论医疗数据权利配置——医疗数据开放利用法律框架

An Entitlement of Clinical Data:the Lega Framework of Clinical Data Sharing

医疗数据关系患者个人、医疗机构和社会公共利益,如何配置权利以构建医疗数据流通利用秩序成为健康医疗大数据应用关键。医疗数据是由医疗机构采集、制作、存管形成的,服务于医疗机构运营、医疗水平改善,但经治理后可以转化为医疗大数据资源,医疗数据财产权应当配置给医疗机构。医疗数据源于患者,患者隐私权可以延伸到医疗数据,医疗机构只有征得患者同意才能进行以识别个人为目的的医疗数据利用;同时,卫生健康管理部门基于公共利益目的可以调取和使用医疗数据,实现医疗数据的社会公共价值,但这并非说医疗数据是公共数据。赋予医疗机构对医疗数据利用权利的同时,配置相应的安全管理义务,促使建立良好的数据治理体系,由此可以开启医疗机构主导的医疗数据资源社会化利用的大门。

It is key institution for application of big data analytics in the clinical data in which there are interests of individual(patient),medical institution and the public.Property right shall be granted to medical institutions for reason that they collect,compile and keep the data and change the data into resource by data governance.Privacy right of the patient extend to the clinical data for relating to themselves and a patient’s consent is a precondition for the clinical data processing to identify or to target the patient.At the same time,the public health administration has right to access to and use the clinical data for public health interests,but this is not the reason totreat them as public data.It is also medical institutions to be liable for security and accountability for processing clinical data and to provide the data to society for utilizing socially by mature data governance.