Hussein Rada, Balaur Irina, Burmann Anja, Ćwiek-Kupczyńska Hanna, Gadiya Yojana, Ghosh Soumyabrata, Jayathissa Prabath, Katsch Florian, Kremer Andreas, Lähteenmäki Jaakko, Meng Zhaoling, Morasek Kathrin, C Rancourt Rebecca, Satagopam Venkata, Sauermann Stefan, Scheider Simon, Stamm Tanja, Muehlendyck Christian, Gribbon Philip
Ludwig Boltzmann Institute for Digital Health and Prevention, Salzburg, Austria.
Luxembourg Centre for Systems Biology, University of Luxembourg, Luxembourg, Luxembourg.
Open Res Eur. 2024 Jul 30;4:160. doi: 10.12688/openreseurope.18179.1. eCollection 2024.
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.
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.
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.
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.
The IDERHA's plan and our collaboration with other EHDS initiatives/projects are critical in advancing the implementation of EHDS2.
欧洲健康数据空间（EHDS）塑造了欧洲医疗保健的数字转型。EHDS法规还将加速健康数据在研究、创新、政策制定以及数据二次使用的监管活动（称为EHDS2）中的应用。异构数据与证据整合以实现监管和卫生技术评估认可（IDERHA）项目按照EHDS2要求构建了首批泛欧洲健康数据空间之一，并以肺癌作为试点。
在本研究中，我们对EHDS法规、EHDS2的技术要求以及相关项目进行了全面审查。我们还探讨了迈向欧洲健康数据空间联合行动（TEHDAS）的成果，以确定IDERHA与EHDS2保持一致的框架。我们还与EHDS专家举办了一次内部网络研讨会和一次外部研讨会，以分享关于EHDS要求和挑战的专业知识。
我们确定了从现有项目中吸取的经验教训以及使IDERHA基础设施与EHDS2保持一致的最低要求集，包括用户旅程、概念、术语和标准。IDERHA框架（即平台架构、标准化方法、文档等）正在相应地制定。
IDERHA与EHDS2的一致性计划需要实施三类标准化：数据可发现性方面：数据目录词汇表（DCAT-AP）；实现语义互操作性方面：观察性医疗结局伙伴关系（OMOP）；以及健康数据交换方面（DICOM和FHIR）。主要挑战在于一些标准仍在完善中，例如DCAT-AP的扩展（HealthDCAT-AP）。此外，仍需要对观察性健康数据科学与信息学（OHDSI）的OMOP通用数据模型（CDM）进行扩展，以表示患者生成的健康数据。最后，标准之间（FHIR/OMOP）的正确映射是进行正确数据交换的先决条件。
IDERHA的计划以及我们与其他EHDS倡议/项目的合作对于推进EHDS2的实施至关重要。
