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  • BSI
    PD CEN ISO/TS 82304-2:2021 Health software - Health and wellness apps. Quality and reliability
    Edition: 2021
    $538.63
    / user per year

Description of PD CEN ISO/TS 82304-2:2021 2021

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.



Standard NumberPD CEN ISO/TS 82304-2:2021
TitleHealth software - Health and wellness apps. Quality and reliability
StatusDefinitive
Publication Date2021-08-12
Identical National Standard OfCENISO/TS 82304-2, ISO/TS 82304-2
DescriptorsComputer software, Software (computers), Quality, Reliability, Application software
ICS35.080 Software, 35.240.80 IT applications in health care technology
CommitteeIST/35
ISBN978 0 539 05674 7
PublisherBSI
Pages88

About BSI

BSI Group, also known as the British Standards Institution is the national standards body of the United Kingdom. BSI produces technical standards on a wide range of products and services and also supplies certification and standards-related services to businesses.
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