The European Commission announced earlier this month that it has has set up a working group to develop guidelines for assessing the validity and reliability of the data that health apps collect and process.
Based on their expertise, 20 members representing civil society, research and industry organisations were selected to participate in the working group. The guidelines are expected to be published by the end of this year.
The development of the guidelines is one of the follow-up activities to the Commission’s Green Paper on mobile health (April 2014). A public consultation on the Green Paper was carried out in 2014 and collected stakeholders’ views on how to tackle the challenges to the mHealth market in Europe. The results of the public consultation were published in January 2015.
Safety and transparency of information were identified by the respondents to the consultation as one of the main issues for mHealth uptake. The large number of lifestyle and wellbeing apps available, combined with no clear evidence on their quality and reliability, is raising concerns about the ability of consumers to assess their usefulness. This could limit the effective uptake of mHealth apps to the benefit of public health.
In order to fully benefit from the mobile health apps that people increasingly use to monitor their lifestyle and health status or to manage their chronic disease, it should be possible in the future to link data from these apps to the electronic health records.
This means that patients would be able to give access to their health professionals to consult the data collected by the apps.
Also, health professionals need the reassurance about the reliability of the apps, in order to be able to recommend apps to their patients and take apps’ data into consideration in a treatment/monitoring process.
The guidelines that the new Working Group will develop are expected to build on existing initiatives and best practices in Europe.
The group will seek to provide common quality criteria and assessment methodologies that could help different stakeholders (users, developers, vendors of electronic health record systems, payers etc.) in assessing the validity and reliability of mobile health applications.
Full details of the Working Group and the development of the guidelines can be found on the European Commission website here.