个人医疗信息知情同意原则的困境与对策

Dilemmas and Countermeasures Regarding the Principle of Informed Consent for Personal Medical Information

摘要: 随着大数据技术在医疗卫生领域的应用，传统的知情同意原则面临着来自技术革新与制度调整等方面的多重挑战与考验。我国现行法律体系中，对于个人医疗信息的分类尚缺乏细致划分，普遍采取了一种全面而严格的同意机制。尽管这种“特别同意”模式旨在为个人医疗信息安全设置最高级别的防护，但实际上，因其设定了较为严苛的信息采集与处理标准，不经意间导致信息主体与信息处理机构之间的关系趋于紧张。这种状况揭示了在执行知情同意原则过程中遇到的诸多难题，使得在大数据时代下知情同意原则面临形式化、成本增加、有效性降低等多种问题，以至于学界出现了抛弃知情同意原则的论调。笔者认为，无论什么时代下，个人自主决定权体现了人之为人的自主意志，绝不应该被抛弃。通过直面问题，重构知情同意原则才是唯一可行的路径。将信息主体从被动、消极的被保护者转为信息处理的参与者，加入分级同意模式、信息处置者的持续披露和告知义务来完善和延续知情同意模式是大数据时代下的方式之一。

Abstract: With the application of big data technology in the healthcare sector, the traditional principle of informed consent faces multiple challenges arising from technological innovation and institutional adjustments. Within China’s current legal framework, the classification of personal medical information lacks granularity, and a comprehensive yet stringent consent mechanism is widely adopted. Although this “specific consent” model aims to provide the highest level of protection for personal medical information security, it inadvertently creates tension between data subjects and information handlers by imposing stringent standards for data collection and processing. This situation reveals numerous difficulties in implementing the informed consent principle, leading to issues such as formalism, increased costs, and reduced effectiveness in the big data era. Consequently, some academic circles have advocated abandoning the informed consent principle. The author argues that the right to personal autonomy—reflecting the essence of human self-determination—must never be discarded, regardless of the era. The only viable path forward is to confront these challenges and reconstruct the informed consent principle. Transforming data subjects from passive, protected entities into active participants in information processing, alongside adopting tiered consent models and imposing ongoing disclosure and notification obligations on information handlers, represents one way to refine and sustain the informed consent framework in the age of big data.