Last ned spesifikasjonen

Programvare for helse - Del 2: Apper for helse og velvære - Kvalitet og pålitelighet (SN-CEN ISO/TS 82304-2:2021) er tilgjengelig fra nettsiden til Standard Norge.

Formål og bruksområde

Programvare for helse - Del 2: Apper for helse og velvære - Kvalitet og pålitelighet (SN-CEN ISO/TS 82304-2:2021) er en internasjonal spesifikasjon.

Dokumentet beskriver hvilke kvalitetskrav som bør følges når apper for helse skal utvikles og vedlikeholdes. I tillegg viser det hvordan slike apper kan merkes for å kommunisere fire kvalitetskriterier: Helse og sikkerhet, hvor enkel appen er å bruke, datasikkerhet og hvor solid den er [robust build].

Gjelder for

Programvare for helse - Del 2: Apper for helse og velvære - Kvalitet og pålitelighet (SN-CEN ISO/TS 82304-2:2021) anbefales brukt slik det er beskrevet vi Annex G "Potetial uses of this document" i spesifikasjonen, se norsk sammendrag av de viktigste bruksområdene og tekst i engelsk under.

Norsk sammendrag av de viktigste bruksområdene

Spesifikasjonen kan brukes av følgende:

Apputviklere gjennom livssyklusen til en helseapp. Dette inkluderer, men er ikke begrenset til design, utvikling, validering, implementering, forretningsutvikling og markedsføring.
Sertifiseringsorganisasjoner for helseapper. Slike organisasjoner kan bruke standarden til for eksempel å gi ut kvalitetsstempel, gi råd om hvordan kvaliteten kan forbedres og gjennomføre analyser.
Virksomheter som utvikler spesifikasjoner. De kan ta utgangspunkt i standarden og tilpasse den konkrete prosjekter.
Potensielle kunder og brukere. De kan sette krav til minimumsscore til apper de vurderer, til kvalitetsmerking av disse og til kvalitetsrapporter. De kan bruke kvalitetsmerking og kvalitetsrapporter til å vurdere ulike apper.
Eiere av digitalt markeder. Sette krav til at en app må ha et kvalitetsmerke dersom den skal gjøres tilgjengelig.
Nasjonale og regionale myndigheter. Sette krav til kvalitetsmerke til apper innen sitt juridiske område.
Personer eller virksomhet som anbefaler helseapper. Som del av vurderingsprosessen.

"Annex G. Potential uses of this document

G.1 Health app manufacturer

This document can be used throughout the lifecycle of the health app, including but not limited to the following:

Design: The app manufacturer can determine during the design phase of the project how they intend to be able to answer the assessment questions, and what supporting evidence they will collect. This can be done in collaboration with potential custormers and users;
Development: The manufacturer can use the assessment questions as input to he software development plan;
Validation: The manufacturer can use the assessment question to estqablis the quality and reliability of the health app. In addition, a health app assessment organization can do an externatl assessment;
Installation, maintenance and disposal: The assessment questions include processes that the app manufacturer can undertake to ensure the quality and reliability of the health app after it is put on the market;
Business development: Health apps are used in a wider digital health technology and healthcare ecosystem, an a commitment to usint this document can be used to build trust and establish business partnerships;
Marketing and sales: Application of this document can be used to show potential customers and usert the level of quality and reliability of the health app.

G.2 Health app assessment organizations

App assessment organizations can:

Use this document to assess health apps and issue health app quality labels and health app quality reports for a global market;
Provide advice and consultancy to health app manufacturers to improve the quality and reliability of their health apps;
Provide complimentary assessment services, such as gathering and analysing user reviews

G.3 Specification development organizations

Specification development organizations can:

Develop profiles of this document for particular use cases (…)
Develop additional context-specific assessment questions for aspects of quality and reliability that are not included in this document. For example, there can be assessment questions that cover national or regional interoperability frameworks, or local legislation. Such additional questions will not impact the calculation method for the health app quality score but can be communicated to potential customer and users alongside the label and report specified in this document.

G.4 Potential customers and users

Potential customers and users can:

Communitate their quality and reliability requirements to potential manufacturers of health apps. This can be done by setting minimum health app quality scoreds, or by requiring that specific questions are answered positively;
Use the health app quality label or health app quality report to determine whether a health app meets their requirements for quality and reliability. The levels of quality and reliability required can vary depending upon the contex;
Use the health app quality labe and health app quality report in the process of selecting health apps to be included in clinical guidelines, care pathways and care contracts.

G.5 Digital marketplace provider

A digital marketplace provider such as app stores and repositories can require that a health app ha a health app quality label issued by a trusted app assessment organization to quality fo their health and wellness section. This would reduce the reputational and other risks associated with including health apps of unknown quality and reliability on the marketplace.

G.6 National and regional authorities

National and regional authorities can require that any health app put on the market within their jurisdiction ha a health app quality label issued by a trusted app assessment organization.

G.7 Person or organization recommending health apps

Health app quality labels and reports can be used for or in the process of recommending health apps, avoiding the riske to recommend health apps or unknown quality. For example, individuals, journalists, or organizations representing patients or consumers can make recommentations for a specific health app, or a 'top ten' list of health apps."

Referanse: SN-CEN ISO/TS 82304-2:2021
Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021), s. 73-74.

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