Since 2023, France and Germany have been working together to define a joint roadmap for digital healthcare. This cooperation aims to strengthen quality, safety and access to innovation for patients, notably through the scientific evaluation of digital medical devices for therapeutic purposes used by patients, under the accelerated "DiGA" (Germany) and "PECAN" (France) procedures.

Concrete actions for 2025 and 2026

• The organization of joint workshops between ministries and evaluation agencies (HAS and BfArM) to share their practices and analyze concrete cases of digital medical devices.
• The establishment of in-depth exchanges of experts between the two agencies, in order to observe the respective assessment processes.
• The joint publication of a scientific article outlining each country's assessment principles.

• Regular communication on the progress of the cooperation and the publication of a review at the end of 2026.

A commitment to the future of European evaluation of MNDs

This cooperation is part of a European dynamic, with the ambition of preparing for possible joint evaluations of digital medical devices at European Union level. It aims to guarantee equal access to innovative, safe and high-quality care, while offering companies in the sector a clear, documented framework.

By cooperating with their German counterparts, the Ministry and the HAS are reaffirming their commitment to innovation and European cooperation in the field of digital health.