The European Committee for Standardization is one of three European Standardization Organizations (together with CENELEC and ETSI) that have been officially recognized by the European Union and by the European Free Trade Association (EFTA) as being responsible for developing and defining voluntary standards at European level.
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Reference | CEN ISO/TS 82304-2:2021 |
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Title | Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021) |
Work Item Number | 00251339 |
Abstract/Scope | 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. |
Status |
Published
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Reference Document |
ISO/TS 82304-2:2021 (EQV)
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date of Availability (DAV) | 2021-08-11 |
ICS | 35.080 - Software 35.240.80 - IT applications in health care technology |
A-Deviation(s) | |
Special National Condition(s) |
Directive(s) | |
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Mandate(s) | |
Citation in OJEU |
date of Ratification (DOR) (1) | 2021-06-28 |
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date of Availability (DAV) (2) | 2021-08-11 |
date of Announcement (DOA) (3) | 2021-11-30 |
date of Publication (DOP) (4) | |
date of Withdrawal (DOW) (5) |
(1) Date of ratification (dor) date when the Technical Board notes the approval of an EN (and HD for CENELEC), from which time the standard may be said to be approved
(2) Date of availability (dav) date when the definitive text in the official language versions of an approved CEN/CENELEC publication is distributed by the Central Secretariat
(3) Date of announcement (doa) latest date by which the existence of an EN (and HD for CENELEC), a TS or a CWA has to be announced at national level
(4) Date of publication (dop) latest date by which an EN has to be implemented at national level by publication of an identical national standard or by endorsement
(5) Date of withdrawal (dow) latest date by which national standards conflicting with an EN (and HD for CENELEC) have to be withdrawn
(6) This list of normative references is purely indicative. The only official list of normative reference is the list of the published standard.
In the case of undated standard, a link to the last dated version is provided.
In the case of series, a link to each standard identified in the series is provided.
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