The European Health Data Space in 2026

A new era of digital sovereignty is taking shape across the European healthcare sector as the region seeks to turn its immense data diversity into a formidable research asset. Historically, the absence of a cross-border framework meant that European health data was often underutilised, leaving the region at a disadvantage compared to more streamlined global competitors.

To address this fragmentation, the EU introduced one of its most ambitious digital health initiatives to date: the European Health Data Space (EHDS).

Formally adopted in 2025 following several years of legislative development led by the European Commission, the EHDS establishes a new governance and technical framework for how health data is accessed and reused across EU Member States. Now, as implementation planning progresses into 2026, stakeholders across the clinical research ecosystem are beginning to assess its real-world implications.

Is the EHDS the structural catalyst needed to modernize European clinical research, or will its complexity slow adoption?

Early indicators suggest a nuanced answer. The regulatory architecture is ambitious and comprehensive, but operational readiness across EU Member States remains uneven. The EHDS has clearly established the direction of travel; the question now is how quickly implementation can match that ambition.

Explaining the European Health Data Space

To understand the EHDS, it is important to recognise the fundamental structural shift it introduces. The initiative is designed to regulate and standardise two distinct categories of health data usage across the EU: primary use and secondary use.

Primary use refers to the direct use of health data for patient care. One of the initiative’s core objectives is to enable patients to access their electronic health records and share them securely with healthcare providers across borders. This builds on earlier EU digital health policies but introduces stronger interoperability requirements.

Secondary use, however, is where the EHDS carries its most transformative implications for the life sciences sector. Secondary use refers to the reuse of health data for purposes including scientific research, regulatory decision-making, public health policy and AI development.

Under the regulation, EU Member States must establish national Health Data Access Bodies (HDABs), which will evaluate and approve requests for access to datasets for these purposes.

In this framework, organisations such as hospitals, public health institutions, and pharmaceutical companies may act as Health Data Holders, while research organisations, academic institutions, and industry sponsors act as Health Data Users.

Access is granted through a permit-based system, with data processed within secure environments designed to minimise risks to privacy and confidentiality.

Building the Infrastructure: HealthData@EU and Early Implementation Work

The EHDS is not being implemented in isolation. It builds upon several existing EU digital health and data infrastructure initiatives, including HealthData@EU, which aims to create a federated network connecting national health data platforms.

Rather than centralising datasets into a single European database, the EHDS adopts a federated model, meaning that data remains within national or institutional environments while being made discoverable and accessible under common standards.

Several EU-funded projects are already supporting this transition. Joint Actions such as TEHDAS and TEHDAS2 are working to define governance models, technical specifications, and operational best practices for secondary data use.

This staged implementation reflects the scale of the challenge. European health datasets vary widely in structure, quality, and accessibility, meaning interoperability must be built gradually rather than imposed immediately.

Why the EHDS Matters for Clinical Research

For the clinical trials ecosystem, the EHDS has the potential to address one of the most persistent bottlenecks in European research: fragmented access to real-world data.

Historically, clinical trial feasibility and recruitment have often been constrained by the difficulty of identifying patient populations across multiple countries. Data frequently sits within national registries or hospital systems that is not easily searchable or interoperable.

By introducing standardised dataset catalogues and cross-border governance processes, the EHDS aims to make these datasets more discoverable.

This could significantly improve three key areas of clinical research, namely optimising real-world evidence (RWE) into trial design, patient recruitment for rare disease trials and AI development, each of which are expanded upon below.

Real-World Evidence and Trial Design

Regulatory agencies such as the European Medicines Agency and the U.S. Food and Drug Administration have increasingly incorporated RWE into regulatory decision-making.

The EHDS is expected to support this trend by providing a clearer legal and technical framework for accessing observational health datasets.

Initiatives such as DARWIN EU (Data Analysis and Real World Interrogation Network) already demonstrate how federated data models can support regulatory research. While DARWIN EU is not formally part of the EHDS, it is widely considered a precursor to its broader infrastructure.

Greater access to structured real-world datasets may allow sponsors to refine eligibility criteria, conduct feasibility assessments and improve endpoint selection, with all three being particularly relevant for complex or targeted therapies.

Rare Disease Recruitment and Precision Medicine

One of the most widely cited benefits of cross-border data access is its potential impact on rare disease research.

Rare disease trials often require multi-country recruitment due to small patient populations. Federated metadata catalogues, if implemented effectively, could allow sponsors to identify patient cohorts across multiple jurisdictions more efficiently than current processes allow.

Parallel European initiatives, including the European Genomic Data Infrastructure (GDI), are also exploring ways to connect genomic datasets across EU Member States. While these projects remain in development, they illustrate the broader strategic direction of European research infrastructure.

AI Development and Data-Driven Research

The EHDS explicitly allows secondary data use for algorithm development under controlled conditions. This aligns with growing regulatory interest in AI-enabled healthcare tools.

Secure Processing Environments (SPEs) are expected to play a key role here. These environments allow researchers to analyse datasets without directly exporting raw data, reducing risks associated with data transfer.

