Data Strategy Briefing — March 20, 2025
Member States must designate European Health Data Space access bodies by March 2025, compelling hospitals and digital health platforms to align permit workflows and evidence packs with national supervisory expectations.
Executive briefing: The European Health Data Space (EHDS) regulation requires each Member State to designate health data access bodies within 12 months of the regulation's entry into force, targeting March 2025. Those bodies will gatekeep secondary-use permits, monitor anonymisation safeguards, and coordinate with HealthData@EU infrastructure.
Key governance checkpoints
- Stakeholder mapping. Identify likely access bodies and establish liaisons to understand application formats, security requirements, and audit expectations.
- Permit readiness. Assemble documentation demonstrating lawful access, minimisation, and protection measures for research, innovation, or public-interest requests.
- Infrastructure integration. Ensure data-sharing platforms can interoperate with MyHealth@EU and HealthData@EU specifications, including pseudonymisation and logging capabilities.
Operational priorities
- Policy harmonisation. Align internal governance policies with EHDS Chapter V obligations covering secondary-use data handling and de-identification.
- Security assurance. Validate that processing environments meet the cybersecurity and access control requirements that access bodies will enforce.
- Training. Educate research and compliance teams on national application processes, timelines, and appeal rights.
Enablement moves
- Draft template applications and risk assessments for priority use cases (public health surveillance, AI development, quality improvement).
- Integrate EHDS obligations into broader EU data governance programmes covering AI, GDPR, and sectoral regulation.
Sources
Zeph Tech equips EHDS programmes with permit templates, access body engagement playbooks, and cross-regulation governance frameworks.