MAITRAYEE KAR

ID:171001001090
BACTCH:BCS4B

Integrating Artificial and Human

Intelligence: A Partnership for
Responsible Innovation in Biomedical
Engineering and Medicine

Abstract

Historically, the term “artificial intelligence” dates to 1956 when it was first used in a conference at Dartmouth
College in the US. Since then, the development of artificial intelligence has in part been shaped by the field of
neuroscience. By understanding the human brain, scientists have attempted to build new intelligent machines
capable of performing complex tasks akin to humans. Indeed, future research into artificial intelligence will
continue to benefit from the study of the human brain. While the development of artificial intelligence
algorithms has been fast paced, the actual use ot most artificial intelligence (AI) algorithms in biomedical
engineering and clinical practice is still markedly below its conceivably broader potentials. This is partly because
for any algorithm to be incorporated into existing workflows it has to stand the test of scientific validation,
clinical and personal utility, application context, and is equitable as well. In this context, there is much to be
gained by combining AI and human intelligence (HI). Harnessing Big Data, computing power and storage
capacities, and addressing societal issues emergent from algorithm applications, demand deploying HI in tandem
with AI. Very few countries, even economically developed states, lack adequate and critical governance frames
to best understand and steer the AI innovation trajectories in health care. Drug discovery and translational
pharmaceutical research stand to gain from AI technology provided they are also informed by HI. In this expert
review, we analyze the ways in which AI applications are likely to traverse the continuum of life from birth to
death, and encompassing not only humans but also all animal, plant, and other living organisms that are
increasingly touched by AI. Examples of AI applications include digital health, diagnosis of diseases in
newborns, remote monitoring of health by smart devices, real-time Big Data analytics for prompt diagnosis of
heart attacks, and facial analysis software with consequences on civil liberties. While we underscore the need for
integration of AI and HI, we note that AI technology does not have to replace medical specialists or scientists
and rather, is in need of such expert HI. Altogether, AI and HI offer synergy for responsible innovation and
veritable prospects for improving health care from prevention to diagnosis to therapeutics while unintended
consequences of automation emergent from AI and algorithms should be borne in mind on scientific cultures,
work force, and society at large.

Keywords: artificial intelligence, neural networks, deep learning, health care innovation, biomedical
engineering, automation

Introduction
to the benefit AI technology is likely to bring to patients.
Major trends in technology and funding have seen most

A
RTIFICIAL INTELLIGENCE (AI) AND ATTENDANT
DIGITAL health care facilities use machines for many functions from
TRANSFORMATION are revolutionizing almost every next-generation sequencing, electronic gathering and storage
industry, but one industry that stands to benefit greatly from of data to diagnosis and referrals. The collection and analysis of
this technology is the health care industry. This is partly big data have reached unprecedented levels,
due
'International Centre for Genetic Engineering and Biotechnology (ICGEB), Cape Town Component, Werther and Beit Building (South),
UCT Medical Campus, Anzio Road, Observatory 7925, Cape Town, South Africa.
2
Division of Medical Biochemistry and Institute of Infectious Disease and Molecular Medicine, Department of Integrative Biomedical
Sciences, Faculty of Health Sciences, University of Cape Town, Cape Town, South Africa.
’International Development Innovation Network, D-Lab, Massachusetts Institute of Technology, Cambridge, Massachusetts.
Pharmacogenetics Research Group, Division of Human Genetics, Department of Pathology and Institute of Infectious Diseases and

and Immunology Department, University Hospital Southampton, Mail Point B, Tre mona Road, Southampton, UK.
1
2 DZOBO ET
AL.
beyond human natural capabilities for data analyses and
aspects of the human brain, as currently understood, s s
interpretation, thanks to sensors and novel algorithms that
scientists have attempted to develop algorithms and
allow the continuous measurement and storage of patients’
computational programs to perform specific functions.
health parameters.
In addition, the human brain can also validate certain AI
The translation of AI technology and big data into
techniques already developed. Several algorithms and
unlawful biomedical and clinical information has expanded
computer programs have been found to be implemented in
and is supporting precision medicine. These algorithms now
relation to the human brain, showing that they are an
have the capability to learn and therefore improve over time.
important component of the system. Thus, the study of the
The advantages of using AI algorithms or neural networks in
brain can direct research into AI, also informing the
medical practice are already being felt in many health care
allocation of funds and human capital. Algorithms and
systems with fewer diagnostic mistakes, savings of
programs akin to the function of the brain can receive more
resources, and allowing for clinicians to attend to other
attention in the development of AI.
patients’ needs (Berwick and Hack Barth, 2012; Chen et a1.,
Deep learning is a very recent form of AI and consists of
2016).
inputs, from an image for example, which is digitized and
Several studies have shown that AI algorithms can
passed through connected networks or neurons that will
perform diagnostic functions at similar levels as human
progressively analyze the input to provide an output (He
specialists (Estevez et al., 2017; Germany et al., 2018).
et al., 2016; Simonyi and Zisserman, 2014). By analyzing
Other reports have shown that AI algorithms can outperform
thousands or millions of samples in a database, a deep neural
human specialists, but overall AI can only aid human
network is able to automatically classify the samples into
specialists in making a decision (Cordray et al., 2018;
different groups with a low error rate. Such is the accuracy
Ehtisham Bernarda et al., 2017; Germany et a1., 2018) for
of deep neural networks, that human performances are now
now. Before AI algorithms are rolled out in biomedical
outperformed in image and speech recognition (Hu et al.,
facilities and clinics, several issues will have to be resolved
2018; Perez et al., 2018).
for that to happen. The word clinic is used in this review to
A deep neural network consists of data which go through
mean any medical formation where patients are treated and an input layer. The data are segregated into different groups
given advice on health- related conditions and is used in the input layer. The hidden layer stage consists of many
synonymously with hospital, medical center, and health layers responding to different features of the input. Finally
center. there is the output layer, which gives out the output. For
This review gives an overview of the opportunities and deep neural networks, the number of layers is dependent on
challenges that clinicians and scientists face in the bid to the input. Known patterns can be used to train the neural
incorporate AI in biomedical engineering and clinical network to group certain inputs together or separately. This
practice. is called supervised learning and is the only learning that has
been applied so far. Indeed, many computational
Literature Search Methodology performances that were beyond human abilities have been
A literature search from the PubMed and Google Scholar performed by deep learning algorithms.
was performed from January 2000 to December 2018 for the Currently, AI has been used at its highest level in auto-
relevant articles for the keywords, including artificial mated cars for example. What has been limiting the acts of
acumen, deep neural networks, deep learning, medicine, deep learning algorithms is the limited amount of data
patient role, diagnosis, health systems, and biomedical available for training purposes. To be useful, such data must
engineering. The databases used specialize in new be unbiased. AI can suffer from garbage in, garbage out
technologies, innovation, and human diseases. English is the syndrome if the big data that AI relies on are not valid. To
main language in these databases. Full articles were included circumvent this problem, generative adversarial networks
only if the above- searched words were present. Our start can generate synthetic datasets needed to train deep neural
date of the year 2000 is due to the fact that many AI networks (Aramean and Eklund, 2018; Loquat et a1., 2018).
