology be fairly distributed?
• Does it imply a “digital divide”/”information divide” – a gap between have
and have-nots?
• Can e-Inclusion be ensured in other than public services?
• Should the technology be used to even out inequalities stemming from “the
natural lottery”?
Questions pertaining to assumptions
• Would you prefer independent/social living?

• Would you prefer invasive/non-invasive technology?
6. Guidelines 2: An Ethical Matrix
Distinguishing different steps in a technology project clarifies the role of ethics within
the project. A project consists of four steps:
1. Investigation of the perceived needs of the target group of users by an
interview study,
2. Investigation of the technological resources available to meet these needs,
3. Investigation of the perceived needs and the technological resources from an
ethical point of view in order to find ways to avoid, accommodate or “solve”
ethical problems and ethical dilemmas (or “risks”),
4. Development of a technical product appropriate for the target group, taking
the results of the previous three steps into consideration.
Table 1. An ethical matrix
Stakeholders Patient/ Relatives Friends Health care Social care County Municipality Private Technology
E. Palm et al. / Guidelines for Interactive Ethical Assessment of Personal Health Monitoring
client professionals professionals council care developers
provider
Values to be realised
Satisfaction of individual needs
and preferences (utility)
Privacy
(of data)
Privacy by confidential human

handling of technically transferred data
Privacy by respect for a private sphere

(local, physical, mental)
Security and safety

Autonomy/
Freedom of choice
Informed consent
Social relations:
Patients-personnel Other
A good balance of
independence and social contact
Robustness
Easy to use
Affordable price
Cost-effectiveness
Ownership of data
111
The ethical matrix (see Table 1) consists of values to be realised (for example,
satisfaction of needs and preferences, privacy, independence, social contact, cost-
effectiveness) and stakeholders (for example, the patient/client, health care
professionals, the county council, the municipality, and technology developers).
However, the matrix is only a tool for identifying ethical problems. To be useful in
clarifying, accommodating or solving ethical problems the values outlined in the matrix
must be specified and balanced regarding specific stakeholders in specific contexts.
7. Guidelines 3: General Reflection
In this way, the matrix offers input for an overall concluding ethical reflection, which
can take various forms. One traditional format is that an ethicist writes an advisory
report in which the technology is discussed, applying both the normative framework
(top-down) and the matrix (bottom-up) to specify ethical arguments and problems.
Alternatively, or complementary, reflection can take the form of a structured discussion
among stakeholders, prepared by an ethicist. If problems are well-defined, it is often
the stakeholders themselves who are in the right position to decide how problems can
be best avoided or accommodated.
8. Areas of Application
Preferably, interactive ethical technology assessments of PHM-technologies should be

conducted where the technologies are to be used – in the course of the patients’
everyday life. This may mean in their homes or dwelling places or during certain
activities outside home. Living labs have been established all over Europe and
communities have been formed such as the European Network of Living Labs
(ENoLL) with the ambition to, as far as possible, test novel ideas and prototypes in
natural user environments. 2 For example, ExCITE is a three-year European Project
recently established to evaluate socially interactive robotics and in particular robots
developed for elderly care. Central ambitions within this project are to involve users
and integrate their perspectives on technology, hence accommodating user needs. 3
Despite the many living labs and tests beds around Europe however, few of them are
currently conducting tests on PHM-technologies.
9. Conclusions
Technology has a strong potential to shape society and our lives. In many ways
technology can empower us and facilitate our lives but it may also alter conditions and
behaviours in unforeseen and unwanted ways. Health care technology may alter the
conditions of a rather vulnerable group of people – individuals with care needs. Thus,
health care technology deserves particular attention. What is an ethically sound
technology? A possible answer is a technology that realizes important values and
norms and fulfils the aims of the involved stakeholders more efficiently than alternative
2
http://www.openlivinglabs.eu/
3
http://www.oru.se/excite
technologies. In order to achieve this goal, emergent technologies should be ethically

assessed and the stakeholders’ views and values must be known. Health care is
basically a moral practice and thus, values of health care should be embedded in health
care technologies.
This chapter relates some ways to assess emergent PHM-technologies from an
ethical point of view. Interviewing stakeholders and reflecting on different stakeholders’
values and interests are some ways to put an ethical assessment into practice. The
results provide a basis for an ethical evaluation of PHM-technologies.
References
[1] E. Palm, S.O. Hansson, The Case for Ethical Technology Assessment (eTA), Technological Forecasting
and Social Change 73 (2006), 543–558.
[2] J. Schot, Constructive Technology Assessment as Reflexive Technology Politics, In: Technology and
ethics: a European quest for responsible engineering, Peeters, Leuven, 2001.
[3] R. Reuzel, G. van der Wilt, H. ten Have, P. de Vries Robbe, Interactive Technology Assessment and
Wide Reflective Equilibrium, Journal of Medicine & Philosophy 26 (2001), 245–261.
[4] E. Palm, När vården flyttar hem till dig – den mobila vårdens etik. Etikk i praksis 2 (2010), 71–92.
[5] E. Palm, Who cares? Moral obligations in formal and informal care provision in the light of ICT-based
home care, Health Care Analysis (2011), http://www.springerlink.com/content/nk4602n376811025/.
[6] P. Brey, Disclosive Computer Ethics: The Exposure and Evaluation of Embedded Normativity in
Computer Technology,' Computers and Society, 30(4): 10-16.
[7] R. Bemelmans, J.G. Gelderblom, P. Jonker, L. De Witte, Socially Assistive Robots in Elderly Care: A
Systematic Review into Effects and Effectiveness, Journal of the American Medical Directors
Association 13 (2012), 114–120.e1.
[8] J. Broekens, M. Heerink, H. Rosendal, Assistive social robots in elderly care: a review, Gerontology 8
(2009), 94–103.
[9] E. Burns, E. Haslinger-Haufmann. (2008) Evaluation of the nursing diagnosis “social isolation” and the
use of evidence-based nursing, Pflege 21 (2008), 25–30.
[10] S. Carretero, J. Garces, F. Rodenas, V. Sanjose, The informal caregivers’ burden of dependent people:
theory and empirical review, Archives of Gerontology and Geriatrics 49 (2009), 74–79.
[11] G. Collste, Under my Skin: The Ethics of Ambient Computing for Personal Health Monitoring. In:
S. Nagy Hesse-Biber (ed.) The Handbook of Emergent Technologies in Social Research, Oxford
University Press, Oxford, 2011.
[12] G. Collste, M. Verweij, Personal Health Monitoring and Human Interaction, The American Journal of
Bioethics 12 (2012), 47–48.
[13] M. Decker, Caregiving robots and ethical reflection: the perspective of interdiscipinary technology
assessment, AI & Society 22 (2008), 315–330.
[14] H. Draper, T. Sorell, (advance publication online) Telecare, remote monitoring and care, Bioethics
(2012). DOI: 10.1111/j.1467-8519.2012.01961.x.
[15] A. Dunér, M. Nordström, The roles and functions of the informal support networks of older people who
receive formal support: A Swedish qualitative study, Aging and Society, 27 (2007), 67–86.
[16] A. Essén, The two facets of electronic care surveillance: An exploration of the views of older people
who live with monitoring devices, Social Sciences & Medicine 67 (2008), 128–136.
[17] A. Fex, From Novice Towards Self-Care Expert – Studies of self-care among persons using advanced
medical technology at home, Doctoral thesis, Division of Nursing Science, Department of Medical and
Health Sciences, Faculty of Health Sciences, Linköping University, Sweden, 2010.
[18] P.B. Koff, R.H. Jones, J.M. Cashman, N.F. Voelkel, R.W. Vandivier, Proactive integrated care
improves quality of life in patients with COPD, European Respiratory Journal 33 (2009), 1031–1038.
[19] L. Kuokkannen, H. Leino-Kilpi, Power and empowerment in nursing: three theoretical approaches,
Journal of Advanced Nursing 31 (2000), 235–241.
[20] M.W. Martin, R. Schinzinger, Ethics in Engineering (4th ed.), MacGraw Hill, Boston, 2005.
[21] H. Nissenbaum, Privacy as contextual integrity, Washington Law Review 79 (2004), 119–158.
[22] A. Nordgren, The web-rhetoric of companies offering home-based personal health monitoring, Health
Care Analysis 20 (2012), 103–118.
[23] A. Nordgren, Remote Monitoring or Close Encounters? Ethical Considerations in Priority Setting
Regarding Telecare, Health Care Analysis (2012), DOI 10.1007/s10728-012-0218-z
[24] E. Palm, An interactive ethical assessment of surveillance-capable software within the home-help
service sector, Journal of Information, Communication & Ethics in Society (forthcoming).
[25] A. Sharkey, N. Sharkey, Granny and the robots: ethical issues in robot care for elderly, Ethics and
Information Technology 14 (2012), 27–40.
IV
Broadened Perspectives on Personal Health
Monitoring
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-117
PHM-Ethics and ETICA:

Complementary Approaches
to Ethical Assessment
Brent MITTELSTADT,1 Bernd STAHL and Ben FAIRWEATHER
Centre for Computing and Social Responsibility,
Abstract. The chapter undertakes a comparison of different approaches to the

ethical assessment of novel technologies by looking at two recent research projects.
ETICA was a FP7 sister project to PHM-Ethics, responsible for identification and
ethical evaluation of information and communication technologies emerging in the
next 10-15 years. The aims, methods, outcomes and recommendations of ETICA
are compared to those of PHM-Ethics, with identification of linkages and similar
findings. A relationship is identified between the two projects, in which the
assessment methodologies developed in the projects are shown to operate at
separate, but complementary levels. ETICA sought to reform EU ethics
governance for emerging ICTs. The outcomes of PHM-Ethics are analyzed within
the policy recommendations of ETICA, which demonstrate how the PHM-Ethics
toolbox can contribute to ethics governance reform and context-sensitive ethical
assessment of the sort called for by ETICA.
Keywords. ETICA, PHM-Ethics, ethics, anticipatory, emerging technology, ICT,

personal health monitoring, ambient intelligence, governance
Introduction
As novel technologies are developed and implemented in various contexts of use,

normative issues accrue which must be addressed at local, national and international
levels. Within the EU, this need for ‘ethics governance’ is met through a variety of
approaches including research, policy, and ethics review committees. The EU approach
to governance has been found lacking in its ability to respond to the challenges
presented by emerging information and communication technologies (ICT), both in
terms of proactive identification and resolution of normative issues, and in the
development of context-sensitive solutions and understanding of norms and moral
values. The 7th Framework Programme (FP7), sponsored by the European Commission,
placed calls for the development of approaches for ethical, social and legal assessment
of emerging technologies to address the limitations of current governance.
PHM-Ethics and ETICA were among the research projects that responded to these
calls. ETICA was a sister research project to PHM-Ethics, which focused on the ethical
implications of a broad set of emerging ICTs. Through a shared orientation towards
policy and development, the two projects provided concrete recommendations and
1
Correspondence can be sent via e-mail to the first author at bmittelstadt@dmu.ac.uk.
118 B. Mittelstadt et al. / PHM-Ethics and ETICA: Complementary Approaches to Ethical Assessment
practical tools for ethics governance based upon interdisciplinary theoretical and
empirical perspectives and methodologies. This chapter focuses on the similarities
between these complementary projects, in terms of overlapping aims, methods,
outcomes and recommendations.
Responsible innovation requires the integration of ethical, social and legal
perspectives into ICT research, development and regulation. Despite their disparate
technological foci, the sister projects provide complementary analyses and assessment
tools for the improvement of innovation and ethics governance within the EU.
Consideration of their outcomes and recommendations together will therefore
strengthen practical activities aimed at proactively identifying and resolving ethical
implications of Personal Health Monitoring (PHM) in particular, and emerging ICTs in
general.
The structure of the chapter reflects the exploration of linkages between the two
FP7 research projects, achieved through comparison of aims, methods, ethical issues
and outcomes. The chapter opens with a brief summary of each project, followed by a
thematic summary of their aims and scope in Section 2. Interdisciplinary methods of
identification and evaluation of ethical, social and legal issues are then reviewed in
Section 3, followed by a comparison of the ethical issues of Ambient Intelligence
(AmI) in ETICA, and PHM in PHM-Ethics, respectively. Section 5 compares outcomes
and the assessment methodologies built and validated in each project, concluding that
as part of ongoing dissemination activities the two methodologies should be united to
improve ethics governance and responsible research and innovation in the EU. The
primary contribution of both projects was the creation of compatible methodologies for
the ethical assessment of emerging ICTs, representing a unified European perspective.
1. Project Summaries
Before detailed comparisons can be made between the projects, it is helpful to

summarize their aims, scope, methods and outcomes.
1.1. ETICA2
ETICA (Ethical Issues of Emerging ICT Applications) was a European Commission

funded research project under the 7th Framework Programme (GA 230318) which ran
from April 2009 to May 2011. Its objective was to identify and evaluate emerging
ICTs, potential applications, and their ethical implications. These activities, supported
by critical evaluation of existing ethics governance in the EU, led to policy
recommendations intended to facilitate proactive and acceptable evaluation of the
ethics of emerging ICTs [1]. The project included partners from universities throughout
Europe to ensure a broad European perspective.3
Review of ICT ethics literature led to the identification of eleven emerging
technologies with predicted ethical relevance: Affective Computing, Ambient
2
Further information on ETICA, including project deliverables and reports can be accessed via the
ETICA website at: http://ethics.ccsr.cse.dmu.ac.uk/etica.
3
Project partners: De Montfort University (UK), VTT Technical Research Centre (Finland), Delft
University of Technology (Netherlands), ForschungsZentrum Karlsruhe (Germany), University of Namur
(Belgium), Steinbeis University Berlin (Germany), Eötvös Károly Public Policy Institute (Hungary),
University of Lodz (Poland).
B. Mittelstadt et al. / PHM-Ethics and ETICA: Complementary Approaches to Ethical Assessment 119
Intelligence, Artificial Intelligence, Bioelectronics, Cloud Computing, Future Internet,

