欧盟健康数据共享之法律规制考察与启示

Study and Enlightenment on the Legal Regulation of Health Data Sharing in EU

厘清欧盟健康数据共享中的基本问题,考察其共享法律规制的基础性条款、立法的取向、考量要素以及其中所蕴含的法律原则,阐明作为数据共享法律关系主体之一的健康数据控制者应承担数据采集时确保数据主体知情同意的义务、配合数据查询的义务、网络安全保障义务;针对我国健康数据共享的现状与困境,从欧盟健康数据共享法律规的经验中获得启示,提出完善我国相关立法以保障健康数据共享,以及制定和统一行业标准以合理有序地共享健康数据等建议。

This paper clarifies the basic issues in the sharing of health data in the EU,examines the basic provisions of the sharing of legal regulation,the orientation of legislation,the considerations and the legal principles contained therein,clarifies that the health data controller,as one of the subjects of the legal relationship of data sharing,should assume the obligation to ensure the informed consent of the data subject during data collection,the obligation to cooperate with data query,and the obligation to ensure network security,draws inspiration from the experience of health data sharing laws and regulations in the EU according to the current situation and predicament of health data sharing in China,and puts forward suggestions to improve relevant legislation in China to ensure health data sharing,and formulate and unify industry standards to share health data in a reasonable and orderly manner.