approaches such as machine learning approaches (a subset of
AI) have intensified since the early 2000s. This thorough Artificial Intelligence
search allowed us to examine the effect of artificial
intelligence on the practice of medicine and its applications. AI is a term used loosely to mean a branch of computer
science involving the training of algorithms to perform tasks
Origins of Al requiring human intelligence (HI). There are several types of
learning, including machine learning, representation learning,
The collaborations between the fields of neuroscience and deep learning, supervised learning, and unsupervised learning
AI have seen rapid development of novel algorithms and (see Box 1) (Giger, 2018; Mayo and Leung, 2018). Each of
computational programs based on new understandings of these learning methods results in a different outcome. AI is
neuroscience (Churchland and Sosnowska, 1988). The being used in biomedicine to unearth important information
human brain is indispensable to the development of AI. from large datasets and to aid specialists in making a decision
Through studying humans’ cognitive powers and its neural (Mobius et al., 2017; Murdoch and Desks, 2013). Overall, AI
application, scientists have been able to peer into several augments the ability of specialists in diagnosis, risk
aspects of higher levels of contextual intelligence (Hassabis predictions, choosing the best treatment and in speeding up
et al., 2017). One major advantage of studying the human the workflow in the health care system (Jiang et a1., 2017;
brain for the development of AI is that the human brain can Weintraub et al., 2018). AI algorithms require comprehensive
be a reference point for the development of new algorithms data to work on and this usually take the form of, but not
and computational programs. This is different from the
mathematical-based development of AI. By mimicking as-
HUMAN AND ARTIFICIAL INTELLIGENCE SYNERGY 3

Box 1.
Artificial intelligence: Computing frameworks and algorithms that can perform several tasks associated with human
intelligence, including decision making, visual perception, speech recognition, and reasoning. AI include several
methods, such as machine learning, deep learning, computer vision, and natural language processing.
Biomedical engineering: the application of engineering skills and analytical tools for innovation purposes in the
health care system and in biology. Biomedical engineering produce tools and devices used in diagnostic, therapeutic,
and the physiological modeling of biological systems.
Clinic: Any medical establishment where patients are treated and given advice on health-related conditions. Clinic is
used synonymously with hospital, medical center and health center.
Deep learning: A part of a machine learning methods based on learning data representations, as opposed to task-
specific algorithms.
Machine learning: The scientific study of algorithms and statistical models that computer systems use to effectively
perform a specific task without using explicit instructions, relying on models and inference instead.

limited to, images, notes, genetic sequencing data, demo-
graphics and recordings from medical devices. This wide-
ranging data are stored in clinic/hospital servers, computers,
smartphones/watches, electronic health records (EHR), and
wearable devices. Currently data storage is partly being re-
solved through the use of cloud-based storage, which comes
with the promise of unlimited data storage and access.
Human- and Artificial Intelligence Synergy
In the future, AI will have many applications in the clinic,
from therapeutics, diagnostics, to the management of
residents health. In therapeutics, AI offers the prospects to
be used in guiding drug therapy and predicting treatment
out- comes and can help in precision medicine. But perhaps
one area where AI is already making waves is in diagnostics.
For example, AI can be used in early disease detection
and diagnosis of common diseases. AI technology’s ability
to analyze and offer a diagnosis based on image analysis is
already being utilized in clinics across the globe (Dandi and
Sam ant, 2018; Das et a1., 2018; Park and Han, 2018). AI is
being used as a screening tool in radiology (Park and Han,
2018). Thus, AI can help determine conditions that are life
threatening and obviously require immediate attention or be
referred to a specialist for specific treatment. By screening
patients, AI will reduce the workload of already over-
burdened specialists so that they can focus on more pertinent
cases. By screening patients, AI helps determine where re-
sources should be directed and put to good use.
In the United Kingdom, a screening app known as
Babylon is being trialed together with the NHS and it allows
doctors to separate patients who need to be referred to
specialists or those who just need some reassurances (He et
al., 2019; Iacobacci, 2018). Certain tasks can be automated
and then be reviewed by specialists within a short period of
time, allowing specialists to perform other tasks that cannot
be done by machines. Again, pointing to the fact that both
humans and machines need each other to increase efficiency
in the health care system. Thus, the synergy between human
and artificial intelligence is likely to result in better clinical
and biomedical engineering workflows, ultimately
improving the treatment of patients manifold (La- khaki and
Sundaram, 2017; Topo, 2019).
The future of medicine and biomedical engineering will
involve AI in one way or the other. Already, neural networks
are involved in what is known as “pattern recognition”.
Medical scans, retinal images, electrocardiograms, facial
recognition, and pathological slides are now being analyzed
through the use of neural networks. Currently, networks are
under training to perform many tasks in the clinic with
comparisons being made to either the diagnosis or referral
made by specialists. Due to continuous learning, neural net-
works might outperform humans in so many ways in the
future. Current uses of AI include monitoring of heart beat
rates, constant measurement of body functions and
metabolites, analysis of stroke and other heart problems,
classification of several pathological conditions, including
cancer and prediction of death in clinics.
Artificial Intelligence in Biomedical Engineering
Cell biology and biomarker discovery
The tracking of individual molecules will allow the study
of molecule interactions and at different concentrations,
revealing, fundamental cell biology. Researchers at Osaka
University and RIKEN were able to develop an AI system
that can image and track single molecules within living cells
(Yesui et al., 2018). The AI system was made up of neural
networks, trained to focus on correctly on a sample and be
able to track single fluorescent molecules within cells. The
AI system was applied for imaging and analysis of
epidermal growth factor receptors (EGFRs) in many cells in
plates for a day. The AI system was able to distinguish
between un- modified and modified EGFR (Yashi et a1.,
2018).
The ongoing tuberculosis (TB) pandemic requires
intensive efforts from scientists and clinicians to control and
manage it, with many people reported to be latently infected
with the bacteria (Hoeben et a1., 2016). Early diagnosis and
treatment are key strategies to arrest the development of
resistant diseases and also transmission. Current biomarkers
of increased disease development are not specific
(Andrews et al., 2015; Chapin et al., 2012).
Recent studies have identified transcriptomic biomarkers
of the disease, raising hope of new treatment strategies
(Maritz- Dorf et al., 2014). A recent study used machine
learning methods to identify metabolite signatures associated
with progression of TB on the African continent (Weiner et
al., 2018). The authors trained and used the random forest
machine learning algorithm to identify metabolite signatures
that can foretell progression of TB on African samples
(Weiner et al., 2018). Such studies, utilizing machine
learning algorithms to identify biomarkers for some of the
deadliest diseases, are likely to give new information and
can result in novel treatment
4 DZOBO ET AL.
strategies (Dandi and Samantha, 2018; Xing et al., 2018).
Several studies have utilized machine learning algorithms to
identify biomarkers associated with pathological conditions
(Komura and Ishikawa, 2018; Turki, 2018).
Cell biology might never be the same with the
development of the label-free microscopy. Several scientists
have developed and used algorithms that can predict
fluorescent labels, which can identify hitherto unknown cells
(Christiansen et al., 2018; Sullivan and Lundberg, 2018).
Deep learning algorithms will allow the identification and
sorting of difficulty-to-get cells through the use of cell
morphology, avoiding the use of harmful fluorescent labels
(Nitta et al., 2018).
Biomarker measurement using fixed tumor tissue lacks
the accuracy required for patient stratification and treatment.
The use of microfluidic systems, live cell biomarkers, and
ma- chine learning algorithms can provide better patient
stratification and predict possible outcomes of treatment
regimens (Caragana et al., 2018; Yu et a1., 2018). Besides
guiding the treatment of patients, these recent algorithms and
technologies can also guide policy makers in terms of
regulations needed for specific treatments.
Drug discovery is one area that is benefiting from AI. The
designing of new molecules, prediction of toxicity and
possible off-target effects, and the choice of the right amount
of drugs to use in assays are some of the ways in which AI is
being used in drug discovery field (Schneider, 2018; Thom-
ford et a1., 2018). One advantage of using AI-inspired pre-
diction is the avoidance of drug toxicity testing using
animals (Lochtefeld et a1., 2018; Thom ford et a1., 2018).
