Schneider Katharina L, Alves de Sousa Luís, Sava Ionut, Heß Steffen, Umuhire Denise, Morales Daniel R
Data Access and Coordination Office, Federal Institute for Drugs and Medical Devices, Bonn, Germany.
European Centre for Disease Prevention and Control, Stockholm, Sweden.
Eur J Public Health. 2025 Sep 1;35(Supplement_3):iii5-iii10. doi: 10.1093/eurpub/ckaf115.
The future European Health Data Space (EHDS), a network for secure cross-border data use, could be beneficial for public health initiatives. The HealthData@EU pilot project evaluated possibilities of secondary data use based on five use cases and established a pilot IT infrastructure. This article reports overarching experiences from two public health use cases and the IT development. Experiences were reported by the Users' Journey steps (data discovery, application, use, and finalization) elaborated in the context of the European Health Data Space (TEHDAS), the first conceptual EHDS project. The European Medicines Agency's use case analysed coagulopathy-related events in COVID-19 patients, the one led by the European Centre for Disease Prevention and Control assessed the feasibility of HealthData@EU to support antimicrobial resistance surveillance. The IT work package developed the infrastructure for information exchange. The use cases indicated that standardized procedures, wherever available, were considered highly beneficial. In the application phase, node-specific requirements slowed down the progress. A distributed approach in combination with the use of Secure Processing Environments (SPE) was successfully conducted. The IT infrastructure was piloted, tested, and published as open source. It supports data discovery and applications in the future. The HealthData@EU pilot project has achieved major steps regarding data discoverability and accessibility, where a need for more standardized procedures was detected in the use cases. Distributed analyses in combination with SPE use may be possible approaches for the data use phase, which require further investigation in TEHDAS2 and other initiatives.
未来的欧洲健康数据空间（EHDS）是一个用于安全跨境数据使用的网络，可能对公共卫生倡议有益。“欧盟健康数据”试点项目基于五个用例评估了二次数据使用的可能性，并建立了一个试点IT基础设施。本文报告了两个公共卫生用例和IT开发方面的总体经验。经验是根据在欧洲健康数据空间（TEHDAS）（第一个概念性EHDS项目）背景下阐述的用户旅程步骤（数据发现、应用、使用和完成）报告的。欧洲药品管理局的用例分析了新冠肺炎患者的凝血病相关事件，由欧洲疾病预防控制中心牵头的用例评估了“欧盟健康数据”支持抗菌药物耐药性监测的可行性。IT工作包开发了信息交换基础设施。用例表明，只要有标准化程序，就被认为非常有益。在应用阶段，特定节点的要求减缓了进展。成功实施了一种分布式方法，并结合使用安全处理环境（SPE）。IT基础设施进行了试点、测试并作为开源发布。它支持未来的数据发现和应用。“欧盟健康数据”试点项目在数据可发现性和可访问性方面取得了重大进展，在用例中发现了对更标准化程序的需求。结合使用SPE进行分布式分析可能是数据使用阶段的可行方法，这需要在TEHDAS2和其他倡议中进一步研究。
