Vande Catsyne Charles-Andrew, Slot Matilde, Buble Tamara, Eriksen Katrine, Svajda Marija, Bradasevic Emanuel, Vukovic Jakov, Jensen Simon Kok, Ivanković Helena, Doupi Persephone, Christiansen Christian Fynbo, Schutte Nienke
Data Governance, Sciensano, Brussels, Belgium.
CONNECT, Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
Eur J Public Health. 2025 Sep 1;35(Supplement_3):iii11-iii17. doi: 10.1093/eurpub/ckaf017.
The European Health Data Space aims to transform health data management across the EU, supporting both primary and secondary uses of health data while ensuring trust through General Data Protection Regulation compliance. As part of the HealthData@EU Pilot, this study investigates coronavirus disease 2019 (COVID-19) testing, vaccination, and hospitalization metrics across six European countries, with a focus on socioeconomic disparities and challenges in cross-border data access and standardization. This observational, retrospective cohort study used a federated analysis framework across Belgium, Croatia, Denmark, Finland, and France. Data were linked from administrative, social, health, and care records within each country's trusted research environment. A Common Data Model (CDM)-guided data harmonization, enabling nodes to perform independent analyses and share aggregated results. Key data processes (discovery, access, preparation, and analysis) were decentralized, with significant variability in data access procedures, security protocols, and available resources among nodes. The study revealed substantial differences in COVID-19 testing, vaccination, and hospitalization rates across countries. Denmark exhibited notably higher testing and infection rates. However, the study encountered key challenges: complex data access procedures, fragmented and incomplete socioeconomic data, and the need for extensive harmonization. Learnings from this pilot underscore the importance of streamlined, cross-country data access and standardization processes, which the European Health Data Space (EHDS) framework aims to address. The pilot demonstrates the feasibility of federated health data analysis across multiple countries while highlighting limitations in data access and interoperability. The EHDS framework offers a promising path to overcome these barriers, supporting efficient and standardized cross-border health research in the EU.
欧洲健康数据空间旨在转变欧盟范围内的健康数据管理，支持健康数据的一次和二次使用，同时通过遵守《通用数据保护条例》确保信任。作为“欧盟健康数据试点项目”的一部分，本研究调查了六个欧洲国家的2019冠状病毒病（COVID-19）检测、疫苗接种和住院指标，重点关注社会经济差异以及跨境数据访问和标准化方面的挑战。这项观察性回顾队列研究在比利时、克罗地亚、丹麦、芬兰和法国使用了联邦分析框架。数据来自每个国家可信研究环境中的行政、社会、健康和护理记录。采用通用数据模型（CDM）指导的数据协调，使各节点能够进行独立分析并共享汇总结果。关键数据流程（发现、访问、准备和分析）是分散的，各节点在数据访问程序、安全协议和可用资源方面存在显著差异。该研究揭示了各国在COVID-19检测、疫苗接种和住院率方面存在重大差异。丹麦的检测率和感染率明显更高。然而，该研究遇到了关键挑战：复杂的数据访问程序、零散和不完整的社会经济数据以及广泛协调的必要性。从该试点项目中吸取的经验强调了简化的跨国数据访问和标准化流程的重要性，欧洲健康数据空间（EHDS）框架旨在解决这些问题。该试点项目证明了多国联合进行健康数据分析的可行性，同时突出了数据访问和互操作性方面的局限性。EHDS框架为克服这些障碍提供了一条有前景的途径，支持欧盟高效、标准化的跨境健康研究。
