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.
Artificial Intelligence; European health data space; cancer; digital health; healthcare standards; interoperability; secondary use of data.; Multidisciplinary
Abstract :
[en] [en] 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.
Research center :
Luxembourg Centre for Systems Biomedicine (LCSB): Bioinformatics Core (R. Schneider Group)
Disciplines :
Computer science Public health, health care sciences & services
Author, co-author :
Hussein, Rada ; Ludwig Boltzmann Institute for Digital Health and Prevention, Salzburg, Austria
Balaur, Irina ; Luxembourg Centre for Systems Biology, University of Luxembourg, Luxembourg, Luxembourg ; Luxembourg National Data Service (LNDS)
Burmann, Anja ; Fraunhofer Institute for Software and Systems Engineering, Dortmund, Germany
Gadiya, Yojana ; Discovery Research ScreeningPort, Fraunhofer Institute for Translational Medicine and Pharmacology, Hamburg, Germany ; Fraunhofer Cluster of Excellence for Immune-Mediated Diseases (CIMD), Frankfurt, Germany ; Bonn-Aachen International Center for Information Technology, University of Bonn, Bonn, Germany
GHOSH, Soumyabrata ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Bioinformatics Core
Jayathissa, Prabath; Ludwig Boltzmann Institute for Digital Health and Prevention, Salzburg, Austria
Katsch, Florian ; Ludwig Boltzmann Institute for Digital Health and Prevention, Salzburg, Austria ; Institute of Medical Information Management, Center for Medical Data Science, Medical University of Vienna, Vienna, Austria ; Institute of Outcomes Research, Center for Medical Data Science, Medical University of Vienna, Vienna, Austria
KREMER, Andreas ; University of Luxembourg ; ITTM S.A, Luxembourg, Luxembourg
Lähteenmäki, Jaakko; VTT Technical Research Centre of Finland Ltd, Espoo, Finland
Meng, Zhaoling; Clinical Modeling and Evidence Integration, Sanofi, Cambridge, MA, USA
Morasek, Kathrin ; Institute of Outcomes Research, Center for Medical Data Science, Medical University of Vienna, Vienna, Austria ; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Vienna, Austria
C Rancourt, Rebecca ; Medical School Berlin, Berlin, Berlin, Germany
SATAGOPAM, Venkata ; University of Luxembourg > Luxembourg Centre for Systems Biomedicine (LCSB) > Clinical and Translational Informatics
Sauermann, Stefan; Faculty Life Science Engineering, FH Technikum Wien, Vienna, Austria
Scheider, Simon; Fraunhofer Institute for Software and Systems Engineering, Dortmund, Germany ; Chair for Industrial Information Management, TU Dortmund, Dortmund, Germany
Stamm, Tanja; Institute of Outcomes Research, Center for Medical Data Science, Medical University of Vienna, Vienna, Austria ; Ludwig Boltzmann Institute for Arthritis and Rehabilitation, Vienna, Austria
Muehlendyck, Christian; Johnson & Johnson Medical GmbH, Norderstedt, Germany
Gribbon, Philip; Discovery Research ScreeningPort, Fraunhofer Institute for Translational Medicine and Pharmacology, Hamburg, Germany ; Fraunhofer Cluster of Excellence for Immune-Mediated Diseases (CIMD), Frankfurt, Germany
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.
HE - 101112135 - IDERHA - Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance
Funders :
Horizon Europe Framework Programme European Union
Funding text :
This project has received funding from the European Union's Horizon Europe research and innovation programme under grant agreement No [101112135] (Integration of heterogeneous Data and Evidence towards Regulatory and HTA Acceptance [IDERHA]) through the Innovative Health Initiative (IHI) Joint Undertaking (JU). Support is also received from life science industries represented by COCIR, EFPIA / Vaccines Europe, EuropaBio and MedTech Europe. Support is also received from our Swiss and UK partners.
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