European Union: European Commission opened consultation on draft implementing regulation on minimum metadata elements for European Health Data Space including metadata design requirements

On 14 April 2026, the European Commission opened a consultation on the draft implementing regulation laying down the minimum metadata elements and their characteristics to be provided by health data holders for dataset descriptions for the secondary use of electronic health data until 12 May 2026. The implementing regulation was issued in line with Article 77(1) of Regulation 2025/327 establishing the European Health Data Space. The draft implementing regulation requires health data holders to express minimum metadata elements using the definitions, structure, cardinalities, and controlled vocabularies set out in the HealthDCAT-AP. The minimum metadata elements, listed in Part B of the Annex, include access rights, applicable legislation, coding system, custodian, distribution, geographical coverage, health category, health data access body, identifier, provenance, temporal coverage, and variables. The HealthDCAT-AP builds on the general DCAT-Application Profile and is developed and maintained by the Commission to support the description of health datasets made available for the secondary use of electronic health data.