Human/Machine Symbiosis, Neuroelectronics, Quantum Computing, Robotics and
Virtual/Augmented Reality. Technologies were defined as “high-level socio-technical
systems that have the potential to change the way humans interact with the world” [1,
p.4]. Emergence hinged upon current research and development, which indicates
technologies that will be socially and economically relevant in the next 10-15 years.4
The identified emerging technologies are expected to overlap in future ICT
developments, and are believed to exist in an enabling hierarchical relationship [1,
p.15], in which ethical implications are shared across multiple technologies. A
methodology for identification and evaluation of the technologies, ethical, legal and
social issues, and limitations of current governance was described and validated within
the project. Once identified, ethical issues of the eleven technologies were ranked
according to severity judged from an interdisciplinary perspective.
Recommendations were aimed towards policy-makers and industry which sought to
improve current ethics governance approaches. While policy-makers were
recommended to establish an environment in which participatory ethics governance is
required and supported, industry, researchers and civil society organizations (CSOs)
were encouraged to use the tools provided by policy-makers to undertake ethical
assessment before implementation of emerging ICTs.
1.2. PHM-Ethics5
The main aim of the collaborative PHM-Ethics research project was to “conduct
scientific interdisciplinary research to analyze the dependencies between ethics, law
and psychosocial sciences in personalized health monitoring in relation to the major
types and steps of this very dynamic part of IT-development from a European
perspective” [2, p.8]. PHM was defined as “all technical systems collecting, processing,
and storing data linked to a person. It allows monitoring parameters of that person and
can lead to health-related information of that person" [3, p.6]. An integrated European
approach to the combined regulation of ethical, philosophical, legal and psychosocial
constraints was developed [2]. PHM-Ethics was funded under the European
Commission’s 7th Framework Programme (GA 230602).
Strong emphasis was placed on the creation of a reflexive, open-ended PHM-Ethics
‘toolbox’ for ethical, legal and psycho-social assessment of emerging PHM
applications in future contexts. An assessment methodology was developed to meet this
goal consisting of five components:
1. Dependencies Map. A multi-layered, complex network of relationships that
illustrates dependencies and relationships between parties involved in PHM.
2. Taxonomy. A classification system which categorizes PHM technologies and
applications representing the state of the art in PHM. It generates groups with
similar characteristics and allows users to makes distinctions between similar
technologies.
4
The 10-15 year period was chosen to reflect the technology development life cycle. Technologies
currently in development are expected to be implemented and impact on humans and society in that
timeframe.
5
Further information, deliverables and dissemination activities can be found on the project’s web-site:
http://ethics.p-h-m.org/. First paragraph taken from the PHM-Ethics Final Report.
3. Psychosocial Assessment Module. An integrated module for psycho-social

health technology assessment. It consists of a map highlighting selective
psychosocial issues of relevance when applied to a PHM application. It covers
various domains of technology perception and psychosocial outcome criteria.
4. Ethical Assessment Module. A module which allows evaluating existing and
upcoming PHM technologies from an ethical point of view. Ethical values and
principles are put into perspective with Personalized Health Monitoring. It
provides questions in the fields of privacy, autonomy, freedom of choice,
justice, and further content relevant in PHM ethical assessment.
5. Legal Framework. A comprehensive legal report that describes the legislation
at the European level, regarding telemedicine and/or health monitoring. It
takes into account the consequences of recent decisions by the European Court
of Justice important for PHM, dealing with privacy and reimbursement of
monitoring systems. Limitations and gaps in current regulation and
governance schemes are identified, along with differences in ethical
constraints between EU directives and national legislation [2, p.8-9].
Each methodological component can be viewed as an assessment tool to be applied
to future PHM applications and contexts. The tools are complementary in the sense that
results from one can be used to inform application of the others. For example, the
created methodology allows for assessment at multiple levels of the taxonomy, guided
by the interrelationships identified in the dependencies map. They can also be
considered provisional, as it is the intention of the project consortium to update the
taxonomy and dependencies map in light of future PHM developments. While created
for PHM, the project consortium has started to test the methodology with other
emerging ICTs6 in accordance with the goals of FP7 [2].
Recognizing the importance of context in understanding the future ethical
implications of PHM, an ethical assessment questionnaire was created which explores
ethical implications according to stakeholders. The ethical assessment methodology
created in the project, although general enough to be applied to a diverse range of
future PHM applications, nonetheless provides a tool for individualized context-
sensitive assessment.
If widespread adoption of this methodology by EU policy-makers and industry
occurs, a reduction in the time between development, ethical assessment and
implementation is expected. Facilitation of a proactive approach to ethics governance,
in which context-sensitive participatory assessment occurs simultaneously with
development, is therefore the overall goal of PHM-Ethics. The developed tools assist in
both identifying and managing emerging ethical issues of PHM through engagement of
stakeholders in these processes. Furthermore, an evidence base is created for evidence-
based policy-making through assessment with the PHM-Ethics toolbox.
6
For example, the dependencies map technique has been used in considering e-commerce in Saudi
Arabia in PhD research by Fahad Aleid at De Montfort University.
2. Project Aims
The 7th Framework Programme emphasizes the need for ethically and socially aware
innovation in the EU. PHM-Ethics and ETICA both contributed to this need through
the development of a European perspective on the ethics of PHM and emerging ICT,
respectively. The necessity of a unified European perspective is based upon recognition
of the central role played by ICT in society, business and research. Acknowledging that
all ICT has potential ethical and social implications, incorporation of a diversity of
stakeholder perspectives in ethics governance becomes paramount in societies guided
by democratic ideals. The establishment of an EU perspective in these projects allows
for recognition of the shared values between member states, and contributes to the
establishment of widely acceptable standards for responsible research and innovation.
2.1. Contributions to European Discourse
The importance of proactively identifying and dealing with ethical problems arising
from ICT innovations was emphasized in both projects. Proactive ethical assessment of
emerging ICT is required to prevent foreseeable ethical problems from occurring.
While the predictions made in the projects may never come to pass, the position of
uncertain proactivity is preferable to merely reacting to ethical problems as they occur
[1]. Researchers, policy-makers and civil society tend to undertake actions meant to
shape the future in desirable directions without absolute certainty over its course [4,5];
proactive ethical assessment should be seen in this light.
The aims of ETICA and PHM-Ethics need to be viewed with the desirability of
proactive ethics in mind. Future-oriented research is seen as inherently uncertain;
foresight and scientific predictions are not analogous. The contributions of these
projects are done a disservice when conceptualized as merely predictions, to be
evaluated on the basis of whether or not they come true. Rather, foresight research
contributes to discourse on the future of European societies as shaped by emerging ICT
innovations. Each project provides an overview of possible ethical issues emerging
from ICT currently in development or on the horizon. When considered alongside
analysis of the limitations of current regulation and governance frameworks, the
projects provided a well-grounded basis for future discourse and ethical assessment
within specific future contexts, as created by the interaction between policy-makers,
civil society and emerging ICTs.
2.2. Technological Scope
The scope of ETICA was much broader than that of PHM-Ethics. Both projects
focused on technologies, as opposed to artefacts or applications. A distinction was
made between these three in ETICA, seen as a spectrum proceeding from general to
specific [1]. To use ‘smart homes’ as an example: PHM is a technology, sensors around
the home are artefacts, and fall detection combining data from various sensors is an
application.
ETICA focused on ‘high-level’ technologies [1, p.4], and based ethical analysis on
general defining features of each technology as opposed to specific applications.
However, general descriptions of emerging applications were created to assist with
ethical analysis. Although PHM was not identified as such in ETICA, many (but not
all) PHM applications would fit under its definition of Ambient Intelligence.
PHM-Ethics, although very broad in its definition of PHM, was comparatively

focused by exploring a specific area of use (health and medicine). Even so, the
technical possibilities and ethical implications of the many sub-fields and applications
of PHM preclude an insightful evaluation at the artefact or application level. General
procedural codes were therefore developed for application to PHM as a high-level
technology. This focus was appropriate considering the early stage of development and
implementation at which PHM currently exists; broad EU regulatory frameworks are
still feasible.
2.3. Analytical Disciplines
The analytical perspectives taken varied in the projects, although similarities were
found. Both ETICA and PHM-Ethics analyzed emerging technologies from ethical and
(EU) legal perspectives, with awareness of current challenges in these areas based on
research into existing and analogous technologies. PHM-Ethics developed a psycho-
social analytical module, while ETICA included perspectives on gender. Technology
Assessment informed a critical analysis of current governance schemes in ETICA, and
formed the basis for the ethical assessment tool (EAT) developed in PHM-Ethics [6].
The influence of the interdisciplinary approach was seen clearly in PHM-Ethics in the
Dependencies Map, which revealed interrelationships between ethics, law, medical
informatics, and psycho-social and medical sciences [2].
2.4. Procedural and Substantive Aims
In contrast to prior procedural governance approaches [7], neither project sought to

provide a comprehensive list of ethical issues and solutions for emerging ICTs or
PHM, respectively. Rather, each sought to provide early indication of potential ethical
issues for policy-makers and civil society, with recommendations for further discourse
between stakeholders to seek solutions. Beyond providing a basis for discussion of the
issues, the projects developed methodologies for the incorporation of ethical, social and
legal methodologies into innovation and governance.
It is useful to distinguish between the procedural and substantive aims of the
projects. Procedural aims relate to the development of methodologies and assessment
tools for future ethical assessment, while substantive aims consist of the identification
and evaluation of ethical, social and legal issues of the respective technologies. While
links between the substantive outcomes of each project are highlighted below, greater
importance is placed on procedural outcomes due to the transience of substantive
results. Ethical issues based upon defining features of the technologies were
highlighted in each project, yet these issues will change according to future
developments and contexts. A list of future issues can therefore never be considered
comprehensive or complete. While the substantive outcomes of each project are
important for sketching our current understanding and concerns with the future, and for
guiding discussion of these issues, the generic methodologies developed in each project
assume more importance for their ability to shape future discourse. The procedural
outcomes of each project are “future-proof” in the sense that they have been designed
for application to both predicted and unforeseeable future technologies, applications
and contexts.
The relative importance of procedural versus substantive outcomes can best be seen
in the recommendations from each project, which emphasize the inclusion of ethical
perspectives in development and regulation. The resulting discourse can be guided by

the substantive contributions of each project, facilitated in ETICA by the establishment
of an ICT Observatory, and in PHM-Ethics by updates to the Taxonomy and
Dependencies Map. Furthermore, both projects contributed to the improvement and
standardization of ethical assessment procedures in the EU through development of
validated interdisciplinary assessment methodologies and policy-oriented
recommendations [7,8]. For these procedural outcomes to be successful, ethical
assessment must precede technology implementation [2], made possible through
widespread adoption of the projects’ recommendations and assessment tools.
2.5. Context-Sensitivity
A reason for the guarded value attached to the substantive outcomes of each project is
the importance of context and stakeholder perspectives in understanding ethical issues
and concepts. The predictions of each project therefore quickly lose ‘currency’ as ICT
development changes over time [1, p.26].
Both projects share a concern with the lack of context-sensitivity in current
governance approaches, which reflects hermeneutic epistemological and ontological
commitments [9–11]. Norms are prescriptive statements given content and relative
importance within specific contexts by stakeholders. Current governance approaches
treat norms as statements separable from context, amenable to logical deduction [1,12].
Norms and ethical issues are often formulated in committees by experts far-removed
from day-to-day practice, and are limited by the expert’s frame of reference, leading to
the exclusion of relevant perspectives and emphasis on sectoral and specialist interests
[1]. Such a situation is unacceptable in societies that claim to be democratic.
Approaches which seek to provide general specifications of norms applicable across
multiple contexts therefore fail to capture the importance of context in articulating and
comprehending norms. In light of this concern, emerging technologies need to be
assessed within specific contexts of use, in which stakeholders unique to that context
can be identified and included in development and regulation. Through civil
participation, ethical, social and legal issues of practical importance can be identified
and headed off. ETICA and PHM-Ethics sought to redress the imbalance in current
governance through the creation of assessment methodologies and tools which
emphasize context-sensitivity and broader stakeholder involvement in research,
development and regulation. Both projects therefore respond to the ethical challenges
of the future by preventing the emergence of ethical problems.
3. Research Methods
As both projects aimed to contribute to European discourse through the creation of

tools for the ethical assessment of emerging technologies, their methods must be
understood in terms of development and validation of the methodologies. Innovation
development is viewed as an open-ended process, which necessitates reflexive
assessment tools open to revision on the basis of unforeseen technologies and ethical,
social and legal implications [13]. Initial identification of PHM and emerging ICTs,
and initial understanding of their normative implications was necessary to build the
first iteration of the tools, which are intended to be updated as technological and ethical
developments occur [1,2]. The initial research was condensed in the course of both
projects into practically useful assessment tools [2].
3.1. Identification of Emerging Technologies and Ethical, Social and Legal Issues
Review of relevant academic and governance literature on ethical, legal and social
perspectives provided the groundwork in both projects for identification of
technologies, applications, and their implications. ETICA created descriptions of each
technology consisting of defining features, applications in development, areas of use
and ethical, legal and social issues identified in the literature. The identification of
technologies and issues was descriptive, led by a dual discourse analysis of academic
literature in the field of ICT ethics, as well as EU governmental and funding
publications [14–16]. Technologies were arranged in a matrix which assisted
identification of ethical issues. Bibliometric analysis of the reviewed literature
indicated avenues for ethical analysis through identification of the frequency with
which ethical concepts appeared, as well as relationships between technologies and
concepts in the literature [15].
PHM-Ethics consisted of three phases, the first of which identified ethical,
psychosocial and legal implications of emerging PHM applications. Issues were
identified through a descriptive literature review and empirical research, which
contributed to the creation of the Taxonomy and Dependencies Map.
The PHM-Ethics Dependencies Map identifies specific stakeholders and areas in
which ethical, social and legal issues may arise in the future. ‘Dependencies’ were
identified between nodes representing the stakeholders, application areas and
relationships relevant to implementation and regulation of PHM (in the EU). Several
levels of relationships were identified in the map, with the highest level consisting of
connections between: People, Society, Government, Operation (of the technology),
Law, Medics and Allied Professionals, Health Informaticians, Social Scientists and
Philosophers, Healthiness, and PHM Instruments.
The scope of the potential ethical, legal and social issues of PHM is incredibly large
as reflected in the Dependencies Map, which necessitated the creation a ‘critical
dependencies map’ of issues and relationships of critical importance which should be
considered before the development cycle ends [17]. A similar approach was taken in
ETICA in creating an enabling hierarchy of technologies, with potential ethical
implications ranked in terms of severity. Although both projects relied upon descriptive
methods for identification of technologies and issues, thereby avoiding adoption of a
single ethical perspective, some prescription was necessary in assigning relative
importance to each finding. In both cases issues were ranked according to severity,
conceived in terms of likelihood of occurrence in the near future, or of such normative
importance as to necessitate immediate attention to prevent widespread or particularly
catastrophic ethical problems. The influence of prescription in the identification and
evaluation of ethical issues should not be underplayed; classifying a predicted outcome
as ‘ethical’ necessarily invokes norms. Prescription does not, however, represent a
weakness in the initial findings of the projects; rather, it is a necessary component for
an initial normative overview of PHM and emerging ICT ethics, provided by expert
members of the consortia.
3.2. Critical Review of Current Governance
In both projects EU legislation and approaches to ethics governance (e.g. ethics review
committees, FP7 programs, Technology Assessment) were critically reviewed to
identify procedural gaps and limitations to overcome through development and
implementation of the assessment methodologies [16,18]. The reviews revealed both
short and long-term problems related to context-sensitivity, reliance upon expert
opinions in governance, ethical “blind spots” which preclude consideration of emerging
ethical issues, and various legal challenges to be overcome in implementing PHM and
emerging ICT, such as liability law reform [1, p.5; 2]. Areas of conflict were also
identified between values and principles embodied in EU directives and the ethical
issues identified earlier in the project; these legal barriers are predicted to require legal
reform before implementation of the technologies can proceed [16,18], otherwise
conflicts in values between EU institutions and stakeholders in ICT development and
deployment will create ethical problems [19].
3.3. Initial Ethical Analysis
Following the reviews of ethical, legal, social and governance issues, ethical analysis
occurred in both projects to create an initial overview of the ethical implications of
PHM and emerging ICT. Different methods of analysis were used in each project,
although similarities did exist. Both projects created and validated assessment
methodologies for this purpose, meaning assessment tools were created and then used
(and tested) to develop initial ethical understanding of the projects’ respective fields
Future ethical scenarios are often represented through thought experiments or case
scenarios, which reduce the technology to its ideal or defining characteristics for ethical
analysis. This approach was used in ETICA (technology descriptions) and PHM-Ethics
(case scenarios). Idealized versions of the technologies and applications in
development were considered in imagined contexts of use. While unfailing predictions
of the future remain necessarily out of reach, this type of illustrative analysis was
helpful in relating possible futures to current practices and concepts to ensure relevant
issues were not ignored.
3.3.1. ETICA
Ethical analysis in ETICA focused on describing, evaluating and ranking the ethical
issues identified earlier in the project through analysis of the matrix of emerging
applications. Technology-level analysis identified broad ethical issues not yet on the
agenda of EU policy-makers and developers.
A separate ethical analysis was conducted for each technology guided by the
technology descriptions [1]. Defining features and application areas and examples were
discussed for each technology, followed by cross-referencing the bibliometric analysis
to ensure all related concepts and issues were considered.7 A concluding discussion
was then written which summarized the possible ethical issues and their relative
severity for each technology. This process was not conducted entirely by a single
consortium partner; rather, ranking occurred in a second round of analysis focusing on
ethical standards, principles and values identified in EU and national level ethical
7
Defining features and applications were constructed in Work Package 1, and are available for review
on the ETICA web-site.
reviews, advisory reports and policies [16,19,20]. The second analysis used legal,
gender, ethical and Technology Assessment perspectives in evaluating the technology
descriptions and the results of the initial ethical analysis, which was based on the
literature review, bibliometric and technology description analyses [15]. Ranking was
necessary to ensure issues of immediate or severe importance to policy-makers were
highlighted. Common issues, principles and concepts were identified across the range
of technologies, which is unsurprising considering the enabling technological hierarchy
established in ranking the ethical issues [19].
3.3.2. PHM-Ethics
The second phase of PHM-Ethics was dedicated to the assessment of PHM from
ethical, legal and psycho-social perspectives. Assessment tools from ethical, legal and
psycho-social perspectives were developed and used for this purpose. In comparing
analysis in PHM-Ethics and ETICA, the most relevant feature is the ethical assessment
tool (EAT), which is based upon interactive Technology Assessment (iTA) [6].
Development of the methodology required adaptations to iTA to meet the
challenges of policy-oriented ethics research related to context sensitivity and
stakeholder participation. The EAT incorporates an open-ended (revisable)
questionnaire in which stakeholders identify (the relative importance of) moral values
and principles affected by a PHM application in a specific context. Crucially, the EAT
separates participatory evaluation from theoretical analysis. Ethical analysis is limited
to experts—the methodology is therefore participatory only so far as stakeholders help
develop context-sensitive understanding by identifying, evaluating and ranking moral
values and principles, ensuring a wide range of perspectives are considered in ethical
analysis.
3.3.3. Comparison of Analytical Methodologies

The approaches taken in PHM-Ethics and ETICA stand in contrast to iTA, in which
experts act as discourse moderators, “setting the horizon for contexts, not determination
of issues, based upon the interpretation of narrative information” [1]. Ethicists therefore
structure the discourse with reference to ethical theory and concepts, but do not
determine the ethical issues or their relative importance—this task is left to the
stakeholders (e.g. users, developers, policy-makers). ETICA goes beyond iTA in
encouraging experts to not only moderate discourse but to “construct the norms” which
condition a specific context. Ethical issues can then be predicted by comparing the
constructed norms to knowledge of the R&D process of a specific application. The
issues can then be resolved through R&D. This role is slightly different than the one
prescribed in PHM-Ethics because appropriate resolution of foreseeable ethical issues
is left to stakeholders in R&D in ETICA, whereas experts conducting PHM-Ethics’
EAT both identify ethical issues and recommend solutions through policy and
development [1, 6, 7]. Importantly, both projects identify experts as crucial in grasping
the context-sensitive interpretation of norms, values and principles in ethical analysis.
Such an approach was found to be missing from many current governance frameworks
[2, 7].
Despite the analytical role of experts in both projects, a single ethical perspective
was not dominant in ETICA or PHM-Ethics—theoretical insights from normative
frameworks such as utilitarianism, deontology and virtue ethics were used where
appropriate. Issues were not cast in terms of controversial concepts such as rights,
human dignity, risks or moral obligations, although these and similar concepts often
appeared in current EU legislation [16, 18]. This approach ensured analysis was not
limited to the issues considered important by consortium members.
3.3.4. Validation of Identification and Analysis Phases

