How the First Medical Imaging Cancer Atlas EUCAIM Was Populated: The Experience of a Reference Hospital.

<ns3:p>The fragmentation and decentralization of medical data, including radiological imaging, continue to challenge large-scale observational research across Europe. Artificial Intelligence (AI) applied to big datasets is transforming diagnosis and treatments towards precision medicine across many diseases, yet the lack of findable, accessible, and interoperable datasets still limits model development, validation, and final clinical translation. The European Federation for Cancer Images (EUCAIM) project was launched in 2023 to address these challenges by establishing a secure centralized and federated infrastructure for the secondary use of large-scale oncological imaging and related clinical data. By consolidating fragmented datasets, EUCAIM lays the groundwork for harmonized data governance and trusted cross-border sharing. Implementing a robust documentation framework is essential to ensure regulatory compliance, safeguard data integrity, and support secure data flows across institutional and national boundaries, fully aligned with European regulations and ethical standards. EUCAIM builds on the AI for Health Imaging (AI4HI) initiative (Predictive In-silico Multiscale Analytics to support cancer personalized diagnosis and prognosis, empowered by imaging biomarkers - PRIMAGE, Accelerating the lab to market transition of AI tools for cancer management - CHAIMELEON, Novel pan-European imaging platform for artificial intelligence advances in oncology - EuCanImage, An AI Platform integrating imaging data and models, supporting precision care through prostate cancer’s continuum - ProCancer-I, A multimodal AI-based toolbox and an interoperable health imaging repository for the empowerment of imaging analysis related to the diagnosis, prediction and follow-up of cancer - INCISIVE and integrates over 94 partners and more than 180 stakeholders spanning medical imaging, high performance computing, data standardization, innovation, and legal compliance. This large collaborative ecosystem reinforces EUCAIM’s role as a reference for General Data Protection Regulation (GDPR) and European Health Data Space Regulation (EHDSR) adherence. This publication presents the real-world experience of integrating imaging and clinical data from a reference university hospital into the EUCAIM infrastructure. It outlines the procedural, ethical, and legal challenges encountered, and details the strategies implemented to ensure compliance with data protection regulations, including privacy, security, and ethical standards. These insights offer a practical framework for future large-scale oncological imaging datasets harmonization and AI development, contributing to scalable, reproducible, and legally compliant research that strengthens Europe’s capacity for trustworthy AI-driven oncology solutions.</ns3:p>