On 1 July 2016, the Federal Agency for Medicines and Health Products published a call for applicants concerning its pilot project for mobile health apps. The initiative aims at evaluating a number of health apps in pilot projects to assess the adequate regulations, legal framework and reimbursement schemes that should be applied to such digital health products.
On 5 December 2016, the agency announced the selection of 24 projects for health apps from the 98 that were submitted. The selected projects relate to different applications of mobile health such as self-management, tele-monitoring and/or wearables within five therapeutic areas: acute stroke care, treatment of diabetes, cardiovascular diseases, chronic pain and mental health. The projects will be launched in the beginning of 2017 and last six months.
With this initiative the Minister for public health, Maggie De Block hopes to test the use of apps in the health sector in a controlled manner, with the aim of defining a general framework in which more health apps can be developed.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, December 2016 Issue (Thomson Reuters).