Jurisdiction

France

France regulates health products through the ANSM, which supervises medicines and medical devices, and the HAS, which assesses clinical benefit for reimbursement. France has also moved early on digital health, with dedicated reimbursement pathways for digital medical devices.

Regulation Category Type · Breadth Date

Ségur du numérique en santé: regulatory framework for paramedical professionals and midwives published

Official publication of the decree establishing the Ségur du numérique en santé programme for paramedical professionals and midwives, setting the regulatory framework for software interoperability and secure health data exchange.

ANS - French Digital Health Agency · France
Digital Health & AIHealth Data, Privacy & Security InteroperabilityHealth dataElectronic health records
Rule change Sector
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