New consideration for data collection and application of clinical research under the back-ground of ligalization of data administration in China / 中华消化外科杂志

ABSTRACT

The medical data processed and analyzed in clinical research often contain a large number of personal information. Therefore, researchers should pay attention to the safety management of medical data during clinical research. The Data Security Law of People's Republic of China and the Personal Information Protection Law of People's Republic of China implemented on 1 st September and 1 st November 2021 respectively establish legal basis for data security and personal information protection and point out the direction for medical data security, which indicate that data governance has entered the 'strong regulatory era'. In the process of medical data collection and application of clinical research, respecting and protecting the privacy and safety of patients, ensuring the quality of medical data, safely managing medical data and carrying out high-quality clinical research will be an important test for the collection and application of clinical scientific research data under the new legal background.