European Committee for Standardization (CEN)

From the eHealth Standards EU website:

A new CEN Technical 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 there being a clear way for users to establish which ones are reliable and provide evidence to support claimed benefits.

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

• App developers are a disruptive community, with many members who are entering the Health and Wellness IT market without prior experience in a Health Informatics context. These developers will not have experienced a transfer of health informatics knowledge and good practice from co-workers and broader corporate memory. The specification will compensate for this by providing a set of requirements that have been through a rigorous standards development process.
• This community does not expect to have to read multiple documents, and map generic standards into their context of use. Apps are typically developed to deliver a small piece of functionality, building on an existing platform – often with a small team doing the work. The specification will directly address the needs and concerns of app developers.
• Apps run on platforms, and are made available through distinct channels such as app stores and libraries. These platforms and channels provide potential points of control where quality and reliability of apps can be influenced, and this will be taken into account during the development of the specification.
• There is a need for a specification to establish a consistent set of criteria for among the controlled channels being maintained as trustworthy sources of health and wellness apps in the many national health initiatives within the EU.

The Technical 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, to ensure that it is consistent with international standards. The project team includes members from the following CEN member countries: Belgium (NBN), 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.”