European Health Data Space dataset descriptions

Technical comment to Annex Ares(2026)3843449: The metadata elements in Part C contain "Access rights" but not sufficient clarification of the reason for restricted access. The Art 77(1) of the EHDS Regulation says: Dataset shall include information concerning conditions for making those data available.

Thank you very much for the opportunity to provide feedback on the EHDS Implementation Act regarding data description. The Health Data TFs EOSC-EHDS Alignment Group has reviewed the content in detail. We strongly support the general direction of mandating the annotation of health datasets with rich metadata, based on widely used data models and terminologies.

Feedback from VALO Value from Nordic health data on the draft act of dataset descriptions VALO Value from Nordic Health Data is a joint project between Denmark, Finland, Iceland, Norway and Sweden, with Estonia and Lithuania as observers. It is coordinated by Sitra (the Finnish Innovation Fund) and funded by the Nordic Council of Ministers.

Epic, a global healthcare technology company working hospitals and clinics throughout the EU and EEA, welcomes the opportunity to comment on the draft Implementing Regulation on minimum metadata elements for dataset descriptions under the EHDS. Full reasoning and recommendations are provided in the attached submission. This response summarises our principal concerns. Single authoritative source.

Region Stockholm welcomes this Implementing Regulation and supports its timely adoption. The adoption of HealthDCAT-AP as a common metadata framework lays important groundwork for cross-border secondary use of health data within the European Health Data Space.

The European Medicines Agency (EMA) welcomes the opportunity to provide comments on the draft Implementing Regulation laying down the minimum metadata elements for dataset descriptions for the secondary use of electronic health data under Article 77(1). Our comments are listed in the attached document.

The National Committee for Medical and Health Research Ethics in Norway (NEM) welcomes the opportunity to provide comments on the draft Implementing Regulation establishing minimum metadata elements and related characteristics for dataset descriptions pursuant to Article 77(1) of Regulation (EU) 2025/327 on the European Health Data Space (EHDS).

The European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) represents small and mid-sized innovative companies in the pharmaceutical, biotechnology and medical technology sectors across Europe. EUCOPE welcomes the opportunity to comment on the draft implementing regulation setting out minimum metadata elements and their characteristics for dataset descriptions required from health data holders under Article…

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 they can be included in the dataset catalogues. This initiative sets out the basic information that these data holders must provide for each dataset, along with the details of those requirements.

Filed in Italian · English published by the European Commission

We contribute to this consultation from the perspective of UNCAN-Connect and CANDLE: two EU-funded projects building a federated European cancer data research ecosystem (UNCAN.eu) and National Cancer Data Nodes, respectively. UNCAN.eu will use metadata to identify datasets and assess how they can be linked and compared.

The European Society for Medical Oncology (ESMO), representing over 50,000 members globally, welcomes the publication of the draft Implementing Act laying down the minimum metadata elements and their characteristics to be provided by health data holders for dataset descriptions for the secondary use of electronic health data under the European Health Data Space (EHDS) Regulation.

We strongly support the objective of improving discoverability, comparability and usability of health datasets across Member States. A harmonised metadata framework based on HealthDCAT-AP will provide an essential foundation for cross-border research, innovation, evidence-based policymaking, digital health solutions and responsible use of AI in medicine.

The European Health Data Space (EHDS) Regulation represents an important step towards enabling the secure, trustworthy and efficient secondary use of electronic health data across the European Union. MedTech Europe welcomes the Commissions efforts to operationalise the EHDS by specifying requirements for dataset descriptions.

The ongoing public consultation regarding the draft implementing act for dataset descriptions under Article 77 of the EHDS Regulation provides a necessary framework for aligning technical standards across the European health data landscape, and the initiative is generally supported as a practical step towards harmonising metadata essential for data discoverability.

The General Pharmaceutical Council of Spain (CGCOF) is the public law body representing and coordinating the pharmacy profession in Spain, bringing together 52 Official Pharmacists Chambers and 81,081 registered pharmacists.

Overall, the draft act lacks clear mechanisms for defining confidentiality levels and access conditions, creating a critical gap in the protection of intellectual property (IP) and trade secrets (TS) in EHDS implementation. Missing safeguards: There is no clear process or tag for data holders to label commercially sensitive information or define confidentiality levels.

Within the TEF-Health European network (tefhealth.eu), a dedicated working groupcomprising 10 European hospital institutionsis currently discussing minimal requirements for defining datasets from a customer perspective. The goal is to quickly match demand and provision while ensuring compliance with EHDS requirements.

This contribution is submitted by experts from European PopulationBased Cancer Registries participating in the CancerWatch Joint Action (Task 6.3 metadata and EHDS implications). The CancerWatch Joint Action brings together PBCRS organized in ENCR, GRELL and ANCR. Please see the attached file for details.

We suggest that any abbreviations used (e.g. HealthDCAT or DCAT) would be spelled out in order to be clear to anyone reading the document. Annex, Part C Metadata elements: The wording of the draft is acceptable. However, it needs to be taken into account that the response to this section depends on how HDABs are organised at the national level.

The project documentation is vague about the dataset, the level of granularity here must be clearly documented. The project should clarify how dataset descriptions should be handled for complex databases such as clinical data warehouses where the physical data model, logical clinical domains, and reusable datasets do not necessarily well aligned.

The European Association of Urology (EAU) and the EAU UroEvidenceHub (UEH) welcome the development of a harmonised metadata framework for dataset descriptions under the European Health Data Space (EHDS). As data holders and data users, establishing a common approach to dataset cataloguing is an essential step toward enabling cross-border discovery and reuse of health data.

As CEO of EduVerso, a University of Málaga technology-based spin-off company, and as a member of the AMETIC National Digital Health Committee, I would like to submit several comments on the Draft Commission Implementing Regulation on the European Health Data Space (EHDS).

