CEN ISO/TS 82304-2:2021

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

ACTIVE

About this standard

Languages
German and English
Type
NBN
Standards committee
CEN/TC 251
Status
ACTIVE
Publication date
13 August 2021
ICS Code
35.080 (Software)
35.240.80 (IT applications in health care technology)
Withdrawn Date

About this training

Summary

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.