ArticleOpen research Europe2024
Getting ready for the European Health Data Space (EHDS): IDERHA's plan to align with the latest EHDS requirements for the secondary use of health data.
Article in Open research Europe, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.
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Who cites it
17 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
- Harmonising Pharmacovigilance and Pharmacoepidemiology: Lessons from Europe for Cohesive Medicines Safety Science.Drug safety · 2026Article
- Healthcare Digital Twins Across Scales: A Narrative Review and Five-Level Conceptual Framework.Healthcare (Basel, Switzerland) · 2026Review
- Nordic AI-Health: a unique opportunity for discovery and clinical impact.The Lancet regional health. Europe · 2026Article
- From Reactive to Predictive One Health: AI-Enabled Frameworks for Integrated Zoonotic Surveillance and Governance.International journal of environmental research and public health · 2026Article
- Orchestrating the Development of a Sustainable Network IT Solution for a Research Network: Qualitative Participatory Multimethod Design.JMIR formative research · 2026Article
- An OMOP Common Data Model pipeline for electrocardiography dataset integration by standardizing signal metadata and heart rate variability features.Frontiers in bioinformatics · 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
- RareLink: scalable REDCap-based framework for rare disease interoperability linking international registries to FHIR and Phenopackets.NPJ genomic medicine · 2025Article
- AI Act Compliance Within the MyHealth@EU Framework: Tutorial.Journal of medical Internet research · 2025Article
- Reality Check: The Aspirations of the European Health Data Space Amidst Challenges in Decentralized Data Analysis.Journal of medical Internet research · 2025Article
- Genomic data sharing in research across Europe: legal challenges and upcoming opportunities within the European Health Data Space.European journal of public health · 2025Article
- 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.Journal of medical Internet research · 2025Article
- Lessons Learned From European Health Data Projects With Cancer Use Cases: Implementation of Health Standards and Internet of Things Semantic Interoperability.Journal of medical Internet research · 2025Article
- The Innovative Health Initiative public-private partnership: a catalyst for big data-driven health research and innovation.Frontiers in medicine · 2025Article
- The FLAIR-GG federated network of FAIR germplasm data resources.Scientific data · 2024Article
- Lessons from federated networks for implementing the European health data space. Empirical study.Digital healthArticle
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Authors and funding
19 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: The European Health Data Space (EHDS) shapes the digital transformation of healthcare in Europe. The EHDS regulation will also accelerate the use of health data for research, innovation, policy-making, and regulatory activities for secondary use of data (known as EHDS2). The Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance (IDERHA) project builds one of the first pan-European health data spaces in alignment with the EHDS2 requirements, addressing lung cancer as a pilot. Methods: In this study, we conducted a comprehensive review of the EHDS regulation, technical requirements for EHDS2, and related projects. We also explored the results of the Joint Action Towards the European Health Data Space (TEHDAS) to identify the framework of IDERHA's alignment with EHDS2. We also conducted an internal webinar and an external workshop with EHDS experts to share expertise on the EHDS requirements and challenges. Results: We identified the lessons learned from the existing projects and the minimum-set of requirements for aligning IDERHA infrastructure with EHDS2, including user journey, concepts, terminologies, and standards. The IDERHA framework (i.e., platform architecture, standardization approaches, documentation, etc.) is being developed accordingly. Discussion: The IDERHA's alignment plan with EHDS2 necessitates the implementation of three categories of standardization for: data discoverability: Data Catalog Vocabulary (DCAT-AP), enabling semantics interoperability: Observational Medical Outcomes Partnership (OMOP), and health data exchange (DICOM and FHIR). The main challenge is that some standards are still being refined, e.g., the extension of the DCAT-AP (HealthDCAT-AP). Additionally, extensions to the Observational Health Data Sciences and Informatics (OHDSI) OMOP Common Data Model (CDM) to represent the patient-generated health data are still needed. Finally, proper mapping between standards (FHIR/OMOP) is a prerequisite for proper data exchange. Conclusions: The IDERHA's plan and our collaboration with other EHDS initiatives/projects are critical in advancing the implementation of EHDS2.
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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.