Pervasive Health and Regulatory Frameworks
Alexandra Queirós
1
, Anabela Silva
2
, Hilma Caravau
3
, Alina Ferreira
3
, Margarida Cerqueira
2
,
Joaquim Alvarelhão
1
, Milton Santos
1
and Nelson Pacheco Rocha
4
1
Health Sciences School/IEETA, University of Aveiro, Aveiro, Portugal
2
Health Sciences School/CINTESIS, University of Aveiro, Aveiro, Portugal
3
IEETA, University of Aveiro, Aveiro, Portugal
4
Health Sciences Department/IEETA, University of Aveiro, Aveiro, Portugal
Keywords: Pervasive Computing, Pervasive Health, Mobile Health, Ambient Assisted Living, Regulatory Frameworks.
Abstract: Pervasive health deals with the application of pervasive computing for health and wellness management and
its developments should be subject of regulatory oversight. The paper presents a general overview of
pervasive health concepts and applications, and aims to verify the level of conformity of current
developments with existing regulatory frameworks.
1 INTRODUCTION
Pervasive health has emerged as a specialization of
eHealth and deals with the application of pervasive
computing (Cook et al., 2009) for health and
wellness management, aiming to make health care
more seamlessly to our everyday life (Korhonen and
Barddram, 2004).
A special attention should be given to eHealth
appliances and applications that, by nature and if
critical aspects are not safeguarded, have the
potential to be a source of harm in normal use or if
misused. This means pervasive health developments
should not merely consider a technological
perspective but must combine both the technological
and the societal requirements.
One of the most important requirements that
should be considered is the level of conformity with
regulatory frameworks. Therefore, the paper
presents a study based on literature review aiming to
systematize concepts related to pervasive health and
to verify the level of conformity of current
developments with regulatory guidelines and
requirements.
In addition to this section (Introduction), the
paper comprises three more sections: Literature
Review, Discussion and Conclusions.
2 LITERATURE REVIEW
During the last two decades, there was a
considerable increase in the capacity to develop and
manufacture systems that employ smart components
highly integrated and miniaturized (Cook and Das,
2012). As a consequence of this remarkable
development, pervasive computing is nowadays part
of our everyday and social life, and impacts our
surrounding environments. Pervasive computing is a
multidisciplinary research field aiming the
development of appliances and applications to allow
convenient access to relevant information and
services. It involves technologically oriented
research on topics like embedded hardware,
software, middleware, wireless communications or
cloud computing among others. There are three
important enabling technologies related to pervasive
computing: ubiquitous computing, ubiquitous
communication and ubiquitous user interaction
(Korhonen and Barddram, 2004).
According to the vision of Weiser (1993),
ubiquitous computing aims to enhance the computer
use by bringing computing devices into everyday
life (e.g. integration of computing power and sensing
features into anything, including everyday objects
like white goods, toys or furniture), making them
available throughout the physical environment in
such a way that the users would not notice their
presence. In turn, ubiquitous communication
comprises multiple technologies to allow the
494
Queirós A., Silva A., Caravau H., Ferreira A., Cerqueira M., Alvarelhão J., Santos M. and Pacheco Rocha N..
Pervasive Health and Regulatory Frameworks.
DOI: 10.5220/0005249204940501
In Proceedings of the International Conference on Health Informatics (HEALTHINF-2015), pages 494-501
ISBN: 978-989-758-068-0
Copyright
c
2015 SCITEPRESS (Science and Technology Publications, Lda.)
interaction among multiple devices anytime
anywhere. Finally, since ubiquitous computing
allows the individuals, within a single session, to
interact with multiple devices, user-friendly
interfaces are required. These should support natural
interaction (e.g. speech or gestures) and should
consider the preferences of the users.
A pervasive computing infrastructure, hence, is a
seamless environment of computing, networking,
and natural user interfaces to provide applications
supported by a wide range of appliances with
unobtrusive, continuous and reliable connectivity.
On the other hand, the Ambient Intelligence concept
(Augusto, 2008) shares with pervasive computing
the vision of technology being embedded and
invisible in our natural surroundings, available when
needed and providing an effortless interaction.
However, Ambient Intelligence also includes the
adaptation to the users and the capacity of providing
context awareness (Augusto et al., 2012). Therefore,
pervasive technologies together with artificial
intelligence are used to provide embedded intelligent
devices that can sense the environment state,
perceive the presence of human beings, track their
activities and learn their preferences. For that,
artificial intelligence technology is being used not to
emulate human intelligence, a goal of its
developments in the past, but to combine the
synergies of humans and pervasive technologies
(Mann, 2001).
