The European Commission has proposed new rules under the European Health Data Space (Regulation (EU) 2025/327) to standardize dataset descriptions for the secondary use of electronic health data across EU Member States.

The regulation requires health data holders to provide mandatory metadata elements, including dataset source, scope, characteristics, and access conditions, ensuring transparency and usability.

A key component is the HealthDCAT-AP framework, which enables standardized, machine-readable dataset descriptions and supports seamless data sharing.

The initiative focuses on improving semantic and technical interoperability, allowing national and EU-level dataset catalogues to be interconnected efficiently.

Stakeholders can submit feedback until 12 May 2026. Health data holders must also annually verify and update dataset metadata to maintain accuracy and reliability.

This regulation strengthens data accessibility, cross-border research, and digital health innovation across the EU.