Svingel Lise S, Jensen Caroline E, Kjeldsen Gitte F, Pedersen Maria H, Kalra Dipak, Christiansen Christian F, Vad Katrine H
Department of Clinical Epidemiology, Department of Clinical Medicine, Aarhus University and Aarhus University Hospital, Aarhus, Denmark.
CONNECT - Center for Clinical and Genomic Data, Aarhus University Hospital, Central Denmark Region, Aarhus, Denmark.
Eur J Public Health. 2025 Sep 1;35(Supplement_3):iii32-iii38. doi: 10.1093/eurpub/ckaf033.
European Union (EU) Member States face challenges in using health data for secondary purposes, constrained by inconsistent digital health systems and limited cross-border sharing. One aim of the European Health Data Space (EHDS) is to facilitate secondary health data use through the HealthData@EU infrastructure and Health Data Access Bodies (HDABs). This article provides recommendations essential for HDAB implementation, informed by the HealthData@EU Pilot project. From October 2022 to December 2024, Work Package 4 gathered insights from the HealthData@EU Pilot project, including from technical work packages and use cases, and complementary insights from the members of the HDABs Community of Practice and the External Advisory Board. Data collection involved workshops, interviews, and questionnaires, with thematic analysis guided by the EHDS user journey and the World Health Organization's National eHealth Strategy Toolkit. Recommendations cover infrastructure, services, and interoperability. Each Member State should designate HDABs to manage secondary health data use and facilitate cross-border access. National infrastructure components deployed by HDABs and National Contact Points and a metadata catalogue compliant with the newly developed HealthDCAT-AP specification are advised to support data discovery, with a common data access application form to streamline the data permit application process. Harmonized validation procedures are recommended for ensuring high data quality and semantic interoperability. Implementation of HDABs within the HealthData@EU infrastructure represents an important step towards accessible health data for secondary use across the EU. Effective implementation requires collaboration at both national and EU level, addressing remaining ambiguities for HDAB functionality within the EHDS framework.
欧盟成员国在将健康数据用于次要目的方面面临挑战，受到数字健康系统不一致和跨境共享有限的限制。欧洲健康数据空间（EHDS）的一个目标是通过“HealthData@EU”基础设施和健康数据访问机构（HDAB）促进健康数据的二次利用。本文根据“HealthData@EU”试点项目提供了HDAB实施必不可少的建议。从2022年10月到2024年12月，工作包4从“HealthData@EU”试点项目中收集了见解，包括来自技术工作包和用例的见解，以及HDAB实践社区成员和外部咨询委员会的补充见解。数据收集涉及研讨会、访谈和问卷调查，主题分析以EHDS用户旅程和世界卫生组织的国家电子健康战略工具包为指导。建议涵盖基础设施、服务和互操作性。每个成员国应指定HDAB来管理健康数据的二次利用并促进跨境访问。建议由HDAB和国家联络点部署的国家基础设施组件以及符合新开发的HealthDCAT-AP规范的元数据目录来支持数据发现，并使用通用的数据访问申请表来简化数据许可申请流程。建议采用统一的验证程序以确保高数据质量和语义互操作性。在“HealthData@EU”基础设施内实施HDAB是朝着在整个欧盟实现可访问的健康数据用于二次利用迈出的重要一步。有效的实施需要国家和欧盟层面的合作，解决EHDS框架内HDAB功能的剩余模糊问题。
