ISO/TS 82304-2:2021

TECHNICAL ISO/TS
SPECIFICATION 82304-2
First edition
2021-07
Health software —
Part 2:
Health and wellness apps—Quality
and reliability
Reference number
©
ISO 2021
© ISO 2021
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ii © ISO 2021 – All rights reserved

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
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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electrotechnical standardization.
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different types of ISO documents should be noted. This document was drafted in accordance with the
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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).
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iv © ISO 2021 – All rights reserved

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
...