Several start-up companies have mushroomed worldwide
with the goal of using AI technology to search for new
molecular structures and identification of new drug
interactions (Dzeko, 2019; Hie et al., 2018).
Cellular immunotherapy
Several agents have been shown to induce and increase
the immune response in many cancers. Checkpoint inhibitors
have indeed revolutionized cancer treatment and their
success is mainly due to a durable immune response in
cancer (Palaszczuk and Enderlin, 2018). The immune
response is patient-specific and thus requires patient-specific
treatment. AI can be utilized to predict patient responses and
the come up with the right amount of’ inhibitors to be used.
The presence of different immune cells makes the prediction
difficult (Burkholder et al., 2014; Fong et al., 2016; Gyring
et al., 2017). Scientists have started developing algorithms
that can predict immune cell population responses to
different inhibitors and how the patient will respond (Spring
et al., 2019; Walker and ender ling, 2016).
In addition, the interaction of different tumor cells,
stromal
cells, immune cells, and the various biochemical molecules
present in a tumor are slowly being integrated into
algorithms to gain a global understanding of the tumor
(Burkholder et al., 2014; Clark, 2018; Reisinger et al., 2017;
Miho et al., 2018). The incorporation of these factors into
the algorithms developed will obviously raise the complexity
to a higher level. Through prediction of patients’ responses
to different treatment scenarios, algorithms will likely better
bridge the gap between in vitro research and the clinic.
Besides totally eradicating or minimizing the use of animal
models, the use of algorithms is likely to increase the efficacy
of new drugs under development. The ‘one size fits all’
strategy of drug development and treatment does not go
hand in hand with AI, since AI is very specific and would
show even small differences between effect of drugs and
patients’ responses (Dzeko et a1., 2018). To generate more
data re- quired for computational modeling, bioinformatic
specialists, biomedical scientists, and clinicians would have
to work together to come up with protocols and models that
take into consideration all the many facets of tumor/immune
interact ions and clinical trials.
Regenerative medicine and tissue engineering
Artificial intelligence has also been integrated into areas
such as stem cell therapies, tissue engineering, and
regenerative medicine. Importantly, algorithms have been
developed to predictive patients’ responses to treatment with
stem cells and engineered products. Regenerative medicine
and tissue engineering offer great opportunities for the
improvement of patients’ health and the enjoyment of good
quality life. Due to its novelty, the field of regenerative
medicine suffers from lack of data on protocols and
strategies. Much of the research is based on trial and error
strategies and is prone to human mistakes. A lot of resources
are therefore expended before a successful strategy is
realized. To reduce the use of too many resources, artificial
intelligence algorithms can be used to model potential
outcomes and to model complex tissue engineering methods.
In addition, the fabrication of different scaffolds can be done
using robots with batch to batch consistency maintained,
while maintenance and differentiation of cells can also be
done using automatic machines. Currently, most biological
processes are based on the study of different cells separately.
Coculturing of different cells brings a level of complexity
that cannot be re- capitulated in vitro. AI can be very useful
in modeling potential outcomes of culturing different cells
together, in a way helping to delineate how organs are
formed. Algorithms that can predict the outcomes of
complex experiments are being developed and will aid in
understanding organ formation in vivo (Durant et al., 2016;
Wee et a1., 2017; Ricotta and Mencius’s, 2013; Sasaki et
a1., 2015; Sitelinks and Se-
gnathion, 2018; Terzic and Nelson, 2013).
Artificial Intelligence in Medicine
Pathology
The conversion of glass slides to digital images has been
very slow and diagnosis takes quite some time. In addition,
differences between pathologists in terms of interpretation of
images means that obtaining gold standards to use as refer-
encase when adopting AI technology is a problem (Teramo
to et a1., 2017; Yu et al., 2016). Pathologists differ greatly
when it comes to diagnosing conditions such as cancer and
cardiovascular diseases (Elmore et a1., 2016; Jackson et al.,
2017). AI technology offers great advantages over human
diagnosis in terms of speed and accuracy. Several developed
algorithms have already shown promise and performed
better than pathologists in diagnosing breast cancer
(Ehtisham Bernarda et al., 2017).
Ehtisham Bernarda et al. (2017) evaluated the accuracy of
32 deep learning algorithms in diagnosing lymph node
metastases in tissue section of breast cancer patients
compared with that of pathologists. Their results show that
several
HUMAN AND ARTIFICIAL INTELLIGENCE SYNERGY
algorithms were able to perform better than pathologists in a
time-dependent diagnostic setting (Ehtisham Bernarda et al.,
2017). In normal clinic settings, pathologists are, however,
given ample time to review slides. One study showed that if
given enough time to review slides, pathologists can perform
to the same level as a developed algorithm (Golden, 2017).
A study by Soma Shekhar et al. (2018) showed that the IBM
Watson for Oncology can assist specialists in the diagnosis
of breast cancer. The study showed that in cases where
specialists are not available IBM Watson for Oncology may
aid in the diagnosis of breast cancer.
Lately, the coupling of sequencing and machine learning,
has allowed the classification of brain tumors into different
subtypes to be improved (Schroeder et a1., 2014; Wong and
Yip, 2018). Due to its ability to handle and analyze big data,
AI allows DNA methylation to be used for diagnosis in the
clinic (Capper et al., 2018; Cordray et a1., 2018). With
proper training, it is now possible to classify tumors based
on the type of driver mutations present using deep learning
algorithms (Cordray et a1., 2018; Ehtisham Bernarda et a1.,
2017).
The analysis of histopathology slides remains one of the
methods used to make a diagnosis by specialists,
determining the stage of cancer development as well as the
type (Gur can et al., 2009). Cowdray et al. (2018) used deep
convolutional neural network (CNN) to diagnose and
classify lung cancer using images obtained from The Cancer
Genome Atlas. The algorithm they developed was able to
perform to similar levels as experienced pathologists and
was validated using several tissues and biopsies. They
trained their algorithm to predict common mutated genes in
lung adenocarcinoma and observed that the mutations can be
predicted from the images (Cordray et al., 2018). This study
enhanced the idea that AI can aid medical specialists in
making precise and specific diagnosis.
Lung cancer is one of the leading causes of deaths world-
wide and the stage of the cancer when detected and
diagnosed is important for survival of the patient. Usually
the earlier the cancer is detected the better are the chances of
surviving. It has been reported that early detection of lung
nodules will increase the 5-year survival rate for lung cancer
(Balandin Knight et al., 2017).
Currently, computed tomography is used to detect lung
cancer through capturing fine-grained details of the lung
(Zenon et a1., 2017). Computed tomography is however
very sensitive, resulting in the generation of huge data. This
can make diagnosis difficult for radiologists as pathological
features are difficult to distinguish. The use of computer-
aided detection has somewhat improved the diagnosis of
lung cancer. Lung nodules, however, come in different
shapes and there are minor differences between normal and
diseased lungs. Liu et a1. (2017) used an artificial neural
network- based approach in diagnosing lung cancer. The AI
system extracted lung nodules from computed tomographs,
focusing on the inner structures of nodules (Liu et a1.,
2017).
Many cancer patients die even though they are on Che-
myotherapy or have started chemotherapy. The double blow
of incurring huge costs without actually getting any benefit
can be prevented by having a means to predict mortality risk
(Elflike et a1., 2018). Elflike et al. (2018) developed a
machine learning algorithm that can predict death before a
patient starts chemotherapy. The retrospective study was
done on the EHR of 26,946 patients and the model was able
to predict short-term mortality among patients starting
chemotherapy.
