New consideration for data collection and application of clinical research under the back-ground of ligalization of data administration in China
10.3760/cma.j.cn115610-20220104-00006
- VernacularTitle:数据治理法制化背景下我国临床研究数据收集和应用新考量
- Author:
Xiao ZHANG
1
;
Hui ZHOU
;
Jingjing HE
;
Hongwei YAO
;
Su CHEN
;
Zhongtao ZHANG
Author Information
1. 首都医科大学附属北京友谊医院普通外科 国家消化系统疾病临床医学研究中心，北京 100050
- Keywords:
Biomedical research;
Clinical protocols;
Medical data;
Data security;
Personal information protection;
Data application
- From:
Chinese Journal of Digestive Surgery
2022;21(1):89-92
- CountryChina
- Language:Chinese
-
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.