The research related to pervasive computing and
the associated intelligent components has matured to
the point where tangible prototype test beds are
becoming a commonplace (Cook and Das, 2012).
2.1 Pervasive Health
One of the most important application areas of
pervasive computing is health care. Pervasive health
can contribute, with different roles, to personalize
health and wellness services promoting an evolution
from a medical approach to individual-centric
operational models, in which the individual becomes
an active partner in the care process (Korhonen and
Barddram, 2004). The term personalization can be
related to different concepts, such as personalized
medicine, i.e. individual customization of diagnosis
and therapy based on information related to the
genomic profile of each patient (Genet et al., 2011),
monitoring personalization (e.g. using wearable
sensors), or personalized care (i.e. care services
delivered independent of time and location
according to choice and preferences of the
individuals (Blobel, 2012; Rigby, 2012), allowing
them the possibility of being actively involved in
their health and care pathway).
2.1.1 Monitoring Applications
The advances on sensing technology make it
possible the development of mobile and wearable
sensors able to continuously monitor physiological
parameters, activities and behaviours in out-hospital
conditions. Additionally, the existing ubiquitous
communications make possible anywhere, anytime
transfer and access of health-related information
such as measurement data or medical knowledge.
Therefore, a typical pervasive health application
consists in monitoring health conditions or the
progress of some illness, namely chronic diseases.
For monitoring applications, sensors are required
to collect relevant physiological data. A wide range
of sensors, including pressure and thermal sensors,
might be used to measure blood pressure,
temperature of the body, blood glucose, heart sound,
heart rate, respiration, blood oxygen saturation or
perspiration. Some sensors are non-invasive, but
various biological signals require invasive sensors
such as electrodes. Non-invasive wearable and
textile devices present a considerable potential and,
for instance, they allow to measure physiological
parameters through the use of techniques such as
infrared or optical sensing (Rashidi and Mihailidis,
2013).
However, health conditions are influenced by a
wide range of factors distributed across different
levels of impact that interact with each other
continuously and in subtle ways (Glass and McAtee
2006). These include behavioural (e.g. data
associated with medication adherence), social (e.g.
data associated with activities and participation) and
environmental factors. For instance, a diet plan is
influenced by an individual's health conditions as
well as behavioural factors (e.g. physical activity)
and environmental factors that either hinder or
facilitate these behaviour factors (Alvarelhão et al.
2012). In this particular, it is important to consider
mobile and wearable sensors not only able to
monitor physiological parameters, but also to
monitor activities and behaviours (e.g. recognizing
social activity or identifying any changes in
activities might be an indicator of decline) (Queirós
et al., 2013a).
Monitoring physiological parameters, together
with monitoring daily activities (i.e. identifying
consistency and completeness in these activities), to
assess, in a naturalistic and continuous way, health
and cognitive status (Rashidi and Mihailidis, 2013;
PervasiveHealthandRegulatoryFrameworks
495
Suzuki et al., 2007) might help to automate
assistance and prevent accidents or disease
exacerbations.
Concerning emergency situations, monitoring
patients and providing alerts for health care
providers might facilitate prompt intervention. In
this respect, pervasive health applications might
improve access to care, particularly when time is
vital (e.g. in stroke or acute trauma).
As falls constitute an important cause of
morbidity and mortality in older adults, fall
detection is another application area (Rashidi and
Mihailidis, 2013). It can be envisaged various types
of fall detection systems based on wearable devices
(e.g. devices such as accelerometers and gyroscopes
to measure posture and motion), ambience sensors
(e.g. pressure or floor vibration detection sensors) or
real time video and audio analysis (Lai et al., 2011;
Rashidi and Mihailidis, 2013).
2.1.2 Other Applications
Considering the envisioning goal of personalized
care, pervasive health should be much more than
monitoring applications. Pervasive health also
includes a wide range of applications, namely
preventive applications, applications to enhance the
communication between care providers and patients
and between caregivers or applications to support
frail citizens, such as elderly people, to live
independently and with wellness.
