Europe's two largest digital healthcare markets have decided to pool their expertise. France's Haute Autorité de Santé (HAS) and Germany's Federal Institute for Drugs and Medical Devices (BfArM), in collaboration with their respective health ministries, have begun in-depth exchanges on their assessment practices for patient-used, therapeutically-aimed digital medical devices (DMDs).

"This Franco-German cooperation is an important step towards a European perspective of harmonizing the assessment of digital health technologies"

underlined David Sainati, Co-responsible for digital health at the French Ministry of Health.

With the aim in a single market for digital health, but also in the interests of citizens, it is essential to promote, at European level, faster access to DMNs that have demonstrated a benefit whether clinical for patients or organizational.

In fact, these two countries have, one after the other, set up a fast track to give access to DMNs. Germany, with its DiGA program launched in 2020, has already approved some 60 digital solutions. France, meanwhile, introduced Prise en Charge Anticipée Numérique (PECAN) in 2023.

BfArM in Germany and HAS in France have also been part of a working group bringing together experts from the public and academic sectors since its launch in 2022, the "European Taskforce for Harmonised Evaluations of Digital Medical Devices". At the end of 2024, this taskforce will publish recommendations on MND taxonomy and evaluation criteria.

"With the DiGA and PECAN systems, Germany and France are international pioneers in MND reimbursement. Close exchange between national authorities strengthens this position in the interests of citizens and innovators."

said Dr. Lars Hunze, Deputy Head of Unit at the Federal Ministry of Health

Representatives from both countries exchanged around their evaluation principles and practices around concrete cases and in-depth analyses of the findings of some previously evaluated dossiers. This first meeting will be followed by other regular exchanges, responding to the many expectations of the ecosystem, in particular companies wishing to position themselves simultaneously on both markets.