Following the example of the German Digital Health Applications (DiGA), France now also has a fast-track procedure for digital therapeutics with Decree 2023-232 for digital medical devices (PECAN). Similar to the German BfArM, the French health authority Haute Autorité de Santa (HAS) is responsible for approval. Relevant data collected outside France are also accepted as proof of efficacy. Some important questions such as prices are still open. German DiGA manufacturers will be keeping a close eye on developments with a view to entering the sales market in the neighboring country.
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