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Hospitals Race to Certify Systems Before Health Data Deadlines

Lund: In the medical-technology cluster around this southern Swedish city, software teams have spent the winter working through certification checklists. The reason lies in a new European rulebook that reshapes how hospitals, clinics and record vendors handle the most sensitive information they hold, the patient’s own health data.

The European Health Data Space Regulation entered into force in March 2025 and now moves through a long, staged transition. The Commission has published guidance and an updated set of frequently asked questions this year, and it expects to finalise the rules on the secondary use of health information during the first half of 2026. The general date of application falls on 26 March 2027.

The law rests on two pillars. The first gives patients firmer control over their records for primary use, letting them read, download and share summaries, prescriptions and test results, and carry that information across borders when they travel or move. A Swede treated in Portugal should, in time, hand a clinician a legible history rather than a language barrier.

The second pillar governs secondary use. Researchers, regulators and public bodies will apply to national health data access bodies for permission to study large, pseudonymised datasets. Supporters argue that this could speed up work on cancer, rare diseases and pandemic preparedness, fields where Europe’s fragmented records have long slowed discovery.

Vendors feel the pressure first. Electronic health record systems must meet common interoperability and security standards, and manufacturers must certify that their products comply. Hospitals that run ageing software now weigh costly upgrades against the risk of falling foul of the timetable.

Privacy advocates watch the secondary-use provisions closely. They warn that pooling sensitive records, even stripped of names, carries real re-identification risks, and they press for tight opt-out rights and strong oversight. Lawyers, meanwhile, puzzle over where the new regime meets the older General Data Protection Regulation, an uneasy pairing that will keep courts busy.

The heaviest lifting still lies ahead. Cross-border exchange of the first priority categories, patient summaries and electronic prescriptions, is not due in every member state until 2029, and richer categories such as imaging and lab results follow later still. A joint action involving twenty-nine countries is assembling the shared infrastructure in the meantime.

For clinicians in Lund, the promise is concrete: fewer repeated tests, faster referrals and a record that follows the patient rather than the institution. The task now is to build the plumbing carefully enough that trust travels with the data.