New specification supports Member State connection to HealthData@EU
TEHDAS2 has published a technical specification explaining how Member States can connect to HealthData@EU, the EU infrastructure for secondary use of health data under the European Health Data Space (EHDS).
The document is intended for health data access bodies (HDABs) and national authorities preparing for EHDS implementation. It focuses on the common technical components and interfaces used to link national systems with HealthData@EU, enabling structured and interoperable information exchange between countries.
Connecting to HealthData@EU in practice
The HealthData@EU infrastructure serves as the digital backbone connecting National Contact Points with the HealthData@EU Central Platform. This distributed architecture ensures a balanced governance model: the European Commission operates the central core, while Member States implement and maintain their national components.
The specification describes how national components interact with the HealthData@EU Central Platform operated by the European Commission, outlining the main technical elements, operational roles and division of responsibilities between Member States and the EU.
The specification makes clear that health datasets themselves are not exchanged through this infrastructure. Instead, the common IT layer supports the secure exchange of information required for secondary use processes, such as dataset descriptions, data access applications and related decisions.
National components needed to participate
The document outlines the national components required to participate in HealthData@EU, including:
- national contact points (NCPs) for secondary use, acting as each country’s operational gateway to HealthData@EU; and
- a technical operability layer, including dispatchers and eDelivery access points that validate, secure and route structured messages between national environments and the EU-level platform.
These components interact with the HealthData@EU Central Platform, which receives and distributes information in a standardised manner across participating countries.
Clarifying national and EU-level responsibilities
By focusing on the technical backbone of HealthData@EU, the specification provides a clear reference model for national system design. It explains what needs to be implemented at national level, what is provided at EU level and how the different components interact to ensure secure, traceable and General Data Protection Regulation (GDPR)-compliant exchanges across borders.
Building upon the foundational HealthData@EU pilot project funded by EU4Health, which deployed an agnostic infrastructure in coordination with the European Commission, the current specification transitions from proof-of-concept to practical implementation.
“Enriched by stakeholder contributions, this deliverable provides a vital policy‑level roadmap for Member States. By bridging the gap between technical infrastructure and stakeholder needs, we have created a robust specification that ensures HealthData@EU is both responsive to users and built on a foundation of trust,” said Marianne Benderra, EU Project Manager at Health Data Hub, who leads the team responsible for the report.
The specification forms part of a broader set of TEHDAS2 technical and guidance documents addressing different aspects of secondary use of health data, together supporting national readiness under the EHDS.
Download document: Technical specification for health data access bodies on the implementation of the common IT infrastructure
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
The EHDS regulation establishes HealthData@EU, a dedicated common European infrastructure. It provides the technical, functional and security frameworks necessary to facilitate the secure and standardised secondary use of electronic health data across national borders.
For Member States
- Leverage the Interoperability Test Bed (ITB) to rigorously validate system conformance with messaging protocols and data structures prior to live infrastructure connection.
- Maintain continuous synchronisation of national dataset metadata with the EU Dataset Catalogue, strictly adhering to the common metadata format (e.g. HealthDCAT-AP) to guarantee data discoverability.
- Engage actively in the EHDS governance framework to ensure alignment on operational decisions and the phased rollout of future technical infrastructure releases.
For the European Commission
- Streamline and simplify documentation regarding the Central Platform, ensuring regular updates that empower Member States to understand technical requirements and fulfil their secondary use obligations within the mandated timeframes.
- Uphold the Interoperability Test Bed (ITB) and provide dedicated technical support to Member States throughout the onboarding and connectivity validation phases.
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