CEN ISO/TS 82304-2:2021
(Main)Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021)
Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021)
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.
Gesundheitssoftware - Teil 2: Gesundheits- und Wellness-Apps - Qualität und Zuverlässigkeit (ISO/TS 82304-2:2021)
Das Dokument stellt Qualitätsanforderungen für Gesundheits-Apps auf und legt ein Qualitätslabel für Gesundheits-Apps fest, um die Qualität und Zuverlässigkeit solcher Apps anzugeben.
Dieses Dokument ist anzuwenden für Gesundheits-Apps, die eine Sonderform von Gesundheitssoftware darstellen. Es deckt den gesamten Lebenszyklus von Gesundheits-Apps ab.
Dieses Dokument richtet sich an App-Hersteller ebenso wie an Bewertungsorganisationen für Apps und soll diesen dabei helfen, die Qualität und Zuverlässigkeit einer Gesundheits-App zu vermitteln. Verbraucher, Patienten, Pflegepersonen, Fachkräfte der Gesundheitspflege und deren Organisationen, Gesundheits¬behörden, Krankenversicherer und die breitere Öffentlichkeit können das Qualitätslabel für Gesundheits-Apps nutzen und melden, wenn sie eine Gesundheits-App für die Nutzung, die Übernahme in Pflegeleitlinien, Pflegekonzepte und Pflegeverträge empfehlen oder auswählen wollen.
ANMERKUNG 1 Gesundheits-Apps können nationalen Gesetzen, z. B. für Medizinprodukte unterliegen.
ANMERKUNG 2 Siehe Anhang C für weitere Einzelheiten zum Anwendungsbereich.
Außerhalb des Anwendungsbereiches dieses Dokuments liegen Leitlinien zur Einhaltung der Medizin-produkteverordnung.
Logiciels de santé - Partie 2: Applications de santé et de bien-être - Critères de qualité tout au long du cycle de vie - Code de pratique (ISO/TS 82304-2:2021)
Programska oprema v zdravstvu - 2. del: Aplikacije za zdravje in dobro počutje (wellness) - Kakovost in zanesljivost (ISO/TS 82304-2:2021)
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2021
Programska oprema v zdravstvu - 2. del: Aplikacije za zdravje in dobro počutje
(wellness) - Kakovost in zanesljivost (ISO/TS 82304-2:2021)
Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS
82304-2:2021)
Gesundheits- und Wellness-Apps - Qualitätskriterien während des gesamten
Lebenszyklus - Verhaltenskodex (ISO/TS 82304-2:2021)
Logiciels de santé - Partie 2: Applications de santé et de bien-être - Critères de qualité
tout au long du cycle de vie - Code de pratique (ISO/TS 82304-2:2021)
Ta slovenski standard je istoveten z: CEN ISO/TS 82304-2:2021
ICS:
35.080 Programska oprema Software
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TS 82304-2
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
August 2021
TECHNISCHE SPEZIFIKATION
ICS 35.080; 35.240.80
English Version
Health software - Part 2: Health and wellness apps -
Quality and reliability (ISO/TS 82304-2:2021)
Logiciels de santé - Partie 2: Applications de santé et de Gesundheits- und Wellness-Apps - Qualitätskriterien
bien-être - Critères de qualité tout au long du cycle de während des gesamten Lebenszyklus -
vie - Code de pratique (ISO/TS 82304-2:2021) Verhaltenskodex (ISO/TS 82304-2:2021)
This Technical Specification (CEN/TS) was approved by CEN on 28 June 2021 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 82304-2:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/TS 82304-2:2021) has been prepared by Technical Committee ISO/TC 215
"Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health informatics” the
secretariat of which is held by NEN.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/TS 82304-2:2021 has been approved by CEN as CEN ISO/TS 82304-2:2021 without any
modification.
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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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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 maintenanc
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