This cooperation involves the French and German health authorities, including the Ministry of Labor, Health, Solidarity and Families, the Haute Autorité de Santé (HAS), the German Federal Ministry of Health and the Federal Institute for Drugs and Medical Devices (BfArM).

A strategic partnership for innovation in digital healthcare

Since 2023, France and Germany have been working closely together to develop a joint roadmap for digital healthcare. This joint initiative aims to improve the quality of care, enhance patient safety and facilitate access to innovations. In particular, it is based on a scientific assessment of digital medical devices for therapeutic purposes, used by patients under the "DiGA" accelerated procedures in Germany and "PECAN" in France.

Concrete actions for 2025 and 2026

• Organization of joint workshops between ministries and assessment agencies (HAS and BfArM) to share their practices and analyze concrete cases of digital medical devices.
• Setting up in-depth expert exchanges between the two agencies, to observe the respective assessment processes.
• Joint publication of a scientific article outlining each country's assessment principles.
• Regular communication on the progress of the cooperationand the publication of areview at the end of 2026.

A commitment to the future of European evaluation of DMNs

This initiative is part of a European drive to prepare common evaluations of digital medical devices across the European Union. It aims to ensure equitable access to innovation and offers companies in the sector a clear, documented framework.

By joining forces with their German counterparts, the Ministry and HAS are reaffirming their commitment to innovation and European convergence in digital health.