健康医疗大数据应用的法治风险与规制路径^*

Legal Risks and Regulatory Pathways for the Application of Health and Medical Big Data

摘要

随着健康医疗大数据被提升为“国家重要基础性战略资源”，其在公共健康治理、个体权利保障与资源配置优化中的法治意义日益凸显。世界卫生组织（World Health Organization, WHO）《全球数字健康战略（2020–2027年）》提出，数字健康发展应遵循伦理、安全、公平与可持续原则，将数据治理作为实现全民健康权的重要支撑；我国出台《人工智能科技伦理审查与服务办法（试行）》，将生命健康、公共秩序及算法决策等高风险领域纳入全流程伦理审查，初步构建“法治+伦理”的双重规制框架。然而，技术逻辑与法治价值之间仍存在结构性张力，健康医疗大数据应用中逐渐显现出匿名化失灵、算法歧视、数据利益失衡及伦理失范等多重风险。基于此，本文从场景化视角出发，系统识别核心法治风险，并提出分类分级保护、动态匿名化、算法审计及公共利益返还等规制路径，以期在释放数据价值的同时维护数字时代的生命尊严与公共卫生安全。

Abstract

As health and medical big data is elevated to a “national key strategic resource,” its legal significance in public health governance, individual rights protection, and resource allocation optimization has become increasingly prominent. The World Health Organization (WHO)Global Strategy on Digital Health 2020–2027 states that digital health development should adhere to the principles of ethics, security, equity, and sustainability, with data governance serving as critical support for realizing the universal right to health. China has issued the Measures for Ethical Review and Service of Artificial Intelligence Technology (for Trial Implementation), which incorporates high-risk areas such as life and health, public order, and algorithmic decision-making into a full-process ethical review, thereby initially establishing a dual regulatory framework of “rule of law + ethics.” However, a structural tension remains between technological logic and rule-of-law values. In the application of health and medical big data, multiple risks have gradually emerged, including de-anonymization failures, algorithmic discrimination, imbalances in data-related interests, and ethical misconduct. In light of this, from a scenario-based perspective, this paper systematically identifies the core legal risks and proposes regulatory pathways such as classified and graded protection, dynamic anonymization, algorithm auditing, and the return of public interests, aiming to safeguard human dignity and public health security in the digital era while unlocking the value of data.

关键词

健康医疗大数据 / 法治风险 / 隐私保护 / 算法风险 / 公共卫生

Key words

Health and medical big data / Legal risks / Privacy protection / Algorithmic risks / Public health

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基金资助

*四川省软科学课题(SCJJ25RKX163)