Regulatory Intelligence · EHDS Last verified · Sep 2026
Proposed in 2022 and in force since 25 March 2025, the EHDS Regulation ((EU) 2025/327) rewires how health data moves across Europe — for care and for research. Its deadlines run to 2031, which makes it the regulation where early positioning is cheapest and most decisive.
EHDS is in its secondary-legislation phase: implementing acts and general provisions are due by March 2027, but the patient-facing primary-use rights themselves don't switch on until March 2029 (first priority data categories — patient summaries, ePrescriptions, eDispensations) and March 2031 (the rest — imaging, labs, discharge reports). Secondary use follows the same 2029/2031 split. The joint TEHDAS2 action closed its second stakeholder consultation in January 2026 with over 750 responses, drafting guidance on proportionate fees and Secure Processing Environments. Separately, Art. 64 of the Regulation itself already sets penalties up to 4% of global annual turnover (€20m ceiling) for serious infringements — adopted law since the Regulation entered into force, not a future guidance figure, and comparable to GDPR from day one. For pharma and medtech this is a once-in-a-generation data-access opportunity; for providers and EHR vendors it is a mandatory conformity-assessment regime with a fixed clock and real enforcement teeth.
Deadline for key implementing acts and general provisions (incl. international transfer rules) to apply; EHR common specifications take shape. Patient-facing primary-use rights don't start yet — those phase in from 2029.
Patient summaries, ePrescriptions and eDispensations exchanged EU-wide via MyHealth@EU; secondary use applies for most data categories via HealthData@EU access bodies.
Second priority group — medical images, lab results, discharge reports — plus secondary use of genetic, molecular and clinical-trial data.
⏱ General application & implementing acts due in — days · Patient-facing primary use follows Mar 2029
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