| The outbreak of the epidemic in the world,every country is actively researching vaccines,from the laboratory to the clinic must go through human trials,subjects have an indelible contribution to medical progress,but because of the risky nature of the trials and the status of the subjects in clinical trials,resulting in their rights and interests are extremely vulnerable to infringement.The protection of subjects’ privacy is in line with the basic value of respecting and protecting human rights in China on the one hand,and will promote the development of medical research on the other.In the United States,the Act on the protection of subjects’ privacy rights was established as early as 1996,with clear provisions from the substantive law,supplemented by a supporting administrative accountability mechanism to provide protection for the remedy of subjects’ privacy rights,thus forming a relatively complete system for the protection of subjects’ privacy rights.Through the analysis of the U.S.privacy rules,it can be found that the protection of subjects’ privacy in China has problems such as scattered legislation,duplication of provisions,and lack of special administrative supervision mechanism.In this regard,it is necessary to adopt special legislation,enhance enforceability,and support administrative procedures for the protection of subjects’ privacy in China.The content framework of this paper is as follows:The first part: the legislative background and basic concepts of the federal government of the United States.Firstly,it puts forward that the international community should pay attention to the rights of the subjects;Secondly,the concept of subject is analyzed to clarify the research object of this paper;Thirdly,it defines the scope of the right of privacy of the subjects in the United States,clarifies the distinction between the right of privacy in the United States and the right of privacy in China’s legislation,introduces the current legislative model and analyzes its advantages and disadvantages,so as to provide reference for the choice of the subject privacy legislative model in China.The second part is the core discussion of HIPAA privacy rules,which is a special legislation of subject privacy protection in the United States.As the core content of this paper,this part mainly expounds: 1.A brief introduction of HIPAA privacy rules.2.The substantive part of HIPAA privacy rules includes the subject of subject privacy protection regulation,the subject of privacy protection regulation,the subject of privacy protection regulation,the subject of privacy protection regulation.The principle of privacy rules protection,the protection standard of electronic personal health information.3.The role,composition,role and review of privacy Committee.4.The organization responsible for the implementation of HIPAA privacy rules,the implementation method and the implementation results.5.This paper summarizes the characteristics of HIPAA privacy rules of the federal government of the United States.In the third part,on the basis of summarizing the current legislative status of the protection of subjects’ privacy in China,we analyze the current problems of low level of legislation,lack of special legislation,and emphasis on substance rather than procedure in the protection system of subjects’ privacy in China,and put forward specific protection suggestions of enacting special laws,clarifying the subject of infringement,enhancing enforceability,and determining the supervision mechanism and accountability mechanism in a targeted manner. |
