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Regulation establishing the European Health Data Space
The European Health Data Space Regulation creates a framework for primary use (patient access and portability) and secondary use (research, innovation, policymaking) of electronic health data across the EU. It mandates interoperable EHR systems, data permit mechanisms for secondary use, and the MyHealth@EU cross-border infrastructure.
96
Articles
5
Priority Data Categories
600K+
Healthcare Providers Affected
Mar 2027
Applies
11 February 2025
Adopted by EU Parliament and Council
26 March 2025
Entered into force
30 June 2025
Member States designate National Digital Health Authorities
26 March 2027
Full application date — all provisions enforceable
26 March 2029
Priority health data group 1 exchangeable cross-border
Free, immediate electronic access to priority health data categories (patient summaries, prescriptions, medical images, lab results, discharge reports), right to download in standard format, right to transmit to provider of choice.
Mandatory CE marking for EHR systems processing priority health data, compliance with European electronic health record exchange format, security specifications and audit logging, pseudonymisation safeguards.
Health Data Access Bodies (HDABs) assess and issue data permits, processing in secure environments only, re-identification attempt prohibition, public health authority override for serious cross-border threats.
Mandatory interoperability platform for cross-border data exchange, standardised data format via implementing acts, third-country connections with compliance verification.
National Digital Health Authorities per Member State, market surveillance authorities, GDPR supervisory authority enforcement for primary use, HDABs enforce secondary use.
EUR 20 million or 4% worldwide turnover
Unauthorized access, failure to provide patient access, failure to rectify data
EUR 10 million or 2% worldwide turnover
Incomplete logging, minor non-compliance
EUR 20 million or 4% worldwide turnover
Re-identification attempts, extraction of personal data, non-compliance with HDAB measures
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