医疗数据共享背景下个人健康信息保护的冲突与平衡

Conflicts in personal health information protection in the context of medical data sharing and the countermeasures

医疗数据共享与个人健康信息保护均是智慧化医疗建设中的重要内容,然而在实践中存在个人信息保护与公共利益难以权衡、形式化的知情同意原则,以及法律滞后等多重冲突。为平衡两者之间的关系,应当确立公共利益优先原则,但强调在紧急公共事件之外,以医学研究为目的的数据共享仍需获得信息主体的同意。通过优化知情同意原则,采用“泛化同意+动态同意”模式,提高知情同意的有效性。通过制定专门性法规和配套实施细则,完善医疗数据保护的法律框架,确保数据共享过程的合法、安全与高效。

Medical data sharing and the protection of personal health information are integral to the development of smart healthcare systems.However,in practice,there are multiple conflicts such as the difficulty in protecting personal information and safeguarding public interests,formalized principle for informed consent,lag of legal services,and other issues.To reconcile these tensions,it is imperative to establish a principle that prioritizes public interests,while also emphasizing that,aside from emergency public events,data sharing for medical research should still secure the consent of the information subject.Enhancing the informed consent principle through an optimized"broad consent+dynamic consent"model can improve the effectiveness of informed consent.Additionally,by enacting specialized regulations and complimentary implementation guidelines,the legal framework for medical data protection can be refined to ensure the legality,security and efficiency of the data sharing process.