Europe's two largest digital health markets have decided to pool their expertise. The French National Authority for Health (Haute Autorité de Santé - HAS) and the German Federal Institute for Drugs and Medical Devices (BfArM), in collaboration with the respective health ministries, have initiated bilateral in-depth discussions on their practices of assessing digital medical devices (DMDs) for therapeutic purposes and individual patient use.

“Cooperation between France and Germany in this field is an important step towards harmonising the assessment of digital health technologies at European level,” emphasized David Sainati, co-head of the Digital Health Delegation at the French Ministry of Health. 

It is not only in the interest of a digital health single market but also for citizens to promote at the EU level faster access to DMDs that have demonstrated clinical benefits for patients or organisational benefits. 
As a matter of fact, these two countries have, one after the other, set up fast track procedures to provide access to DMDs. Germany, with its DiGA framework launched in 2020, has already approved around sixty digital solutions. France, meanwhile, introduced the Prise en Charge Anticipée Numérique (PECAN) framework in 2023.

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

“Through the DiGA and PECAN pathways, Germany and France are now international pioneers in DMD reimbursement. A close exchange between national authorities may strengthen this position both in the interest of citizens and innovators” said Dr Lars Hunze, Deputy Head of Unit at the Federal Ministry of Health.

Representatives of France and Germany discussed commonalities and differences in their evaluation principles and practices, based on concrete cases and in-depth analyses of the conclusions of previously evaluated dossiers. This first meeting will be followed by other regular exchanges, responding to the many expectations of the ecosystem, in particular from companies wishing to position themselves simultaneously on both markets.