数据与计算发展前沿 ›› 2026, Vol. 8 ›› Issue (5): 153-164.

CSTR: 32002.14.jfdc.CN10-1649/TP.2026.05.012

doi: 10.11871/jfdc.issn.2096-742X.2026.05.012

• 技术与应用 • 上一篇    下一篇

健康医疗数据的二次利用：欧盟与美国的跨区域考察

路禹臻1(),赵福乾2,*()   

  1. 1 兰州理工大学， 法学院， 甘肃 兰州 730050
    2 甘肃政法大学， 民商经济法学院， 甘肃 兰州 730070
  • 收稿日期:2026-04-14 出版日期:2026-10-20 发布日期:2026-10-20
  • 通讯作者: *赵福乾（E-mail: zfq7523gsupl@.edu.cn）
  • 作者简介:路禹臻，兰州理工大学法学院，讲师，经济学博士。主要研究方向为数据治理、卫生科技政策。
    本文中负责资料收集、论文撰写和修改。
    LU Yuzhen is a lecturer at the School of Law, Lanzhou University of Technology, and holds a Ph.D. in Economics. Her main research interests include data governance and health technology policy.
    In this paper, she is responsible for data collection, paper writing, and revision. E-mail: 20250015@lut.edu.cn|赵福乾，甘肃政法大学民商经济法学院，讲师，经济学博士。主要研究方向为网络安全与数据治理。
    在本文中负责框架设计、资料收集和校对。
    ZHAO Fuqian is a lecturer at the School of Civil, Commercial and Economic Law, Gansu University of Political Science and Law, and holds a Ph.D. in Economics. His main research interests include cybersecurity and data governance.
    In this paper, he is responsible for framework design, data collection, and proofreading. E-mail: zfq7523gsupl@edu.cn
  • 基金资助:
    2025年度法治甘肃省级课题“甘肃健康医疗数据授权运营的规则体系研究”(2025FZKT041);兰州理工大学2026年度人文社科培育基金项目“甘肃健康医疗数据授权运营的制度创新研究”(062601/12)

Secondary Use of Health Data: A Cross-Regional Study of the European Union and the United States

LU Yuzhen1(),ZHAO Fuqian2,*()   

  1. 1 School of Law, Lanzhou University of Technology, Lanzhou, Gansu 730050, China
    2 School of Civil, Commercial and Economic Law, Gansu University of Political Science and Law, Lanzhou, Gansu 730070, China
  • Received:2026-04-14 Online:2026-10-20 Published:2026-10-20

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摘要：

【目的】探究欧盟与美国针对健康医疗数据差异化二次利用制度的发展脉络、实践进路及核心特点，能够为中国特色健康医疗数据二次利用方案的形成提供理论参考。【方法】对欧盟、美国在健康医疗数据二次利用的运行理念、主导主体及治理策略等方面的比较分析中，总结了二者的主要进路与基本特点，并揭示了二者核心差异。【结果】通过对欧盟与美国健康医疗数据二次利用制度内容的考察和对比，在遵循我国实际国情与立法现状的基础上，提出构建监管数据二次利用活动的健康医疗数据利用委员会、建立统一的国家健康医疗数据安全利用平台与制定健康医疗数据二次利用分级管理制度三项优化路径。【结论】因此，形成极具中国特色的健康医疗数据二次利用方案，在健康医疗数据安全保护与价值挖掘之间寻求平衡。

关键词: 健康医疗数据, 二次利用, 欧洲健康数据空间, 机构审查委员会, 数据治理

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