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.
Ensuring quality of the data that health apps collect and process is also essential for linking apps to electronic health records and for their effective uptake in clinical practice. In two open stakeholder meetings (on 12 May 2015 and 6 July 2015), stakeholders confirmed that it would be useful to work on common assessment methodologies for mHealth.
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.
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.
As a result of a public call for expression of interest, which closed on 04 December 2015, the Commission received 75 applications. 20 of them were selected taking into account the balanced representation of relevant know-how and areas of interest in order to ensure the highest level of expertise, as well as gender and geographical balance.
The group will have its first meeting in March 2016. The guidelines are expected to be finalised by the end of 2016.