Research On The Collection And Sharing Policy Of Precision Medicine Big Data

As the leading direction of medical science and technology development,precision medicine has now become the strategic commanding height of the new round of scientific and technological competition in the world.In order to accelerate breakthroughs in major disease prevention and control,to occupy the leading power in the development of future medical and related industries,and to create a new driving force for the development of China’s life and health industry,our country has actively strengthened its research on precision medicine and incorporated it into the national "13th Five-Year Plan",and lists "Precision Medical Research" as one of the key special projects of the National Key Research and Development Program.With the implementation of China’s precision medicine program,massive,heterogeneous,precision medicine big data will be produced.These data are not only the important outputs of the precision medical research project,but also the valuable knowledge sources of the future medical research work,if they can not be collected and shared reasonably,,it will be difficult to exert its maximum value and cause a great waste of human,material and financial resources.However,the collection and sharing of precision medicine big data is a complex activity,it can not be achieved by relying solely on the progress of technology but also requires the use of policy enforcement measures to guarantee and regulate.China has not yet released a policy document for precision medicine big data,which will inevitably affect the management of data and the transformation of results.In foreign countries,relevant policies have been introduced in the management of precision medicine big data,which can provide reference for China’s policy formulation.Therefore,this study will be based on extensive investigations and analysis of typical data related to precision medicine at home and abroad,taking the key research projects in the National Key Research and Development Program "Precision Medical Research" which the highest level and the most influential power in the precision medicine research funded by China as an example,analyze the data transfer and sharing requirements,the interest appeals of various stakeholders,and the policy recommendations of major stakeholders.Through the analysis of existing policies and China’s actual needs,we have tried to put forward policy recommendations for realizing the collection and sharing of precision medicine big data in China.The main contents include:(1)Combing domestic and foreign researches related to different levels of scientific data policies Systematically,learning from their research ideas and policy content analysis framework,summarizing the limitations of existing research,including:①The exploration of Data Policy in Precision Medicine Segments is not enough;②The research on the content of the policy of the data submitting is not enough;③Policy recommendations tend to be at the macro level,and micro-level proposals for specific content need to be strengthened.(2)Investigating typical policies for the scientific data submitting and sharing of domestic and international scientific research funding agencies,analyzing both their basic characteristics and specific contents,and learning useful experiences to provide reference for follow-up researches.(3)Based on our country’s actual situation,summarizing the requirements for data submitting and sharing of the key project "Precision Medicine Research",the data transfer and management subjects that may be involved,and analyzing and investigating the suggestions on rights and interests and policy of major stakeholders.(4)Based on policy research and China’s actual situation,the recommendations for the formulation of sharing and sharing policies for precision medicine big data in China are proposed,including macro and micro levels of advice:The macro-level recommendations include:① Strengthen the national co-ordination,improve the policy system;②Pay attention to the protection of rights and interests,optimize the balance of interest mechanism,③Set up the supervision Department,improve the supervision management system,④Strengthen the quality construction,unify the data standard specification.At the micro level,the macro recommendations have been refined and supplemented,content is defined in detail focusing on seven aspects of data submitting data preservation and management,data sharing,data submitting and sharing plans,stakeholder responsibilities,rights and interests protection,as well as supervision,reward and punishment mechanisms.