About

French HDS v2.0 health-data hosting rules are now fully in force

Published
Score
12

Why it matters

France's health-data hosting certification regime has entered full enforcement under its revised HDS v2.0 framework. Certification bodies must now issue and renew certificates exclusively under the new rules rather than the 2018 version. The shift is not a new statute but the completion of a transition period that began in November 2024, making the updated requirements legally binding for all providers hosting personal health data in France.

The Agence du Numérique en Santé (ANS) administers the framework under Article L.1111-8 of the French Public Health Code, which mandates appropriate certification for entities hosting certain personal health information. Major cloud vendors—Google Cloud, Microsoft, AWS, and OVHcloud—publicly track HDS compliance because it is a prerequisite for serving French health-data workloads. The framework was published in the French Official Journal in May 2024 and provided a two-year transition window now expiring.

HDS v2.0 tightened requirements around data sovereignty, including exclusive storage within the EEA, greater transparency on international access and transfers, and alignment with ISO 27001:2022. Providers can no longer rely on the prior framework for new or renewed certifications. Any organization hosting French health data must now audit its cloud architecture, vendor certifications, and contract terms against the new standard. This is a hard compliance deadline for the health-tech and cloud sectors.

mail Subscribe to Health Care email updates

Primary sources. No fluff. Straight to your inbox.

Also on LawSnap