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健康医疗数据个人信息保护的欧盟经验与中国启示OA

EU experience in protecting personal information in health and medical data and its implications for China

中文摘要英文摘要

在全球医疗数字化转型背景下,健康医疗数据的利用与保护面临挑战.我国《个人信息保护法》仍存在匿名化标准滞后、二次利用机制缺失等结构性缺陷.欧盟通过《通用数据保护条例》和《欧洲健康数据空间条例》构建了动态平衡的治理框架,其核心在于创设"一次利用"与"二次利用"的分层治理模式,并设立健康数据访问机构实施集中监管,为权利保障与数据利益释放提供了范本.借鉴欧盟经验,我国应从三方面完善:制定健康医疗数据专门立法,区分利用场景;设立统一监管机构;引入动态匿名化评估与数据主体反对权机制,最终构建兼顾保护与利用的治理新格局.

In the context of global healthcare digital transformation,the utilization and protection of healthcare data face challenges.China's Personal Information Protection Law still exhibits structural flaws,such as lagging anonymization standards and a lack of secondary utilization mechanisms.The European Union has established a dynamically balanced governance framework through the General Data Protection Regulation and the European Health Data Space Regulation.The core of this framework lies in creating a tiered governance model for"primary use"and"secondary use",and establishing a health data access authority to implement centralized supervision,providing a model for rights protection and data benefit release.Drawing on the EU's experience,China should improve in three aspects:formulating specialized legislation for healthcare data,distinguishing between utilization scenarios;establishing a unified regulatory authority;introducing dynamic anonymization assessment and a data subject objection mechanism,ultimately constructing a new governance framework that balances protection and utiliza-tion.

邵雪

上海政法学院,上海 201701

社会科学

健康医疗数据个人信息保护法通用数据保护条例欧洲健康数据空间

healthcare dataPersonal Information Protection LawGeneral Data Protection RegulationEuropean Health Data Space

《网络安全与数据治理》 2026 (8)

62-69,8

10.19358/j.issn.2097-1788.2026.08.008

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