European development of a quality standard for evaluating health apps

European development of a quality standard for evaluating health apps

CEN, the European Committee for Standardisation, is pleased to announce the start of a project to address concerns about the Quality and Reliability of Health and Wellness Apps.

A new specification for ‘Quality and Reliability of Health and Wellness Apps’ is being developed at the request and with the support of the European Commission. It is due to be completed in 2020. It will help to establish a common framework across Europe for the evaluation of these apps, giving users and health professionals confidence that the apps are fit for purpose, and providing app developers easier access to European markets.

Europe is experiencing a fast growing market for Health and Wellness Apps. At the same time, concerns about the quality and reliability of apps have risen. Many Health and Wellness Apps are being published without clarity on the level of quality and reliability.

This specification addresses the specific needs of the developers of Health and Wellness Apps:

The Specification is being developed by the European standardisation committee CEN/TC 251 Health Informatics in collaboration with experts from the standardisation organisations ISO and IEC. The project team includes members from the following CEN member countries: France (AFNOR), United Kingdom (BSI), Germany (DIN), Netherlands (NEN), Sweden (SIS), Finland (SFS) and Italy (UNI). Quoting the project leader Charles McCay: “Initial work for this standard has already been done in the United Kingdom with the publication by BSI of the publicly available specification PAS 277. This project will expand that work to meet the wider European requirements and ensure compatibility with the world health informatics standards from ISO and IEC.”

Further details about the project can be found here

Those interested in participating on this project should contact their national standards organisation via ISO and/or CEN-CENELEC.

For more information on European standardization activities in relation to eHealth, please see the CEN website:

For more information about CEN/TC 251 ‘Health informatics’:



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