数据主体控制个人健康信息的困境与解决对策

Solution and Dilemma of Data Subject Control Personal Health Information

广泛知情同意模式难以保障数据主体的知情权,医疗健康大数据打破了“知情”的可预测性;匿名化处理阻碍了数据主体的信息自决权且该技术存在缺陷;专业保密协议在医疗健康研究备受关注的背景下缺乏可预见性。对此,数据可携带权能够提高数据的互操作性和可访问性。《中华人民共和国个人信息保护法》在立法层面已确立数据可携带权,可在此基础上借鉴欧盟关于数据可携带权的具体规范,并加以本土化调试后明确我国的相关实施细则。构建个人健康信息电子动态知情同意机制能够促使数据主体及时、充分了解其个人健康信息的使用目的、方式等,故而应实现知情同意书的电子化,基于电子知情同意书建立电子同意管理机制,进而基于电子同意管理机制引入动态同意模式。

Extensive informed consent models is difficult to guarantee the data subject’s right to know, and healthcare big data breaks the predictability of "information". Anonymization prevents data subjects from deciding on their own personal health information and it has defects. And professional confidentiality agreement lacks predictability in the context of much attention in medical and health research. For this, right to data portability of data can improve data’s interoperability and accessibility. "Personal information protection law of the people’s republic of China" has established the right at the legislative level. On the basis, we can learn from the EU’s specific regulations on the right to data portability, and localize it to clarify our country’s relevant implementation rules. By constructing an electronic dynamic informed consent mechanism for personal health information, data subjects can promptly and fully understand the purpose and method of using their personal health information, etc. Therefore, it is necessary to realize the electronicization of informed consent, establish an electronic consent management mechanism based on electronic informed consent, and then introduce a dynamic consent model based on the electronic consent management mechanism.