The preventive measures seek to act in several
dimensions (social, family and individual
dimensions), to contribute to the adoption of active
and healthy lifestyles, to give advice and to promote
adherence to long term therapies or to facilitate the
early detection of potential problems (Alcaniz et al.,
2009; Botella, 2009). Still, in terms of prevention,
the information provided by intelligent components
makes possible to tailor efficient interventions (e.g.
intelligent prediction of the moment and place when
intervention can optimally be delivered).
In some instances, pervasive health applications
might promote the engagement with primary care,
replace time-consuming visits and provide
rehabilitation care or assistance (Alcaniz et al.,
2009). This might benefit specialties that require
frequent follow-up care. For instance, specialized
training systems useful to treat stroke patients can be
controlled by remote physiotherapists with access to
the results, namely in terms of exercise levels
(Teixeira et al., 2013).
Furthermore, it should be understood how
pervasive health might facilitate the individuals to be
actively involved in their health and care pathway.
In patients with chronic diseases, applications might
allow them to receive information to better control
their diseases. For instance, educational information
about pain (e.g. general information, symptoms or
causes) can be provided, as well as information
relating to individual health conditions or pain relief
(e.g. relaxation techniques or pain reduction
techniques, such as acupressure), through a variety
of media, including images, video or animations
(Rosser and Eccleston, 2011). Furthermore,
applications can be used for cognitive rehabilitation
and to support older adults suffering from cognitive
decline (Cruz et al., 2014).
Other applications promote self-management,
namely lifestyle management, prescriptions
reminders, care appointments management, health
care record access (e.g. patients having the ability to
securely share their health information with
clinicians or others, as needed) or help the patients
to contribute with observations of their daily living
(e.g. Personal Health Records - PHR).
Within the pervasive health paradigm, different
groups of technologies, although focused in specific
aspects, can contribute to an idealized model of care
personalization. Among these groups, mobile health
(mHealth) (Boulos et al., 2014) and Ambient
Assisted Living (AAL) (i.e. the development of the
Ambient Intelligence concept to enable elderly with
specific demands to live longer in their natural
environment) (Queirós et al. 2013a; Rashidi and
Mihailidis, 2013) have been object of relevant
research. Although, there is a significant overlap
between the two concepts, i.e. there are applications
that can be classified as mHealth or AAL, mHealth
emphasizes mobility and considers applications to
support the care of the patients in their homes as
well as applications to be used in clinical
environments for professional activities (e.g. training
of medical students), while ALL might include static
devices and intends to support elderly living at home
not only in aspects related to health care but also
independent living.
2.2 Mobile Health
The World Health Organization has defined
mHealth as “medical and public health practice
supported by mobile devices, such as mobile phones,
patient monitoring devices, personal digital
assistants, and other wireless devices” (WHO, 2010:
6). Therefore, mHealth deals with the use of mobile
communication devices, such as smartphones or
tablets to support health services (Mosa, Yoo and
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496
Sheets, 2012), both in terms of disease and
wellbeing management.
Since health care services involve multiple
locations (e.g. clinics, outpatient’s services or
patients’ homes) they are highly mobile in nature
(Mosa, Yoo and Sheets, 2012). This means mHealth
might support communication and collaboration
among different health professionals in activities
related to disease diagnosis, drug reference, medical
calculations or literature search, among others.
The pervasive computing landscape includes
massive numbers of portable devices (e.g.
smartphones or tablets) that gather and store
information. Current smartphones are fairly robust,
truly pervasive and accessible, - they are accessible
to over 90% of the global population (Cook and Das,
2012; ITU, 2011) - and they provide ubiquitous user
interfaces and have the ability to collect, store and
communicate information (Cook and Das, 2012).
Therefore, they are considerable relevant to
mHealth. Furthermore, an interesting feature of
smartphone devices is the availability of short-
distance wireless data transmission, such as
Bluetooth (Mosa et al., 2012). This enables the
smartphone applications to work with a wide range
of hardware devices (e.g. glucose meters, pulse
oximeter or thermometers) from different vendors.
Concerning health care professionals,
smartphones are being used to perform mobile
diagnostic tests, to access Electronic Health Records
(EHR) and other patient information, to support
decisions related to drugs prescription or to provide
new means of medical education and teaching
(Boulos et al., 2014), among other activities.
