European Union: European Commission opened consultation on draft implementing regulation on minimum metadata elements for European Health Data Space including interoperability 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 mandates that dataset catalogues be standardised and machine-readable to ensure semantic and technical interoperability across Member States. It requires health data holders to use the HealthDCAT-Application Profile (HealthDCAT-AP) as the common metadata framework, enabling the interconnection of national dataset catalogues and dataset catalogues of authorised participants into the EU dataset catalogue established under Article 79 of Regulation (EU) 2025/327.