In the era of health and medical big data,data compliance of medical institutions is not only an innovative governance,but also important to strengthen the protection of patients'personal information and legally standardize the use of medical data resources.The essence of data compliance is to prevent legal risks in data processing.There are three realistic barriers in the development of data compliance,which are untyped medical dataset,technical risks of data compliance and inadequate technical capabilities in medical institutions.In order to build a data compliance system for medical institutions,it is necessary to be based on the legal and regulatory framework,adhere to the basic principles of informed consent,legitimate purposes,minimum impact and so on.In addition,it is important to clarify the process and normative content of data collection,data desensitization,data storage,and data utilization of medical institutions.It is also significant to create management mechanism which is divided into pre-stage,inbetween-stage and post-stage,including risk identification,scene supervision,and risk resolution.Moreover,strengthening the coordinated supervision of relevant departments and sorting out the key points of law enforcement,is to ensure the development of medical institutions'data compliance.
medical institution datadata compliancedata classified managementprinciple of informed consent