Royo Romina, Garcia Eva, Schlünder Irene, Hilmarsen Christina, Thomsen Mette Kielsholm, Cauët Emilie, Jensen Simon Kok, Giardina Simona, Hebrant Aline, Raicevic Toungouz Gordana, Van Den Bulcke Marc, Arenas Juan, Christiansen Christian Fynbo, Hovig Eivind, Holub Petr, Valencia Alfonso, Capella-Gutierrez Salvador
Life Sciences Department, Barcelona Supercomputing Center, Barcelona, Spain.
BBMRI-ERIC, Graz, Austria.
Eur J Public Health. 2025 Sep 1;35(Supplement_3):iii25-iii31. doi: 10.1093/eurpub/ckaf070.
The European Health Data Space (EHDS) will help researchers use health data across EU Member States (MS). Currently, cross-border research faces heterogeneous data access processes. Using a real-world use case, this paper analyses challenges and opportunities brought by the upcoming implementation of the EHDS, assessing the situation before and after the regulation comes into force. The use case focused on metastatic colorectal cancer, analysing the relations between mutational signatures and clinical trajectories while addressing data access procedures across MS. The regulatory landscape and the challenges that need to be addressed for the EHDS to enable the secondary use of health data, particularly genomic data, are complex and heterogeneous across MS. We describe the pathway from data application to access to pseudonymized data in secure processing environments, emphasizing the legal requirements, including the role of ethics committees. Finally, we analyse the success factors for achieving access to the data and the reasons for access denial to support shaping the upcoming EHDS implementation. Several challenges remain unaddressed for cross-border data use, especially in the context of genomic data, where the complexity and heterogeneity of informed consent can impact or even impede data-sharing efforts. While EHDS can simplify processes across MS, it is crucial to ensure that additional safeguards do not negatively impact or block access to health data and that EHDS infrastructure is ready for effective and affordable processing of large volumes of genomic and other data.
欧洲健康数据空间（EHDS）将助力研究人员使用欧盟成员国（MS）的健康数据。当前，跨境研究面临数据访问流程各异的问题。本文通过一个实际用例，分析了EHDS即将实施所带来的挑战与机遇，评估了该法规生效前后的情况。该用例聚焦于转移性结直肠癌，在处理各成员国的数据访问程序时，分析了突变特征与临床轨迹之间的关系。EHDS要实现健康数据（尤其是基因组数据）的二次使用，其监管环境以及需要应对的挑战在各成员国之间复杂且多样。我们描述了从数据应用到在安全处理环境中获取假名化数据的流程，强调了法律要求，包括伦理委员会的作用。最后，我们分析了获取数据的成功因素以及访问被拒的原因，以支持塑造即将实施的EHDS。跨境数据使用仍有若干挑战未得到解决，尤其是在基因组数据方面，知情同意的复杂性和多样性可能影响甚至阻碍数据共享工作。虽然EHDS可以简化各成员国之间的流程，但至关重要的是要确保额外的保障措施不会对健康数据的访问产生负面影响或造成阻碍，并且EHDS基础设施已准备好有效且经济地处理大量基因组数据和其他数据。
