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[To Eurosmart members only]
mHealth label published by ISO, CEN and IEC
A new technical specification has been published to evaluate the quality and reliability of health and wellness apps. These apps are increasingly popular and fulfill many functions, ranging from counting calories to tracing COVID-19.
The specification enables the assessment of the apps with a scoring methodology that gives them a label. It aims to provide better guidance to users and health professionals when comparing different apps. The European Commission promoted this mHealth label on its website.
The two documents are the following:
ISO/TS 82304-2, Health software – Part 2: Health and wellness apps – Quality and reliability, brings together and builds on guidelines and requirements for apps by many local and national health organizations around the world to ensure they are safe, reliable and effective.
ISO/TS 82304-2 was developed by ISO technical committee ISO/TC 215, Health informatics, in collaboration with IEC/TC 62, Electrical equipment in medical practice, of the International Electrotechnical Commission (IEC). The project was led by CEN, the European Committee for Standardization.
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