The assessment tools and initial ethical analyses of both projects were validated
through empirical research which assessed the relative importance of the issues to
stakeholders. The empirical studies also contributed previously unidentified ethical
issues and norms. ETICA conducted two focus group sessions with members of the
public, an online questionnaire of FP7 project coordinators, and a Technology
Assessment conducted by project partners [1]. PHM-Ethics validated all five of its
components through consideration of case scenarios at consortium meetings, although
validation was impossible for the report on legal and ethical constraints due to its
descriptive nature [8]. Improvements were made to the EAT through small-scale
interviews. The psycho-social module was also validated through empirical research
with students at consortium universities [8,13].
4. Initial Ethical Issues
As identified through the initial ethical analyses, the ethical implications of PHM and
emerging ICTs mostly consist of pre-existing ethical issues, principles and concepts, as
opposed to genuinely new contributions [7,15,18]; however, the need for extensions or
other revisions to pre-existing concepts and principles was noted [1,15]. Although
ETICA studied eleven technologies in total, significant overlap was found between its
analysis of AmI and PHM-Ethics’ analysis of PHM.
ETICA classified AmI according to six defining characteristics:
“(1) embeddedness and invisibility of the sensors and computational devices,
(2) interconnectedness of the sensors and computational devices, (3) the AmI
system is adaptive, that is, the system adapts to its circumstances, (4) the
system is personalized, tailored to the needs of its users, (5) the system is
anticipatory, that is, it can anticipate its users needs and desires, and (6) the
system is context-aware, it can recognize specific users and its situational
context and can adjust to the user or context" [15, p.37].
In ETICA, privacy, surveillance, data protection, autonomy, freedom, equity and
liability were seen as important ethical concepts in understanding the implications of
AmI [15], and by extension PHM. Every one of these topics was reflected in PHM-
Ethics. The more intense focus of PHM-Ethics could therefore be seen as reinforcing
the validity of the conclusions of ETICA related to AmI.
Collection, storage, transfer and fair use of data took central importance in both
projects. Contextual surveillance of health and daily behaviors made possible through
both technologies is a major problem for the privacy of users [15]. Profiling, behavior
monitoring and social sorting are made possible through such surveillance [15,21,22],
which has been compared to a modern panopticon [23,24] due to its ‘long memory’ and
influence on the behavior of users [18]. The sensitivity of data brought into existence
by PHM creates the potential to peer deeply into the personal lives of users, revealing
information about their health which is seen in legislation as a sensitive topic requiring
extra protection [25, 26]. Unforeseen combinations of PHM applications may create
opportunities for non-health monitoring, in which the combination of monitoring data
about multiple individual parameters provides insight into daily behaviors and the
user’s private life [17]. This extension of PHM systems to new users and unintended
uses is referred to as ‘usage creep’ [17, p.20; 27]. At its most extreme, usage creep
could lead to biometric profiling through the linkage of biometric data with PHM and
AmI systems, enabling tracking of individuals [15, 28]. All of these imagined scenarios
involve infringement of expectations of privacy, and further complicate protection
mechanisms such as informed consent, which rest upon the adequacy of knowledge
about risks and benefits. Trust in ‘systems’ is considered a crucial element in avoiding
perceptions of surveillance in PHM, justified or not [15, 17, 29, 30].
PHM and AmI may also have implications for user autonomy, defined as “the
ability to construct one's goals and values, and to have the freedom to make one's
decisions and perform actions based on these decisions” [22, p.94]. While the scenarios
imagined in ETICA are relatively benign, such as a ‘smart refrigerator’ ordering
undesirable groceries, the implications for PHM are more severe, ranging from risks of
social isolation to technological dependency in carrying out daily behaviors [22, 31–
35]. In both cases the user experiences the technology infringing upon or removing
their control over a situation. The possibility of autonomy infringements increases as
emerging technologies are used to replace humans in mundane or difficult activities, a
problem recognized in ETICA’s analyses of Robotics and Ambient Intelligence [15].
Replacements are enabled by (for example) the intentions of the developer or perceived
socioeconomic benefits (e.g. cost savings in healthcare) [6, 15]. If problems occur in
situations in which human work is supplemented or replaced by emerging technologies,
it is also unclear where liability rests for the failure of the system [15].
Equity was also a concern in ETICA, with relevance for ongoing assessment
conducted by PHM-Ethics. If PHM comes to be used widely for preventative purposes,
the predicted benefits to health associated with early diagnosis could further widen the
healthcare gap between developed and developing nations [15]. An argument can be
made that equitable distribution is required, which guarantees that PHM is available
regardless of socioeconomic status or nationality.
A majority of attention in PHM ethics literature is dedicated to applications for the
elderly and chronically ill, particularly Ambient Assisted Living [3, 36]. When
focusing on these demographics, the ethical implications identified tended to describe
issues of “ageing and technology,” as opposed to personalized health monitoring as a
unique development in ICT and healthcare [3]. However, ethical assessment of PHM
must consider other demographics because the target audience of PHM is manifold, as
seen through intended uses in both managing existing conditions and preventing or
hastening the diagnosis of developing conditions [3].
The stakeholders in the ethics of PHM are not limited to users alone; family
members [37], medical personnel, data custodians, and a variety of institutions
including insurers and telecommunication companies are involved in the collection,
movement and usage of PHM data. This much is reflected in the literature reviewed in
PHM-Ethics, which typically focused on the impact on social systems rather than users
[3]. Engagement of these often ignored stakeholders in future ethical assessment is
necessary according to the methodologies developed in these projects.
5. Recommendations and Outcomes
The defining feature of future-oriented ethics governance and research in the EU is that
the inherent uncertainty of the future precludes confident identification of the ethical,
social and legal implications of emerging technologies. Furthermore, norms and
implications occur in specific contexts, and rely upon stakeholders for meaning and
relative importance. Current governance approaches (and the experts responsible for
them) do not always recognize these limitations. ETICA and PHM-Ethics both aimed
to improve this situation.
Evidence of the shortcomings of existing governance can be seen in the gulf
between issues of importance as identified by experts and civil society. The ETICA
focus groups mentioned above involved members of the public, who were introduced
to emerging ICT and asked to identify and evaluate moral values, principles and ethical
implications. While this step served to validate the results of the identification phase of
ETICA, it also revealed discontinuity between public and expert concerns [1]. The gap
reveals potential problems with the relationship between researchers and civil society.
It may be that sufficient effort is not dedicated to the dissemination of findings (in
comprehensible language), or that the public is not interested or unaware of the
existence of such research. Researchers may also be failing to familiarize themselves
with public opinion through (for example) empirical research.
Regardless of the specific cause(s) of the gap, both projects sought to lessen it
through the creation and dissemination of assessment methodologies and governance
recommendations which require public engagement and participatory development.
These efforts can be placed within practice-oriented and participative trends in ICT
research in recent decades, seen best within approaches such as Participatory
Technology Assessment [38, 39] and Empirical Ethics [40–42], both of which engage
members of the public in the assessment (and development) process.
The desire for improvement of governance schemes is reflected in the outcomes of
both projects, which focus on the limitations of current approaches. In comparison to
PHM-Ethics, ETICA provided broad policy and development oriented
recommendations to create an environment in which proactive ethical assessment is
possible. ETICA’s recommendations are aimed at policy-makers as well as industry,
researchers and CSOs, recognizing their diverse roles in ICT governance: policy-
makers formulate regulatory frameworks which govern ICTs as they emerge, while
industry, researchers and CSOs are “innovators and users of ICT…who ought to be
proactive in their consideration of ethics” [1, p.3]. In contrast, the recommendations
made by the more tightly focused PHM-Ethics project are, although primarily policy-
oriented, focused mainly on the specifics of stakeholder engagement and context-
sensitive assessment. The recommendations of PHM-Ethics therefore operate best in a
supportive environment of the kind recommended by ETICA, and flesh out the latter’s
broad recommendations with practical guidance and tools. With that said, PHM-Ethics’
recommendations operate at a broader level as well by emphasizing the importance of
establishing a regulatory framework which encourages “interactive ethical assessment,”
in which contextual understanding of norms and stakeholder participation in
assessment and development take primary importance.
5.1. ETICA Recommendations
The ETICA project aimed separate recommendations at policy-makers and industry,

researchers and CSOs. 8 An institutional framework was detailed which assists in
delegating the responsibilities for ethical assessment across stakeholder groups through
discourse [1]. In general, policy-makers were recommended to establish an
environment in which participatory ethics governance is required and supported, while
industry, researchers and CSOs were encouraged to use the tools provided by policy-
makers to undertake ethical assessment before implementation of emerging ICTs. The
recommendations detail the responsibilities and activities required in conducting an
‘Ethical Impact Assessment’ prior to implementation of an emerging ICT [1].
Policy-makers were recommended to (1) provide a regulatory framework which
will support Ethical Impact Assessment for ICTs, which encourages industry and
government to recognize and respond to the ethical implications of technological
developments; (2) establish an ICT Ethics Observatory, which updates the initial
ethical assessments performed by ETICA and disseminates updated analysis alongside
theoretical and normative information required for Ethical Impact Assessment; and (3)
establish a forum for stakeholder involvement, which institutionalizes the discourse
between industry, policy-makers and civil society to ensure a broad range of
perspectives and societal concerns are reflexively considered in development and ethics
governance.9 The rationale for these recommendations is that the establishment of an
“institutional framework, background, repository and societal discourses” creates
favorable conditions for the “incorporation of ethics and reflexivity into technical work
and application usage” [1].
Once favorable conditions are established, industry, researchers and CSOs are
recommended to (1) incorporate ethics into ICT research and development through
discourse with a diverse range of stakeholders in which ethical issues are identified and
norms specified, demonstrating that fulfillment of “legal requirements is not always
sufficient to address ethical issues”; and (2) facilitate ethical reflexivity in ICT projects
and practice, affirming the context-dependency and transience of ethical issues,
solutions and norms. Ethical implications of future technologies are most effectively
solved through prevention rather than reaction [4,43], so the incorporation of an ethical
perspective in development and research is crucial to ethically responsible innovation.
5.2. PHM-Ethics Recommendations
In a similar way to ETICA, the PHM-Ethics project identified problems with current
ethics governance which can be resolved through implementation of participatory
assessment and context-sensitive understanding in ethics governance, achieved through
discourse with a variety of stakeholders. These recommendations can be enacted with
national and EU policy. However, through dissemination of the developed assessment
tools, PHM-Ethics aims to improve current governance through a change of mindset,
rather than solely through policy advice.
8
Full details of ETICA’s recommendations can be found in [1,7].
9
The upcoming FP7 research project CONSIDER (Civil Society Organisations in Research
Governance, GA 288928) aims at establishing a stakeholder forum of the kind described here. Consortium
partners from the Centre for Computing and Social Responsibility at De Montfort University are involved in
the project.
Additionally, cross-border legal barriers to the optimal implementation of PHM

were identified which suggest organizational, regulatory, ethical and legal solutions. In
the short term, medical liability legislation, working conditions for healthcare
professionals, informed consent and electronic health records require clarification and
revision in response to the challenges of cross-border PHM usage. In the long term,
policy-makers need to reconsider national and international positions on respect of
privacy, the relationship between health professionals and patients, and economic and
organizational challenges, especially those relating to reorganization of healthcare and
the (perhaps troubling) introduction of a relationship between industry and patients in
healthcare [18]. While specific solutions are not suggested, the details of each
challenge are explored in the PHM-Ethics’ Report on Ethical and Legal Constraints
[18], which suggests avenues forward for policy-makers, researchers, developers and
other stakeholders.
5.3. Realization of Recommendations
The majority of recommendations in ETICA for policy-makers and industry relate to

the creation and involvement in an environment supportive of ethical assessment of
emerging ICT. The activities undertaken in each research project have already
contributed to some of the specific recommendations offered in ETICA. These
activities, along with the relevant recommendations, are highlighted here.
ETICA recommended the establishment of a regulatory framework, “to provide
appropriate tools and methods to identify and address ethical issues” [1]. A stakeholder
forum which utilizes these tools is recommended, in which “consensus concerning
good practice in the area of ICT and ethics” can be reached by bridging the gap
between civil society, experts and policy-makers [1, p.6]. PHM-Ethics contributed to
both recommendations with its tools for assessment, which may prove to be applicable
to emerging ICTs beyond PHM. The PHM-Ethics toolbox could therefore be utilized
by policy-makers in creating a supportive regulatory framework, and establishing the
methodology of a stakeholder forum.
The creation of an ICT Ethics Observatory that provides “a community-owned
publicly accessible repository and dissemination tool of research on ICT ethics,” which
gives “examples of approaches and governance structures that allow addressing ethical
issues” has been started by ETICA in its maintenance of a project web-site
(http://ethics.ccsr.cse.dmu.ac.uk/etica) [1, p.6]. The tools provided by PHM-Ethics
could be included on the site as an example of a context-sensitive, participatory
approach to governance. Both projects emphasize the importance of keeping the
Observatory current, through updates to the PHM-Ethics taxonomy and dependencies
map reflecting new developments in ICT, and the application of ETICA’s methodology
to future emerging ICT. This is being partly realized by an ICT Ethics Observatory
which is being developed in the context of a new UK EPSRC funded project on a
Framework for Responsible Research and Innovation in ICT (http://www.responsible-
innovation.org.uk), and will be further developed in the upcoming RESPONSIBILITY
(Global Model and Observatory for International Responsible Research and Innovation
Coordination, GA 321489) project.
The industry-oriented recommendations made by ETICA are met in part by the
methodological contributions of PHM-Ethics. ETICA recommended incorporation of
ethics into ICT research and development to create context-sensitive specifications of
ethical issues and norms through stakeholder engagement [1]. The EAT requires this
type of discourse, in which as many stakeholders are engaged as possible, to include at

