Belgium’s EHDS Readiness: Critical Milestones, “Meaningful Use” Criteria, and Implementation Risks

Introduction

The European Health Data Space (EHDS) changes digital health from a national modernization agenda into a binding European interoperability, patient-rights, and secondary-use agenda. The EHDS Regulation establishes a common EU framework for electronic health-data exchange, strengthens individuals’ access to and control over their health data, enables regulated reuse for research and policymaking, and introduces harmonised interoperability and security requirements for EHR systems (European Commission, 2025a). For Belgium, the issue is not whether digital health exists: Belgium already has strong assets, including the eHealth platform, regional data vaults, ePrescription infrastructure, patient portals, Belgian Integrated Health Record (BIHR), BeSafeShare, Fast Healthcare Interoperability Resources (FHIR) implementation work, and the Health Data Agency (HDA). The central challenge is whether these assets can be made coherent, consistent, measurable, legally aligned, and operational by the EHDS deadlines.

The EHDS transition began when the European Health Data Space Regulation (EHDS) entered into force on 26 March 2025. The European Commission must adopt key implementing acts by March 2027; by March 2029, all Member States must support exchange of patient summaries and ePrescriptions/eDispensations for primary use, while secondary-use rules apply to most categories such as EHR data; by March 2031, medical images, laboratory results, and hospital discharge reports must be operational for primary use, with remaining secondary-use categories such as genomic data also covered (European Commission, 2025a). Therefore, Belgium’s critical path is 2026–2029, not 2029 itself.

Critical Milestones for Belgian Healthcare

1. Establish a single Belgian EHDS execution architecture before the 2027 implementing acts

Belgium should treat the March 2027 implementing acts as a “design-freeze” deadline. By then, Belgium needs an agreed national EHDS implementation programme with clear accountability across federal, regional, community, and local levels. This is essential because Belgium’s health system is structurally fragmented: federal authorities remain responsible for compulsory health insurance, hospital budgeting, regulation of health products and professionals, and patients’ rights, while federated entities are responsible for primary care organization, older people’s care, mental health care, rehabilitation, prevention, and health promotion (Gerkens & Merkur, 2024).

The 2026–2029 Interfederal eHealth Action Plan already defines the strategic direction: Belgium must develop an eHealth architecture in which hundreds of ICT components and platforms are shared transparently, with BIHR as a major step toward continuity of care, citizen dashboards, interoperability, and cross-border EU exchange (INAMI/RIZIV, 2026a). This needs to become an EHDS delivery office with named owners for primary use, secondary use, EHR certification, terminology, patient rights, cybersecurity, procurement, vendor onboarding, and clinical adoption.

Note: European countries should not gold-plate EHDS by adding excessive national complexity, nor should it sugarcoat European standards as if formal compliance guarantees meaningful interoperability. The practical objective should be narrower and harder: implement the mandatory EHDS requirements correct and on time, make them usable in daily clinical care (primary use), enforce vendor and provider compliance, and prove that data can be exchanged and reused safely at scale (secondary use, Findable, Accessible, Interoperable en Reusable (FAIR)). 

2. Operationalize BIHR as the national primary-use integration layer

The Belgian Integrated Health Record (BIHR) should be Belgium’s main clinical integration vehicle for EHDS primary-use obligations. INAMI/RIZIV describes BIHR as an initiative through which citizens can consult their health and well-being data and professionals with a therapeutic relationship can access the data needed to provide quality care (INAMI/RIZIV, 2026b). Importantly, BIHR is not intended to create a new EHR; it is an interdisciplinary IT framework linking user interfaces to authentic sources, with more standardized consultation, presentation, and registration while reducing administrative burden (INAMI/RIZIV, 2026b).

By 2027, Belgium should define the BIHR minimum dataset for EHDS priority data categories. By 2028, every hospital, GP software system, pharmacy system, laboratory system, imaging platform, and relevant ambulatory-care system should be technically tested against BIHR/Belgian FHIR profiles. By March 2029, patient summaries and ePrescription/eDispensation exchange should be production-ready through BIHR-aligned services. By March 2031, the same should apply to imaging, laboratory results, and discharge reports.

Note: The formal implementation of syntactic and semantic standardization in healthcare requires establishing uniform rules for data transport (syntax) and shared clinical meaning (semantics) to eliminate data silos and vendor lock-in. It involves aligning technical structures, adopting standard (open international) vocabularies, and enforcing interoperability "at the source" of data capture.

3. Convert BeSafeShare CareSets into enforceable national semantic standards

"Care Sets" act as standardized information models that outline all essential data points tied to a specific care process or patient condition (e.g., an "allergy" care set covers the causal agent, reaction severity, and diagnostic date). Within the context of the EHDS, they serve as the operational building blocks to meet the requirements of the European Electronic Health Record Exchange Format (EEHRxF).

Belgium’s EHDS readiness depends on structured data at source. BeSafeShare provides an important method: care content is formalised into CareSets, validated by field experts, discussed with HL7 Belgium, converted into Belgian FHIR profiles, and published as implementation-guide standards for software suppliers (INAMI/RIZIV, 2026c). This is exactly the mechanism Belgium needs to avoid building a health-data space on unstructured, inconsistent, locally defined data.

