(fra kommisjonsforordningen)

(1) Article 77(1) of Regulation (EU) 2025/327 requires health data access bodies to make publicly available dataset catalogues with description, in the form of metadata, of the datasets available for the secondary use of electronic health data, including information on the source, scope, main characteristics and nature of the electronic health data in the datasets and the conditions for making those data available. 

(2) For that purpose and in accordance with Article 60(3) of Regulation (EU) 2025/327, health data holders are to communicate to the health data access bodies such a description of the dataset they hold, irrespective of whether the datasets contain personal and/or non-personal electronic health data. 

(3) In accordance with Article 60(3) of Regulation (EU) 2025/327, health data holders are required to verify, at least annually, that dataset descriptions are accurate and up to date. This is essential to ensure the reliability and usability of dataset catalogues for the secondary use of electronic health data. 

(4) As provided for in Article 77(1) of Regulation (EU) 2025/327, dataset catalogues are to be standardised and machine-readable, in order to ensure semantic and technical interoperability across Member States. This is necessary to enable the interconnection of national dataset catalogues and dataset catalogues of authorised participants into the EU dataset catalogue established under Article 79 of that Regulation. Health data holders should therefore use a common approach to metadata for dataset descriptions when providing the minimum metadata elements and the characteristics of those elements. 

(5) It is appropriate that the HealthDCAT-Application Profile (HealthDCAT-AP) is used as that metadata framework. HealthDCAT-AP builds on the general DCATApplication Profile and is a technical specification developed and maintained by the Commission, specifically designed to support the description of health datasets made available for the secondary use of electronic health data. Those specifications are provided in accordance with the operational decisions of the relevant bodies established pursuant to Articles 92 and 95, within the governance framework of the European Health Data Space. 

(6) This Regulation contributes to the interoperability of digital infrastructures supporting the European Health Data Space, including those related to cross-border data access. An interoperability assessment has been carried out and the resulting report will be published on the Interoperable Europe Portal upon adoption of this Regulation. 

(7) The measures provided for in this Regulation are in accordance with the opinion of the committee established by Article 98(1) of Regulation (EU) 2025/327,