Health and wellness apps

What makes an health app efficient and reliable

The EU and many national authorities start initiatives to support COVID lockdown exit strategies through standards-compliant mobile data and apps. The expert group realizes the relevance of its work on EN-ISO TS 82304-2 Health informatics – Part 2 Health and wellness apps - Quality and reliability. Herewith we share with you a preview of the working draft: the chapter on the quality criteria. Please note that this is a working draft and we are still developing it and including a conformity assessment procedure. If you are interested to jointly improve the document please contact NEN or your national standardization body. The European toolkit for covid19 tracing apps references EN-ISO- 82304-2 for assessing the quality and reliability of apps. >> Read the document

There are thousands Health and Wellness apps: to quit with smoking, to track sporting activities, to guide lifestyle change. Without any medical knowledge these apps can be downloaded and used. However there is also concern about the safety and reliability of many of these apps.

Building upon the existing international initiatives and ISO and IEC standards, the European Commission has commissioned the development of a Technical Specification for Quality and Reliability Requirements for Health and Wellness Apps.

The objective of the Technical Specification is to define quality and reliability criteria which support app developers to design and users of apps to select better apps. Compliance to the criteria results in a score that is reflected in a label (design: Bureau OS), inspired by the Energy label used in Europe and elsewhere.

CEN, CENELEC, ISO and IEC jointly work on the TS. The project team includes experts from 14 countries: Australia, Belgium, China, Finland, France, Germany, Ireland, Italy, Japan, Netherlands, Nigeria, Sweden, United Kingdom and United States.

Interest to participate?

The project started in 2019. The draft text on the checklist has been tested by a multinational Delphi panel. The Delphi on assessment and interpretation is ongoing.
At all stages the expert group welcomes comments to jointly improve the Technical Specification.

Anybody with an interest in the development and maintenance of the quality and reliability criteria can participate by providing comments or proposing dissemination-, acceptance or implementation activities.

This project is especially interesting for:

  • Care professionals who want to know which apps are useful and reliable to be used in health care;
  • Users of apps, or consumers who want to know which apps are safe, and deliver on what they promise;
  • App developers and app checkers who want to know what criteria are used to assess whether the app is safe, useful, user friendly and technically sound.

Why participate?

Participating in the development has benefits:

  • Make sure that existing (national) criteria are incorporated in the international document;
  • Cooperate in a network of dedicated experts on the subject;
  • Know early about the quality criteria that will be used to assess health and wellness apps.


When you want an update of the developments so far or have interest to participate please contact your national standardization body or NEN.

Send an e-mail

Additional information is available on CEN/TC 251 or ISO/TC 215.