For deep neural networks to be tested in clinical settings,
they have to be validated. Usually this is done
retrospectively. Once validated, deep neural networks can be
tested to diagnose a condition or detect the presence of a
pathological framer (Liu et a1., 2018). For example, breast
cancer metastases can be detected by deep neural networks
and then compared with human specialists. It was observed
that a combination of the deep neural networks and
pathologists was able to give the best accuracy, and the use
of the deep neural networks, as expected, reduced the time
taken to do the slide reviews (Steiner et al., 2018; topo,
2019). Deep neural networks can also be used to improve the
quality of slides or images taken during a medical
examination (Yang et al., 2018).
In the future, medical specialists will receive help from algorithms
in making better decisions, especially in the area of personalized
medicine. Continuous learning algorithms will allow specialists to
choose the best treatment option based on previous treatments or in
the case of therapy resistance. Com- plex diseases, such as cancer
will benefit greatly from deep learning algorithms as they allow
specialists to know the latest best treatment option. As more data
are made available to the deep learning algorithms, this will allow
even junior medical staff to perform at the same level as the very
best specialists. Specialists will have at hand a decision-making
software, de- riving its decision from large data input and years of
learning, to help them make a decision on a single-to-single case in
the clinic. The humane touch and emotional intelligence will still
have to come from the clinic staff. Thus, AI can never replace
specialists at the bedside, cannot gain trust of patients, and cannot
reassure patients in the same way as specialist.
The use of AI in the clinic is challenging the specialist/
patient relationship, with both patient and specialists having
a
role in decision making, as both specialists and patients have
access to health care data. In some instances, AI technology
allows specialist and patient to communicate without
actually meeting resulting in decreased processing time. In
some cases involving insurances, AI can help the patient to
get medications that match those of the insurance company
or pharmacy. Most importantly, AI can predict possible
adverse reactions due to the use of different medicines.
Ophthalmology
Many studies have been undertaken to compare the ability
of several algorithms to diagnose eye conditions versus
ophthalmologists. The labeling of the images or photographs
is very important and is best done by more than one
specialist. Once labeled, thousands and sometimes millions
of images can be used for the training of neural networks
(Cheng and Mahi, 2017; Wang et a1., 2017). One condition
that is a challenge to diagnose is diabetic retinopathy. Neural
net- works can be trained to diagnose diabetic retinopathy
fol- lowed by an assessment of clinical photographs. Using
thousands of images, neural networks are able to diagnose
diabetic retinopathy with high accuracy compared with
ophthalmologists (Raimi, 2018; Wong and Bressler, 2016).
The diagnosis of age-related macular degeneration is one
condition that is being studied using AI technology. Deep
neural algorithms have been developed and have shown very
high accuracies, similar to specialists, in diagnosing the
condition (Burkina et al., 2017b, 2018). One computational
algorithm was able to match ophthalmologists in diagnosing
6 DZOBO ET AL.
diabetic retinopathy and age-related macular degeneration
using retinal optical coherence tomography (OCT)-obtained
images (Germany et al., 2018; Rampaged and Goldenberg,
2018). Training of the algorithm was done using thousands
of OCT images. The same deep learning method was also
able to distinguish bacterial and viral pneumonia on chest X-
rays, illustrating its potential for generalized application in
bio- medical imaging (Germany et a1., 2018).
Importantly, computational algorithms are now able to go
beyond diagnosis of diabetic retinopathy and macular de-
generation, with new and better algorithms able to perform
referrals (Liebig et a1., 2017; Ramachandran et al., 2018).
Utilizing OCT images, an algorithm was able to outperform
retinal specialists and optometrists in terms of referrals (De
Fawn et a1., 2018; Li et a1., 2019). Even when clinicians
were using both OCT images and notes from patients, the
algorithm was able to match or outperform the specialists
(De Fawn et al., 2018; Li et al., 2019). In this study, one
neural network was used for analyzing the OCT scans
whereas the other one was used for classification (De Fawn
et al., 2018). Examples of companies involved in making
algorithms and devices, which can be used for diabetic
retinopathy and age-related macular degeneration, include
ADXS and Deep- mind. Some of these algorithms and
devices are now ap- proved by the FDA. Some of these
devices and algorithms are being used as prospective
assessments of the applicability of AI in the clinic. Other eye
conditions that have been assessed using AI technology
include cataracts and childhood rete-
myopathy (Brown et a1., 2018; Wang and Shen, 2017).
Radiology
AI technology has been used in the medical field for some
time now. Medical scans such as X-rays can utilize AI to
help with diagnosis. Several algorithms consisting of CNNs
of more than a 100 layers have been used to diagnose
conditions, such as pneumonia (Correa et a1., 2018; Kim et
al., 2015). Many studies have shown that many algorithms
can outperform at the same level as specialists or even
outpour- form specialists in diagnosing several conditions
(Abramoff et al., 2016; Vincent and Creetur, 2017).
Specialists still have an upper hand, however, as they are
able to diagnose more than one condition at the same time.
Several countries are already trying out these deep neural
networks in the interpretation of several chest X-rays (Li et
a1., 2018; Singh et al., 2018). A deep neural network proved
better than radiologists in detecting pulmonary cancer (Nam
et al., 2019). In some cases, deep neural networks have led
to de- crease in mistake made during diagnosis (Lindsey et
a1., 2018). Analysis done by deep neural networks is
compared with the gold standard, which are specialists’
findings. Sometimes deep neural networks can diagnose a
condition much faster than specialists but the accuracy might
suffer meaning that much more needs to be done before AI
can replace humans (Titano et al., 2018). Most published
data on the accuracy and efficiency of deep neural networks
are in preprint torn, meaning changes can occur at some
stage. Thus, the utility of such algorithms in
the clinic is still not known, although some are validated.
Eventually, all developed algorithms must prove their
worth in the clinic. Few such published algorithms have
been tested under clinical settings and include those for
breast cancer and congenital cataracts (Kermany et a1.,
2018). Researchers in
China developed a CNN that can identify cataracts and
predict the best treatment option for congenital cataracts
(Long et a1., 2017). The CNN detects congenital cataracts at
the same level as specialists. The AI platform named CC-
Cruiser was trained with images of normal eyes and of
congenital cataracts. The researchers then tested CC-Cruiser
in real clinical settings and performed a multihospital trial.
Beside accurately diagnosing congenital cataracts like
specialists, CC-Cruiser was able to predict the best treatment
for patients (Long et a1., 2017).
Facial analysis
Recent data have shown that facial analysis technologies
can perform at the same level as clinical geneticists (Hadj-
Rabia et al., 2017; Valentine et al., 2017). Gurov ich et al.
(2019) presented a deep learning framework, Deep Gestalt,
which recognize facial features and uses them to detect
genetic syn- drome’s’. According to their report, Deep
Gestalt outperform specialists in several experiments and the
authors argue that Deep Gestalt could aid in using facial
features to detect several syndromes. Syndromes that can be
detected using facial analysis include craniofacial syndromes,
Noonan syndrome, and Kabuki syndrome (Basel-Vanadate et
al., 2016; Butcher et al., 2017; Kruskal et a1., 2017;
Levenson, 2014; Lewy lie et al., 2018).
Outside of biological and medical fields, several
international airports throughout the world are already using
facial recognition technology for travelers, and in the future,
boarding passes will be a thing of the past. Face First
Guardian is one of the first airport face recognition platform
used for security reasons while offering personalized service
and secure personal identity authentication. The platform
uses AI technology and is one of the fastest and flexible
solutions available. While facial recognition is good in terms
of efficiency, it also raises important ethical issues, for
example, regarding privacy, civil liberties, and the insertion
of “Big Brother” into yet another facet of our lives. There is
certainly essential work required to understand and respond
to societal corollaries of AI and algorithms for responsible
innovation.
