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TECHNICAL ISO/TS
SPECIFICATION 82304-2
First edition
2021-07
Health software —
Part 2:
Health and wellness apps—Quality
and reliability
Reference number
ISO/TS 82304-2:2021(E)
©
ISO 2021
ISO/TS 82304-2:2021(E)
© ISO 2021
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ii © ISO 2021 – All rights reserved
ISO/TS 82304-2:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
3.1 General terms . 1
3.2 Terms relating to apps . 5
3.3 Terms relating to risk management . 7
4 Health app assessment process . 8
4.1 Quality assessment . 8
4.2 Quality requirements . 8
4.3 Health app quality report . 9
4.4 Health app quality evidence pack . 9
4.5 Health app quality label . 9
5 Quality requirements . 9
5.1 Product information . 9
5.1.1 Product . 9
5.1.2 App manufacturer .10
5.2 Healthy and safe .11
5.2.1 Health requirements.11
5.2.2 Health risks .14
5.2.3 Ethics .17
5.2.4 Health benefit .18
5.2.5 Societal benefit .23
5.3 Easy to use .24
5.3.1 Accessibility .24
5.3.2 Usability .26
5.4 Secure data .30
5.4.1 Privacy .30
5.4.2 Security .36
5.5 Robust build .42
5.5.1 Technical robustness .42
5.5.2 Interoperability .45
Annex A (normative) Health app quality label .47
Annex B (normative) Health app quality score calculation method .54
Annex C (informative) Rationale .58
Annex D (informative) Product safety and lifecycle process recommendations .59
Annex E (informative) Application profile – Contact tracing apps .67
Annex F (informative) Ethical considerations in health apps .70
Annex G (informative) Potential uses of this document .73
Bibliography .75
ISO/TS 82304-2:2021(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 215, Health informatics, in collaboration
with Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC 62A,
Common aspects of electrical equipment used in medical practice, and with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 251, Health informatics, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 82304 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
ISO/TS 82304-2:2021(E)
Introduction
Context
Health and wellness apps are a fast-growing market, and there are now hundreds of thousands, with
the most popular of these having many millions of downloads each. Some of these apps fall under
medical devices regulations, most do not. These apps are often promoted directly to consumers through
app stores without going through any formal evaluation. The apps often collect sensitive personal
information yet do not have appropriate privacy controls, and provide advice on topics such as fertility,
diet or activity that are not supported by any evidence. There are widespread concerns about the risks
involved. At the same time, health apps that have proven to be effective and add to quality of life and
even length of life, are not necessarily adopted at scale and reimbursed.
Many health organizations have projects to evaluate, endorse and procure apps that meet locally
defined requirements. These activities are important for any app manufacturer who want to promote
or sell their product to or through providers of health and wellness services, as providers want the
reassurance that the apps they recommend to patients will be safe, reliable and effective. However,
the cost of responding to different extensive sets of criteria and different evaluation regimes in each
country, organization, or region is a barrier for app manufacturers wanting to make their products
available in multiple markets. It is also a problem for those evaluating apps and maintaining libraries
of health and wellness apps. They can miss out on products that effectively address health issues and
health system inefficiencies, do not benefit from economies of scale of others evaluating the same
apps and different evaluations can contradict one another, causing further confusion instead of trust.
Because of the time investment involved, the vast majority of apps are not evaluated at all, although top
10 lists suggest otherwise.
There are several International Standards on health software related to product safety and lifecycle
processes that are applicable to all health software, including health apps. This document provides
quality requirements and health app quality labels as ways for app manufacturers and app assessment
organizations to communicate the quality and reliability of health apps.
The working practice within app development is to deliver a focused piece of functionality, building
on an existing platform - often with a small team doing the work who can be unfamiliar with health
software development. This document includes Annex D to provide guidance specific to this community.
A vibrant transparent market for health apps will benefit individuals and programs across the world
that are addressing issues such as aging population, unhealthy lifestyles, chronic diseases, affordability
of or constrained budgets for health and care, unequal quality and access to health services, and
shortages in health professionals.
This document makes no attempt to determine whether a health app is or should be regulated.
Development methodology
The quality requirements (Clause 5) and health app quality
...