European Health Data Space (EHDS): A New Era for RWE and Health Technology Assessment
The European Union’s formal adoption of the European Health Data Space (EHDS) Regulation in 2025 marks a significant shift in health data governance. More than a legal milestone, it represents one of the most ambitious efforts to build a connected, interoperable health data infrastructure across borders. Designed to support clinical research, public health, and informed policymaking, EHDS aims to dismantle long-standing silos and establish a shared foundation for secondary use of health data across Europe.
At the same time, the EU Health Technology Assessment (HTA) Regulation is entering force, setting the stage for coordinated evaluations of new therapies. The convergence of these policies offers the potential for evidence to travel more freely across systems and for research and reimbursement decisions to be based on more complete, real-world insights.
From Legal Framework to Data Ecosystem: What EHDS Enables
The EHDS Regulation (EU) 2025/3272 creates a dual-purpose framework for health data: one pathway for direct patient care, and another for secondary uses such as scientific research, regulatory oversight, and system planning.
EHDS goes beyond interoperability by mandating that each EU member state establish a Health Data Access Body (HDAB), while also contributing to a pan-European platform called HealthData@EU. These national and EU-level systems are built on the principle of federated access: data remains at its source but can be securely queried and analyzed under consistent rules1.
Key data categories to be made accessible include:
Electronic health records
Prescription and pharmacy data
Laboratory and diagnostic data
Imaging and genomic data
Hospital discharge summaries
Claims and registry data
EHDS aligns with the GDPR, the Data Governance Act, and the Data Act, but introduces specific health-sector provisions particularly the requirement for both public and private institutions to share data in structured formats under clear safeguards.
A Phased Timeline: 2025–2037
The implementation is gradual but strategic:
Each milestone is designed to allow countries and institutions to scale up readiness, adjust governance models, and validate technical infrastructure.
Why This Matters for Real-World Evidence
Until now, efforts to generate real-world evidence (RWE) in Europe have faced considerable friction fragmented data systems, differing consent standards, and inconsistent access rules. EHDS offers a coordinated framework that will enable:
Discovery and access of curated datasets via central catalogues
Transparent, secure application processes through HDABs
Distributed analysis using common data models
More consistent and reproducible evidence generation across the region
This holds particular value for post-marketing studies, safety surveillance, outcomes research, and health economics where timely, multi-country data can provide crucial context. It also allows better inclusion of patient populations that traditional clinical trials often overlook, such as those with chronic conditions, multiple comorbidities, or advanced age.
A Foundation for HTA Readiness
The EU HTA Regulation, active from 2025, introduces a system of Joint Clinical Assessments (JCAs) beginning with cancer and advanced therapy medicinal products (ATMPs). Over time, this will expand to cover more therapeutic areas. The success of this model hinges on a strong data backbone. EHDS provides that foundation, allowing national HTA bodies to draw from consistent data sources when evaluating cost-effectiveness, supporting early access programs, or re-evaluating therapies after initial approval. With common data access protocols and cross-border cooperation, EHDS will help reduce duplication, improve transparency, and support faster decisions about which innovations reach patients and when.
How Maxis Clinical Sciences is Contributing
While not a formal partner in European EHDS initiatives, we leverage our advisory and digital health expertise to support organizations preparing for EHDS compliance:
Offering RWE advisory and data transformation services aligned with EHDS-compatible data standards (e.g. OMOP, FHIR)
Advising clients on governance, consent models, and regulatory alignment for secondary data use
Drawing on best practices from European programs like DARWIN EU and EHDEN to shape evidence frameworks and analytical planning
This positions our teams to help clients build readiness for federated access, metadata harmonization, and aligned consent strategies.
Conclusion
The EHDS is not a one-time reform. It’s a long-term investment in how Europe values and uses health data. By creating a system that respects privacy while allowing data to flow securely, EHDS will make evidence more timely, more inclusive, and more impactful. This moment demands preparation not only in IT systems or legal frameworks, but in how we think about collaboration, transparency, and accountability. The future of real-world evidence and HTA in Europe is being built now, milestone by milestone, dataset by dataset. For those ready to engage meaningfully with that future, EHDS is not just a regulation. It’s a shift in the very infrastructure of trust behind health decision-making. Connect with us to explore how we can support your RWE and HTA readiness journey in the context of EHDS.
References
European Health Data Space Regulation (EHDS). Public Health. Published June 25, 2025. https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space-regulation-ehds_en#who-benefits-from-ehds
Regulation - EU - 2025/327 - EN - EUR-Lex. Europa.eu. Published 2025. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32025R0327
Implementation of the Regulation on health technology assessment. Public Health. Published October 29, 2024. https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment_en
Author: Nishaa Panwaar