least developers and potential users. Stakeholder discourse, in which norms, values and
principles can be exchanged, is therefore encouraged under PHM-Ethics, which is
unsurprising considering the influence of interactive Technology Assessment in the
development of the EAT.
5.4. Complementary Assessment Tools and Implementation in EU Governance
While ETICA provided an extensive set of policy and industry oriented

recommendations, its assessment tools are somewhat less useful once discourse has
been established between stakeholders. This situation is perhaps unsurprising—ETICA
was not designed to provide a conclusive list of emerging ICTs and their ethical
implications, but rather to act as an “early warning system” within broad policy
advisory schemes [7]. This gap has been met by PHM-Ethics, with its focus on
providing evidence for evidence-based policy. ETICA and PHM-Ethics maintained
complementary and occasionally overlapping research agendas: the former at the level
of policy and general foresight, the latter at the level of context-specific ethical
assessment and identification of general ethical issues and themes relevant to that
context.
The different levels of assessment are reflected in the ethical assessment tools
developed in each project. While ETICA developed a broad early warning
methodology based on foresight, PHM-Ethics’ ethical assessment tool consists of two
parts: in the first, stakeholders (technicians, politicians, health care workers, users) are
interviewed with a questionnaire consisting of generic questions relating to the
characteristics, aims and implications of emerging technologies, which encourage
stakeholders to identify and evaluate context-specific norms and principles [6]. The
interview data, conceived of as moral values relevant to ethical assessment, is then
entered in a matrix of ‘moral values to be realized’ and ‘stakeholders’. The matrix
assists in the identification of ethical issues relevant to a specific application or context,
which must then be specified and balanced by stakeholders. The tool is meant to be
used before widespread implementation, meaning the outcomes of the matrix can
inform development of the application in question [13].
If the PHM-Ethics toolbox proves to be applicable to other emerging technologies,
then it can take up the work of ethical assessment where ETICA leaves off. Specifically,
it provides an assortment of modules to identify and evaluate ethical issues arising in
specific contexts through discourse with stakeholders. While these tools are currently
limited to PHM, their underlying methodologies can be tested with the technologies
highlighted in ETICA. If successful, PHM-Ethics has created a set of tools for context-
sensitive ethical assessment of emerging technologies, which builds upon and
encourages the sort of discourse recommended by ETICA. The two projects are
therefore complementary; the former provides a methodology for ethical assessment
and solutions at a context-specific, development stage, while the latter provides a
methodology for early warning of ethically relevant emerging technologies at a policy
level. PHM-Ethics can therefore build upon the findings of ETICA in developing its
tools for context-specific ethical assessment through recognition of broader ethical
issues. If considered together in revising EU ethics governance, the two projects form a
multi-level package of policy and practice oriented assessment methodologies.
6. Conclusion
ETICA and PHM-Ethics have been shown to be complementary in their aims, methods
and outcomes. Apart from developing a knowledge base and assessment methodology,
a change in mindset towards ethical assessment is required to realize the integrative
aims of context-sensitive assessment promoted by both projects. Reflexivity is required,
in which norms are understood from the perspective of a particular stakeholder in a
specific context. Current governance emphasizes the triumph of “the better argument,”
favoring abstract, universal, context-free arguments to integrate different perspectives.
In place of the dominance of abstraction, reflexive understanding, stakeholder
participation, and context-bound norms must be given equal consideration in
integration. Without a reflexive mindset, the ideal of context-sensitive governance will
remain elusively out of reach.
Despite having officially completed research activities in 2011, both projects
continue to engage in dissemination activities in an attempt to change the mindset and
methodology of ethical assessment of emerging ICTs in the EU. Each consortium
maintains a web site, with ETICA’s offering acting as groundwork for an ICT Ethics
Observatory which is being developed in the context of a new UK EPSRC funded
project on a Framework for Responsible Research and Innovation in ICT
(http://www.responsible-innovation.org.uk). Interdisciplinary validation workshops and
dissemination conferences have occurred across the EU, complemented by numerous
peer-reviewed journal and conference publications [1, 2]. It would appear that
consortium partners in ETICA and PHM-Ethics take their obligation to contribute to
responsible innovation in the EU through improvement to ethics governance and
ethically-sensitive technology development seriously. However, going forward the
projects should emphasize the relationship between their outcomes, which when
combined form a robust package of methodologies for ethical assessment of emerging
ICTs.
7. Acknowledgements
Community's Seventh Framework Programme (FP7/2007-2013) under grant
agreements no. 230318 and 230602.
References
[1] B. Stahl, ETICA - Project Final Report, De Montfort University, 2011.

[2] PHM Ethics Consortium, PHM-Ethics - Final Report, PHM Ethics Consortium, 2012.
[3] PHM Ethics Consortium, PHM-Ethics - Deliverable D2.1: Report on Review, University Medical Center
Göttingen, Ernst-Moritz-Arndt University, 2011.
[4] P. Brey, Anticapatory Technology Ethics for Emerging IT, CEPE 2011: Crossing Boundaries (2011),
13–26.
[5] B. Stahl, What Future? Which Technology? On the Problem of Describing Relevant Futures,
Researching the Future in Information Systems, pp. 95–108, Springer, Berlin Heidelberg, 2011.
[6] PHM Ethics Consortium, PHM-Ethics - Deliverable D5-9.1: Ethical Assessment Methodology,
Linköping University, Ernst-Moritz-Arndt-University Greifswald, 2011.
[7] P. Goujon, C. Flick, ETICA - Deliverable D4.1 - Governance Approaches: A Critical Appraisal of
Theory and Applications, University of Namur, 2011.
[8] PHM Ethics Consortium, PHM-Ethics - Deliverable D7-9.1: Report on Validation Results, Ernst-Moritz-
Arndt-University Greifswald, 2012.
[9] H.G. Gadamer, Truth and Method, Continuum International Publishing Group, London, 2004.
[10] Z. Bauman, Hermeneutics and Social Science: Approaches to Understanding, Hutchinson and Son,
London, 1978.
[11] M.E. Patterson, D.R. Williams, Collecting and analyzing qualitative data: Hermeneutic principles,
methods and case examples. Advances in Tourism Application Series, Sagamore Publishing, Inc.,
Champaign, IL, 2002.
[12] A.W. Musschenga, Empirical Ethics, Context-Sensitivity, and Contextualism, Journal of Medicine &
Philosophy 30 (2005), 467–90.
[13] PHM Ethics Consortium, PHM-Ethics - Deliverable D5-9.2: Methodology Validation Report, Ernst-
Moritz-Arndt-University Greifswald, 2012.
[14] V. Ikonen, M. Kanerva, P. Kouri, B. Stahl, K. Wakunuma, ETICA - Deliverable D1.2 - Emerging
Technologies Report, VTT Technical Research Centre and De Montfort University, 2011.
[15] R. Heersmink, J. Van den Hoven, J. Timmermans, ETICA - Deliverable D2.2 - Normative Issues
Report, Delft University of Technology, 2011.
[16] I. Szekely, B. Vissy, M. Szabo, ETICA - Deliverable D3.2.3 - Legal Evaluation, Eötvös Károly Policy
Institute, 2011.
[17] PHM Ethics Consortium, PHM-Ethics - Deliverable D2-4.2b: Second Version of Dependencies Map,
De Montfort University, 2010.
[18] PHM Ethics Consortium, PHM-Ethics - Deliverable D5.1: Report on Analysis of Ethical and Legal
Constraints, Lawfirm Callens, INSERM, Linköping University, University of Utrecht, 2011.
[19] M. Nagenborg, R. Capurro, ETICA - Deliverable D3.2.2 - Ethical Evaluation, Steinbeis Hochschule
Berlin, 2011.
[20] W. Olesky, E. Just, K. Zapędowska, ETICA - Deliverable D3.2.4 - Gender Issues, University of Łódź,
2011.
[21] D. Lyon, Surveillance as social sorting: privacy, risk, and digital discrimination, London, Routledge,
2003.
[22] P. Brey, Freedom and privacy in ambient intelligence, Ethics and Information Technology 7 (2005).
157–66.
[23] A. Albrechtslund, The postmodern panopticon: surveillance and privacy in the age of ubiquitous
computing, Sixth International Conference of Computer Ethics: Philosophical Enquiry, Netherlands,
Enschede. (2005), 11–19.
[24] A. Light, The Panopticon reaches within: how digital technology turns us inside out, Identity in the
Information Society 3 (2010), 583–598.
[25] UK Department of Health, Data Protection Act 1998: Guidance for the NHS, 1998.
[26] EU Parliament, Data Protection Directive, 1995.
[27] A. Lymberis, Smart wearables for remote health monitoring, from prevention to rehabilitation: current
R&D, future challenges, 4th International IEEE EMBS Special Topic Conference on Information
Technology Applications in Biomedicine (2003), 272 – 275.
[28] K.D. Haggerty, R.V. Ericson, The surveillant assemblage, The British Journal of Sociology 51 (2000),
605–622.
[29] W. Yuan, D. Guan, S. Lee, Y.K. Lee, The role of trust in ubiquitous healthcare, Proceedings of
HEALTHCOM 2007: Ubiquitous Health in Aging Societies - 9th International Conference on e-Health
Networking, Application and Services (2007), 312–315.
[30] M. Ziefle, C. Röcker, A. Holzinger, Medical technology in smart homes: Exploring the user’s
perspective on privacy, intimacy and trust, 35th Annual IEEE International Computer Software and
Applications Conference Workshops, COMPSACW (2011), 410–415.
[31] M. Friedewald, E. Vildjiounaite, Y. Punie, D. Wright, Privacy, identity and security in ambient
intelligence: A scenario analysis, Telematics and Informatics 24 (2007), 15–29.
[32] J. Percival, J. Hanson, Big brother or brave new world? Telecare and its implications for older people’s
independence and social inclusion, Critical Social Policy 26 (2006), 888–909.
[33] H. Remmers, Environments for ageing, assistive technology and self-determination: Ethical
perspectives, Informatics for Health and Social Care 35 (2010), 200–210.
[34] G. Demiris, M. Rantz, M. Aud, K. Marek, H. Tyrer, M. Skubic, A. Hussam, Older adults’ attitudes
towards and perceptions of ‘smart home’ technologies: a pilot study, Informatics for Health and Social
Care 29 (2004), 87–94.
[35] P. Tiwari, J. Warren, K.J. Day, B. McDonald, Some non-technology implications for wider application
of robots assisting older people, Health Care and Informatics Review Online 14 (2010), 2–11.
[36] B. Mittelstadt, B. Fairweather, N. McBride, M. Shaw, Ethical Issues of Personal Health Monitoring: A
Literature Review, ETHICOMP 2011 Proceedings, 2011.
[37] E. Palm, Who Cares? Moral Obligations in Formal and Informal Care Provision in the Light of ICT-
Based Home Care, Health Care Analysis (2011), 1–18.
[38] S. Joss, S. Bellucci (eds.) Participatory technology assessment: European perspectives, University of
Westminster, London, 2002.
[39] J. Van Eijndhoven, R. Van Est, The Choice of Participative Technology Assessment Methods. In:
S. Joss, S. Belucci (eds.) Participatory Technology Assessment: European Perspectives, Centre for the
Study of Democracy, University of Westminster, London, (2002), 209–234.
[40] P. Borry, P. Schotsmans, K. Dierickx, Empirical Ethics: A Challenge to Bioethics, Medicine, Health
Care and Philosophy 7 (2004), 1–3.
[41] S. Hurst, What “Empirical Turn in Bioethics”? Bioethics 24 (2010), 439–444.
[42] A. Kon, The Role of Empirical Research in Bioethics, American Journal of Bioethics 9 (2009), 59–65.
[43] D. Collingridge, The Social Control of Technology, Macmillan, Palgrave, 1980.
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-137
Development of a
Personal Health Monitoring System –
The IT-Systems Industry View
Irene MAUCHER1 and Wolfgang Weyand
T-Systems International GmbH
Abstract. The Development and Implementation of PHM systems require a

different approach than typical application development processes. Based on a
practical example it is described how ethical and legal aspects will be considered
during the development process. The result is a cohesion and adoption of different
methods with defined interaction points to reiterate the solution design by legal
and ethical aspects.
Keywords. Personal health monitoring system, human machine interaction,

requirements engineering, Intelligent Home Alarm System, system integration,
software development, AAL Joint Programme
1. Prerequisites in the Development of a PHM System -

