Data Strategy Briefing — December 6, 2023

Executive briefing: On 6 December 2023 the Council of the European Union adopted its general approach to the European Health Data Space (EHDS) proposal. The position authorises negotiations with Parliament on mandatory cross-border exchange of electronic health records, permits for secondary data use, and the architecture for MyHealth@EU and HealthData@EU services.

Key data-space checkpoints

Primary use readiness. Align EHR systems with MyHealth@EU formats, data sets, and security requirements outlined in the Council text.
Secondary use governance. Prepare for health data access bodies to vet research, innovation, and policy analytics requests, including pseudonymisation and secure processing spaces.
Infrastructure planning. Scope investments for national contact points, logging, and consent services required to interface with EU platforms.

Operational priorities

Gap assessments. Compare Council amendments against existing national health data laws to identify conflicts requiring legislative updates.
Stakeholder engagement. Coordinate with hospitals, insurers, and research partners on data quality, interoperability, and governance obligations.
Funding strategy. Evaluate EU and national funding envelopes supporting EHDS infrastructure rollout and workforce development.

Enablement moves

Integrate EHDS milestones into healthcare data strategy roadmaps alongside GDPR and national e-health programmes.
Develop training for health data access body applicants covering permit criteria, security measures, and audit expectations.

Sources

Zeph Tech enables EHDS readiness with interoperability gap assessments, secondary-use governance frameworks, and EU funding advisory support.