Abstract:

[Objective] Exploring the development trajectories, practical pathways, and core characteristics of the divergent secondary use systems for health data in the European Union and the United States can provide a theoretical reference for the formulation of a health data secondary use solution with Chinese characteristics. [Methods] Through a comparative analysis of the EU and the US in terms of their operational philosophies, leading subjects, and governance strategies for the secondary use of health data, this study summarizes the main pathways and fundamental features of both systems, and reveals their core differences. [Results] Based on an examination and comparison of the institutional frameworks for secondary use of health data in the EU and the US, and grounded in China’s actual national conditions and existing legislative landscape, this study proposes three optimization pathways: establishing a Health Data Utilization Committee to regulate secondary use activities, creating a unified national secure platform for health data utilization, and developing a tiered management system for the secondary use of health data. [Conclusions] These pathways aim to facilitate the formulation of a solution for secondary use of health data with distinctive Chinese characteristics, striking a balance between the protection of health data security and the unlocking of its value.

Key words: health data, secondary use, European Health Data Space, institutional review board, data governance