The implementing regulation’s draft defines what hospitals, registries, and health authorities must disclose about their datasets under the European Health Data Space: feedback opened today
April 14th, 2026 – A new Draft for an Implementing Regulation on the minimum metadata elements for health dataset descriptions has been uploaded today to the Have Your Say page for feedback. If adopted without changes, the measures would be expected to apply from March 26th, 2029.
The European Health Data Space Regulation, which was adopted in February 2025 through Reg. (EU) 2025/327, requires national health data access bodies to publish standarised, machine-readable catalogues describing the health datasets available for secondary use, including research, policy, and public health purposes beyond the care of the individual patient. To populate these catalogues, health data holders, such as hospitals or insurers, are required to submit structured descriptions of the datasets they hold. The new draft would define exactly what those descriptions must contain.
The draft specifies 28 minimum metadata elements that health data holders must provide for each dataset. These cover the dataset’s identity and content (title, description, type, health category, health theme, keywords) as well as its technical characteristics, including whether it is structured, what coding systems it uses (such as ICD-10 or SNOMED-CT), and what format it is available in.
Governance and access information is also required: who holds and manages the dataset, what access rights apply, which health data access body is responsible for facilitating access, and what legislation governs the dataset’s existence. Where the dataset contains personal data, holders must say so explicitly. Where it covers identifiable individuals, an estimated count of unique natural persons must be provided.
The metadata framework to be used is HealthDCAT-AP, an Application Profile developed and maintained by the Commission specifically for health dataset description, building on the general DCAT standard used across EU data governance infrastructure. Use of HealthDCAT-AP controlled vocabularies is mandatory where defined. Health data holders may voluntarily provide additional metadata elements beyond the minimum, using the same framework.
The individual dataset descriptions submitted by health data holders feed upward into national dataset catalogues maintained by health data access bodies, which in turn connect to the EU-level dataset catalogue established under Article 79 of the EHDS Regulation. The draft explicitly frames interoperability between these three catalogue layers as a primary objective.
The Have Your Say consultation is open to all stakeholders. Given the subject matter, the Commission is implicitly targeting health data holders who will bear the compliance obligation, hospital IT and data governance teams, national health data access bodies still being established under the EHDS Regulation, health informatics specialists, patient organisations with an interest in data access conditions, and researchers who are the intended users of the secondary use catalogues. Legal and compliance professionals advising health sector entities on EHDS implementation are also a natural audience for this consultation.
