Data Strategy Briefing — May 3, 2022
The European Commission proposed the European Health Data Space, defining governance for cross-border primary care access and secondary use of health data across the EU.
Executive briefing: The European Commission adopted the European Health Data Space (EHDS) proposal on 3 May 2022, introducing rules for cross-border patient access, electronic health record standards, and secondary-use permits managed by national health data access bodies. The regulation will serve as a flagship common European data space.
Key data-space checkpoints
- Primary use readiness. Align electronic health record systems with mandatory formats, certification, and MyHealth@EU cross-border exchange requirements.
- Secondary use governance. Identify datasets eligible for permits, including research, public health, and regulatory purposes, and define pseudonymisation and access controls.
- Data holder obligations. Map responsibilities for hospitals, payers, and health app providers to respond to data access requests and logging requirements.
Operational priorities
- Programme governance. Establish EHDS steering groups coordinating IT, clinical, privacy, and policy stakeholders.
- Standards adoption. Track implementing acts on EHR interoperability, terminology, and certification to inform procurement and vendor management.
- Risk management. Update compliance risk registers covering enforcement, penalties, and supervisory cooperation with data protection authorities.
Enablement moves
- Launch readiness assessments measuring maturity across interoperability, consent, and secondary-use capabilities.
- Engage with national health data access bodies during consultation phases to influence permit processes and data quality expectations.
Sources
- Proposal for a Regulation on the European Health Data Space
- Commission press release on the EHDS proposal
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