Subject matter and scope
Article 1
1. This Regulation lays down the minimum metadata elements for dataset descriptions, and the characteristics of those elements, that health data holders are required to provide to health data access bodies pursuant to Article 60(3) of Regulation (EU) 2025/327 for the secondary use of electronic health data, as well as the metadata framework to be used for that purpose. 2. This Regulation also applies, where relevant, to authorised participants in HealthData@EU when providing dataset descriptions in accordance with Regulation (EU) 2025/327. 3. This Regulation shall not prevent health data holders from providing additional metadata elements and their characteristics on a voluntary basis, using for that purpose the metadata framework referred to in the first paragraph.