医疗数据使用权的理论证成与立法平衡

Theory Certification and Legislative Balance of the Right to Use Medical Data

医疗数据使用直接关系医疗救治效能的提升。医疗数据具有高度的专业性,医疗数据来源者、控制者、使用者、经营者享有不同的医疗数据权利,医疗数据使用权主体及取得方式具有限定性,其本质上遵循“人财两分”“三权分置”立法规律。在医疗卫生二元立法框架下,更宜采用集中立法模式制定医疗数据使用专项规则,并将其纳入医疗事务立法范围。医疗数据使用规则制定,需要有效解决医疗数据使用权实现所面临的矛盾和冲突。相较于单一机构配置或全系统接入方式,医疗数据使用权配置适宜从医联体数据众益出发,以单元化平衡为路径,设定医疗机构的数据提供义务,推动医联体医疗数据合规共享;以“场景化”平衡为方法,推进医疗数据调用合比例的边界设定;以动态化平衡为方式,创建非个人数据使用立法路径,制定医疗健康企业非个人数据许可使用专项限制与转售禁止规则。

The use of medical data is directly related to the improvement of medical treatment efficiency.Medical data is highly professional,the source,controller,user and operator of medical data have different rights towards medical data,and the subject of the right to use medical data and the way of obtaining medical data are limited,in essence,it follows the legislative law of“division of wealth and human resources”and“separation of powers”.Under the framework of dual health legislation,it is more appropriate to adopt centralized legislation model to formulate special rules for the use of health data and bring them into the scope of health legislation.To make the rules of medical data use,it is necessary to effectively solve the contradictions and conflicts in the realization of the right of medical data use.Compared with single-organization configuration or system-wide access mode,medical data right-of-use configuration should set the obligation of medical organization's data supply based on the benefit of Medical Association's data,to promote the medical data compliance sharing of medical consortia;to push forward the setting of the boundary of the proportion of medical data calls with the method of"Scenario-based"balance;to create a legislative path for the use of non-personal data with the method of dynamic balance;To formulate special restrictions on the licensing and resale of non-personal data in health care enterprises.