The European Health Data Space (EHDS), established under Regulation (EU) 2025/327, is a framework that defines rules, common standards and practices, data-sharing infrastructure, and governance with an explicit goal to facilitate pan-European access to medical data for primary and secondary uses and the creation of a European Single Market for digital health systems. Its implementation is set to unfold over the coming years, with key milestones expected between 2027 and 2031 to ensure a progressive and coordinated rollout across Member States.
IHE-Europe can play a pivotal role in establishing the EHDS by leveraging the IHE™ Methodology (ISO TR28380:2014) for creating technical specifications.
In this use case driven methodology base standards such as HL7 FHIR, DICOM and SNOMED CT are leveraged for creating implementable and testable technical specifications which have been successfully adopted by many organizations and vendors around the world to address specific use cases. These specifications form a framework of well aligned, and in general globally applicable, building blocks which can be combined in multiple ways for covering larger scenarios. The methodology also allows to address regional needs, ideally in alignment with the global framework.
All specifications from IHE are created in an open, consensus driven process and are made freely available under creative commons license. This allows stakeholders to create derivative specifications and continued maintenance even if IHE would stop doing so.
EURIDICE
To leverage these IHE strengths for the EHDS, IHE-Europe has joined forces with HL7 Europe in the newly established EURIDICE initiative. As independent European organizations affiliated with the international IHE and HL7 communities, both organizations are well positioned to ensure that the specifications meet the needs of the European Commission and the Member States. At the same time, they can build on and align, where appropriate, with global experience and internationally established best practices.
EURIDICE creates well-architected, implementable specifications that can be leveraged by the European Commission and the Member States for the EHDS Implementing Acts. By combining HL7 Europe’s HL7® FHIR® expertise with IHE’s methodology and testing approach, EURIDICE turns ideas into strong, community-validated artifacts, supporting implementation, validation, and alignment across EU Member States, EU-funded projects, and SDO processes.
To anker the IHE-Europe contribution to EURIDICE in the global IHE framework and for optimally making use of global IHE expertise IHE-Europe has established an IHE PRISM EHDS. An IHE PRISM is a program which allows the IHE organization to support local needs in an optimal and accelerated way. See IHE PRISM EHDS for more information.
IHE-Europe White paper
Due to the intricate challenges of achieving interoperability across diverse health systems and infrastructures, IHE-Europe is thrilled to present its latest whitepaper, "Leveraging the IHE Methodology to Accelerate the Successful Implementation of the European Health Data Space (EHDS)." This document showcases how IHE’s proven methodology, including IHE Profiles and conformance testing frameworks, supports seamless, secure, and scalable health data sharing across Europe. By addressing interoperability challenges and building on existing infrastructure, the white paper offers a clear path to achieving the ambitious EHDS vision.
The EHDS is a fast-evolving ecosystem. To keep up with these developments, this page will be updated regularly. Be sure to check back frequently to stay informed on IHE-Europe updates.