[Case Introduction]

According to the public information on the website of the Ministry of Science and Technology of the People's Republic of China, the China Human Genetic Resources Management Office (hereinafter referred to as the “Genetic Office”) investigated the Hua Shan Hospital about the international research cooperation on “a large sample case-control study of Chinese women with unipolar depression”. It was found that the following violations occurred: Hua Shan Hospital and Shenzhen Hua Da Gene Technology Service Co., Ltd. conducted an international cooperation study on human genetic resources with the University of Oxford without permission. Hua Shan Hospital transmitted some human genetic resources information from the Internet to foreign country without permission. The Ministry of Science and Technology of China decided to punish as follows: 1. The execution of the research work should be stopped immediately. 2. Destroy all non-exit genetic resources materials and related research data in the research work. 3. From the date of delivery of this decision, Hua Shan Hospital will stop international cooperation on human genetic resources and carry out rectification.

[Lawyer analysis]

Medical data, involving patients' personal privacy (personal information), social order and good customs, national ethnic security, therefore, the protection of medical data has always been the focus of the legislative and law enforcement agencies in China. Violation of the law, resulting in the disclosure of medical data, may bear civil liability, administrative responsibility, serious circumstances, and even bear criminal responsibility.

In the context of current big data, traditional paper medical records have gradually been replaced by electronic medical records, and data sharing has been realized within medical institutions or within certain administrative areas. This has greatly facilitated the medical institutions to use medical data for commercial development, and the problem of medical data security has also emerged.

In the above case, Hua Shan Hospital collected a large sample of Chinese women with unipolar depression, cooperated with the University of Oxford without permission, and transmitted some human genetic resources information online without permission.

According to Article 4 of the Interim Measures for the Administration of Human Genetic Resources in China: “The State implements a registration system for important genetic families and genetic resources in specific regions. Units or individuals that discover and hold important genetic families and genetic resources in specific regions shall report in a timely manner. Without permission, no unit or individual may collect, trade, export or leave the country without authorization.” Article 11 (1): “All international cooperation projects involving human genetic resources in China shall be submitted for approval by the Chinese partner.... ” Article 16: “When carrying, mailing and transporting human genetic resources for export and exit It should be truthfully declared to the customs..." In this case, according to the investigation of the Genetics Office, the medical institution did not report, apply for approval or declare according to law.

Therefore, the Ministry of Science and Technology of China has ordered the medical institution to stop research work, destroy all non-exit genetic resources materials and related research data, and stop international cooperation and carry out rectification according to the provisions of Article 21 of the Interim Measures for the Administration of Human Genetic Resources.

In fact, the scope of medical data is very broad, including not only the genetic resources data in the above cases, but medical information collected by medical institutions to patients can be considered as medical data. These data should be included in the protection of medical data, and in practice, it is mainly reflected in the form of medical records. According to Article 2 of the “Regulations on the Management of Medical Records of Medical Institutions”: “The medical records refer to the sum of the texts, symbols, charts, images, slices and other materials formed by medical personnel in the course of medical activities.”

The use and protection of medical data in medical records is a very worthwhile research issue. The above cases provide us with a perspective of passing through the country. However, in practice, even if we do not leave the country, we should follow the principle of legal use and legal protection. Control legal risks and avoid economic losses and legal liabilities.

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