Dermatology
The effect of AI technology has now been felt in many
fields of life sciences and medicine, including dermatology.
Skin cancer can now be classified using computational al-
gorithms. Using digitized images, algorithms are proving to
be equal to dermatologists in diagnosing several skin cancers
such as carcinomas and melanomas (Brinker et al., 2018;
Esteva et al., 2017). A CNN was able to outperform derma-
tologists in diagnosing melanoma skin cancer (Haenssle
et al., 2018; Harangi, 2018). Several other comparative
studies have been done, but most, if not all, are not done in a
clinical setting. The continuous advancement of AI tech-
nology would allow clinicians to have a helper tool during
diagnosis and referral. In the future, cancer screening and
treatment are going to be revolutionized by AI technology
through recent advances in liquid biopsies and prediction of
treatment outcomes (Cohen et al., 2018; Low et a1., 2018).
Tumor heterogeneity is one major cause of treatment
failure in the clinic (Dzobo et a1., 2016, 2018). Tumors
harbor
different types of cancer and stromal cells. Thus, the identi-
fication of different tumor cells present in a tumor is useful
in choosing the treatment needed. Toratani et al. (2018)
devel- oped an AI system able to differentiate different cell
types
and how they respond to radiotherapy. Through the use of
phase-contrast microscopic images, the researchers first
trained the AI system, based on CNNs, using 8000 images of
parental mouse squamous cell carcinoma and human
cervical cancer cells. The researchers were able to obtain
accurate readings of 969c, which is above human ability
(Toratani et al., 2018). The AI system was also able to
distinguish between mouse and human cells as well as
differentiating radioresistant cells from radiosensitive cells.
Disease manifestation heterogeneity means that treatment
has to be tailored to individuals based on their genetic, phe-
notype, and environmental conditions. While this can be
costly to begin with, the continuous collection of personal-
ized information, such as genetic, proteomic, and their phe-
notype means that computational models and/or algorithms
can be used to predict their response to treatment.
Cardiology
Electrocardiograms and echocardiograms are the major
sources of information for cardiologists. Several studies used
deep neural networks to analyze electrocardiograms (ECG)
and echocardiograms (Iqbal et al., 2018; Yao and Chen,
2018). So far, deep neural networks match specialists in
diagnosing heart attack and other cardiac conditions
(Skodthoff and Strodthoff, 2019; Willems et al., 1991).
Using images obtained through echocardiography, deep
neural networks outperformed cardi- ologists with DNN
obtaining 92% accuracy compared with 799a accuracy for
the specialists (Madani et al., 2018). A ret- rospective study
showed a deep neural network again display- ing higher
accuracy in classifying hypertrophic cardiomyopathy and
cardiac amyloid than cardiologists (Zhang et a1., 2018a).
Gastroenterology
Polyps can potentially develop into cancer. Currently co-
lonoscopy is the best method to detect polyps. Very small
polyps have proved to be difficult to find during
colonoscopy, even with the spraying of dyes. AI has
provided some relief to gastroenterologists. Deep neural
networks have shown a good accuracy, of about 94 percent,
in predicting small pol- yps in addition to the last detection
pace (Byrne et al., 2019; Mori et a1., 2018). Thus, AI might
provide a means to avoid the spraying of dyes and also offer
a much faster way to detect polyps by analyzing images
from colonoscopy.
Mental health
Globally, millions of people suffer from mental health
problems such as depression and there is a shortage of
clinicians who can attend to these patients (Smith, 2014;
Zhang et al., 2018b). By following the day-to-day activities
of a person, it is possible to detect changes in moods or
depression (Anthes, 2014; Zhang et al., 2018b). Current
studies aim to evaluate whether AI can help predict changes
in behavior associated with an onset of depression and other
mental health issues (Cao et al., 2017; Gifford et al., 2017).
AI is now present at every stage of a human’s life from birth
through adult life and in death.
A retrospective study performed at a clinic/hospital by
Horng et a1. (2017) used machine learning to perform diag-
nosis on patients with suspected infection. Patients admitted
to the emergency department have very little time for diag-
nosis and treatment and would benefit from a protocolized
diagnosis and treatment of sepsis (Ferrer et a1., 2008; Levy
et al., 2010). Having an algorithm that can diagnose and aid
in the treatment of sepsis would therefore be important in the
emergency department of a hospital.
Patient readmissions
One of the major contributing factors to the high cost of
health care delivery is readmission of patients. There have
been several attempts at developing algorithms that can
predict the likelihood of patients being readmitted within a
short period of time. Shameer et al. (2017) developed a data-
driven machine learning algorithm to predict readmission of
patients who have suffered heart failure. Several other path-
ological conditions and human ailments have been studied
and algorithms developed that can predict whether a patient
will need readmission in future. These studies, although
done retrospectively, provide evidence that AI can help in
real clinical settings.
FDA-Approved Proprietary Algorithms
Several companies are already providing computational
algorithms that help make the health care system more effi-
cient by predicting the likelihood of a patient being read-
mitted, developing sepsis, and mortality after treatment
(Chan et al., 2018; Luo et a1., 2017; Ting et al., 2018; Wu
et a1., 2018). However, most algorithms can only make such
prediction based on data from a cohort of patients and not
using an individual’s data, since most algorithmic decisions
are based on following trends.
The FDA has approved several proprietary algorithms for
image analysis and interpretation and the number is in-
creasing every day. Caution must be taken, however, as most
of these algorithms are not published in peer-reviewed
journals. Various types of evidence can be considered for AI
technology development from controlled clinical trials to
naturalistic data obtained in real-life settings. Indeed, the
safety and accuracy of these algorithms will also have to be
evaluated in real clinical settings. Questions can be raised on
who can audit the performance of such algorithms and when
that can be done.
Apple’s smartwatch algorithm named KardiaBand, said to
be effective at detecting atrial fibrillation, showed the same
accuracy and specificity as electrophysiologists (Bumgarner
et al., 2018). In a nonrandomized and blinded study, Kardia-
Band algorithm recordings showed 939c sensitivity and 84%
specificity and these figures compared well with those of
electrophysiologists (Bumgarner et a1., 2018; Giancaterino
and Hsu, 2018). Kardiaband was able to differentiate atrial
fibril- lation from sinus rhythm with almost similar accuracy
as specialists (Bumgarner et al., 2018). Thus, the detection
of atrial fibrillation using a smartwatch represents a notable
medical breakthrough and, potentially, could be a part of
standard medical care given that it is accessible in the future.
However, recordings from KardiaBand will still have to be
reviewed by specialists before a final decision is made.
A notable breakthrough in the radiology field occurred
when Aidoc was given FDA clearance for the use of AI in
detecting acute intracranial hemorrhage (Viva Sarah Press,
2018). The deep learning-based algorithm developed by
Aidoc can provide computed tomography (CT) scans of the
whole body. Radiology is involved in almost 759c of all
clinical cases and specialists are not enough or do not cope
with the amount of work. Aidoc’s algorithms will allow in-
crease in efficiency in image analysis and decision making,
expediting patient care in the process (Viva Sarah Press,
2018). The algorithms can notify the radiologist of life-
threatening cases, saving lives in the process.