The milestone is therefore not merely “publish FHIR profiles.” It is to make CareSets mandatory in reimbursement, certification, procurement, and reporting for EHDS priority domains. The initial CareSets should cover allergies, active problems, medication lists, patient summaries, ePrescription/eDispensation, care-team identity, laboratory observations, imaging metadata, discharge reports, referrals, vaccination, implants/devices, and consent/opt-out metadata. Belgium’s eHealth FHIR site already publishes federal FHIR implementation guides, profiles, value sets, code systems, and naming systems; this publication infrastructure should become the authoritative EHDS conformance layer (eHealth Platform, 2026).

4. Complete vendor registration, conformance testing, and certification before 2029

The EHDS introduces strict security and interoperability criteria for EHR systems and requires manufacturers to certify compliance (European Commission, 2025a). Belgium already has a useful model for software onboarding: technical validation checks FHIR structure, mandatory fields, formats, values, codes, business rules, workflow scenarios, and manual integration; validation is mandatory for software to be considered registered (INAMI/RIZIV, 2026d).

EHDS (European Health Data Space) compliance for Electronic Health Record (EHR) systems involves a mandatory pre-market CE marking process. This requires thorough testing, technical validation, and verification against standardized specifications for interoperability, security, and data protection. To avoid mere "window dressing" in European Health Data Space (EHDS) compliance, testing and verification must look beyond surface-level administrative checkboxes. Manufacturers and institutions must rely on high-quality automated European testing environments and independent audits to ensure true adherence to Annex II requirements. European digital testing environments will have to provide automated testing to verify compliance of harmonised software components of EHR systems with the EHDS Regulation.

Belgium should make EHDS conformance testing a prerequisite for public procurement, reimbursement-linked digital services, hospital accreditation, and professional software registration. By 2028, vendors should be required to demonstrate successful creation, retrieval, update, deletion, export, import, audit, consent, and cross-border exchange functions for the 2029 EHDS categories. By 2030, testing should expand to laboratory, imaging, and discharge-report flows.

5. Build the secondary-use operating model around HDA, metadata catalogues, and secure processing environments

For secondary use, Belgium should anchor a competent and capable Health Data Agency (HDA) as the operational hub for health-data access functions. HDA states that its framework is designed to align with EHDS and support cross-region and cross-border collaboration (Health Data Agency, 2026a). Belgium’s registry policy is also evolving toward a federated model, “only once” recording, standardization at source, automated standardized exchange, reuse of existing components, FAIR principles (Findable, Accessible, Interoperable, Reusable), and secure use (Health Data Agency, 2026a).

The 'Health Data Enabled for Re-use Across Belgium' (HeDERA) project is especially important because it supports HDA’s capacity, metadata interoperability, data quality, HealthData@EU alignment, secure processing environments, and cross-border gateway design (Health Data Agency, 2026b). By March 2029, Belgium should have a working national metadata catalogue, standard data-access application workflow, permit workflow, opt-out processing, data-holder onboarding, audit process, and at least one production-grade secure processing environment. EHDS rules require that secondary-use processing occurs in secure processing environments, with no download of personal data and a prohibition on re-identification (European Commission, 2025a).

Proposed Belgian “Meaningful Use” Criteria for EHDS

A Belgian “Meaningful Use for EHDS” programme should be a compliance-and-incentive framework, not a copy of the former U.S. programme. The U.S. Promoting Interoperability (PI) programme is still useful as a design analogy because it links certified EHR technology (CEHRT) to measurable objectives such as electronic prescribing, health information exchange, provider-to-patient exchange, public-health and clinical-data exchange, and protection of patient health information (CMS, 2026). Belgium should adapt that logic to EHDS obligations.

The criteria should include six domains.

