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ISO TS 82304-2:2021

(Main)

Health software - Part 2: Health and wellness apps - Quality and reliability

Health software - Part 2: Health and wellness apps - Quality and reliability

This document provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps.
This document is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps.
This document is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts.
NOTE 1 Health apps can be subject to national legislation, such as for medical devices.
NOTE 2 See Annex C for additional details on the scope.
Outside the scope of this document are guidelines to comply to the medical device regulation.

General Information

Status
Published
Publication Date
29-Jul-2021
ICS
35.080 - Software
Technical Committee
SC 62A - Common aspects of medical equipment, software, and systems
Drafting Committee
JWG 7 - TC 62/SC 62A/JWG 7
Current Stage
PPUB - Publication issued
Start Date
10-Sep-2021
Completion Date
03-Aug-2021
Ref Project

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ISO TS 82304-2:2021 - Health software - Part 2: Health and wellness apps - Quality and reliabilityISO TS 82304-2:2021 - Health software - Part 2: Health and wellness apps - Quality and reliability
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Technical specification
ISO TS 82304-2:2021 - Health software - Part 2: Health and wellness apps - Quality and reliability
English language
78 pages
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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

---------------------- Page: 1 ----------------------
ISO/TS 82304-2:2021(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved

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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.
...

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