ACADEMIA Letters

HEALTH and DIGITAL TRANSFORMATION: Legal and

health considerations and reflections
Rolando F. A. Pinchetti, MD and Attorney, Corrientes, Argentina

I. Introduction
Being able to count on with suitable tools to achieve timely informed decision-making means
an undisputed advantage in any field and this necessarily requires the ability to obtain, process
and know how to apply a fundamental input: information. In health, being able to manage
such information in an adequate and timely manner, contributes to a greater transformation of
the paradigm of design of health policies and strategies, to achieve effective responses to the
scarcity of resources, to a better availability, quality and accessibility of health services and
the decisions of the effectors.
This is, in essence, the primary objective of digital transformation in healthcare, but it is
still powerfully striking that the exclusive production and use of data would evidently continue
to be prioritized over the declared result of providing the highest degree of health for all people.
Other times, it is forgotten that speed and economy of resources do not necessarily have a direct
or proportional relationship with the accessibility and quality of services.
The new capacities required of professionals and health institutions that allow them to
navigate adequately the fourth and fifth waves of this technological revolution (not only an
“industrial revolution”), have not usually been accompanied by an adequate conceptualization
and systematization of terminology or by a normative, bioethical and application framework
based on good practices that has the clarity and completeness that would be necessary.

Academia Letters, November 2021 ©2021 by the author — Open Access — Distributed under CC BY 4.0

Corresponding Author: Rolando F. A. Pinchetti, rolandopinchetti@gmail.com

Citation: Pinchetti, R.F.A. (2021). HEALTH and DIGITAL TRANSFORMATION: Legal and health
considerations and reflections. Academia Letters, Article 3838. https://doi.org/10.20935/AL3838.

1
II. Digital transformation in health and Digital Health
The impact of digital transformation and digital health occurs at all levels of management and
health services, and throughout the entire care process, as well as on all the subjects who are
involved. We will try to offer a greater conceptual clarity in those terms of bigger importance
and dissemination.

Digital health
It is not a unique concept, and supports other synonyms such as E-health and telehealth. It
is essential for understanding the depth and scope with which ICT’s impact the healthcare
world. In 2011(1), the WHO, and in 2016, the PAHO(2), developed their definitions with a
notorious degree of variability between them.
We consider that it is essential to provide a clearer conceptualization: digital health is
a health policy strategy, which interrelates the knowledge and procedures of Public Health
and other health-related sciences, with the knowledge and tools generated by ICT’s, aimed at
achieving and maintaining the progressive digital transformation in health.

Telemedicine
Understood almost exclusively as a tool for exclusive application in the medical profession, it
encompasses all actions, mainly those related with direct and indirect care, carried out by any
of the members of the health team(3)(4).
We recommend the modification of this term, to adopt those of “telehealth” or “telecare”,
comprehensively covering all providers of health services (institutional and / or professional),
conceptualizing it as follows: a digital health tool, which has as main objectives: a) improve
comprehensive health care and patient follow-up; b) enable equity in access to healthcare
services regardless of geographic location; c) facilitate continuity of care and care-focused on
the patient’s environment.

Teleconsultation
The definition adopted by the WHO in 2020 says that they are the “Interactions that occur
between a doctor and a patient in order to provide diagnostic or therapeutic advice through
electronic means”(5). It is evident that the scientific production available has focused fun-
damentally on this term, giving it an exaggerated importance in the context of the digital
transformation in health, because it is the best known and most widespread tool, and the one
with which the growing developments achieve commercial profitability.

Academia Letters, November 2021 ©2021 by the author — Open Access — Distributed under CC BY 4.0

Corresponding Author: Rolando F. A. Pinchetti, rolandopinchetti@gmail.com

Citation: Pinchetti, R.F.A. (2021). HEALTH and DIGITAL TRANSFORMATION: Legal and health
considerations and reflections. Academia Letters, Article 3838. https://doi.org/10.20935/AL3838.

2
 For the sole purpose of seeking conceptual clarity, teleconsultation should be defined as:
a healthcare professional act, mediated by ICT’s, be it of a preventive, diagnostic, therapeutic
or rehabilitative nature, carried out directly on a patient, or between two or more professionals
related to the health, being a component of telecare and a digital health tool.

III. Requirements and conditions of Digital Health

They are divided into two large groups of issues: sanitary and non-sanitary. Among the sani-
tary ware, five basic categories can be identified, detailing some of its components:

a) Regulations: all specific regulations and associated and derived regulations

directly related to digital health and its components.
b) Bioethics: deontological and bioethical principles related to the implications
and application of digital health and its components.
c) Cultural and educational: communicational and cultural barriers between the
professional and the patient; resistance and fear of innovation; training in the use
of telemedicine and virtual health tools.
d) Organizational: level of maturity to provide digital health and telehealth ser-
vices; knowledge of the health needs of potential users; specific infrastructure for
implementation.
e) Technological: professional platforms and software, that are adequate, vali-
dated and approved by regulatory and accrediting bodies; effective and reliable
devices and applications; interrelation and interoperability with health informa-
tion systems; cybersecurity of the storage, privacy and confidentiality of sensitive
information and of the procedure itself.

Regarding non-sanitary requirements and conditions, we identify four main categories:

a) Regulatory issues: accessory and derived legislation that influences the devel-
opment and application of digital health and its tools.
b) Technological issues: existence and stability of the electricity supply and cov-
erage of mobile networks; bandwidth and stability of the digital signal; user
accessibility to useful digital devices; provision, maintenance and updating of
equipment and platforms.
c) Cultural issues: acceptability and satisfaction in the use of digital health tools
by users.

