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

## TL;DR

EUCAIM is a European project that creates a secure infrastructure for sharing cancer imaging data to support AI research while ensuring privacy and legal compliance.

## Contribution

The paper presents a real-world case of integrating hospital data into EUCAIM, highlighting practical strategies for legal and ethical compliance in large-scale data sharing.

## Key findings

- EUCAIM consolidates fragmented datasets to enable harmonized data governance and cross-border sharing.
- The project aligns with GDPR and EHDSR to ensure secure and ethical handling of sensitive health data.
- A reference hospital's experience demonstrates feasible strategies for compliant data integration into EUCAIM.

## Abstract

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 (PRIMAGE, CHAIMELEON, EuCanImage, ProCancer-I, 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.

The EUCAIM (European Federation for Cancer Images) project was launched in 2023 to improve the way cancer imaging and related clinical data are shared and reused across Europe. Medical data, such as radiology images, are often fragmented and stored in different places, making it hard for researchers to access large, high-quality datasets. This limits the development, testing and validation of artificial intelligence (AI) tools that could help improve diagnosis and treatment.

EUCAIM aims to solve these difficulties by creating a secure and centralized infrastructure that brings together cancer imaging data from across Europe. It supports the safe and ethical reuse of these data for research, following strict rules on privacy, security, and informed consent. The project includes over 94 partners and 180 stakeholders from different fields (such as medical imaging, computing, data standards, and law) ensuring strong collaboration and extensive expertise.

EUCAIM builds on previous European projects (like PRIMAGE, CHAIMELEON, and ProCancer-I) and aligns with major EU regulations like the General Data Protection Regulation (GDPR) and the European Health Data Space Regulation (EHDSR). A key part of the project is ensuring that the infrastructure meets all legal and ethical requirements for handling sensitive health data.

This article shares the real-life experience of a reference hospital contributing imaging and clinical data to EUCAIM and describes the technical and legal steps taken to ensure compliance and protect patients' information. These insights offer a practical example for other institutions considering participation in similar initiatives.

Overall, EUCAIM is helping to build a trusted European framework for using medical imaging data in AI research, aiming to accelerate innovation in cancer care while protecting patients’ rights.