Smartphone patient oriented applications might
deliver health care services for patients with chronic
conditions (Mosa, Yoo and Sheets, 2012). Examples
of chronic disease management applications include
self-management (e.g. self-management of the
chronic obstructive pulmonary disease) (Marshall et
al., 2008), expert feedback to patients based on their
input (e.g. helping diabetic patients by calculating
the dose of insulin based on carbohydrate intake,
pre-meal blood glucose, and anticipated physical
activity reported) (Charpentier et al., 2011), support
to rehabilitation programs (e.g. real-time remote
monitoring of the heart rate during rehabilitation
exercises), measurement of physical activity level
(Bexelius et al., 2010), integration of data from
wearable health sensors (Boulos et al., 2011) or even
helping patients to practice meditation (Mosa et al.,
2012; Sarasohn-Kahn, 2010).
Furthermore, the scientific literature refers a
considerable number of fall detection applications
using smartphones together with wearable tri-axial
accelerometers (Mosa, Yoo and Sheets, 2012) and
applications being used for pain management
(Boulos et al., 2014; Mosa et al., 2012; Rosser and
Eccleston, 2011).
Smartphone technology has the potential to
provide real-time pain reporting, which is relevant,
since pain is a diverse and prevalent state that is
often hard for patients to describe and, therefore,
difficult for caregivers to diagnose and treat (Mosa,
Yoo and Sheets, 2012). A systematic review of
smartphone applications conducted by Rosser and
Eccleston (2011) analyses 111 smartphones-based
application targeting various types of pain and
different health conditions with pain implications,
including applications that provide basic
measurement of pain level (either using visual
analogue scales or Wong-Baker pain faces scales) or
diary tracking applications (Rosser and Eccleston,
2011). The focus of these applications can be
divided into general pain (i.e. unspecified generic
pain), specified pain syndromes (e.g. headache and
back, neck, chest, dental or menstrual pain) or
chronic pain (e.g. specific long-term health
conditions such as fibromyalgia, arthritis and
degenerative disc disease). Predominantly the
purpose of the reported applications was pain relief
or educational information about pain (e.g. general
information, symptoms or causes). Additionally,
some applications present pain reduction techniques
(e.g.
information on acupuncture, acupressure
tutorials and headache prevention), relaxation
techniques (e.g. meditation or massage tutorials) and
skills training exercises for relieving tension, while
others employ attributes of the smartphones to
reduce pain (e.g. use of the vibration capacity of the
smartphone as a relaxation mechanism) (Rosser and
Eccleston, 2011).
2.3 Ambient Assisted Living
AAL is an emerging field that had attracted global
interest, both in academia and industry, for the
potential of its solutions, namely in terms of health
care applications (Augusto et al., 2012). AAL
concerns and developments are in line with the
World Health Organization active ageing framework
(WHO, 2002). Active ageing emphasizes an
enabling positive thinking. While a disabling
perspective leads to isolation and dependence and
increases the needs of older people, an enabling
view focuses on maintaining the older adults'
functioning and expanding their participation in all
aspects of the society. Enabling instruments such as
PervasiveHealthandRegulatoryFrameworks
497
ALL are essential, considering the fact that as people
age their quality of life (i.e. perception of the
position in life in the context of the surrounding
culture and value system) is largely determined by
their ability to maintain autonomy (i.e. ability to
control, cope with and make personal decisions on a
day-to-day basis) and independence (i.e. the ability
to perform functions related to daily living with no
or little help from others) (WHO, 2002).
AAL intends to address needs of older adults and
respective major diseases (Heath, 2008):
cardiovascular disease, hypertension, stroke,
diabetes, cancer, chronic obstructive pulmonary
disease, musculoskeletal conditions, mental health
conditions or blindness and visual impairment.
Meeting the specific individual needs, namely
providing care services at the home of the
individuals together with intelligent applications, is
one of the main strategies to guarantee independent
living of older people (Kleinberger, 2007).
Considering this context, important AAL goals are
to promote personal (e.g. medication reminder) and
distance support (e.g. tele rehabilitation programs)
or to provide the caregiver with accurate, up to date
information so that the right care at the right time
can be delivered (e.g. continuous monitoring of
physiological parameters or behaviours, emotions
and activities) (Kapoor, 2010; Mirarmandehi, 2010).
These goals can contribute to the overall effort to
provide personalized and affordable access to
essential services with efficacy and efficiency
(Queirós et al., 2013b).
A combination of conventional service provision
together with intelligent applications have been
designed in a considerable number of AAL projects
(Queirós et al., 2013a) to contribute for independent
living.
