title: Getting ready for the European Health Data Space (EHDS): the IDERHA’s plan to align with the EHDS requirements for the secondary use of health data
Creators: name: Rada Hussein
name: Irina-Afrodita Balaur
name: Anja Burmann
name: Hanna Cwiek-Kupczynska
name: Yojana Gadiya
name: Soumyabrata Ghosh
name: Prabath Jayathissa
name: Florian Katsch
name: Andreas Kremer
name: Jaakko Lähteenmäki
name: Zhaoling Meng
name: Kathrin Morasek
name: Rebecca C. Rancourt
name: Venkata Pardhasaradhi Satagopam
name: Stefan Sauermann
name: Simon Scheider
name: Tanja Stamm
name: Christian Muehlendyck
name: Philip Gribbon
Publisher: name: LCSB
Year: 2024

description: Objective: The European Health Data Space (EHDS) shapes the digital transformation of healthcare in Europe. The EHDS regulations 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. 
Materials and Methods: In this study, we conducted a comprehensive review of the EHDS regulations and technical requirements for EHDS2. Mainly utilizing the results of the Joint Action Towards the European Health Data Space (TEHDAS) project to identify the framework of IDERHA’s alignment with EHDS. 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 minimum-set of requirements for aligning IDERHA infrastructure with the planned EHDS regulations, including user journey, concepts, terminologies, and standards. The future IDERHA framework (i.e., platform architecture, standardization approaches, documentation, etc.) will be developed accordingly. 
Discussion: The IDERHA's alignment plan with EHDS2 necessitates the implementation of three categories of standardization for: data discoverability (DCAT-AP), enabling semantics interoperability (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 OHDSI OMOP CMD for representing the Patient-Generated Health Data are still needed. Finally, proper mapping between standards (FHIR/OMOP) is a prerequisite for proper data exchange. 
Conclusions: Collaboration, sharing lessons learned, and creating synergy among the current EHDS initiatives and projects are critical in advancing the implementation of EHDS2. International-European organizations can also provide implementation frameworks and monitoring toolkits to speed up the EHDS alignment framework and processes.

Keywords: 
European health data space, healthcare standards, interoperability, secondary use of data.

Abbreviations: AI, Artificial Intelligence; CDM, Common Data Model; DCAT, Data Catalog Vocabulary; DCAT-AP, DCAT Application profile for data portals in Europe; DICOM, Digital Imaging and Communications in Medicine; EC, European Commission; EFMI, European Federation for Medical Informatics; EHDS, European Health Data Space; EHR, Electronic Health Record; EMA, European Medicines Agency; EOSC, European Open Science Cloud; FAIR, Findability, Accessibility, Interoperability, and Reusability; FHIR, Fast Healthcare Interoperability Resource; FML, Federated Machine Learning; HHR, Holistic Health Records; HL7, Health Level 7; HTA, Health Technology Assessment; EU, European Union; GDPR, General Data Protection Regulation; IDERHA, Integration of heterogenous Data and Evidence towards Regulatory & HTA Acceptance; LC, Lung Cancer; OHDSI, Observational Health Data Sciences and Informatics; OMOP, Observational Medical Outcomes Partnership; PGHD, Patient-Generated Health Data; RWD, Real-World Data; RWE, Real-World Evidence; TEHDAS, Towards the European Health Data Space; WHO, World Health Organization.