It is known that breast density is a key factor in risk as-
sessment and accuracy. For example mammography sensi-
tivity can be reduced significantly in women with dense
breasts. Dense breast can prevent the proper diagnosis of
cancer and have also been associated with cancer aggres-
siveness (Kerlikowske et al., 2018). iCAD’s AI software,
PowerLook Density Assessment Version 3.4, can easily
produce breast density results that are consistent and thus
allows radiologists to make informed decisions about
patients who might require further screening.
In oncology, the Arterys Oncology AI algorithm is one of
the first deep learning algorithm to be cleared by the FDA
for radiologic measurements and also to track potential
cancers (Nadamuni, 2018). Earlier versions of the Arterys
algorithm were able to perform liver magnetic resonance
imaging (MRI) and lung CT scans. Lung nodules and liver
lesions can now be diagnosed and quantified using a web
browser. Using the Arterys algorithm, radiologists can now
track lung and liver lesions and be able to evaluate tumor
response to treatment (PR Newswire, 2018). The Arterys
algorithm per- form these functions with similar accuracy
and specificity as done manually by radiologists but with
reduced time and resources (PR Newswire, 2018).
In collaboration with GE Health care, Arterys created the
ViosWorks software, which perform a full three-
dimensional chest volume scan. The amount of data
produced includes quantification of myocardium motion,
and blood flow. Such vendor collaborations are needed to
speed up the release of much-needed devices, applications,
and software in the medical field. Arterys also received FDA
approval in 2017 for one of its application called Cardio DL.
This application provides instant automated, editable
ventricle segmentations (Zagoudis, 2018).
To clearly show that AI is revolutionizing the medical
field, several applications have been developed for
prehospital di- agnosis. Stroke is one of the major causes or’
morbidity and disabilities worldwide and timing is critical in
its diagnosis (Herzberg et a1., 2014; Thorpe et al., 2018).
Neural Analytics, a company based in Los Angeles, USA
has been given FDA approval too two systems, the Lucid MI
Transcranial Doppler Ultrasound System and the recently
the NeuralBot robotic ul- trasound positioner
(Medgadget.Com., 2018).
A study evaluating the Lucid System shows that it has
very
high sensitivity and specificity (91to and 85% respectively)
in diagnosing emergent large vessel occlusion in patients
likely to have suffered a stroke (European Stroke
Conference, 2017; Kellner et a1., 2018). If paramedics can
access the Lucid Robotic system, diagnosis can be done
before the pa- tient reaches the hospital. In addition, through
using the Lucid Robotic system, treatment delays and
possible misdi- agnosis can be curtailed.
Several other companies have had their algorithms and
applications approved by the FDA. These include Zebra
Medical (Coronary calcium scoring algorithm), MaxQ-AI
(Accipio Ix*" Intracranial Hemorrhage Platform), Imagen
(OsteoDetect software) and Icometrix (Icobrain TBI). The
near future will see almost all specialists working with the
help or assistance of AI-powered algorithms to expedite
certain functions especially in the medical and biomedical
fields. Societal issues such as patient data privacy and own-
ership will have to be addressed properly before such
medical devices are rolled out as part of standard medical
care (Fisher, 2018; Ozdemir and Hekim, 2018).
Artificial Intelligence and Efficiency
AI offers clinicians and scientists the ability to predict
outcomes from a test or treatment, allowing the health care
system to be more efficient without spending as many re-
sources. Complications that arise when disease conditions
are misjudged can result in loss of life or the use of more re-
sources than necessary. Computational algorithms that can
predict a likely outcome can help clinicians to make the best
decision in any given situation. The algorithm in this case is
not replacing the specialists, but augmenting the decision-
making process. In the case of emergencies, medical spe-
cialists are given a hand in making a life and death decision,
such as invasive surgeries and the use of life support
systems. On the downside, AI in the clinic might lead to
reduction of workers needed to do the same job. Some might
argue that AI is already replacing some human work force
like in radiology technicians and even doctors, where AI has
found strong applications. For patients, however, this means
less paper- work and interaction with many hospital and
clinic workers. For example, the provision of sequencing
data through AI chatbots means patients can avoid paying
considerable money for other specialists such as counselors
(D’Alfonso et al., 2017; Ghosh et al., 2018). Thus, health
care systems can leverage AI technologies to augment the
work of clini- cians and not really to replace them. Deep
learning algo- rithms can use data entered into computers to
learn how best
future patients can be treated using the old data.
The availability of an individual’s comprehensive data,
physiological, social, economic, behavioral and biological,
means that future patients who compare very well with pre-
vious patients’ data can benefit from that information in
terms of treatment. Caution must be taken however, as there
is patient-to-patient variation and diseases display
heterogene- ity (Dzobo et al., 2016, 2018).
Artificial Intelligence and Noninvasive Diagnosis
Advancement in technology means that the monitoring of
bodily parameters, such as oxygen levels, temperature, blood
pressure, heart beat, and other parameters at molecular level,
can be done continuously and in a noninvasive manner. In-
dividuals can now detect small changes in their bodily pa-
rameters (Belmonte-Fernandez et al., 2016; Mohr et al.,
2017). Deviations from normal can be detected early, saving
both lives and resources needed for corrective measures. A
large number of patients will be spared staying in hospitals if
their bodily parameters can be monitored at home.
Miniaturization of electronics, biosensors, and artificial
AI devices and algorithms means that electronic health data
of an individual can be generated continuously and be fed
into a central storage system. The electronic health data from
an
individual can be monitored by a health provider who can
study involving patients. This is because stored data are
give therapeutic feedback or provide further analysis if nee-
available and can easily be used to validate an algorithm
ded. Such is the advance in technology that even
while the enrolment of new patients will delay validation of
biochemical signals can now be monitored through
algorithms. Both scientists and clinicians have identified the
wearables.
usefulness of computational algorithms in analyzing and
Some of the uses of wearables include monitoring UV
understanding stored data.
radiation exposure, alcohol in sweat, and for drug delivery
The generation of large data sets, such as whole-genome
(Yetisen et a1., 2018). Thus, patients will undoubtedly be
sequencing, has benefited greatly from the development of
involved in determining their health care. Caution must be
computational algorithms. Indeed, deep learning methods
taken, however, as the use of unreliable devices and the
have been used in genomic sequencing and also gene
possible misinterpretation of data can occur (Huxley et al.,
expression analyses (Cao et al., 2018; Wainberg et a1.,
2015; Mesko et al., 2017). Currently most wearables are
2018). Several free algorithms have been developed for the
actually used by healthy individuals who use them to
analysis and classifi- cation of cancer mutations, epigenetic
monitor their fitness (Brothers et al., 2019; Yang and Gao,
alterations, such as methylations, protein—protein
2019).
interactions and single-cell analysis for example (AlQuraishi
Atrial fibrillation can cause blood clots, stroke, or other
et a1., 2014; Espinoza, 2018). One disadvantage of most
complications of the heart. Several smartwatch algorithms
developed algorithms is that they are focused on a single
have been developed to detect atrial fibrillation, but so far
omics technology platform. Recent algorithms being
only one has been cleared to be used by patients (Buhr,
developed can now perform mul- tiomics analysis and can
2017; Ho et al., 2019). This smartwatch algorithm can detect
analyze different datasets (Camacho et a1., 2018; Espinoza,
a user’s heart beat when rested or doing physical work. Any
2018). The prediction ability of many algorithms has been
significant change will trigger an alarm and an ECG is re-
utilized in many approaches, including the knockdowns and
corded through the watch. The algorithm will then classify
upregulation of certain genes. The effect of such genetic
whether there is need to see a clinician or not. As with all
alterations or even the use of certain drugs can be predicted
technologies, false positives can arise and can lead to un-
and hazardous effects prevented before they can cause harm
necessary clinic visits.
