EU Commission Proposes mHealth App Assessment Guidelines
EU Commission proposes draft guidelines for assessing the validity and reliability of mHealth apps


'In 2016 users will trust health apps more than their doctors'. So predicted Forbes Magazine in 2015 in reference to Mobile Health ("mHealth") apps, which are becoming increasingly popular to monitor health and well-being. However, the rapid proliferation of these apps with no clear evidence on their quality and reliability has raised concerns about the ability of consumers to assess their usefulness, thus potentially limiting their effective uptake for the benefit of public health.

In February 2016, following the results of an earlier public consultation, the European Commission (the "Commission"), appointed a working group to develop voluntary mHealth assessment guidelines ("Guidelines"). The purpose of the Guidelines is to provide common quality criteria and assessment methodologies to assist both consumers and healthcare practitioners in:

  • Deciding which app to use
  • Assessing the quality of each app with regard to clinical effectiveness
  • Ensuring the apps are in line with international standards

It was intended that the Guidelines be issued in four iterations and a third draft is expected before the end of 2016, with the final report expected to be published in January 2017. The second draft of the Guidelines identifies key criteria for assessment: reliability, desirability, credibility, safety, security, transparency, usability, effectiveness, and stability. The Guidelines also propose an app evaluation process that would include:

  • Initial validation of the app
  • Risk assessment that determines appropriate level of scrutiny for the app
  • Scrutiny of both the technological and the medical aspects of the app

It is also envisaged that the final set of Guidelines will include a list of questions to assist an app developer in evaluating the reliability of the app. Another interesting addition to the second draft is the proposal of an app-certification process by either public or private bodies of Member States to ensure compliance with the Commission guidelines.

Follows us on Twitter @WFIDEA

Contributed by Brian McElligott

Key Contacts

David Cullen Partner

Related Practice Areas

Related Industry