欧洲健康数据空间 (EHDS) 塑造了欧洲医疗保健的数字化转型。 EHDS 法规还将加速健康数据用于研究、创新、政策制定和数据二次使用的监管活动（称为 EHDS2）。监管和 HTA 接受的异构数据和证据整合 (IDERHA) 项目构建了第一个符合 EHDS2 要求的泛欧洲健康数据空间，以肺癌为试点。在这项研究中，我们进行了全面审查EHDS 法规、EHDS2 技术要求以及相关项目。我们还探讨了欧洲健康数据空间联合行动 (TEHDAS) 的结果，以确定 IDERHA 与 EHDS2 一致的框架。我们还与 EHDS 专家举办了内部网络研讨会和外部研讨会，分享有关 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，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）正在相应开发中。IDERHA 与 EHDS2 的协调计划需要实施三类标准化：数据可发现性：数据目录词汇 (DCAT-AP)、实现语义互操作性：观察医疗结果合作伙伴关系 (OMOP) 和健康数据交换（DICOM 和 FHIR）。主要挑战是一些标准仍在完善中，例如 DCAT-AP (HealthDCAT-AP) 的扩展。此外，仍然需要对观察健康数据科学和信息学 (OHDSI) 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，标准之间的正确映射 (FHIR/OMOP) 是正确数据交换的先决条件。IDERHA 的计划以及我们与其他 EHDS 计划/项目的合作对于推进 EHDS2 的实施至关重要。版权所有：© 2024 Hussein R 等人。

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.Copyright: © 2024 Hussein R et al.