New TEHDAS2 guideline helps data holders describe health datasets for reuse across Europe
TEHDAS2 has published a new guideline to support health data holders in fulfilling their dataset description obligations under the European Health Data Space (EHDS) Regulation.
The document offers hands-on advice for identifying which datasets must be described and provides detailed instructions on how to use the HealthDCAT-AP metadata model to ensure those datasets are findable, interoperable and compliant.
The EHDS Regulation requires that electronic health data eligible for secondary use be described and included in national and EU-level metadata catalogues. This new guideline walks health data holders through that process – from determining whether their datasets fall within the 17 legal categories outlined in Article 51 of the regulation, to preparing accurate and standardised metadata records.
“One of our goals was to help data holders go from legal obligation to practical action. We show how to assess if your data are in scope, and how to describe your data clearly using HealthDCAT-AP,” said Nienke Schutte of Sciensano, lead author of the guideline.
The guideline includes:
- a plain-language breakdown of all Article 51 data categories, complete with real-life examples;
- practical explanations of key metadata properties (e.g. dataset title, variables, access conditions); and
- guidance on how to apply the FAIR principles and ensure semantic interoperability across borders.
“We tried to make this as accessible and useful as possible – not just a legal checklist, but a tool for enabling high-quality data discovery and reuse under the EHDS,” added Danielle Welter of Luxembourg National Data Service, co-author of the deliverable.
This non-binding guideline reflects expert input from TEHDAS2 partners and public consultation feedback. It complements the technical specification on the national metadata catalogue and provides the foundation for European Commission’s implementing acts that will shape Europe’s shared infrastructure for health data reuse.
Download document: Guideline for data holders on data description
A summary of the comments received during the public consultation and how they were addressed is available in the annex.
View published TEHDAS2 results
Key recommendations stemming from the work
For Member States
- Invest in the creation of rich, high-quality metadata records to improve data discoverability and reduce administrative burden.
- Provide practical support for health data holders, including training, guidance and shared tools for metadata creation and management.
- Promote the adoption of FAIR data principles, common controlled vocabularies and semantic standards to improve interoperability and cross-border data reuse.
- Ensure alignment between national implementations and existing international standards, classifications and sectoral initiatives where possible.
For the European Commission
- Provide clear implementing guidance and technical specifications for the harmonised application of HealthDCAT-AP across the EU.
- Support EU-wide semantic interoperability through common vocabularies, mappings and alignment with existing international standards and initiatives.
- Facilitate common implementation tools, validation services and training materials for health data holders and HDABs.
- Foster interoperability between the EHDS and other European data spaces to support cross-sectoral secondary use of data.
Share away!