Guideline for data holders on data description

This TEHDAS2 expert guideline supports the implementation of the European Health Data Space (EHDS).

This guideline provides practical and legal support for health data holders subject to the obligation to describe and make datasets available for secondary use under the European Health Data Space (EHDS) Regulation. It addresses two fundamental questions: (1) are the electronic health data I hold within the scope of the secondary use framework established by the EHDS Regulation; and (2) if so, how can I comply with the dataset description obligation laid down in Article 77, using the common metadata model (HealthDCAT-AP) that will be formalised through an implementing act?

To address these questions, the document provides:

• Clarification of the categories of electronic health data (as defined in Article 51 of the EHDS Regulation) that must be made available for secondary use. These are accompanied by full-text definitions, legislative context, and real-world examples to help data holders assess whether the data they hold fall within the scope of the secondary use framework.
• Guidance on the dataset description obligation (Article 77), providing an explanation of the legal requirement for data holders to describe datasets made available for secondary use, and of the role of metadata in ensuring transparency, discoverability, and interoperability.
• Introduction to the HealthDCAT Application Profile (HealthDCAT-AP): a comprehensive presentation of the common metadata model to be used to comply with Article 77, including its structure, rationale, and alignment with the broader DCAT-AP framework used across the EU.
• Detailed, practical instructions for each property of the HealthDCAT-AP, with tips and examples based on questions and challenges raised during the TEHDAS2 activities. These instructions are designed to help health data holders accurately complete their metadata records.
• A summary of the analytical and conceptual work carried out in the TEHDAS2 project to assess the applicability of HealthDCAT-AP and to support its refinement and validation, informed by expert feedback.
• A dedicated chapter on cross-cutting implementation considerations, based on TEHDAS2 workshops and expert input from across EU Member States, including key challenges and recommended mitigation strategies. 

By following the guidance provided in this document, health data holders can better understand and prepare to meet their dataset description obligations under the EHDS framework. This guideline may also inform the work of the the European Commission and other stakeholders seeking to understand the technical and organisational considerations involved in the future implementation HealthDCAT-AP across the EU.