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12 Quality and Reliability of
Health Apps
By Petra Hoogendoorn and Charlie McCay
Introduction
There is an established and fast-growing market
for health and wellness apps however, there are
concerns about the safety and reliability of many
of these apps.
While health and wellness apps are popular
with consumers, there are significant barriers to
these products being routinely recommended to
patients by clinicians and integrated into the way
that healthcare provider organizations interact
with patients.
While some health apps fall under medical
device regulation, a recent study1 found that this
was the case for only 21% of a sample of 271
health apps assessed in the Netherlands.
To address the safety and reliability concerns
and lack of confidence among healthcare provid-
ers, many countries and healthcare organizations
have established health app libraries with asso-
ciated assessment schemes. Such initiatives have
resulted in a fragmented assessment landscape,
which reduces the healthcare professionals’ con-
fidence in any specific framework. It also creates
additional burdens for health app suppliers, who
need to put their products through multiple
assessment schemes.
The European Commission (EC) is support-
ing a project2 to develop a technical specification
(TS) addressing the quality and reliability of
health and wellness apps (ISO DTS 82304-2).
The work is being led by the European Commit-
tee for Standardization (CEN) in collaboration
with the International Standards Organization
(ISO), the International Electrotechnical Com-
mission (IEC), and the European Committee for
Electrotechnical Standardisation (CENELEC).
The TS provides a set of quality criteria to
assess health apps, defines the evidence to assess
products against these criteria, and also defines
a scoring mechanism, quality label, and quality
report to consistently and clearly communicate the
quality of a health app. The draft TS is available
from the ISO national standards bodies3 for
commenting between March and May 2021, and
publication is expected in the second half of 2021.
Barriers to Health Apps Adoption
Consumers find it difficult to choose which
health apps to use. The sheer number of health
apps is the most significant reason cited, fol-
lowed by uncertainty about whether the health
apps will actually help.4 An Australian survey
of potential health app users found that they
were most likely to trust a health professional or
health professional organization when looking
for health app recommendations.5,6 However,
another Australian study established that general
practitioners rarely recommend health apps,
giving “lack of knowledge of effective apps” and
“lack of trustworthy source to access apps” as the
top two reasons for their reluctance.7
If consumers are to trust and use health
apps, health professionals and health professional
organizations must feel confident in recommend-
ing them, and for that, they need to be confident
that health apps are safe and effective.
CHAPTER
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183
12 Quality and Reliability of
Health Apps
By Petra Hoogendoorn and Charlie McCay
Introduction
There is an established and fast-growing market
for health and wellness apps however, there are
concerns about the safety and reliability of many
of these apps.
While health and wellness apps are popular
with consumers, there are significant barriers to
these products being routinely recommended to
patients by clinicians and integrated into the way
that healthcare provider organizations interact
with patients.
While some health apps fall under medical
device regulation, a recent study1 found that this
was the case for only 21% of a sample of 271
health apps assessed in the Netherlands.
To address the safety and reliability concerns
and lack of confidence among healthcare provid-
ers, many countries and healthcare organizations
have established health app libraries with asso-
ciated assessment schemes. Such initiatives have
resulted in a fragmented assessment landscape,
which reduces the healthcare professionals’ con-
fidence in any specific framework. It also creates
additional burdens for health app suppliers, who
need to put their products through multiple
assessment schemes.
The European Commission (EC) is support-
ing a project2 to develop a technical specification
(TS) addressing the quality and reliability of
health and wellness apps (ISO DTS 82304-2).
The work is being led by the European Commit-
tee for Standardization (CEN) in collaboration
with the International Standards Organization
(ISO), the International Electrotechnical Com-
mission (IEC), and the European Committee for
Electrotechnical Standardisation (CENELEC).
The TS provides a set of quality criteria to
assess health apps, defines the evidence to assess
products against these criteria, and also defines
a scoring mechanism, quality label, and quality
report to consistently and clearly communicate the
quality of a health app. The draft TS is available
from the ISO national standards bodies3 for
commenting between March and May 2021, and
publication is expected in the second half of 2021.
Barriers to Health Apps Adoption
Consumers find it difficult to choose which
health apps to use. The sheer number of health
apps is the most significant reason cited, fol-
lowed by uncertainty about whether the health
apps will actually help.4 An Australian survey
of potential health app users found that they
were most likely to trust a health professional or
health professional organization when looking
for health app recommendations.5,6 However,
another Australian study established that general
practitioners rarely recommend health apps,
giving “lack of knowledge of effective apps” and
“lack of trustworthy source to access apps” as the
top two reasons for their reluctance.7
If consumers are to trust and use health
apps, health professionals and health professional
organizations must feel confident in recommend-
ing them, and for that, they need to be confident
that health apps are safe and effective.
CHAPTER