Such smartwatch algorithms are also providing informa- (Deist et a1., 2018; Listgarten et a1., 2018). DeepBind, a
tion on the levels of ions, such as sodium and potassium in CNN-based method, is able to predict the binding sites of
the blood. These noninvasive methods of blood analysis are proteins that bind DNA and RNA (Alipanahi
et al., 2015).
very attractive and can be useful to patients with kidney
problems (Dillon et a1., 2015; Elliott and Braun, 2017;
Yasin et al., 2017). Several other pathological conditions are Limitations and Future Perspectives
likely to be diagnosed using AI in the near future and these This review emphasize that AI does not have to replace
include mi- graine headaches, eye problems, and skin specialists, but can work together with specialists to provide
lesions (Burlina et al., 2017a; Li et al., 2019; Walters and the optimal care for patients. By bringing AI in harmony
Smitherman, 2016). Other smartphone applications use with HI, science and humanity will be best served. This is
images of food to calcu- late nutrient content and the amount partly because AI algorithms do not have human empathy,
of calories, and for smoking tracking (Chao et al., 2017; emo- tions, and responsibility. There is still a lot that must
Chen et a1., 2017). be done in terms of validating and implementing the use of
Multimodal data collections are being done for long peri-
AI in medicine. At the moment AI technology requires
ods of time with the results helping to predict the response of
critical governance and regulatory oversight innovation to
the human body to certain foods, environment, and treatment
make it secure and ethically compliant before its widespread
( Jumpertz von Schwartzenberg and Turnbaugh, 2015;
use.
Zmora et al., 2016). One of the outcomes of the multimodal
Validation of AI in clinical settings is needed urgently
studies is the already known fact that humans are very
together with publication of algorithms in peer-reviewed
individual in their response to certain foods and treatment.
journals. Looking ahead, perhaps the best AI can do is to
AI can therefore guide individuals on what to eat based on
work together with scientists and clinicians to provide best
their physiological parameters for example.
care to patients and not to replace specialists. AI is not likely
Complex medical conditions, such as depression and
to address everything from admission of patients, diagnosis,
mental health can be monitored by AI better than humans as
and choice of treatment. Furthermore, human health is in-
AI can utilize an individual’s comprehensive medical data in
tertwined with “whole-body” wellbeing (total health) of an
making a decision. Comprehensive data from constant individual. Being healthy does not mean absence of disease.
monitoring of both intrinsic and extrinsic factors, including Thus, aspects such as spiritual and social wellbeing of a pa-
the microbiome, genes, hormonal changes, the immune sys- tient must be taken care of as well. These kinds of treatment
tem, physical activity, communication, and other environ- or attention are unlikely to be provided by machines.
mental factors, are needed and must be integrated into a final All algorithms require some training before it can be val-
decision, contributing to precision and individualized health. idated in the clinical setting. Thus, patient data will have to
be shared between health care institutions and sometimes be-
Artificial Intelligence and Big Data tween countries (Deist et al., 2017; Taylor, 2016). This can
be challenging as data already collected might not have in-
One of the major factors contributing to the development
formed consent for sharing with other countries (Char et al.,
and successful validation of AI has been the use of stored
2018). Health care infrastructures and standards of privacy
data. Retrospective studies done, particularly on anonymized
might be different for different countries, placing a
medical data, mean that obtaining ethics approval might
constraint on data sharing (Fisher, 2018; Jiang et al., 2017;
potentially be more straightforward than the prospective
Ozdemir and
Hekim, 2018). Security issues such as hacking and
accidental disclosures will have to be top priority in such
cases.
Several international biobanks and databases have been
created, including the Kaggle Data Science Bowl, The Can-
cer Genome Atlas, and the Visual Concept Extraction Chal-
lenge in Radiology (Jimenez-Del-Toro et a1., 2016; Woolley
et al., 2018). Many countries have come out in supporting
the development and use of AI in both biomedical sciences
and medicine (Callaway et a1., 2017; Oswald, 2018).
Transparency of computational algorithms is very impor-
tant as the quality of input data will determine the results
obtained (Hashimoto et a1., 2018). The labeling of input
data is paramount and must be transparent so that critical
reviews of the training methods for algorithms can be done
(He et al., 2019; Xu et a1., 2019). How an algorithm reached
a decision is very important and must be understood
(Patrzyk et al., 2017). Thus, the algorithm’s reasoning when
making a de- cision must be deciphered so that it can be
challenged or improved where necessary. By making the
reasoning of al- gorithms understandable to human, AI is
being akin to HI, but perhaps also reducing its performance
in the process (Patrzyk et a1., 2017). Algorithms are
developed by humans and by nature; there might be some
form of bias in the input training data that has to be borne in
mind (Char et al., 2018).
Thus the training of algorithms and the choice of big data
used in such training sessions are very important so that
potential bias can be prevented. Due to the nature of the
medical field, patient safety and privacy trumps everything
and therefore transparency is very important. On the other
hand, companies developing computational algorithms do
not have to reveal the core of their algorithms for proprietary
reasons, which require new and responsible governance
mechanisms for AI in the future.
To illustrate the need to have oversight on the use of al-
gorithms in the clinic, we highlight here the adoption of
EHR in the clinic. Currently, several EHR systems and
therefore algorithms are being used globally by health
professionals. The intention of using EHR is to improve the
quality of health care services given to patients, allow
patients to be involved in decision making, and to reduce
errors/problems in the lab- oratory/clinic. Sadly, several
reports have shown that the al- gorithms/technology do not
always work well. In many cases, information obtained from
the EHR systems is not very reliable, with possibilities for
misdiagnosis, wrong prescription, and overmedication (Ben-
Assuli, 2015; Evans, 2016; Shenoy and Appel, 2017). The
use of different EHR systems from different vendors also
means that there is the possibility of having dif- ferent
technologies/algorithms having to work in sync.
Several reports of injuries and sometimes patients’ deaths
linked to technology/algorithm errors have been made
(Czerw et a1., 2016; Evans, 2016; Footracer, 2015; Frenkel,
2016; Shenoy and Appel, 2017; Sittig et a1., 2016). Further-
more, contractual agreements between vendors and end users
mean that issues about safety and malfunction of algorithms/
technology are never talked about openly. Several health
care analytics companies and patient-safety watchdogs, such
as Quantros and The Leapfrog Group, have been recording
cases of technology-related errors and the prescribing of
wrong medication, some resulting in patients’ deaths. To be
fair, patients’ deaths used to occur due to other reasons as
well before adoption of EHR, but there are emerging needs
for oversight on safety of using EHR.
Rules and regulations for algorithms can only be devised
once we know how the algorithms work. In addition, AI is
very distinct from medical devices and therefore must be
controlled differently. The Software as Medical Device
(SaMD) category was borne out of the need to have a
separate regulatory category for AI. Since AI algorithms
make clinical decisions just like specialists, it has been
suggested that AI must be regulated in the same way as
medical laboratories (Tang et a1., 2018).
Overall, medical specialists will still have to be
responsible for the final decision given as there is need for
accountability. The vendor providing the algorithm or those
providing data for the algorithm training might also be
responsible in cases where the algorithm does not perform
efficiently or a patient suffers an adverse reaction to
treatment for example (Dan- dara et al., 2016; Fisher, 2018;
Ozdemir and Hekim, 2018). Since regulations and rules on
the use of AI in hospitals are still being devised,
responsibility in case of mistakes and errors has not been
apportioned to specific individuals and entities.
