How can we enable clinical research on sensitive patient data that is FAIR and also within Trusted Research Environments?
To discuss this question, we took part in an international exchange hosted by NFDI4Health, welcoming a delegation from Taiwan's Ministry of Health and Welfare (MOHW), Academia Sinica, the National Biobank Consortium of Taiwan, and the National Health Research Institutes.
The three-hour meeting brought together experts from Taiwan and Germany to discuss Trusted Research Environments (TREs), health data management, and secure data use in research. On our German side, participants included representatives from NFDI4Health, ZB MED, the Federal Institute for Drugs and Medical Devices (BfArM), the University of Göttingen, and us from the University Hospital of Cologne.
Contributing our MeDIC and BI-K insights to the Exchange
Our institute presented two talks that anchored much of the discussion around practical, real-world experience with secure health data infrastructures in Germany.
The first presentation entitled "Making Clinical Data FAIR: Real-world Integration inside Germany's University Hospitals" was presented by the head of our institute Prof. Dr. Oya Beyan together with our colleague Yu-Ting Fu from the Medical Data Integration Center of the University Hospital Cologne. Their talk gave an inside view of how clinical data is made findable, accessible, interoperable, and reusable (FAIR) in practice across German university hospitals - highlighting the concrete steps, infrastructure, and governance needed to turn FAIR principles into everyday clinical data integration work.
The second presentation entitled "Connecting Trusted Research Environments with PADME: Challenges and Insights from the BETTER Project" was presented by our colleague Fu-Sung Kim-Benjamin Tang. His talk addressed how our PADME platform can be used to connect distributed Trusted Research Environments. Drawing on experience from the BETTER project, the talk outlined both the technical and organizational challenges of enabling secure, federated analysis across institutional boundaries - and the lessons learned along the way.
Broader Discussion Themes
Beyond Cologne's contributions, the exchange covered a wide range of topics central to secure and trustworthy health data research, including:
- Data governance and consent management
- Interoperability standards such as HL7, FHIR, and OMOP
- Distributed and federated approaches to data analysis, including distributed analytics, synthetic data
- Controlled analysis environments and other TRE approaches
The Taiwanese delegation, in turn, shared insights into their own health data infrastructure, national biobanks, and the ongoing development of Taiwan's own TRE framework - offering a valuable comparative perspective for the German hosts.
Looking Ahead
We all aligned on our strong interest in continuing the dialogue, particularly around synthetic data, federated learning, data governance, and potential joint research projects. For us as the Institute for Biomedical Informatics, the exchange underscored the growing international relevance of our work being done here in Cologne on connecting Trusted Research Environments and embedding FAIR principles into real-world clinical data infrastructure - and opens the door to further collaboration with partners in Taiwan.
