During the EUCROF Conference 2025, held from 2-4 February 2025 in Copenhagen, the special interests stream titled “The Rise of the European Patient Data Ecosystem” explored the transformative potential of the European Health Data Space and its implications for clinical research.
The session highlighted the significant role the EHDS can play in revolutionising clinical studies by enabling the secondary use of health data.
The impact of the EHDS for clinical research
Dipak Kalra (The European Institute for Innovation Through Health Data) explained the main provisions of the European Health Data Space Regulation, covering primary uses and secondary uses of health data, within and across borders. He identified opportunities for clinical research that these provisions provide, describing measures that key actors in the field (including pharma and CROs) should take now to promote key success factors that need to be properly included within forthcoming EHDS acts. Melodie Bernaux (European Commission) outlined the EHDS vision and its transformative benefits, focusing particularly on the secondary use of health data for clinical research.
xShare and Data Portability Solutions in Europe: Implications for Clinical Research
In his presentation, Vincent Keunen (Andaman7) discussed solutions to the lack of health data interoperability in Europe, such as the EHDS (European Health Data Space). He explored the importance of setting and enforcing data exchange standards, the current state of affairs, and highlighted promising projects such as xShare Yellow Button, the EEHRxF, and XpanDH.
Federated analyses & mastering heterogenous data: Implementing a scalable approach to FHIR/OMOP compliant Common Data Models
Nora Sagel (Honic) explored the challenges of managing heterogeneous Real-World Data (RWD) and how implementing scalable approaches to FHIR/OMOP-compliant Common Data Models (CDMs) can unlock its full potential for research. She provided strategies for CDMs to streamline the analysis of decentralised datasets, and shared in-depth insights on how federated analyses can improve time-to-data and support data-driven decision-making in medicine.
The discussions addressed the opportunities and challenges of creating a robust and collaborative patient data ecosystem within Europe. A key focus of the session was the introduction of the xShare open call aimed at implementing the EEHRxF in the clinical research field. Yoanni Th. Matsakis (Telemedicine Technologies) presented the xShare open call, inviting 10-20 EUCROF25 attendees to participate in implementing the EEHRxF for clinical research, with a focus on GDPR compliance and improving health data sharing.
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