Integrating CEN ISO/TS 82304-2 in the Catalan Health App Assessment Framework: Comparative Case Study.

ABSTRACT:

Background

Health apps are increasingly being used to promote health, manage diseases, and deliver health care services. Still, there is scarce objective information regarding their quality beyond the required Conformité Européenne mark for medical apps, leading to potential risks for users. To address these challenges, several authorities have developed health app assessment frameworks. In 2017, the TIC Salut Social Foundation (FTSS) in Catalonia developed its own health app assessment framework, which has been in use since that year. The publication of CEN ISO/TS 82304-2 (abbreviated as 82304-2)-a Technical Specification for assessing health apps-and the cocreation of the Label2Enable 82304-2 handbook for certified assessment organizations provide a unique opportunity to harmoniz

SUBMITTER: Llebot Casajuana B 

PROVIDER: S-EPMC12154936 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature