Data Strategy Briefing — March 15, 2024

Executive briefing: The Council presidency and European Parliament negotiators struck a provisional agreement on the European Health Data Space (EHDS) on 15 March 2024, aligning rules for cross-border patient access, data altruism, and secondary use permits.

Key data governance checkpoints

• Data holder obligations. Identify electronic health record systems and registries that must support common technical specifications and access through national EHDS contact points.
• Secondary-use compliance. Map datasets eligible for health data access bodies, including quality metrics, pseudonymisation requirements, and data permit workflows.
• Cross-border services. Assess readiness to provide patient access to electronic health data in a standardised format across the EU.

Operational priorities

• Governance design. Prepare to engage with health data access bodies, ensuring governance charters, ethics reviews, and application pipelines meet EHDS standards.
• Technical alignment. Track forthcoming implementing acts on EHR interoperability, semantic standards, and data quality indicators.
• Stakeholder outreach. Coordinate with hospitals, insurers, and digital health vendors to align on consent, logging, and breach notification obligations.

Enablement moves

• Run maturity assessments covering EHR interoperability, consent capture, and audit trails against EHDS requirements.
• Update regulatory roadmaps to incorporate EHDS adoption alongside HTI-1 and TEFCA investments.

Sources

• Council press release on the EHDS provisional agreement
• European Parliament press note on the EHDS deal

Zeph Tech guides health and life-science organisations through EHDS planning, covering interoperability, governance, and cross-border compliance.

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