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

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