The IT-Systems Industry View
PHM systems as part of health application systems for professionals and citizens –
How to manage and consider ethical and legal aspects within the development of new
technological solutions documented at an example.
1.1. The consideration of non-functional requirements in Requirement Engineering
As a rule, software projects begin with the definition of general goals and the inquiry of
functional requirements. For concretization of the requirements, use cases are
developed together with future customers. A systematic Requirement Engineering that
contains a comprehensive analysis of requirements, in which the process of information
gathering, the process of documentation and the coordination between stakeholders is
set, remains undone most of the time.
Regulatory framework, which results from statutory provisions (e. g. data security,
information security, medical products law, etc.), is considered mostly at a later point
in the course of system development. As a consequence, the relevant system context for
the developed product is not considered sufficiently most of the time.
PH-Systems, which in perspective can be used in the secondary health care market
as well as in the primary (legally regulated) healthcare, are subject to both to
requirements from regulatory framework and the approval of relevant requirements.
Additionally, PH-Systems should be generally qualified for the criteria of ethics.
1
138 I. Maucher and W. Weyand / Development of a Personal Health Monitoring System
Formal mapping
andEthicRequirements…
User
Requirements required
Definitions
Legal, Regulatory
Implementation
Design
Developer
Opportunities
conflicts negotiation solution

* Derived fromAlexander Rachmann
– confidential – Dr. Irene Maucher, Wolfgang Weyand / Prerequisites in the Development of a PHM System June 26th 2012 4
Figure 1. Scheme to make sure that values are considered in the design of a solution.
Legally, the creation of an ethics opinion is required when a PH-System ends up in

a medical product that is used by medical professional.
Typically, PH-Systems affect the privacy of their users. Within the social and
scientific discourse, a link will be established between an ethical control and user
acceptance. In this context, criteria of ethics refer to the protection of privacy and rights
relating to personality which can be operationalized in particular as to protect personal
data. This requirement applies to the intelligent home alarm system, which is used as a
home automation system. In further discussion, the intelligent home alarm system is
reflected as representative of telemonitoring systems.
The framework of Requirement Engineering (cf. Pohl 2008) describes the
development of complex and innovative systems as iterative processes (Figure 1).
Based on the relevant system context, regulatory framework and specific quality
requirements (e. g. ethic requirements) can be addressed at an early point and can be
integrated into the system design.
Ethic requirements describe values and are the result of social discourse. Measures
of value can be specified early as an agreement between different stakeholders within
Requirement Engineering. Within agreements it is agreed upon which later system
solutions are desirable and which are not.
1.2. Example Intelligent Home Alarm System (IHAS)
At this point it is required to describe the basis of the „Intelligent Home Alarm
System“ (Figure 2), which is an example of a PH-System, before going into further
detail about the process model.
The development of our system started in 2010 with the implementation of a pilot
project within the BMBF-funded research and development project (eHeath@Home).
Practice partner in the framework of the pilot project was the Liebenau Foundation,
I. Maucher and W. Weyand / Development of a Personal Health Monitoring System 139
which focuses on the care and support of elderly and disabled people in rural areas in
southern Germany.
They also investigate and develop district policies, outpatient solutions within the
care sector and prevention. Among other things, the Liebenau Foundation provides
multigenerational houses and home bound flats.
Figure 2. Example System Overview Intelligent Home Alarm System.
During the analysis phase of the pilot project, it was identified that a home alarm
system worn on the body (e.g. Funkfinger) deals with acceptance problems and leads to
the problem that home care isn’t available in many critical situations. Moreover, people
with mental disorders are excluded from the use of a body-worn home emergency
system that is activated manually in critical situations. This triggered the development
of a domotic system that works effectively in the background.
An intelligent home alarm system differs from traditional implementations by way
of use and technological aspects. In general, specific groups should not be excluded
from usage.
A technological innovation is the event based concept of the “Intelligent Home
Alarm Systems”.
As part of the technological concept, critical situations – such as downfall or not
being able to get up after falling down – are described by algorithms. The second step,
when a critical situation has been identified, is a voice based verification by the user.
An alarm will only be triggered when the user confirms a critical situation and is in
need of assistance. This is the only point where data will be made available outside of
the user’s premises.
The process is normally controlled by an emergency call centre which is available

24/7. Unlike to traditional home alarm systems, multiple sources of information are
available to verify and classify the situation. Besides the traditional audio
communication, sensors will provide images of the situation. With such detailed
information the emergency call centre is able to initiate the required support.
1.3. Modelling of a socio-technical system by Requirement Engineering
A socio-technical system includes the interaction between actors and a technical system
(human-machine-interaction) and the description of the requirements as a source of
information for the development of the system. As part of RE, there will be defined
interaction scenarios, which the overall system will accept as relevant actors. The
actors can be divided into three classes in accordance with the scheme of the AAL Joint
Programme (AAL JP):
• Primary users: users of the “Intelligent Home Alarm System”; consumer of a PH-
System
• Secondary users: users who have an indirect benefit from the use of the “Intelligent
Home Alarm System”, such as emergency call centres or care services, which are
able to provide new service offerings by using a PH-System. They represent a value
for the primary user. Furthermore, PH-Systems are integrated into the workflow of
the secondary users, which requires the functional processes of the requester to be
described by a formal method of process modelling.
• Tertiary users: legislative authorities, e. g. health care funds, which are interested
equivalent to their mandate to receive benefits from the use of a PH-System
These stakeholder groups demonstrate how different forms of information gathering
are applied in interaction scenarios. In addition to interviews and interaction tests,
which are performed with the primary user, the requirements of secondary users are
reflected by service opportunities and are supplemented by document analysis. As for
the requirements of tertiary users, mainly laws have to be considered.
Based on the empirical results of the aforementioned research and development
project, T-Systems has decided to develop the “Intelligent Home Alarm System”. The
usability tests of traditional home alarm systems, the results of surveys regarding user
acceptance and security requirements of primary users and the security promise of
home care providers were considered in addition to the requirements of the secondary
users. Crucial to the design of the “Intelligent Home Alert System” is the legal
framework, reflected by the terms of the social system and its feasibility regarding the
implementation of a business model. To enable the description of differentiated
interaction scenarios it is required to provide a consolidated documentation of the PH-
System that is to be developed. A consolidated version of a system under development
is possible as a compromise between the different views of the stakeholder groups.
Natural language based methods for modelling are the prerequisite for the discussion
and coordination of various views. Within the final stage of the development, a
consolidated document will be available, describing the solution-oriented approach
using formal methods.
Synthesisof applicationserviceengingeering* andrequirements

engineering*.
Service Prepa- Implemen-
Engineering Start Analysis Concept Test
ration tation
Requirements
Engineering Exploitation Documentation
Management Validation
Agreement
Identification of requirements:
Iterativ, Agile, Documentation of requirements and negotiation with stakeholders
* Derived fromPohl, K. (2008). RequirementsEngineering. 2., korrigierte Auflage. Heidelberg: dpunkt.
And Alexander Rachmann
–confidential– IreneMaucher, WolfgangWeyand / Prerequisitesin theDevelopment of a PHM System June26th 2012 5
Figure 3. Overview of process model in use.
The framework of the RE provides methods of information-gathering, its

documentation and verification, involving different views and discussions of the
different groups of actors. Normative requirements of different groups of actors are
incorporated at an early stage of software engineering.
2. Conclusion
By considering the different requirements on one hand and the possible compromise
solutions on the other hand, it is possible to avoid costly and ineffective developments.
2.1. Example derived from project
With the adoption of requirements engineering in a selected project at T-Systems the

theses of the model described earlier are being verified and enhanced. This project
deals with a very complex structure of actors and stakeholders. All participating parties
have defined different requirements and these have to be aligned within the project. In
the following we will discuss two examples how to deal with the different requirements
and values.
2.1.1. Ethical example 1

Assumption: By using telemonitoring systems the autonomy of human beings could be
guaranteed.
The assumption here is that under certain circumstances individuals are helpless within
their own premise. Helpless means that they are not able to call for help using today’s
technical support systems. A telemonitoring system used within private premises
should overcome this issue and provide autonomy. In this context, autonomy would
mean that the individual is not limited within his activities and duties.
Value: The provider is improving sustainability under social aspects.
All telemonitoring systems are run and maintained by a provider. Today’s strategic
goals of major companies are also defined by sustainability goals. Such goals will help
to align business activities to reduce the environmental impact of a company and
typically define the value a company provides towards mankind. Those values are not
described in dollars or number of items. These are values which cannot be measured in
financial values. The social aspect for telemonitoring systems is the ability to support
people from remote within their personal and private environment.
Result: Assuming telemonitoring services would improve autonomy of human beings
and this could be associated with the sustainability of a provider, then its usage is
recommended.
The discussion of the requirements and the values between the participating parties
concludes that the telemonitoring system is of help due to the ability to provide support
from remote. The support could be provided on demand and is not limited to any
individual and hence doesn’t discriminate anybody. Since there is no discrimination
and the provider is interested in improvements of sustainability, the combination of
both makes sense. The rules for such communications have to be documented – see
next viewpoint.
2.1.2. Data security and data privacy as example 2

Assuming the above described telemonitoring services would be provided, the data
privacy is affected and data security has to be guaranteed. It is affected while the
telemonitoring service is performed within a private property and the control centre
from outside is able to take a look into the same.
Viewpoint individual assumption: Individuals are interested in keeping details about
their personal life / behaviour protected
When being in public places a lot of individuals know that there is e.g. CCTV available
and used or other individuals take pictures. It is difficult to protect your personal image
within public places. Within private property you typically assume that you know who
is taking a look at you or what you are doing. Using a remote telemonitoring system,
the individual will also be interested in having the same protected.
Value: individuals are respected and not offended against attack by others
In case some private data will be publicly available, people are offended. Individuals
don't accept information and data being shared under the seal of silence. Individuals
expect that this value is neither affected nor broken in any case.
Result: data privacy is a must-have for IT-Systems to protect individuals from offense.
All IT-Systems have to be developed in accordance with local laws. A lot of countries
have decided to protect the privacy of individuals without any exception. In other
countries there is no formal law to protect the privacy of an individual but the
population assumes this protection implicitly. Hence the population assumes that their
lives are not negatively impacted by the use of IT.
Viewpoint healthcare provider’s assumption: reduce costs by providing early support
within critical situations and immediate action taking
Healthcare providers are one of the actors within this application example. Their
interest within this example is to provide new types of personal healthcare support at
optimal costs and reduce the cost base of the standard services. Today’s services are
typically planned and follow a particular order. This system is very inflexible and
doesn’t allow ad hoc services to be provided at lower costs. In addition, today’s
services could not be planned or provided on real priority.
Value: in case of an accident the follow up costs are significantly reduced
Not having an accident and first aid or any other support being provided within short
term, the costs to service an injured individual start raising significantly. Those
increases in costs are caused by e.g. complications of broken bones or any increase of
physical or mental disorder, in very rare cases people die because of the absence of first
aid.
Result: Analysing the movement within the household and early notification help to
provide new healthcare services on demand.
The current healthcare providers serve their clients at certain points in time. In case of
an accident in between, the ability to call for support depends on the severity of the
accident. In case of severe accidents the time of waiting for first aid depends on the
healthcare plan of the individual. The time lag between the accident and the services
showing up at the location could be reduced by a system which analyses the movement
of the individual. This observation system allows to provide healthcare services on
demand.
2.1.3. Solution
The examples discussed earlier describe different requirements from different actors
and their viewpoints. Since some optimal solutions for individual requirements end up
in less optimal solutions for other actors, the project management’s responsibility is to
provide a solution (or a compromise). Such a solution for the examples described
above may look like the following:
The continuous observation of the movements of individuals in private households
may be of interest of healthcare providers. Due to the nature of dealing with private
data and not getting in conflict with local law, the access from outside to such data
should not be given continuously. Access should be allowed only in extraordinary
(critical) situations. In addition, only authorized personal should have access to this
data. Having the access to this data limited in such a way would be satisfying for
healthcare providers as well as for individuals. The privacy of individuals would not be
affected nor would the service ability for health care providers be limited.
References
[1] K. Pohl (2008), Requirements Engineering: Grundlagen, Prinzipien, Techniken. Heidelberg:

dpunkt.Verlag GmbH.
[2] A. Rachmann (2012), Modellbasiertes Service Engineering einer Telemonitoring-Dienstleistung,
Dargestellt am Beispiel der Altenhilfe unter besonderer Berücksichtigung von Kontrolle und
Privatsphäre als berufsethische Aspekte. Göttingen: CUVILLIER Verlag.
IOS Press, 2013
doi:10.3233/978-1-61499-256-1-145
Personalized Use of ICT –

from Telemonitoring
to Ambient Assisted Living
Thomas NORGALLa,1 and Reiner WICHERT b
a
Fraunhofer Ambient Assisted Living Alliance,
c/o Fraunhofer-Institut für Integrierte Schaltungen, Erlangen
b
Fraunhofer Ambient Assisted Living Alliance,
c/o Fraunhofer-Institut für Graphische Datenverarbeitung, Darmstadt
Abstract. Individual availability of information and communications technology

