Commission updates EHDS FAQ to 67 questions on regulation's first anniversary

DG SANTE published version 1.1 of the EHDS Frequently Asked Questions, a 61-page guidance document now covering 67 questions across primary use, secondary use, EHR requirements, HDABs, governance, and international aspects. The update adds six new questions — on EHR product scope, future data access extractions, HDAB appeal procedures, and the EHDS relationship with the Cyber Resilience Act and social security coordination — and expands three existing entries on EHR definitions and territorial scope. This is the first update since the original FAQ was published in March 2025, landing exactly one year after the regulation entered into force. For EHR vendors, the new Q24 clarifies which products fall within the regulation's scope — a definition that determines certification obligations under Chapter III. Member States preparing national implementing measures now have Commission guidance on HDAB appeal procedures and cross-regulation interplay ahead of the March 2027 deadline for implementing acts.