Academia Letters, November 2021 ©2021 by the author — Open Access — Distributed under CC BY 4.0

Corresponding Author: Rolando F. A. Pinchetti, rolandopinchetti@gmail.com

Citation: Pinchetti, R.F.A. (2021). HEALTH and DIGITAL TRANSFORMATION: Legal and health
considerations and reflections. Academia Letters, Article 3838. https://doi.org/10.20935/AL3838.

3
 d) Financial issues: costs of maintenance and renewal of equipment and mainte-
nance of the platforms; costs of connectivity, licenses and training; recovery and
billing of services and their inclusion in the basket of health services.

Many of the aspects mentioned, by way of example only, have been incorporated and
analyzed in a PAHO document entitled “Eight guiding principles of the digital transforma-
tion of the health sector. A Pan American Call to Action”(6), and in other recent technical
documents(7). We will only address some health regulatory aspects.
Regulatory health requirements and conditions
The main criticisms of the current regulatory framework in Argentina can be summarized
as follows: incomplete, mostly for exclusive administrative purposes, with doubtful general
applicability and, since 2020, the product of emergency circumstances.
Making abstraction from national laws 26,529 and 27,553, the current regulations are no
more than a set of recommendations and administrative authorizations with restricted appli-
cation, limited to financers and providers of the national public subsector and social security,
with the exception of the authorization for the use of the EHR, which does not even take into
account the special particularities that should be considered respect to the informed consent
of patients in the use of digital tools.
There are regulatory gaps that directly affect an adequate implementation with legal cer-
tainty of digital health tools, particularly in a country with a federal structure, in which legisla-
tive powers in health matters are concurrent between the various levels of the State, and where
the organization and administration of health systems, regulation of professional practice and
health police powers are under administration of the provincial governments.

IV. Preliminary reflections

We share a series of reflections, with the clear awareness of their lack of completeness and
the need for a deeper and more extensive analysis that each one of them raises:

1) All regulations that seek to regulate issues related to digital tools applied to
health should enshrine in their text the full applicability and protection of certain
basic principles:
a) Digital tools, in their application, should always be considered as professional
acts mediated by technologies.
b) They must be evaluated and authorized prior to their use and commercializa-
tion, like any other health technology.

Academia Letters, November 2021 ©2021 by the author — Open Access — Distributed under CC BY 4.0

Corresponding Author: Rolando F. A. Pinchetti, rolandopinchetti@gmail.com

Citation: Pinchetti, R.F.A. (2021). HEALTH and DIGITAL TRANSFORMATION: Legal and health
considerations and reflections. Academia Letters, Article 3838. https://doi.org/10.20935/AL3838.

4
 c) The principles of autonomy of the will and beneficence of the patient must
always prevail in the possibility of their use.
d) The use should never be detrimental to professional practice.
2) Absence of well-known validating bodies of the systems and procedures related
to digital health.
3) Lack of protocols and guides of good professional practices for the use of
digital tools.
4) Multiplicity of technological advances, with extreme speed, excellent market-
ing and little scientific evidence on their effectiveness and safety.
5) Subsistence of well-founded doubts regarding the inalterability, custody and
storage of data, the protection of sensitive information and the effective protection
of the rights of consumers / users.
6) Training deficiencies, lack of digital training, dubious tariff recognition of
health professionals, with risks and responsibilities aggravated by the use of tech-
nology.

Academia Letters, November 2021 ©2021 by the author — Open Access — Distributed under CC BY 4.0

Corresponding Author: Rolando F. A. Pinchetti, rolandopinchetti@gmail.com

Citation: Pinchetti, R.F.A. (2021). HEALTH and DIGITAL TRANSFORMATION: Legal and health
considerations and reflections. Academia Letters, Article 3838. https://doi.org/10.20935/AL3838.

5
References
1. OMS, 2011 https://www.paho.org/hq/dmdocuments/2011/CD51-13-s.pdf

2. Organización Panamericana de la Salud, Marco de Implementación de un Servicio de

Telemedicina. Washington, DC : OPS, 2016

3. OMS, 2010: http://www.who.int/goe/publications/ehealth_series_vol2/en/

4. Organización Panamericana de la Salud, Marco de Implementación de un Servicio

de Telemedicina. Washington, DC : OPS, 2016 https://iris.paho.org/handle/10665.2/
28413

5. OPS, Hoja informativa sobre salud digital, 2020.

6. Ocho principios rectores de la transformación digital del sector de la salud. Un lla-

mado a la acción panamericana,OPS/EIH/IS/21-0004. OPS: Washington, D.C.: 2021.
www.paho.org.ar/ish/8p

7. Connectivity and Bandwidth: Key Areas for Improving Public Health, Pan American
Health Organization, 2021, https://iris.paho.org/handle/10665.2/54578. Attribution-
NonCommercial-ShareAlike 3.0 IGO

Academia Letters, November 2021 ©2021 by the author — Open Access — Distributed under CC BY 4.0

Corresponding Author: Rolando F. A. Pinchetti, rolandopinchetti@gmail.com

Citation: Pinchetti, R.F.A. (2021). HEALTH and DIGITAL TRANSFORMATION: Legal and health
considerations and reflections. Academia Letters, Article 3838. https://doi.org/10.20935/AL3838.