(ICT) has enabled “Personal Health” applications like the continuous ubiquitous
telemonitoring of vital signs. The concept of Ambient Assisted Living (AAL) goes
beyond health and care applications utilizing home automation technology for
supporting individuals with specific needs, particularly enabling elderly to live in
their accustomed home as long as possible. These users usually suffer from more
than one disease and need compensation of several impairments. Most current
AAL projects and products however provide insulated solutions addressing only a
small selection of these user needs. For comprehensive dynamic system adaptation
to changing user needs an open platform supporting interoperable components is
required. While the industry-driven Continua Health Alliance developed a corre-
sponding Personal Health ecosystem, the ongoing European project universAAL
aims at a universal platform for both AAL and Personal Health applications.
Keywords. Personal Health, telemonitoring, Ambient Assisted Living (AAL),

Continua Health Alliance, interoperability, platform concept, universAAL project
Introduction
In the last decades new ways of individual access to health-related information and
services were established. A virtually unlimited amount of health-related information
became available using Personal Computers and Internet – with the remarkable impli-
cation of noticeably fostering patient empowerment. Ubiquitous wired and wireless
communication and information infrastructures, low cost smart devices and miniatur-
ized biosensors enabled “Personal Health” applications like telemonitoring, i.e. the
(conceptually continuous) remote monitoring of individual health-related parameters
(like ECG, blood oxygen saturation, blood pressure, blood glucose level, pulse, weight,
activity etc.) in homecare and even mobile settings.
1
146 T. Norgall and R. Wichert / Personalized Use of ICT – From Telemonitoring to AAL
1. Telemonitoring and Personal Health Systems
The visible components of a typical telemonitoring system at the patient’s site consist
of – generally multiple – sensors units and a base station which is either worn by or
located in the immediate vicinity of the user. Using wireless network links of limited
range (Body Area Network / Personal Area Network, usually based on Bluetooth tech-
nology), the sensor units communicate with the base station, most practically a stand-
ard smartphone or PDA (Figure 1). This base station captures and stores the sensor data,
possibly performs compression and/or (pre-)processing and communicates the data
with a service center via wired or wireless transmission (GSM, UMTS, LTE, WLAN).
However, a complex multi-vendor telemonitoring system as suggested in Figure 1 is
currently most difficult to implement and operate particularly due to lacking interoper-
ability among available off-the-shelf-components. It is also important to note that the
functionality and quality, but even more the patient’s acceptance and compliance of
telemonitoring depend on the organization and professional expertise of the service
center and its staff.
Beyond patient information, telemonitoring and numerous other applications for
disease and lifestyle management, “Personal Health” also indicates and implies a new
healthcare organization paradigm [1]: The integration of professional healthcare stake-
holders using telematics infrastructures – traditionally identified as eHealth – is sup-
plemented by personalized forms of prevention, diagnostics, therapy and care, which
go beyond the traditional scope of healthcare and include personal lifestyle coaching
and support regarding nutrition, fitness/wellness activities etc. These activities are
organized in collaboration between patients and healthcare service providers of their
choice – potentially the accustomed family doctor, who thus could gain a new field of
professional activity and an additional source of income.
Figure 1. Typical telemonitoring system components and communication paths.

T. Norgall and R. Wichert / Personalized Use of ICT – From Telemonitoring to AAL 147
Extending classical eHealth concepts to “pHealth”, advanced Personal Health sce-

narios include personal health status monitoring but also imply continuous ubiquitous
access to personalized health-related information, assistance, support and intervention.
Typical pHealth electronic record infrastructure not only provides a long-term reposito-
ry of “professional” data from doctor’s visits and hospital stays, but also quality-
controlled user-generated data documenting the dynamics of relevant health-related
parameters under everyday life conditions. To avoid inefficient and inadequate use of
resources, individualized and self-calibrating automated data tracking services as well
as health-status-based escalation strategies are required to ensure adequate trigger lev-
els for professional intervention. In case of emergency, the alarmed health professional
can e.g. utilize real-time transmitted vital signs (e.g. ECG etc.) in combination with
decision support based on patient history and relevant information from comprehensive
electronic records. Thus ambulance and hospital staff can be optimally informed for ad-
hoc patient treatment.
2. Demographic Change and Ambient Assisted Living (AAL)
Since the early 90s, evolving concepts for communication, automation and computer-
supported cooperation among devices and systems of home installation (appliances,
heating, etc.) which normally operate independently in a private home were marked
with terms like “Smart Home“, “Intelligent House“ or “Intelligent Living“. Fundamen-
tally, the inhabitants’ comfort and security are increased while the use of resources like
energy and water is consequently minimized. Similar technology can enable independ-
ent living for individuals who are limited in their mobility, cognitive abilities and/or
motor skills [2]. The Fraunhofer inHaus, established 2001, provides an overall demon-
strator including explicitly health-related applications like sleep monitoring and activity
profiling for the inhabitants (Figure 2).
Figure 2. Fraunhofer inHaus 1 functions and example presence profile

In near future, demographic change will result in increased demands for social,
medical and care giving services while the shrinking younger population will be de-
creasingly capable of caring for the elderly [3]: Both financial resources to cover care
giving costs and the number of qualified caregivers will be continuously shrinking.
Addressing this problem, but also reflecting changing lifestyles preferences, the idea of
living and being cared for in one’s accustomed living environment versus as an inpa-
tient in a treatment facility becomes increasingly attractive for a growing number of
particularly elderly individuals. Opinion polls reveal that elderly individuals prefer to
remain in their home as long as possible, even accepting increasing dependency on
assistance services and caregivers.
Usually referred to as “Ambient Assisted Living“ (AAL), assistive, health-related
or medical, safety, security and social network applications are seamlessly integrated
into “intelligent“ environments addressing the needs of particularly elderly users [4]. In
AAL environments (Figure 3) generally various motivational or usage aspects overlap.
This can be illustrated e.g. by the real life example of automatic opening and closing of
windows and blinds that – in combination with turning on and off lighting – increase
the overall comfort level of inhabitants as well as the home’s security level by reducing
the risks of burglary. Further combined with adequate control of heating and air condi-
tion, home energy savings are enabled, and, last but not least, preconditions for ill or
handicapped individuals to remain living in their own private surroundings are likewise
improved. In the last years, AAL has dominated the scientific and market-oriented
research aiming at the aging population in Germany and Europe. While numerous na-
tional and European AAL projects have provided prototype solutions for various spe-
cific impairments or diseases and user scenarios, there is no substantial market for
AAL products and applications yet.
Figure 3. Scenarios from AAL Project PERSONA.

Real-life elderly individuals however – particularly when in need of care – usually

suffer from more than one disease resulting in numerous, sometimes mutually exacer-
bating symptoms and medical requirements [5]. This multi-morbidity regularly coin-
cides with multiple deficiencies requiring compensation by assistance in everyday life.
Adequate technical answers have to cover the aging person’s overall picture of needs
and requirements, which is necessarily subject to permanent change. Hence insulated
solutions and monolithic proprietary products have to be abandoned in favor of an
overall approach: Components and services from various manufacturers and providers
have to be easily and dynamically integrated using a common “platform“ concept.
Ideally such a platform should equally support both “Assisted Living“ and “Personal
Health“ applications.
3. Continua: An Open Platform and Ecosystem for Personal Health Applications
The currently most established “Personal Health“ platform – which is however lacking
AAL-specific capabilities – was developed by the Continua Health Alliance [6]
(http://www.continuaalliance.org). The alliance was established 2006 with the first
objective to develop interoperability guidelines for the emerging personal telemonitor-
ing and telehealth ecosystem (Figure 4). Currently more than 250 companies and or-
ganisations cooperate in the definition of common Personal Health guidelines, related
development and test tools based on a comprehensive set of international standards,
predominantly from HL7 and the CEN/ISO/IEEE 11073 family of standards. For the
most frequently used Bluetooth Body Area Network / Personal Area Network technol-
ogy a specific Health Device Profile was defined ensuring both plug&play interopera-
bility and an optimal level of communication security. The organisation is also active
in the development of related regulatory frameworks, markets and business models.
Continua aims to enable the alignment of different vendors and domains, focusing on
management of chronic diseases outside of clinical settings, personal health and fitness
applications, and last not least technologies and services for aging independently in
home environments, thus clearly addressing the “classical” AAL domain.
Continua-defined standard-based interoperability profiles also serve as a basis for
product certification. To ensure compatibility, Continua established a certification and
testing program that includes a detailed set of test specifications and testing tools so
that candidate vendors can verify compliance. Additionally, interoperability events are
organised to ensure that products from different vendors work together. Products that
pass the certification and testing program receive certification and can display the Con-
tinua interoperability logo. There are currently almost 70 Continua certified products in
the market.
Figure 4. The Continua Ecosystem.
4. universAAL: Towards a Universal Open Platform Concept for AAL

Applications
In the AAL domain various international projects resulted in a number of AAL mid-
dleware platform concepts that can be used to build dynamic distributed self-organising
infrastructures for devices, sensors and services. Although each of them provides sub-
stantial benefits as an AAL infrastructure, none has achieved the desired breakthrough.
Hence for the current Framework Program the EU decided to support only one single
research project developing a unified European open source platform for AAL systems
with open protocols and interfaces to ensure the interoperability of sensors, devices and
services.
The project universAAL [7, 8] started in February 2010 with a total budget of ap-
proximately 15 million € and a consortium of 17 institutions from 10 countries. In the
first phase of the project, the most attractive middleware platforms were identified,
analyzed and evaluated regarding interoperability, ease of use, integration of new com-
ponents and elements as well as aggregation of user interaction results. The resulting
universAAL reference platform will bundle the essential benefits of the evaluated plat-
forms and provide a runtime environment for a variety of different AAL use cases and
applications. Related standardization activities are performed throughout the project
lifetime utilizing links of project partners DKE and Continua Health Alliance to rele-
vant standardisation bodies. Based on the universAAL platform an “ecosystem“ shall
be established to attract a community of supporters who use the universAAL platform
for their activities and ensure continuous dissemination and refinements.
Accordingly the universAAL project joined the AAL Open Association (AALOA),
where individuals as well as stakeholders from various AAL projects, companies and
organizations collaborate in forming an open AAL community.
References
[1] T. Norgall, B. Blobel, P. Pharow, Personal Health – The Future Care Paradigm, In: L. Bos, L. Roa, K.
Yogesan, B. O’Connell, A. Marsh and B. Blobel (Eds), Medical and Care Compunetics 3, Series: Stud-
ies in Health Technology and Informatics, Vol. 121, IOS Press, Amsterdam, 2006.
[2] P.L. Emiliani, C. Stephanidis, Universal access to ambient intelligence environments: Opportunities and
challenges for people with disabilities, IBM Systems Journal 44 (2005), 605–619.
[3] Statistisches Bundesamt, Population of Germany till 2050. 11th coordinated population forecast, Wies-
baden, 2006.
[4] R. Wichert, Configuration and Dynamic Adaptation of AAL Environments to Personal Requirements
and Medical Conditions, In: HCI International 2009. Proceedings and Posters, LNCS 5615 [DVD-
ROM with 10 further Associated Conferences], Springer, Berlin, Heidelberg, New York, 2009, 267–
276.
[5] Robert Koch-Institut (ed.): Gesundheit im Alter, Themenheft 10, Gesundheitsberichterstattung des Bun-
des, Berlin, 2009.
[6] R. Carroll, R. Cnossen, M. Schnell, D. Simons, Continua: An Interoperable Personal Healthcare Ecosys-
tem, IEEE Pervasive Computing 6 (2007), 90–94.
[7] T. Norgall, R. Wichert, Towards Interoperability and Integration of Personal Health and AAL Ecosys-
tems, In: B. Blobel, P. Pharow, F. Sousa (eds.), pHealth 2012 - Proceedings of the 9th International
Conference on Wearable Micro and Nano Technologies for Personalized Health, June 26–28, 2012,
Porto, Portugal, Vol. 177, IOS Press, Amsterdam, 2012.
[8] universAAL Open Platform and Reference Specification for AAL, http://www.universaal.org.
Appendix
IOS Press, 2013
About the editors
Prof. Dr. Silke Schmidt
Current Position
• Head of the Department Health and Prevention, University of Greifswald
Education and Employment

