As part of the France 2030 Innovative Medical Devices Plan, a public consultation will be held on the digital challenge in mental health ("Grand défi numérique en santé mentale"). The purpose of this challenge is to create and ensure a framework favourable to digital medical devices in the prevention, detection and care of patients suffering from mental disorders.
According to the French government 1 , psychological disorders affect one in four people over the course of their lives, and represent the top expense item for the French health insurance system. However, there is a significative gap between the growing needs of patients (Covid-19, economic insecurity, geopolitical context, etc.) and the mental health care services available.
Therefore, an action plan on digital medical devices has been set up, in cooperation with various players from the ecosystem, and will be now subject to a public consultation, focusing on four areas:
- innovation and research;
- evaluation of tools;
- user training; and
- coverage and financing 2 .
In particular, the issue of coverage and financing is a key aspect in the development of the digital mental health sector. According to the co-pilots of the digital challenge in mental health, innovative digital medical devices in the field of mental health are not currently covered by health insurance 3 . Indeed, in practice, the medical devices concerned would either be covered by private players (insurer or complementary health insurance), or directly sold to patients.
The public consultation could therefore lead to some improvements in this regard, especially since the new early coverage regime (“PECAN”) of DTx was recently implemented in France (Decree No. 2023-232 of 30 March 2023). As a reminder, this legal framework allows DTx reimbursement by the health insurance scheme for a non-renewable period of 1 year, under strict conditions (Art. L. 162-1-23 of the Social Security Code). For more information, please read our Guide on Key legal aspects of implementing digital therapeutics (DTx) in France.
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