ArticleJournal of medical Internet research2025
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.
Article in Journal of medical Internet research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed.
- Bridging Gaps in Standards for the Secondary Use of Health Data: Exploratory Standard, Tool Assessment, and Feasibility Study.JMIR formative research · 2026Article
- Regulatory science for AI-basedJournal of pathology informatics · 2026Article
- Health Data Quality Skill Gaps and Training Needs Among European Health Data Stakeholders: Cross-Sectional Survey.Journal of medical Internet research · 2026Article
- A new era of precision diagnosis and treatment for lung cancer: artificial intelligence-driven multimodal data integration and clinical applications.Cell death & disease · 2026Review
- BRIDGE pilot study: a bilateral regulatory investigation of data governance and exchange.NPJ digital medicine · 2026Article
- The need for clear medical data ownership laws.Journal of translational medicine · 2026Article
- The European Health Data Space and biobanking in Europe: synergies, tensions and the future governance of data-driven health research.Frontiers in genetics · 2026Review
- From pilot to policy: Adoption of the National mHealth application EZKarta in Czechia.Digital healthArticle
Corrections and comments
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.