Translator：Jiang Wenyu

Following the seminar on “Risk Control of Medical Institutions” held at the headquarters of Shanghai Landing Law Offices on June 2, 2023, Landing lawyers went into the hospital twice to communicate with healthcare staffs. on June 15, 2023, and August 3, 2023, invited by Fudan University Shanghai Cancer Center, Ms. He Chunfeng, Ms. Ji Ming, and Mr. Pu Guiping, senior partners of Shanghai Landing Law Offices, went to the Liver Surgery Department and Phase I Clinical Research Center of Fudan University Shanghai Cancer Center to have lectures and exchanges on medical data compliance management with more than 60 healthcare staffs. Associate Professor Shang Jiangang, Director of Data Law Research Center, Economic Law School, Shanghai University of Political Science and Law（“SHUPL“） was invited to participate in both events.

With years of practical experience in the medical and health industry, Ms. He Chunfeng sorted out the scope and classification of medical data, summarized the compliance points and legal risks of medical data sharing, and pointed out the causes of the current obstacles to the development and utilization of medical data as well as the solutions proposed by experts and scholars. With the increasing number of international cooperation in scientific research and clinical trials, combined with the characteristics of Fudan University Shanghai Cancer Center, Ms. He analyzed the path of medical data exit, applicable circumstances and its compliance points. Detailed Rules for the Implementation of Regulation on the Administration of Human Genetic Resources will come into force on July 1, 2023, and the rules will have a lot of impact on the scientific research and international cooperation of the medical institutions. The changes in administrative licenses for scientific research cooperation and the administrative penalty system were discussed and resonated with the attending doctors.

From the perspective of how drug clinical trial Institutions should carry out clinical trial data compliance management, Ms. Ji Ming firstly introduced the concept of clinical trial, the principle of ethical review, the principle of protecting the rights and interests and safety of the subjects, the principle of guaranteeing the truthfulness and reliability of the data as well as the scope of the clinical trial data to healthcare staffs in turn; and then talked about how hospitals and researchers should understand the responsibilities to be undertaken in clinical trials and how to carry out data management, in terms of the main subjects participating in the clinical trials as well as their respective legal relationships. Then, she introduced the details of non-compliance of clinical trial data that may easily occur in drug clinical trial organizations and reminded healthcare staffs to pay attention to them. Finally, Ms. Ji summarized the content of "Key Points and Judgment Principles of Supervision and Inspection of Drug Clinical Trial Institutions" (draft for comments) which was just promulgated in July 2023, and put forward suggestions and examples on how to achieve the true standardization and integrity of clinical trial data.

Focusing on the criminal risk control of medical data, Mr. Pu Guiping introduced the main crimes of medical data crimes, analyzed in-depth the high incidence of crimes in the medical industry with judicial cases, and made suggestions on how to control the risks.

Prof. Shang Jiangang gave tips on the risks in the process of technology transfer in light of the technology contract litigation cases he has tried. He commented with the sharing of several lawyers and introduced the practice of adopting data compliance tools for data compliance. This is another initiative of the institution and the law firm to jointly promote the practice of law since the cooperation between the Economic Law School of SHUPL and Shanghai Landing Law Offices.

After the meeting, Prof. Shang of SHUPL, Landing lawyers and healthcare staffs of Fudan University Shanghai Cancer Center exchanged and discussed some more issues on subjects' informed consent, subjects' compensation, protection of subjects' personal information, transmission of subjects' personal information, and somatic cell clinical research in clinical trials. The seminar lasted for two hours, and the atmosphere of communication was warm on the spot. Landing lawyers answered the confusion of healthcare staffs on the spot, and at the same time, they also gained a deeper understanding of the pain points of hospitals in medical data compliance management, and healthcare staffs also gained practical legal knowledge and enhanced their awareness of legal compliance and risk prevention. In the future, Landing lawyers will discuss and exchange legal practice issues in related fields with more healthcare practitioners to escort the development of the pharmaceutical and healthcare industry and provide quality legal services.