ISO/TS 82304-2:2021 - Health software — Part 2: Health and wellness apps — Quality and reliability

Тезис

Предпросмотр

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.

Общая информация

Текущий статус
: Published

Дата публикации
: 2021-07
Версия
: 1
Технический комитет
: ISO/TC 215 Health informatics
ICS
:
35.080 Software

35.240.80 IT applications in health care technology

Данный стандарт разработан для достижения следующих Цели в области устойчивого развития:

Хорошее здоровье и благополучие

Индустриализация, инновации и инфраструктура

Уменьшение неравенства

Ответственное потребление и производство

Приобрести данный стандарт

	Формат	Язык
std 1 187	PDF + ePub
std 2 187	Бумажный

CHF187

Жизненный цикл

Сейчас

Published

ISO/TS 82304-2:2021
Этап: 60.60

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