欧洲健康数据空间建设历程分析与启示

The Analysis and Enlightenment of the European Health Data Space Construction

随着欧洲一体化进程不断深入,推进欧盟公民在各成员国间高效、便利就医成为欧盟关注的重要议题。多年来,欧盟持续完善患者跨国境就医保障,形成了较为系统的管理模式。2021年,欧盟在《欧洲数据战略》基础上,提出“欧洲健康数据空间”建设构想,旨在对医疗健康数据高水平保护基础上,充分开发数据价值,在患者层面优化疾病诊断和治疗,在政策制定层面助力实现更为有效的决策,在科学研究层面更大限度挖掘数据价值,从而提升提高医疗系统效率,增进欧盟公民的福祉。为此,欧盟从立法立规、机构设置、基础设施建设等方面统筹谋划,希望在2025年前建设完成“欧洲健康数据空间”,进而在数据保护和充分利用方面实现最优平衡。本文梳理了“欧洲健康数据空间”的提出背景,分析了“欧洲健康数据空间”的面临困境和解决思路,总结提炼了其建设历程并分析得出有关启示和建议。“欧洲健康数据空间”反映出欧盟在平衡数据利用和保护的考量,其中思路和措施值得为我国医疗健康事业发展所借鉴。

With the deepening of European integration,it has become an important issue for the EU to promote efficient and convenient medical treatment for EU citizens among member states.Over the years,the European Union has established a relatively complete management model in terms of protecting patients"cross-border medical treatment.In 2021,the concept of a"European Health Data space"was proposed as an important aspect of the realization of the European Data Strategy.The European Health Data Space aims to improve the efficiency of the healthcare system and improve the well-being of European citizens by maximizing the value of data on the basis of a high level of protection of healthcare data,optimizing disease diagnosis and treatment at the patient level,facilitating more effective decision-making at the policy level,and maximizing the value of data at the scientific research level.To this end,the EU has made overall plans in terms of legislation,institutional setup,and infrastructure construction,hoping to achieve access to member states by 2025,so as to achieve a balance between data protection and full utilization.This paper summarizes the background of the proposal of the"European Health Data Space",analyzes the difficulties and solutions of the"European Health Data Space",summarizes and refines its construction process,and puts forward relevant enlightenment and suggestions.The"European Health Data Space"reflects the EU's consideration of balancing data utilization and protection,and its ideas and measures are worthy of reference for the development of China's medical and health industry.