1. First, certified and conformant EHR use. Providers should use only EHDS-conformant, Belgian-registered systems for relevant functions. Measures should include successful FHIR conformance tests, support for the European Electronic Health Record Exchange Format (EHRxF), secure authentication, audit logging, role-based access, export/import capability, and no information-blocking behaviour (vendor lock-in).
2. Second, structured data capture at source. Providers should record EHDS-priority data using Belgian CareSets and FHIR profiles. Thresholds should be progressive: for example, 70% structured capture in 2027 pilots, 85% in 2028, and at least 95% for EHDS-priority fields by 2029. The key metric should not be “data submitted” but “clinically generated data captured once, coded correctly, reusable for care and secondary use.”
3. Third, patient access and control. Patients should be able to view, download, share, restrict, correct, and delegate access to their data through accessible dashboards. EHDS explicitly includes fast and free access, sharing with professionals across borders, access logs, correction requests, standard European format viewing, and opt-out rights for secondary use (European Commission, 2025a). These measures are not merely legal formalities: a 2024 systematic review found that patient access to EHRs is positively associated with engagement across adherence, self-management, empowerment, communication, satisfaction, health outcomes, resource use, and usability dimensions, while also identifying privacy, usability, technical, and health-literacy barriers (Alomar et al., 2024). 
4. Fourth, care-continuity exchange. By 2029, every eligible encounter should update the patient summary, medication list, allergy list, and relevant care-team information. Hospitals should transmit structured and clinically relevant discharge reports for continuity of care; laboratories should transmit (LOINC) coded laboratory results; imaging providers should transmit imaging metadata and reports. Metrics should include timeliness, completeness, reconciliation rates, duplicate-test reduction, and successful cross-provider retrieval.
5. Fifth, secondary-use readiness. Providers and data holders should maintain metadata (DCAT-AP), data-quality reports, provenance, consent/opt-out status, and pseudonymisation readiness. Registry reporting should move away from separate forms toward automated extraction from structured EPR data, consistent with HDA’s “only once” and standardization-at-source principles (Health Data Agency, 2026a). Measures should include metadata completeness, response time to lawful data-access requests, data-quality error rates, and successful secure-processing-environment provisioning.
6. Sixth, privacy, cybersecurity, equity, and usability. Meaningful Use should include annual security risk analysis, multifactor authentication, encryption, break-glass procedures, access-log review, incident response, Data Protection Impact Assessment (DPIA) completion, and evidence of staff training. It should also measure accessibility for persons with disabilities, support for low digital and health literacy, proxy access, and multilingual usability. This is necessary because EU-level monitoring shows that access to EHRs is improving, but private providers, nursing homes, proxy access, accessibility, and coverage of all data types remain weaker areas across Europe (European Commission, 2025b). (digital-strategy.ec.europa.eu)

Note: Structural and content completeness in Electronic Health Records (EHRs) define how well a patient's medical data is organized (the framework) and whether the necessary clinical information (the details) is actually recorded. These two pillars dictate patient safety, continuity of care, system interoperability, the reliability of clinical analytics, and appropriate reimbursement.

Major Stumbling Blocks for Belgium

1. The first stumbling block is governance fragmentation. Peer-reviewed research on Belgian integrated-care policy found tensions between federal and federated governments and concluded that partial decentralisation created fragmentation of decisive power that undermines integrated-care efforts (Martens et al., 2021). EHDS requires exactly the opposite: unified data definitions, common patient-rights implementation, national conformance rules, cross-border gateways, and coherent secondary-use governance.
2. The second stumbling block is data quality at source. HDA’s 2025 white paper warning is direct: Belgium is hindered by insufficiently structured registration at the source, fragmented data processes and initiatives, diverse ICT applications and tools, and insufficient implementation of medical standards and harmonisation (Health Data Agency, 2025). This is the most serious technical risk. EHDS cannot be achieved by portals alone; it requires structured, coded, interoperable, reusable clinical data.
3. The third stumbling block is vendor heterogeneity and implementation burden. Belgian healthcare uses many (legacy) EHR, pharmacy, laboratory, imaging, hospital, and care-sector systems. If Belgian profiles, CareSets, and certification rules remain optional or unstable, vendors will implement partial interfaces rather than EHDS-grade interoperability. Conversely, if requirements are imposed without financing, testing support, and usability safeguards, clinicians may experience EHDS as another administrative burden.
4. The fourth stumbling block is the gap between patient access and genuine empowerment. EHDS gives individuals important rights, but these rights require understandable interfaces, proxy access, correction workflows, opt-out workflows, support for vulnerable users, and health-literacy-sensitive design. European monitoring shows that legal and technical support for delegated access and accessibility remains uneven across Member States (European Commission, 2025b). (digital-strategy.ec.europa.eu) Belgium should therefore measure actual use, comprehension, and equity, not only portal availability.
5. The fifth stumbling block is secondary-use trust. Researchers, public authorities, and innovators need high-quality data, but patients and clinicians need assurance that data reuse is lawful, transparent, secure, and socially legitimate. EHDS prohibits detrimental individual decisions, marketing misuse, downloads of personal data from secure environments, and re-identification attempts (European Commission, 2025a). (EHDS) Belgium must communicate these safeguards clearly, while giving HDA enough operational capacity to process requests efficiently and audit compliance.

Conclusion

Belgium can meet the EHDS deadlines only if it treats EHDS as a national health-system transformation programme rather than an IT compliance exercise. The critical milestones are clear: establish interfederal governance by 2027, operationalize BIHR as the primary-use integration layer, make BeSafeShare CareSets and Belgian FHIR profiles enforceable, certify vendors before 2029, and build HDA-led secondary-use infrastructure with secure processing environments and HealthData@EU connectivity. The content of Belgian “Meaningful Use” criteria should therefore focus on measurable structured-data capture, patient control, cross-provider exchange, secondary-use readiness, cybersecurity, and equity. Belgium’s main risks - fragmented governance, unstructured source registration, vendor heterogeneity, clinician burden, and public trust - are manageable, but only if the 2026-2029 action plan becomes an execution programme with binding milestones, funding, audit, and consequences for non-compliance.

References

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