Bridging the Gap

The European Health Data Space (EHDS) stands as a monumental initiative in EU health policy, intending to establish a seamless, secure, and standardised framework for accessing, sharing, and reusing health data across Member States. This ambitious vision aims to enable the primary use of health data for continuity of care across borders and to facilitate its secondary use for research, innovation, policymaking, and AI development. However, the journey from the current state of Electronic Medical Record (EMR) adoption in Europe to the fully realised EHDS is far from straightforward, shaped by deep variations in digital maturity, complex regulatory frameworks, and diverse interpretations of what constitutes an Electronic Health Record.

Fragmented EMR Adoption and Interoperability Gaps:

Across Europe, EMR adoption is highly fragmented. Nordic countries and Estonia enjoy near-universal digital health coverage with mature national interoperability frameworks. In contrast, many Southern and Eastern European countries have a more uneven landscape, where paper-based records still coexist with regional or hospital-specific systems. Even in countries with broad adoption, vendor lock-in and incompatible data models remain significant challenges. Interoperability is hindered by the inconsistent use of common terminologies such as SNOMED CT and LOINC, and by the varying maturity of HL7 FHIR implementations. In this context, the EHDS vision of effortless, cross-border data sharing will require setting standards and major investments in transforming legacy systems.

The Definition Challenge: EHDS EHR Definition Meet Real-World EMR Limitations

One of the most underestimated barriers to EHDS implementation lies in the gap between the formal definition of the European Electronic Health Record under the EHDS regulation and the functional reality of existing EMR systems deployed across Member States. While the EHDS requires a harmonised, structured, and semantically interoperable dataset including patient summaries, ePrescriptions, laboratory results, medical imaging, discharge reports, and eventually genomic data, many hospital EMRs were never designed with such pan-European interoperability in mind.

A key friction point is data structure versus unstructured formats. In many hospitals, clinical information exists as narrative text within scanned PDFs or free-text notes, especially in specialities such as oncology, psychiatry, or surgery. Although these documents may be sufficient for internal clinical workflows, they cannot be easily mapped to the structured and coded datasets mandated by the EHDS. This creates a major interoperability bottleneck: without structured formats linked to standard terminologies such as SNOMED CT, ICD-10/11, LOINC, or DICOM, automated cross-border data exchange is technically unfeasible.

Another challenge is the selective or incomplete capture of the EHDS core dataset. For example, ePrescription adoption is high in some countries like Finland or Estonia, but in others, prescriptions are still generated as printed or non-standardised digital forms. Similarly, laboratory data may be stored in separate LIS (Laboratory Information Systems) that are not fully integrated with the main EMR, leading to incomplete or delayed data availability. Imaging data is often held in PACS (Picture Archiving and Communication Systems), which does not share metadata in EHDS-compliant formats, making cross-border retrieval cumbersome.

Semantic alignment is another area where theory and practice diverge. Even when EMRs store structured data, coding systems are often localised, inconsistent, or outdated. For example, lab results may use local code sets rather than LOINC, or diagnosis fields may combine free text with ICD-10 codes in a way that does not map cleanly to EHDS requirements. The EHDS’s emphasis on semantic interoperability means hospitals will need to implement terminology services capable of mapping local codes to European standards in real time something few systems can currently do.

The EHDS also assumes a patient-centric, longitudinal record, whereas many EMRs are episode-based. In other words, a patient’s history may be scattered across multiple encounters, facilities, or even vendors, with no unified, continuously updated record. This fragmentation is especially pronounced in countries with decentralised health systems, where regional EMRs do not automatically communicate with each other, let alone with a European-level infrastructure.

Lastly, the workflow integration burden should not be underestimated. EHDS compliance is not just about exporting data once; it requires real-time, bidirectional data exchange between local EMRs and the European framework. This will demand technical upgrades to interface engines, tighter cybersecurity controls, and robust consent management mechanisms all while ensuring minimal disruption to clinicians’ daily routines.

Bridging these gaps will require strategic investment and staged implementation. Hospitals will need targeted funding to upgrade or replace legacy EMRs, deploy interoperability middleware, implement data mapping tools, and train staff in structured data entry. At the same time, Member States will need to establish national terminology services, provide clear technical guidance, and ensure that vendors deliver EHDS-compliant upgrades. Without addressing these technical and operational mismatches, the EHDS risks becoming a policy ambition that stalls at the point of real-world implementation.

Governance and Legal Alignment

Governance and legal alignment add another layer of complexity. While the EHDS operates under the General Data Protection Regulation (GDPR), it also introduces new mechanisms for cross-border health data exchange. Member States will need to establish Health Data Access Bodies to govern both primary and secondary uses. Yet, interpretations of GDPR vary particularly regarding sensitive areas such as genomic or mental health data. Furthermore, consent management models differ across the EU, ranging from opt-in to opt-out systems, raising questions around patient autonomy, transparency, and trust. Achieving harmonised governance frameworks and clear, culturally adapted communication strategies for patients in all EU languages will be essential.

Technical Infrastructure and National Access Points

The EHDS also requires each Member State to set up a national access point to act as a technical gateway for data exchange. While some countries already have national health data hubs or health information exchanges, their existing architectures may not align with the EHDS’s security, semantic, and interoperability requirements. Smaller countries or those with decentralised health systems may struggle with the infrastructure, cybersecurity readiness, and operational capacity required to handle the scale of EHDS transactions. Investment in secure, scalable, and cloud-based environments ideally incorporating Trusted Research Environments (TREs), will be critical to making this vision a reality.

Cultural and Change Management Barriers

Even with the right technology and governance in place, cultural and change management barriers remain. Clinicians may see new interoperability mandates as bureaucratic burdens rather than clinical enablers, and hospital administrators may resist costly system upgrades if the benefits are not clear and immediate. Overcoming this resistance will require strong change management programmes, clinical leadership, and practical demonstrations of how EHDS adoption can improve patient care and health outcomes.

Ultimately, the European Health Data Space is not simply a technical standard to be implemented, but a catalyst for systemic transformation in healthcare. Moving from today’s fragmented and inconsistent EMR environment to tomorrow’s integrated, pan-European health data ecosystem will require modernising legacy systems to meet the EHDS core dataset definition, adopting common interoperability standards, harmonising legal and governance frameworks, and building the technical capacity to exchange health data securely and efficiently. Above all, success will depend on engaging clinicians and patients alike, fostering trust in the system, and demonstrating its value in improving care, advancing research, and strengthening public health across the continent.

--Issue 06--