UNE CEN ISO/TS 82304-2:2021
Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021) (Endorsed by Asociación Española de Normalización in September of 2021.)
Software sanitario. Parte 2: Apps de salud y bienestar. Calidad y confiabilidad (ISO/TS 82304-2:2021) (Ratificada por la Asociación Española de Normalización en septiembre de 2021.)
| Označení normy: | UNE CEN ISO/TS 82304-2:2021 |
| Počet stran: | 89 |
| Vydáno: | 2021-09-01 |
| Status: | Norma |
UNE CEN 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 Health apps can be subject to national legislation, such as for medical devices.
