Project Progress Update and Feedback Report: University of Warwick

1.      The University of Warwick Role in the INSAFEDARE

The University of Warwick (UoW) is the Technical Director for the INSAFEDARE. They are leading two work packages in the project, “WP2: Assessment and optimization of regulatory decision-making and validation of modern digital intervention applications” and “WP3: Safety and quality assurance of real world and synthetic datasets”. As an academic partner and technical director on the project, the role includes comprehensive oversight and technical leadership across multiple project dimensions. This includes helping the project coordinator and partners mitigate associated risks, ensure quality assurance, and address legal and ethical considerations to maintain compliance and integrity. The UoW also contributes to the oversight of project outcomes, tracking milestones, preparing reports and deliverables, and liaising effectively with the project coordinator. A critical contribution lies in bridging gaps between existing regulations and standards to enable robust data-driven approaches, complemented by rigorous safety analyses. Advanced research tasks involve assessing the statistical equivalence of synthetic and real-world datasets, establishing assurance case patterns for data-driven methodologies, and evaluating their relevance to regulatory frameworks. Furthermore, the partner investigates and reviews cutting-edge machine learning techniques for synthetic data generation, ensuring methodological soundness and practical applicability. Beyond research, the academic partner plays a pivotal role in capacity building by developing training materials on dataset assurance, best practices for dataset generation, and guidance for organizations conducting clinical trials, alongside frameworks for assuring digital health applications. As an academic partner, UoW contributes to publishing research papers, presenting findings at conferences, and organizing seminars and workshops to share knowledge and build capacity within the consortium and the wider community. This multifaceted engagement ensures both scientific excellence and regulatory compliance, reinforcing the project’s impact on innovation and healthcare resilience.

2.      Steps made during the last 3 months (November 2025)

The UoW has been leading the research work in ‘T2.3 - Gap analysis of regulation and standards to address data-driven approaches’." In this context, we prepared a report on "D2.4: Gap analysis of data related standard with respect to the MDR requirements," which is ready for submission by the end of October 2025. UoW also led the "Task 3.2 – Safety analysis (HazID) of data driven approaches" and successfully completed the relevant deliverable (D3.2) by the end of Month 22. In addition, we are leading "Task 3.4: Statistical evidence for the relevance or RW&SD" and working on its deliverable D3.4 in collaboration with LUMC, Syntho, and UoB. This task included work on the equivalence of tabular synthetic data and real-world data, as well as a study on the equivalence of synthetic and real-world data. UoW is supporting "Task 2.2 – Review and modelling of standards and guidance on data and big data safety and quality," led by UoB. This work provides a detailed literature review of standards and guidelines related to data and big data safety and quality, listing relevant frameworks and describing each clearly. The aim is to offer a comprehensive overview of current practices and develop an ontology for these standards. The deliverables D2.2 and D2.3 are ready for submission by the end of October 2025. UoW is also supporting "Task 4.3: Development of a ML method for generation of synthetic imaging data," led by UoB, with its deliverable D4.3 ready for submission by the end of October 2025. We have also supported Task 3.1, which is led by the EFMI. Finally, UoW is contributing to "T5.5: Ensuring privacy, consent and compliance of integrated datasets," led by IIP, by actively participating in meetings with the lead and R&D partners to ensure successful completion.

3.      Papers you have published (November 2025)

                  i.           Waseem, Hafiz Muhammad, Saif Ul Islam, Stuart Harrison, Gregory Epiphaniou, Nikolaos Matragkas, Theodoros N. Arvanitis, and Carsten Maple. "Data-driven FMEA approach for hazard identification and risk evaluation in digital health." Scientific Reports 15, no. 1 (2025): 26856.

                ii.           Harrison, Stuart, Saif Ul Islam, Hazif Muhammad Waseem, and Gregory Epiphaniou. "Digital health interventions use cases: Classification and taxonomy development, a scoping review." Digital health 11 (2025): 20552076251375958.

4.      Potential/tentative manuscripts you are about to submit for publication

                  i.           Jim ACHTERBERG, Bram VAN DIJK, Jing MENG, Saif Ul ISLAM, Gregory EPIPHANIOU, Carsten MAPLE, Xuefei DING, Theodoros N. ARVANITIS, Simon BROUWER, Marcel HAAS, and Marco SPRUIT “OpenExtract: Automated Data Extraction for Systematic Reviews in Health” ready to be submitted to the MIE 2026.

5.      Seminars/Congresses/Conferences/ Workshops you have participated in

                  i.           Workshop on “Challenges for Multimodal AI” on Tuesday 24th of June, 2025. Organised by the Turing-Roche at the Allen Turing Institute, London, UK.

6.      Future Seminars/Congresses/Conferences/ Workshops

                  i.           MetReal Cluster MeetUp October 29, 2025

                ii.           MetReal Cluster Multistakeholder workshop in Copenhagen on 24-25 February, 2026

              iii.           CADE 2026

7.      Any communication actions held.

Leading the Special Collection on “Innovations and Applications of Synthetic Data in Transforming Healthcare Systems: Opportunities, Challenges and Ethical Considerations” in the Digital Health journal, SAGE. Link: Innovations and Applications of Synthetic Data in Transforming Healthcare Systems: Opportunities, Challenges and Ethical Considerations : DIGITAL HEALTH: Sage Journals