The EHDS checklist
What to get right before the 2029 deadline
The European Health Data Space became law in March 2025, with deadlines in March 2029 and March 2031. Four years sounds like room to breathe. It isn’t. EHDS defines “electronic health record system” broadly enough to cover lab systems, radiology and PACS software, patient portals, and connected devices never built with EHDS in mind. If your organization touches patient data anywhere in that chain, you’re already in scope, whether anyone’s said so yet or not.
That’s the gap this checklist closes. Not another summary of what EHDS says. The regulation already does that. This is what to actually check, category by category, before “are we ready?” gets asked more often than you’d like.
The two dates that matter
EHDS arrives in stages. The European Commission’s implementing acts, expected around March 2027, will spell out the remaining technical detail. Two deadlines follow, each with its own scope:
- March 2029 — patient summaries and ePrescriptions/eDispensations exchangeable across EU borders; most secondary-use rules take effect.
- March 2031 — medical images, lab results, and hospital discharge reports join primary use; secondary-use rules extend to the rest, including genomic data.
Treat these as two forcing functions, not one deadline with a grace period. Organizations that treat 2029 as real pressure walk into 2031 in far better shape than those that wait.
What’s inside the checklist
We built this around seven categories that determine whether an organization is actually ready, not just technically compliant on paper:
- Governance & ownership
- Data quality & semantic interoperability
- Technical interoperability & FHIR readiness
- Security & access control
- Patient rights
- Vendor & certification path
- Organizational readiness
Each item comes with a plain-language note on what “good” actually looks like. Not just a box to check, but a reason it matters.
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Frequently asked questions
Is EHDS the same thing as GDPR?
No. EHDS builds on GDPR but adds sector-specific rules for cross-border health data exchange and for secondary use — research, innovation, and policy-making — that GDPR alone doesn’t cover.
Does EHDS apply to us if we’re not based in the EU?
Likely yes, if your systems or services are used by patients, providers, or health organizations inside the EU. Scope follows where the data and the users are, not where your headquarters sits.
What counts as an “EHR system” under EHDS?
More than you’d expect. The definition covers software and hardware that creates, stores, or processes electronic health data — which pulls in lab systems, imaging and PACS software, patient portals, and some connected devices, not just traditional EHR platforms.
What is the EEHRxF?
The European Electronic Health Record Exchange Format — the common format EHDS uses so health data looks consistent no matter which EU country it moves through.
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