• Graduated in Psychology 1996
• PhD University of Jena 2001
• Habilitation University Medical Center of Hamburg-Eppendorf 2006
• Professor at the Institute of Psychology, University of Greifswald since 2008
Research Focus
• Psychosocial analysis of personal health monitoring and health technologies
• Health psychology across the life span
• Prevention psychology in the area of civil protection
• Cross cultural analysis of health and quality of life
• Coordination of many multi-center studies on the national and European level,

including the PHM-Ethics, BeSeCu and DIA-LOC project
Selected Honors and Awards

• Member of the Directors Board of the International Society of Quality of Life
Research
• Member of the Commission of Civil Protection of the Ministry of Interior
• Member of the Expert Circle Personalized Medicine MedicaMedia IT Forum
• DKPM Bio-Psychosocial-Medicine-Award, ISOQOL New Investigators Award,
Lilly Quality of Life Award
Further Information
• www.mnf.uni-greifswald.de/institute/institut-fuer-psychologie/lehrstuehle/
gesundheit-und-praevention-heinz-nixdorf-lehrstuhl.html
About the Editors 157
Prof. Dr. Otto Rienhoff
Current Position
• Chair of Medical Informatics at Göttingen University Medical Center
Education and Employment

• MD University Münster 1973
• Assistant Prof. Medical School Hannover 1982
• Chair of Medical Informatics Marburg University 1984
Research Focus
• Evaluation of new IT-technologies regarding possible utilisation
for health promotion, prevention, care, and rehabilitation
• Current foci: assistive technologies for personal health and
advanced IT-infrastructures for medical research networks
Teaching Focus
• BSc and English MSc curriculum of Health Informatics
(internationally accredited in 2012)
• Member of the Gauss-Graduation School, Göttingen University
Selected Honors and Awards

• Honorary Fellow, International Medical Informatics Association
• International Fellow, American Medical Informatics Association
• Corresponding Member Brazilian and South African Health Informatics Societies
Further Information
• www.mi.med.uni-goettingen.de
IOS Press, 2013
List of Authors1
Callens, Stefaan, Dr.

Director
Callens Law Firm
Brussels, Belgium
stefaan.callens@callens-law.be
Collste, Göran, Prof. Dr.

Professor of Applied Ethics
Linköping University
Centre for Applied Ethics
Linköping, Sweden
goran.collste@liu.se
Deswarte, Céline
Project Officer
European Commission Brussels
Directorate General
DG Communications Networks
Content and Technology
Brussels, Belgium
celine.deswarte@ec.europa.eu
Fairweather, Ben, Dr.

Senior Research Fellow
Centre for Computing and Social Responsibility
Leicester, Great Britain
nbf@dmu.ac.uk
Galot, Adrien
Callens Law Firm
Brussels, Belgium
Gök, Murat
Research Fellow
University Medical Center Göttingen
Department of Medical Informatics
Göttingen, Germany
murat.goek@med.uni-goettingen.de
1
In alphabetical order.
160 List of Authors
Lamas, Eugenia, Dr.

Researcher
INSERM
E-santé - Centre de Recherche des Cordeliers
INSERM U872 Equipe 20
Paris, France
eugenia.lamas@inserm.fr
Maucher, Irene, Dr.

Senior Expert
T-Systems International GmbH
Bonn, Germany
irene.maucher@t-systems.com
Mittelstadt, Brent
PhD Research Student
bmittelstadt@dmu.ac.uk
Mühlan, Holger, Dr.

Research Fellow
Ernst Moritz Arndt University Greifswald
Department of Health and Prevention
Greifswald, Germany
holger.muehlan@uni-greifswald.de
Nordgren, Anders, Prof. Dr.

Professor of Bioethics
Director of the Centre for Applied Ethics
Linköping, Sweden
anders.nordgren@liu.se
Norgall, Thomas
Assistant Spokesman
Fraunhofer Ambient Assisted Living Alliance
c/o Fraunhofer-Institut für Integrierte Schaltungen
Erlangen, Germany
thomas.norgall@iis.fraunhofer.de
Nußbeck, Gunnar
Research Fellow
Göttingen, Germany
gunnar.nussbeck@ med.uni-goettingen.de
List of Authors 161
Palm, Elin, Dr.

Assistant Professor
Centre for Applied Ethics
Linköping, Sweden
elin.palm@liu.se
Rhode, Dieter, Dr.

Research Fellow
Department of Health and Prevention
Greifswald, Germany
dieter.rhode@uni-greifswald.de
Rienhoff, Otto, Prof. Dr.

Director of the Department of Medical Informatics
Göttingen, Germany
haegar@med.uni-goettingen.de
Rogerson, Simon, Prof. Dr.

Professor in Computer Ethics
srog@dmu.ac.uk
Schmidt, Silke, Prof. Dr.

Director of the Department of Health and Prevention
Greifswald, Germany
silke.schmidt@uni-greifswald.de
Stahl, Bernd, Prof. Dr.

Director of the Centre for
Computing and Social Responsibility
bstahl@dmu.ac.uk
Teng, Xia
Research Fellow
Göttingen, Germany
xia.ten@med.uni-goettingen.de
162 List of Authors
Verweij, Marcel, Prof. Dr.

Associate Professor
University Utrecht
Department of Philosophy
Utrecht, Netherlands
m.f.verweij@uu.nl
Weyand, Wolfgang
T-Sytems International
Systems Integration
Leinfelden-Echterdingen, Germany
wolfgang.weyand@t-systems.com
Wichert, Reiner, Dr.

Head of Department
„Interactive Multimedia Appliances“
Fraunhofer Ambient Assisted Living Alliance
c/o Fraunhofer-Institut für
Graphische Datenverarbeitung Darmstadt
Darmstadt, Germany
reiner.wichert@igd.fraunhofer.de
Wilford, Sara, Dr.

Senior Lecturer, Research Fellow
sara@dmu.ac.uk
Zilgalvis, Pēteris
Head of Unit
European Commission Brussels
Directorate General
Communications Networks
Content and Technology
Brussels, Belgium
peteris.zilgalvis@ec.europa.eu
IOS Press, 2013
Subject Index
AAL joint programme 137 method 79
ambient assisted living (AAL) 145 methodology 13
ambient intelligence 3, 117 monitoring 3, 105
anticipatory 117 monitoring devices 3
care 105 nominal group technique 79
care ethics 105 personal health 145
complex systems 79 personal health monitoring 13, 23,
continua health alliance 145 41, 67, 79, 95, 117
dependencies 79 personal health monitoring
emerging technology 117 system 137
ethics 3, 79, 117 personalised health monitoring 55
ETICA 117 personalized care technology 105
European legislation 55 PHM-ethics 79, 117
governance 117 platform concept 145
health care 105 privacy 3
health parameters 23 psycho-social issues 95
health technology assessment 13 requirements engineering 137
heuristics 79 software development 137
home care 105 stakeholders 105
human machine interaction 137 surveillance 105
ICT 79, 117 system integration 137
intelligent home alarm system 137 taxonomy 67
intensive care systems 3 telemonitoring 23, 41, 145
interactive ethical technology transdisciplinarity 79
assessment 105 ubiquitous monitoring 3
interoperability 145 universAAL project 145
legal aspects 55 values 105
IOS Press, 2013
Author Index
Callens, S. 55 Palm, E. 105
Collste, G. 105 Rhode, D. 95
Deswarte, C. v Rienhoff, O. 3, 67
Fairweather, B. 79, 117 Rogerson, S. 79
Galot, A. 55 Schmidt, S. 13, 41, 95
Gök, M. 23, 67 Stahl, B. 117
Lamas, E. 55 Teng, X. 67
Maucher, I. 137 Verweij, M. 13, 105
Mittelstadt, B. 117 Weyand, W. 137
Muehlan, H. 41, 95 Wichert, R. 145
Nordgren, A. 105 Wilford, S. 79
Norgall, T. 145 Zilgalvis, P. v
Nußbeck, G. 23, 67

Interdisciplinary Assessment of Personal Health Monitoring

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Interdisciplinary Assessment of Personal Health Monitoring

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INTERDISCIPLINARY ASSESSMENT OF

PERSONAL HEALTH MONITORING

ISSN 0926-9630 (print)

Amstterdam • Berrlin • Tokyo • Washington, DC

ISBN 978-1-61499-255-4 (print)

Distributor in the USA and Canada

PRINTED IN THE NETHERLANDS

We welcome this book, which presents selected contributions to the pre-conference

1. Towards Smart and Sustainable Healthcare in Europe

2. A New eHealth Action Plan

The Project “PHM-Ethics”

PHM. It is needed in order to provide a systematic basis for communication in trans-

Broadened Perspectives on PHM

Le but du projet de recherche PHMethics a été d’entreprendre une recherche

Le premier chapitre comprend une introduction du monitoring personnalisé en santé et

Dans la “Revue de Littérature Technique” Gunnar Nußbeck et Murat Gök du Centre

Perspectives élargies sur le PHM

Das Projekt „PHM-Ethics“

Das Ziel des europäischen Verbund-Projektes „PHM-Ethics“ bestand darin,

Vorstellung von PHM

Perspektiven auf PHM

Beurteilung von PHM

Erweiterte Perspektiven auf PHM

I. Introduction to Personal Health Monitoring

From Intensive Care Monitoring to Personal Health Monitoring to Ambient

II. Perspectives on Personal Health Monitoring

Technical Literature Review 23

III. Assessment of Personal Health Monitoring

Setting the Scene: Taxonomy of Personal Health Monitoring 67

IV. Broadened Perspectives on Personal Health Monitoring

PHM-Ethics and ETICA: Complementary Approaches to Ethical Assessment 117

About the Editors 155

From Intensive Care Monitoring

Keywords. Intensive care systems, monitoring, monitoring devices, ubiquitous

1. Roots of Monitoring Physiological Parameters

monitoring system. In Germany the Medical Schools in Düsseldorf and Hannover

“Monitoring systems” in medicine are defined as technical solutions which allow

3. Early Observations and New Questions

4. Ambient Assisted Living (AAL)

5. Ethical Questions Accompanying Monitoring Developments

The PHM-Ethics Methodology:

Keywords. Personal health monitoring, health technology assessment,

reaching consequences if some of them team up and establish an interconnected system

1. Personal Health Monitoring

Personal health monitoring technology represents such a further step in technological

2. Objective and Methods

The European collaborative project PHM-Ethics has conceived a methodology for

perspective. An integrated European approach to the combined regulation of ethical,

3. Risks and Chances

4. Key Values and Principles

• Protect and do not undermine a patient’s privacy,

5. The PHM Ethics’ Toolbox

• Taxonomy of personal health monitoring technologies: This tool provides

Since reflection on novel or future personal health monitoring technologies is relevant

Technical Psycho-social Ethical

Dependencies Report on legal and

7. Conclusion and Outlook

Technical Literature Review

Abstract. This review gives a comprehensive overview on the technical perspec-

Keywords. Telemonitoring, personal health monitoring, health parameters

This review on technological perspectives of personal health monitoring gives an over-

1.2. Search Algorithm

At present a lot of research is conducted in the fields contributing to personal health