Interoperability Barriers in the European Health Data Space: A Scoping Review

The European Health Data Space (EHDS) is the EU's most ambitious attempt to standardize cross-border data sharing, yet implementation faces significant interoperability challenges. This scoping review synthesizes literature on EHDS readiness across EU Member States to identify key barriers to seamless data sharing. Using Arksey and O'Malley's five-stage framework, 11 sources addressing EHDS implementation, patient care pathway coordination, and interoperability requirements were analyzed. The findings reveal that while the EHDS addresses technical standardization through frameworks like the European Electronic Health Record exchange Format (EEHRxF), persistent disparities in national implementations create semantic, organizational, and social gaps. Member States show varying adoption of standards such as HL7 FHIR and OMOP, with few shared metadata catalogues. The study contributes a systematic categorization of EHDS interoperability barriers across technical, organizational, and legal dimensions, identifying which challenges the regulation directly addresses versus those requiring additional Member State coordination. These insights inform prioritization strategies for European health informatics standardization efforts.