Commission specifies minimum metadata elements for secondary-use health dataset descriptions under EHDS
Original title: Commission Implementing Regulation (EU) 2026/2098 of 18 September 2026 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 under Article 77(4) of Regulation (EU) 2025/327 establishing the European Health Data Space
The European Commission has adopted Implementing Regulation (EU) 2026/2098, laying down the minimum metadata elements and their characteristics that health data holders must provide when describing datasets for secondary use of electronic health data, pursuant to Article 77(4) of the EHDS Regulation (EU) 2025/327. The regulation enters into force on 11 October 2026, with a further application date of 26 March 2029. Health data holders will need to ensure their dataset descriptions conform to the specified metadata structure when making data available for secondary use purposes.
What changed
- Establishes the minimum set of metadata elements and their characteristics that health data holders are required to provide for dataset descriptions intended for secondary use of electronic health data.
- Sets entry into force on 11 October 2026, with an additional recorded application date of 26 March 2029.
- Implements Article 77(4) of Regulation (EU) 2025/327 (EHDS), translating that mandate into concrete, operational metadata requirements.
What the document requires
Health data holders must provide minimum metadata elements and their characteristics for dataset descriptions for secondary use of electronic health data as specified in the regulation.
Who is affected
Health data holders (as defined under EHDS) in the EU who hold electronic health data subject to secondary use obligations under Regulation (EU) 2025/327.
Summary generated by a language model; the official text prevails. Not legal advice.