Mobile Health

The public consultation on the Green Paper on mHealth identified safety and transparency of information as one of the main issues for mHealth uptake.

The large number of lifestyle and wellbeing apps available with no clear evidence on their quality and reliability is raising concerns about the ability of consumers to assess their usefulness, thus potentially limiting their effective uptake for the benefit of public health. Ensuring quality of data is also essential for linking apps to the electronic health records and for the effective uptake in clinical practice.

While FDA has progressed widely in the mobile Health Applications (mHealth), the Eu is lagging behind

In February 2016, the European Commission appointed a working group to draft mHealth assessment guidelines. The group includes representatives of patients, health professionals and providers, payers, industry, academia and public authorities.

The group will seek to provide common quality criteria and assessment methodologies that could help different stakeholders, in particular end-users, in assessing the validity and reliability of mobile health applications. The guidelines are expected to build on existing initiatives and best practices in Europe. Results are expected by the end of 2016.