Dependency is strongly related to the ability to
perform Activities of Daily Living (ADL). The
impossibility of performing basic ADL (e.g.
personal hygiene, dressing and undressing, self-
feeding or ambulation) and instrumental ADL (e.g.
housekeeping, managing money, shopping or
clothing, use of telephone and other forms of
communication or transportation within the
community) usually implies that the individual
(although, in some circumstances, living alone) is on
the border of dependency and needs help and
support. It is clear that technology cannot supply
these needs completely, but it can mitigate the
dependency impacts by means of specialized
solutions (e.g. a nutritional adviser or an electronic
commerce solution for shopping) with the general
aim of increasing the performance of older adults in
their activities and participation.
All these AAL applications can maintain, or even
increase, the confidence of the individual in their
domestic spaces and thus increase their well-being at
home in general. However, assistance applications
must also address less tangible values such as
participation. In particular, they should consider, in a
comprehensive way, the possibility of the
technologies facilitate social, religious, civic and
political participation of older citizens.
3 DISCUSSION
Pervasive health has a huge potential in terms of
innovative solutions that might mitigate, in political,
economic and social terms, the consequences of the
contemporary demographic ageing.
A relevant finding of the study is that the
developments related to pervasive health are still
focused on technology and often potential users,
both patients and professionals, are not conveniently
involved.
For instance, the systematic review conducted by
Rosser and Eccleston (2011) reports a significant
percentage of applications (86%) with no health-care
professional involvement, either as the application
creator or as a source of information or evaluation of
the application content. Furthermore, a systematic
literature review related to AAL (Queirós et al.,
2013a) shows a high percentage of articles on
specific components (87%) when compared to the
percentage (13%) related to full systems. This
review also shows that a considerable number of the
articles describing systems focus on how technology
can be used in the AAL context instead of looking at
the users’ needs and proposing ways to address
them.
In order to solve this identified problem, it is
required that research teams should be composed of
professionals with different backgrounds and skills
such as health or social professionals and engineers
and that all the stakeholders, including potential
users, should be actively involved in all the stages of
the applications developments and evaluation
processes, including the conceptualization phase.
The studies reviewed also show the applications
are subject to very little or absolutely no regulatory
oversight, with a small percentage of articles
reporting evaluations or trials. However, pervasive
health solutions deal with sensitive health-related
aspects of a person’s life and this should put strong
demands in the development of these technologies.
Therefore, it is necessary to consider the risks
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associated with pervasive health appliances and
applications, including the possibility of the
individuals being misled. This is reinforced by the
fact that, often, the potential users are fragile and
vulnerable individuals, or their families, desperately
seeking solutions to acute problems. Thus, even for
appliances or applications that appear to be
extremely useful, there should be a concern for their
efficacy and efficiency, or for possible adverse
effects when being used.
3.1 Regulatory Frameworks
The obligation of an appliance or application being
classified as a medical device depends on its
functions and the corresponding level of patient
risks. For instance, a device able to measure heart
rate as a fitness tool is not a medical device, but it is
definitively a medical device if the resulting
information is sent to a health care professional
(FDA, 2013).
Worldwide, a wide range of organisms, including
the Food and Drug Administration (FDA) of the
United States and the European Medicines Agency
(EMA) of the European Union, have the mission to
safeguard the interests of the citizens by establishing
standards for the development, manufacture and
marketing of medical devices.
In 2013, the FDA issued a guidance concerning
the regulation of mobile medical applications (FDA,
2013). It considers that all the applications that
transform a mobile platform into a medical device
by using attachments, display screens, sensors, or
other such methods, regardless of the mechanism
behind the transformation, should be regulated
(FDA, 2013). Furthermore, FDA intends to exercise
enforcement discretion for mobile applications that
(FDA, 2013): help patients self-manage their disease
or conditions without providing specific treatment or
treatment suggestions; provide patients with simple
applications to organize and track their health
information; provide easy access to information
related to patient's health conditions or treatments;
help patients to document, show or communicate
potential conditions to health care providers;
automate simple tasks for health care providers; or
enable patients or health care providers to interact
with health care record systems (e.g. EHR).
In the European Union, the European Medical
Device Directive (MDD 93/42/EEC) defines a
medical device as any instrument, apparatus,
appliance, software, material or other article that
when used alone or in combination with accessories,
including specific software, aims to prevent,
diagnose, treat, monitor, or alleviate an illness or
injury in humans (EC, 1993). The CE mark assigned
to a device guarantees to users and health
professionals that the device complies with all
guidelines provided by all the applicable regulatory
frameworks.
