The Regulation lays down the minimum metadata elements, and their characteristics, that health data holders must provide to health data access bodies for dataset descriptions under Article 60(3) of the EHDS Regulation (EU) 2025/327, supporting the public dataset catalogues required by Article 77(1) for the secondary use of electronic health data. It designates the HealthDCAT-AP, a technical specification built on the general DCAT-Application Profile, as the common metadata framework, and extends the same requirements to authorised participants in HealthData@EU. The Annex lists minimum metadata elements including access rights, applicable legislation, coding system, custodian, description, distribution, has-personal-data, health data access body, health data category, identifier, provenance, publisher, temporal coverage, title, type, and variables, each expressed using HealthDCAT-AP's definitions, structure and controlled vocabularies. The health data category element must use the controlled vocabulary in Article 51(1), points (a) to (q), of Regulation (EU) 2025/327. Health data holders may add further elements voluntarily, and must verify descriptions at least annually per Article 60(3). It applies from 26 March 2029.
Author: European Commission
Status: Adopted / Published
Adoption date: 2026-09-18
Last updated: 17 Oct 2026
Category: Relevant legislation
Subcategory: Implementing Regulation