Real World Evidence in Europe
To better understand the availability and use of health data across Europe, RWE4Decisions has worked with national authorities, HTA bodies, and other key stakeholders across Europe to gather consistent, comparable information on the data sources that support research and/or policy decision-making.
EUROPEAN HEALTH DATA SPACE
HTA REGULATION
EUROPEAN HEALTH DATA SPACE
The official entry into force of the European Health Data Space (EHDS) Regulation in March 2025 marked a significant step towards the integration of European health data resources and infrastructures for better health healthcare delivery and biopharmaceutical R&D.
The Regulation provides a common European framework for the secure and ethical use of health data across borders – covering both primary and secondary use. For secondary use, the Regulation will facilitate – as of 2029 – the use of RWE from all Member States in research, innovation, regulatory decision-making and HTA.
The success and longevity of the new European health data ecosystem can only be ensured by open consultations with all health stakeholders: the RWE4Decisions Learning Network will continue to support the European Commission and national authorities throughout the Regulation’s implementation period in order to future-proof the development of secondary-use frameworks.
Along 38 other leading representatives in the European health community, RWE4Decisions has been involved in publishing a Joint Statement welcoming the publication of the EHDS and calling for effective stakeholder engagement and capacity building during its implementation, which can be accessed here.
HTA REGULATION
EUROPEAN HEALTH DATA SPACE
HTA REGULATION
The HTA Regulation, which entered into force in 2022, aims to enhance collaboration in the clinical evaluation of health technology across the EU to support better patient access to innovative therapies across the EU.
By integrating HTA expertise from all Member States into the Coordination Group on Health Technology Assessment (HTACG), the Regulation seeks to streamline resources and harmonise the scientific advice and clinical assessment of new medical products and devices, and has published methodological guidelines and procedures for assessing data and evidence across the European Union.
Since January 2025, all oncology and advance therapeutic medicinal products have been subject to Joint Clinical Assessment under the Regulation, and scientific evidence has been available through the Joint Scientific Consultation process.
RWE4Decisions monitors the progress of implementation of the Regulation and seeks to learn lessons for RWE generation.
National Health Data Sources
- Main national health data sources
- How data is collected, managed, and maintained
- Governance structures and access conditions
- Relevant legislation, privacy safeguards, and interoperability frameworks
Click on each country to find out more.
As we move into the implementation phase of the European Health Data Space (EHDS), we seek to regularly update the country snapshots and highlight national readiness for EHDS adoption. Ongoing contributions will help track progress, share good practices, and identify areas where support is needed.
Share your country’s response by completing our updated questionnaire
International collaboration
While an EU-focused project at its genesis, RWE4Decisions has grown into an international collaborative project, bringing together stakeholders from outside the EU. Our Learning Network comprises a broad range of stakeholders including assessors, clinicians, and analytics experts from several EU Member States as well as Canada, the United Kingdom and the United States.
Learn more about international multistakeholder representation in our