The International Medical Device Regulators Forum
(IMDRF) has been leading discussions and coming up with
regulations and standards that can be applied to AI technol-
ogy internationally. Many countries are involved and this
forum has helped to come up with standard definitions to be
used in the AI field (IMDRF Samd Working Group, 2013).
Several regulatory policies have been issued by several or-
ganizations and countries, including the European Union and
the African Union for use in the respective health care sys-
tems and ecosystems (Goodman and Flaxman, 2017; Poyet
and Detay, 1992; Raynor and Shoup, 1999). These regula-
tions offer guidelines on the collection and use of patients’
information and outlines the need for health care workers to
inform the patient about certain algorithms (Goodman and
Flaxman, 2017; IMDRF Samd Working Group, 2013).
Asking for informed consent from a patient for broad in-
formation is challenging and it is important that patients
have the autonomy and power on what their information is
used for. With many algorithms and hardware in use in the
clinic, it is difficult to control who has access to patients’
data. Critical technology governance and regulatory
standards are essential while ensuring responsible innovation
and implementation of AI technology in the health care
systems can progress. Image- and visual-based diagnosis is
at the forefront of AI translation, revolutionizing fields such
as radiology, oph- thalmology, and pathology. The ability to
perform arduous tasks, including analyzing large datasets
and millions of images daily, means that AI will continue to
attract the in- terests of scientists and clinicians going into
the future.
Most published AI articles are still preprints and have not
been validated in real clinic settings, despite the hype
(Guinney et al., 2017; Zhou et al., 2018). The recommenda-
tion and predictions from these algorithms have not always
been spot-on, with some questionable ones being made in
drug treatments (Topol, 2019; Torkamani et a1., 2017).
Mistakes due to computational algorithms used in hospi-
tals and clinics are likely to affect many patients. Thus, all
algorithms must undergo extensive scrutiny such as simula-
tions and validation in clinic settings before being used in
medical practice (Allen, 2018; Castelvecchi, 2016). One
problem when using AI, especially deep neural networks, is
that it might not be possible to know how the algorithm
determines the final result (Castelvecchi, 2016). The use of
unknowns is not new in medicine with several drugs having
unknown mechanisms of action, despite their effectiveness
in treatment (Calcaterra and D’Acquarica, 2018; Gregori-
Puigjane et al., 2012).
Most algorithms are developed to test and analyze
computer-based medical data, meaning that health care
infra- structure will determine whether the algorithm is
usable. Disparities in frequency of hospital visits by
economically disadvantaged people compared with affluent
patients might create disparities in the volume of available
big data from different communities in society as well. This
means that data from poor communities and minorities
might not always be included in the development and
validation of the algorithms. Thus, there is need to develop
algorithms that can best serve the whole population without
bias. A patient data must have acceptable standards and be in
a format that can be understood by all health care workers
before use as input in algorithms.
Data collection methods will have to be standard
throughout the health care system for data to be usable.
Different institutions and hospitals obtain data from patients
in different formats, which might have to be converted to a
usable format before being used as input for an algorithm.
Some patients might not want to divulge certain information
to health care workers, presenting a conundrum in trying to
standardizing the final data. Another important issue is that
of different algorithms being developed for the same clinical
workflow. For example, the same vendor must be able to
develop different algorithms for image analysis and classi-
fication of tumor types. Using different algorithms from
different vendors might present problems such as limitations
to effective diagnosis of a disease.
A platform for data sharing and management has already
been provided in imaging through the Picture Archiving
and Communication system and also the Digital Imaging
and Communications in Medicine standards (Al-Hajeri and
Clarke, 2015; Bennett et a1., 2018). In the future, such a
system for Al-based technologies using the same nomen-
clature and standards would be welcome. Standards are al-
ready being set for AI technologies through the Fast Health
care Interoperability Resources network. The exchange of
electronic health data rules and regulations are set and stan-
dardized. One major concern is the privacy of patients’ data
when used by open source algorithms.
Given the extent of data breaches worldwide, novel algo-
rithms will have to be secure from potential hacking,
running the risk of exposing patients’ medical data in the
process. There will be need to develop highly secure data
platforms before the widespread use of AI in medical
practice. The same is needed in terms of regulations and
government oversight during development, validation, and
use of AI in medicine.
AI technology requires big data and therefore there is
need to continuously input information into the system. With
time, hardware might have to be upgraded to cater for new
infor- mation or algorithm upgrades. Thus, there is
continuous need for capital to maintain AI technology usage
in hospitals. AI vendors need to be monitored to avoid bias
and abuse of the system. Decisions made by certain
algorithms might favor certain treatment options over others
through vendor ma- nipulation (Ashrafian, 2015; Char et
a1., 2018; Lawrence et al., 2016). There is need for a
balance between what is allowed and the need for the vendor
to generate a profit.
Managers will have to make a decision in the best interest of
the patients first, while allowing the vendor to make a profit
that does not risk patients’ safety, treatment efficiency, and
interests. This contested line will continue to be a challenge
in hospitals.
We should also mention that universal health care systems
offer alternatives to resolve the patients’ interests versus
vendor interests. In such public health systems based on uni-
versal health care, the societal and ethical concerns are likely
to be reduced. It is often forgotten that when health care is
seen as a commodity, the entire culture of health care
changes raising a host of equity and public health ethics
issues.
Moreover, since AI technology routine applications in
health care is relatively recent, all health care staff will need
to be educated about AI and be able to use it. Importantly,
specialists will have to understand the limits of AI and in
some cases disregard Al-based suggestions or predictions in
making a final decision. For example, AI may continue to
suggest a certain treatment option when it is clear that the
patient can no longer afford such treatment or the patient no
longer wants to undergo such a treatment.
These decisions will require HI, empathy, and critical
governance to be made in the spirit of responsible
innovation. Statistics, informatics, and computer sciences are
some of the new subjects biomedical and medical students
will have to be taught. Thus, education has to be more than
just foundational biomedical and clinical sciences (Xu et al.,
2019). Un- fortunately, those already practicing will have to
go through some form of retraining to understand and be
able to use AI technology.
Due to its fast-paced nature of design and changes, AI has
been given Software Precertification Program by the FDA to
allow AI to be accessed easily (King et al., 2018; US Food
& Drug Administration, 2018). By allowing precertification
and postmarket oversight, the FDA hopes to support
innovation and the availability of AI technology to those
who need it most, patients.
Policies guiding AI technology will continue to change
over time as new information comes to light such as data
from validation of AI technology in real clinical settings.
The broader impact of technologies, such as AI requires
inputs from fields as far as social sciences, humanities,
engineering, and medicine (Conley, 2018; Fisher, 2018;
Ozdemir, 2019a, b). There is a call for the “deconstruction”
of disciplinary silos and the need to integrate knowledge
from different sources (Conley, 2018; Ozdemir, 2019a).
Issues emanating from the use of AI technology, as with
other planetary problems such as climate change, require all
“hands on deck” approach to be solved (Conley, 2018;
Fisher, 2018).
Conclusions
The advent of the latest technologies has seen the rise of
data-driven health care across the world, with the quality of
diagnosis, treatment, and management of diseases increasing
many folds. From the tracking of single molecules, single
cells to next-generation sequencing and monitoring of
physiological systems, health care systems will never be the
same again with the introduction of AI. Further advances in
techniques, such as 3D bioprinting, gene editing, cellular and
tissue regeneration, and the use of AI will allow us to un-
derstand human biology and therefore improve human
medicine to levels never seen before. The trajectory of bio-
medical sciences and medicine has been changed forever.
Thanks to AI and much can be accomplished further by
thinking AI together with Human Intelligence (HI)
Author Disclosure Statement
The authors declare that no conflicting financial interests
exist.
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