Interoperability Framework of the European Health Data Space for the Secondary Use of Data: Interactive European Interoperability Framework-Based Standards Compliance Toolkit for AI-Driven Projects

Abstract

The successful implementation of the European Health Data Space (EHDS) for the secondary use of data (known as EHDS2) hinges on overcoming significant challenges, including the proper implementation of interoperability standards, harmonization of diverse national approaches to data governance, and the integration of rapidly evolving AI technologies. This work addresses these challenges by developing an interactive toolkit that leverages insights from 7 leading cancer research projects (Integration of Heterogeneous Data and Evidence towards Regulatory and HTA Acceptance [IDERHA], European Federation for Cancer Images [EUCAIM], Artificial intelligence Supporting Cancer Patients across Europe [ASCAPE], Personalised Health Monitoring and Decision Support Based On Artificial Intelligence and Holistic Health Records [iHelp], Central repository for digital pathology [Bigpicture], Piloting an infrastructure for the secondary use of health data [HealthData@EU] pilot, and improving cancer diagnosis and prediction with AI and big data [INCISIVE]) to guide in shaping the EHDS2 interoperability framework. Building upon the foundations laid by the Towards the European Health Data Space (TEHDAS) joint action (JA) and the new European Interoperability Framework (EIF), the toolkit incorporates several key innovative features. First, it provides interactive and user-friendly entry modules to support European projects in creating their own interoperability frameworks aligned with the evolving EHDS2 requirements technical and governance requirements. Second, it guides projects in navigating the complex landscape of health data standards, emphasizing the need for a balanced approach to implementing the EHDS2 recommended standards for data discoverability and sharing. Third, the toolkit fosters collaboration and knowledge sharing among projects by enabling them to share their experiences and best practices in implementing standards and addressing interoperability challenges. Finally, the toolkit recognizes the dynamic nature of the EHDS2 and the evolving regulatory landscape, including the impact of AI regulations and related standards. This allows for continuous adaptation and improvement, ensuring the toolkit remains relevant and useful for future projects. In collaboration with HSbooster.eu, the toolkit will be disseminated to a wider audience of projects and experts, facilitating broader feedback and continuous improvement. This collaborative approach will foster harmonized standards implementation across projects that ultimately contribute to the development of a common EHDS2 interoperability framework.