The European Health Data Space (EHDS) regulation requires EHR systems to include an Interoperability Component that provides an interface for secure access to and exchange of personal electronic health data formatted in the European Electronic Health Record exchange Format (EEHRxF). The EU Health Data API Implementation Guide proposes how EHR systems can meet these requirements using existing, internationally recognized standards from IHE and HL7.
This IG is a joint HL7 Europe and IHE-Europe effort under the EURIDICE initiative. It assembles existing IHE and HL7 specifications into a coherent set of EHR functionalities that address the interoperability requirements placed on EHR systems by Article 15 and Annex II of the EHDS Regulation:
- Document exchange using IHE Mobile access to Health Documents (MHD) — for publishing, searching, and retrieving EEHRxF FHIR Documents between systems
- Patient matching using IHE Patient Demographics Query for Mobile (PDQm) — for looking up patients across systems
- Resource access using HL7 International Patient Access (IPA), aligned with IHE Query for Existing Data for Mobile (QEDm) — for querying individual FHIR resources such as conditions, medications, and observations
- Authorization using HL7 SMART Backend Services, aligned with IHE Internet User Authorization (IUA) — for secure system-to-system authorization using OAuth 2.0
The specification defines composite actors for document and resource exchange, and covers the six EEHRxF priority categories: Patient Summary, Laboratory Results, Hospital Discharge Reports, Imaging Reports, Imaging Manifests, and Medicatl Prescriptions. It also shows how these EHR capabilities can be used in real-world EHDS use cases — patient access services, health professional access services, and cross-border exchange via myHealth@EU.
To take part in the development of this specification, check the HL7 EU Confluence for regular project meetings and join the discussion. The specification is targeting ballot in March 2026.
The current draft version of the specification is available here: EU Health Data API – FHIR Specification