This model is already being used in several EU research programmes and is expected to expand as EHDS implementation progresses.

Operational Challenges: Implementation Complexity Remains

Despite its strategic promise, the EHDS introduces significant operational requirements for organisations holding health data.

The regulation establishes new responsibilities around, data documentation, metadata standardisation, interoperability and governance compliance, and for organisations with legacy systems, these requirements may require substantial investment for updates and alterations.

It is also important to note that the EHDS does not impose a single universal technical standard today. Instead, the regulation mandates that common interoperability standards will be defined through implementing acts over time.

While the EHDS does not mandate a single universal technical standard today, two frameworks have emerged as the ‘dual engines’ of the ecosystem: HL7 FHIR (Fast Healthcare Interoperability Resources) and the OMOP Common Data Model (CDM). HL7 FHIR is an agile, web-based messaging standard designed for the real-time exchange of clinical data between live systems, making it the primary tool for patient care in Primary Use.

In contrast, the OMOP CDM is a research-oriented standard that harmonises disparate datasets into a unified structure, enabling the large-scale population analytics and longitudinal studies required for Secondary Use.

By early 2026, technical work within the TEHDAS2 Joint Action has focused on bridging these standards through OMOP-on-FHIR pipelines, ensuring that the rich clinical data captured in FHIR can be efficiently transformed into research-ready OMOP formats with high semantic consistency. This phased approach reflects the reality that European healthcare data systems differ significantly across EU Member States.

Governance and the Role of Health Data Access Bodies

A central operational feature of the EHDS is the creation of national Health Data Access Bodies.

These authorities will be able to evaluate data access applications, ensure compliance with legal safeguards and coordinate secure access mechanisms. While the governance model is clearly defined at a regulatory level, operational readiness varies across EU Member States.

Some countries already operate advanced health data infrastructures, while others are still developing foundational capabilities, and as a result this uneven starting point is one of the most frequently cited implementation risks.

Intellectual Property and Trade Secret Considerations

One of the most widely discussed concerns within the pharmaceutical industry relates to intellectual property protections.

The EHDS requires that certain categories of health data be made available for secondary use under controlled conditions. However, the regulation also explicitly states that trade secrets and commercially confidential information must be protected.

Industry organisations such as European Federation of Pharmaceutical Industries and Associations have highlighted the importance of clear operational guidance to ensure that proprietary research insights are not inadvertently disclosed.

In practice, this means that data access decisions will depend heavily on how national authorities interpret and apply confidentiality safeguards.

Data Quality: The Next Implementation Frontier

As implementation progresses, the conversation is increasingly shifting from data access to data usability.

Access alone does not guarantee research value. Data assets must also be complete, structured, Interpretable and consistently coded EU-funded projects such as QUANTUM are exploring frameworks for assessing dataset quality and utility. These initiatives aim to create standardized metadata descriptors that help researchers understand whether datasets are suitable for specific research purposes.

This focus reflects a broader shift in the digital health ecosystem away from regulatory compliance and towards practical usability.

Synergies with Broader EU Life Sciences Policy

The EHDS is part of a wider European strategy to strengthen the region’s competitiveness in biotechnology and clinical research.

Parallel initiatives include reforms to clinical trial processes, expanded digital infrastructure funding and proposed biotechnology policy frameworks. Together, these initiatives aim to address long-standing structural challenges in the European research environment.

However, policy alignment does not automatically translate into operational alignment. The effectiveness of these reforms will depend on coordination across regulatory, technical, and national governance layers.

Implementation Timeline: A Multi-Year Transition

One of the most important realities often overlooked in discussions about the EHDS is its implementation timeline.

Although the regulation entered into force in 2025, most operational components will be phased in gradually through delegated and implementing acts.

Current projections suggest that the core secondary-use infrastructure will develop between 2025 and 2028, with full operational maturity potentially being extended towards the end of the decade. This gradual rollout is typical for EU regulatory frameworks of this scale.

For industry stakeholders, this means the EHDS should be viewed as a strategic transition, not an immediate operational shift.

Conclusion

The European Health Data Space represents one of the most ambitious digital health initiatives globally. Its objectives are clear: enable cross-border healthcare data exchange, strengthen research infrastructure, improve regulatory decision-making and support innovation in AI and precision medicine.

The regulatory framework is now in place, but implementation will determine its success. Operational readiness, interoperability alignment, and governance consistency across EU Member States will ultimately decide whether the EHDS becomes a competitive advantage for European clinical research. For now, the EHDS should be understood not as a finished system, but as a structural transformation already underway. The opportunity is substantial, but so is the complexity.

About the Author

Rhys

Rhys Wallett joined The PBC Group in October 2025 as a Conference Producer, where he researches and produces life sciences meetings for clinical-stage biopharma organisations. In his role, Rhys develops targeted conference programs that bring together key stakeholders across the clinical research ecosystem, from CROs and pharmaceutical sponsors to biotech innovators and regulatory experts. His work focuses on identifying emerging trends in clinical development and translating complex industry challenges into actionable conference content that drives meaningful dialogue and collaboration within the life sciences community.