Why might the EHDS widen the gap instead of closing it?

Azati observes that states like Finland and Estonia arrive with mature, connected systems already in place. Lower-maturity states arrive with data silos and thin governance, since a shared standard doesn't erase a decade of infrastructure debt.

What gap does a common EHDS standard fail to fix on its own?

Azati highlights Malta's case, where practitioner research points to no reimbursement route for newer digital therapeutics. The directive standardizes data exchange but doesn't address gaps like this that sit outside its scope.

What should states without mature health data infrastructure do before 2029?

Azati recommends fixing the underlying infrastructure foundation first rather than treating interoperability as a simple compliance deadline. Regulation-aware health engineering earns its keep specifically in states facing this kind of foundational build.

What experience does Azati have building traceable, regulated health data systems?

Azati built an AI patent-and-sequence platform that handles more than 50 million regulated life-sciences records with traceability built in. In health data, an answer that can't be audited doesn't count, which is why traceability was designed in from the start.

Does the EU Health Data Space Level the Field for Small States – or Just Widen the Leaders' Head Start?

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August 13, 2026

Does the EU Health Data Space Level the Field for Small States – or Just Widen the Leaders' Head Start?

Maksym Kramarenko

Digital Transformation Advisor, Azati

Quick answer: Most people treat the European Health Data Space as a compliance chore, another certification, another box. That’s the wrong lens. The EHDS entered into force in March 2025, the first implementing act in April 2026 stood up the governing board, and the interoperability clock is now running EU-wide toward 2029. The honest answer to whether it levels the field is: it depends entirely on where you were standing when the gun went off. Same rules, very different starting lines.

One view: it’s the great equalizer

Common standards, cross-border access, mandated interoperability – on paper, a small state gets the same rails as a big one, and patients get their data anywhere in the EU.

The other view: it widens the gap

Finland and Estonia arrive with mature, connected systems; lower-maturity states arrive with data silos and thin governance. In Malta’s case, a practitioner’s research points to something the directive doesn’t fix – no reimbursement route for newer digital therapeutics. A shared standard doesn’t erase a decade of infrastructure debt.

Our read

(And I’m the one speculating here.) The people who’ll actually know are the DPOs running data inside hospitals, not the headlines. If your national plumbing isn’t ready, "interoperable by 2029" is a deadline, not a gift. Fix the foundation first – that’s where regulation-aware health engineering earns its keep.

Where we’ve done this

Read the case study

Azati’s AI patent-and-sequence platform handles 50M+ regulated life-sciences records with traceability built in, because in health data, an answer you can’t audit doesn’t count.

FAQ

When does the EHDS actually start to bite?

It entered into force in March 2025; the first implementing act (April 2026) set up the board, with key primary- and secondary-use obligations applying from March 2029 and 2031.

Does the EHDS help smaller member states catch up?

It gives them the same framework, but not the same starting point – states without mature national infrastructure face a foundational build, not a formality.

Getting a health platform EHDS-ready?

Let’s map the gap

Adapted from a LinkedIn post by Maksym Kramarenko, Digital Transformation Advisor at Azati – read the original. Sources: European Commission / EHDS Regulation (EU) 2025/327; GLOBSEC.