PGEU welcomes the aim of this draft Implementing Regulation to make dataset catalogues for secondary use standardised and interoperable. High-quality metadata can support public-interest research, public health, pharmacovigilance and evidence on medicines use. However, the catalogue must be a transparency tool, not a gateway to commercial exploitation of sensitive health data.

As a future user of the HealthDCAT-AP standard, INSERM would like to thank the Commission for giving us the opportunity to provide feedback on the amendments to Article 77. We would, however, like to draw attention to several points which currently raise questions regarding their implementation.

At the Genomics Coordination Center of the University Medical Center Groningen we are specialized in making metadata catalogues. With the MOLGENIS catalogue we have been standardizing metadata across different fields and types of health data within The Netherlands and in a wide range of European projects. We do so in close collaboration with researchers and data holders.

Response on behalf of ActiZ, the association of health care organisations in elderly care. As ActiZ, we support research and data-driven innovation to improve the quality and accessibility of care. At the same time, we explicitly call for attention to the feasibility of the proposed obligations regarding data descriptions as included in Article 77 of the EHDS.

As a public health institute, we very much welcome the establishment of a minimum set of metadata elements to describe health data for secondary use. It creates binding force. However, there are formal and substantive deficiencies in the documents submitted. Errors in the naming and referencing logic are particularly noticeable.

Filed in German · English published by the European Commission

Out of the 180 HealthDCAT-AP properties reviewed in the Detailed Review sheet, 34 are recommended for inclusion in the minimum metadata set for data owners.The position is structured around six guiding principles : 1. Prefer controlled vocabularies over free text.

Please find enclosed DICA-IKNL review suggestions for the draft implementing act laying down the minimum metadata elements and their characteristics for dataset descriptions for the secondary use of electronic health data under Article 77(1) of Regulation (EU) 2025/327.

The current EHDS proposal focuses heavily on National Health Data Access Bodies (HDABs). However, a purely centralized national model is inefficient for specialized research. For rare diseases, requesting access through multiple national points is a barrier; instead, access should be facilitated through disease-specific access points.

We expect that providing metadata in a standardized way using shared metadata elements will greatly improve the discoverability of health data for secondary use in Europe. Providing and maintaining this information about health datasets will strengthen open science. More detailed descriptions of datasets will be more valuable for discovery and reuse.

Please find enclosed Kela’s comments on the EHDS Implementing Regulation (dataset descriptions). Annex, Part C/Part C Metadata elements: Metadata should indicate how to deal with missing values in the data (e.g. NULL, empty field or NA). The descriptions of different formats (e.g. dates) in the metadata document are also to be welcomed.

Filed in Finnish · English published by the European Commission

Malta operates with a relatively integrated personal identity infrastructure, including universal personal identification numbers used across government departments throughout individuals lifetimes. This may facilitate cross-border data sharing and implementation of the European Health Data Space (EHDS).

EFPIA welcomes the opportunity to comment on the draft Commission Implementing Act laying down the minimum metadata elements and their characteristics for dataset descriptions under the European Health Data Space (EHDS).

The Portuguese Pharmaceutical Society welcomes the objective of this draft Implementing Regulation to ensure that dataset catalogues for the secondary use of electronic health data are standardised and interoperable. High-quality metadata can support research in the public interest, public health, pharmacovigilance, and evidence generation on the use of medicines.

The FJL welcomes the Commission’s work to standardise health data set descriptions under the European Health Data Space. As an actor combining care, clinical research and the creation of longitudinal databases, particularly in the field of genetic diseases, we consider the quality of data descriptions to be a major lever for re-use, scientific reproducibility and the development of European and international…

Filed in French · English published by the European Commission

SNOMED International welcomes the initiative and offers to act as a strategic partner to the European Commission. Recognition of SNOMED CT and terminology consistency: SI welcomes the explicit reference to SNOMED CT and recommends correcting the typography from SNOMED-CT to SNOMED CT to ensure alignment with established naming conventions.

The RWE4Decisions initiative welcomes this draft Implementing Regulation. As a multi-stakeholder initiative dedicated to improving the generation and use of realworld evidence (RWE) to inform HTA and payer decisionmaking, we strongly support the objective of enhancing transparency, discoverability, interoperability and trust in electronic health data for secondary use across the EU.

The information on the datasets being searched is top-level and we do not see any problems in making it available, neither for technical nor legal reasons. However, the information in the Annex is insufficiently described, incorrectly referenced and most likely incomplete (e.g. barely used code lists are required). This should be improved.

Filed in German · English published by the European Commission

The proposed Implementing Regulation is an important and very welcome step towards harmonised and machine-readable metadata standards for health data access within the EHDS framework. In particular, the designation of HealthDCAT-AP as the common metadata standard provides a strong basis for interoperability and future automation of data access procedures across Member States.

Founded in 2016, The Guild comprises twenty-three of Europes most distinguished research-intensive universities in seventeen countries, and is dedicated to enhancing the voice of academic institutions, their researchers and their students.

Even though the metadata set is designated as minimal, its implementation may nevertheless entail significant challenges and demand substantial resources from the relevant stakeholders. It should be explicitly acknowledged that health data holders will face considerable effort in the initial population of the metadata catalogue as well as in carrying out the mandatory annual review.

I am grateful for the opportunity to comment on this draft. I do not consider myself a definitive expert in this domain, and it is entirely possible that the observations below are already known, under consideration, or not relevant in the current policy context. The draft provides a solid foundation for standardised, machine-readable metadata catalogues within the European Health Data Space (EHDS).

Aligning dataset descriptions with clinically meaningful interpretation in the EHDS The proposed implementing regulation represents an important step toward enabling interoperable dataset catalogues under the European Health Data Space.