Yet another public consultation is open for commentary on a European Health Data Space (EHDS)-related implementing act. It is all about metadata (data that provides information about other data) that has to be provided as a result of the EHDS Regulation. The Have Your Say submission deadline for comments is midnight on 12 May 2026.

Background

As part of the European Health Data Space, health data holders will have to provide descriptions of their datasets to the health data access bodies so the datasets can be included in the dataset catalogues.

The draft implementing act on metadata sets out the basic information that health data holders must provide for each dataset, along with the details of those requirements.

Comments on the act are welcome. Several are already visible online.

More about the implementing act on metadata

The implementing act is a very short document, four articles in length. It stipulates its subject matter and scope, definition, and required metadata elements. The eventual act will enter into force on 26 March 2029.

The act is supplemented by a detailed annex that describes and defines a wide range of properties from access rights through to variables.

In particular, Article 3 of the implementing act states:

“Health data holders shall express the minimum metadata elements listed in Part B of the Annex by using the definitions, structure, cardinalities and controlled vocabularies set out in the HealthDCAT-AP referred to in Part A of the Annex.

The metadata framework referred to in Article 1 is based on the HealthDCAT-AP, which is maintained and made publicly available by the European Commission”.

More about HealthDCAT Application profile (HealthDCAT-AP)

“The HealthDCAT Application Profile (HealthDCAT-AP) is a domain-specific metadata model designed to support the implementation of the secondary use framework under the [EHDS].

HealthDCAT-AP introduces new properties that enable semantically consistent dataset descriptions, structured for automated exchange and federation across catalogues. This ensures that metadata can be processed and integrated into local, regional, national and EU-level catalogues, including the one operated by the central platform of the HealthData@EU infrastructure.

A distinctive feature of HealthDCAT-AP is its explicit classification of dataset access rights into three categories: non-public, restricted, and public. Each category is defined with specific technical requirements.

In addition, new controlled vocabularies have been developed to harmonise property values, thereby ensuring comparability and interoperability of dataset descriptions across Member States.”

HealthDCAT-AP was developed by the European Commission's Directorate-General for Health and Food Safety (DG SANTE), in collaboration with the EHDS2 Pilot project and TEHDAS2 Joint Action.

More information

See the European Commission’s Have Your Say website.

See a 25/26 March 2026 keynote speech on the European Health Data Space – state of play.