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

Iiris Karppila¹, Manu Setälä², Laura-Maria Peltonen³

¹Faculty of Management and Business, Tampere University, Tampere, Finland.

Studies in Health Technology and Informatics

|May 23, 2026

Summary

This summary is machine-generated.

The European Health Data Space (EHDS) aims to standardize health data sharing but faces interoperability hurdles. National differences in implementing standards like HL7 FHIR create significant barriers to seamless cross-border data exchange.

Keywords:

EHDS European Health Data Space cross-border healthcare health data standardization health information systems interoperability scoping review

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Area of Science:

Health Informatics
European Public Policy
Data Standardization

Background:

The European Health Data Space (EHDS) initiative seeks to enable cross-border health data sharing.
Significant interoperability challenges hinder the EHDS's implementation and its goal of seamless data exchange.

Purpose of the Study:

To conduct a scoping review of literature on EHDS readiness across EU Member States.
To identify and categorize key barriers to seamless health data sharing within the EHDS framework.

Main Methods:

A scoping review was conducted using Arksey and O'Malley's five-stage framework.
Eleven sources were analyzed, focusing on EHDS implementation, patient care coordination, and interoperability.

Main Results:

While EHDS promotes technical standards (e.g., EEHRxF), national disparities in adopting standards like HL7 FHIR and OMOP persist.
Semantic, organizational, and social gaps exist due to varying national implementations and limited shared metadata catalogues.
Barriers were categorized into technical, organizational, and legal dimensions, differentiating regulatory scope from Member State coordination needs.

Conclusions:

The EHDS regulation addresses some technical standardization but requires further Member State coordination to overcome implementation gaps.
Insights inform prioritization for European health informatics standardization efforts to achieve true interoperability.