Data Strategy Briefing — April 24, 2024

Executive briefing: On 24 April 2024 the European Parliament voted to adopt the European Health Data Space (EHDS) regulation, setting in motion a phased regime for primary and secondary use of electronic health data across the EU. Member States must designate health data access bodies, certify EHR systems against a new EU-level standard, and build data access services enabling researchers, public agencies, and innovators to request de-identified datasets under strict purpose limitations.

Key governance checkpoints

• Access body engagement. Identify national health data access bodies likely to emerge and prepare evidence dossiers supporting public-interest reuse requests.
• EHR certification planning. Inventory clinical systems that will need EU-wide EHR labelling, prioritising modules processing structured documents, imaging, and genomics.
• Secondary-use controls. Strengthen anonymisation, synthetic data, and audit logging capabilities to satisfy EHDS safeguards on re-identification and data combination.

Operational priorities

• Cross-border governance. Align data-sharing agreements with Article 33 obligations, including security requirements for infrastructure joining MyHealth@EU and HealthData@EU.
• Stakeholder alignment. Partner with clinical, research, and compliance leaders to set intake processes for EHDS data permits and appeals.
• Timeline modelling. Track trilogue and Council formal adoption steps that will fix the final application dates across 2025 and 2026.

Enablement moves

• Brief EU subsidiaries on how EHDS interacts with GDPR, AI Act Article 54, and national health data regimes.
• Coordinate with cybersecurity teams on the network and security certification packages expected for EHDS gateways.

Sources

• Parliament gives the go-ahead to the European Health Data Space
• European Commission EHDS overview

Zeph Tech supports EHDS programmes with secondary-use governance playbooks, EHR certification readiness, and cross-border evidence assembly.

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