Medical devices are divided into risk classes
according to different criteria, namely, the intended
purpose, potential risks arising either from its
technical conception and in its manufacturing
methods, duration of contact with the human body
(temporary, short or long period), invasiveness of
the human body (invasive, invasive of bodily
orifices, surgically invasive, implantable and
implantable absorbable) or the anatomy affected by
the use of the device.
As part of the technical documentation, the
developers also need to perform controlled tests and
risk assessment to demonstrate that their products
might improve any existing process used for the
same purpose. This implies the need to assess the
validity (validity refers to the degree of accuracy of
measurements or actions taken by an appliance or
application, i.e. if they actually measure or perform
what they intend to measure or to perform) and the
reliability (reliability refers to the consistency of the
measurements or the actions over time) of the
appliances and applications, which might be
supported by observational clinical trials involving
human subjects that, like all the clinical trials, must
comply with the ethical principles established by the
Declaration of Helsinki (WMA, 2013) and must
follow good clinical practices. These trials can
provide evidence to conclude that the measurements
and actions performed by the appliances or
applications are, respectively, consistent with the
measurements and actions associated with existing
similar appliances and applications.
Despite all the regulations, it is perhaps
surprising that relatively little research has been
undertaken so far to investigate the validity and the
reliability of pervasive health developments (Mosa
et al., 2012; Rosser and Eccleston, 2011).
3.2 Clinical Evidence
Besides the assessment of validity and reliability,
there is a need to understand the quality of the
available solutions and their clinical usefulness. This
requires interventional clinical trials to provide
clinical evidence of efficacy and efficiency of the
pervasive health applications.
Despite a high level of technological innovation
and implementation, and promising early results,
PervasiveHealthandRegulatoryFrameworks
499
most of the developments aimed the design,
development and evaluation of prototypes (i.e.
proof-of-concept). In contrast, evidence-based
medicine is supported on statistical and clinical
significance and the new developments are required
to show they are able to make a difference and are
cost-effective (Korhonen and Barddram, 2004).
Furthermore, high-quality efficacy and efficiency
evidence must also adequately address usability,
accessibility, readability (reading with
understanding) or health literacy needs of target
audiences, since they might have different and
unique usability requirements related to ageing and
physical or cognitive impairments. This requires
adequate development and evaluation methodologies
(Martins, 2012).
Collecting this kind of evidence requires
interventional clinical trials. These demands
considerable resources to integrate new applications
with daily care delivery, to be used by thousands of
users, both patients and health professionals, and
running over long periods of time (Rashidi and
Mihailidis, 2013).
Examples of questions that must be answered by
interventional clinical trials are: Is the information
being provided beneficial in clinical practice to
guide diagnosis, decision making or intervention? Is
that appliance or application going to have an impact
on patients or health care provider's? Is that change
beneficial for the patient in any way? Is the use of
the appliance or application making the diagnosis,
the decision or the intervention processes any better?
Multidisciplinary large-scale collaboration with
technology developers, companies, policy makers,
patient organizations and health professionals is
essential for pervasive health surpass this
methodological challenge (Korhonen and Barddram,
2004).
3.3 Limitations of the Study
The study was not based on a systematic literature
review. Therefore, the degree of generalization of
the study findings needs to be evaluated through
further research. Presently, the authors are
conducting a systematic literature review to support
this exploratory study.
4 CONCLUSIONS
The pervasive health paradigm has a huge potential
in terms of innovative solutions that might mitigate,
in political, economic and social terms, the
consequences of the contemporary demographic
ageing. However, their development should not be
seen merely from the technological point of view
because there is a wide range of ethical and
organizational issues that need to be considered.
In particular, in this paper the authors focused on
the need to complement the pervasive health
developments with strong evidence of their validity,
reliability and clinical usefulness. For that it is
necessary to implement strict evaluation processes
according to regulatory frameworks, which requires
observational and interventional clinical trials
involving patients and care providers.
ACKNOWLEDGEMENTS
This work was supported by COMPETE - Sistema
de Incentivos à Investigação e Desenvolvimento
Tecnológico, Projectos de I&DT Empresas em co-
promoção, under QREN TICE.Healthy.
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