GB/T 12715-1991
Abolished
T/CI 130-2023
Active
Group standards
T/CI 130-2023 Healthcare data sharing ethical requirements
T/CI 130-2023 Healthcare data sharing ethical requirements
Price:
$ 20.00
Basic Information
Standard Code:
T/CI 130-2023
Standard Type:
Group standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
-
ICS Name:
Biology, botany, and zoology
Publish Date:
2023-09-11
Implement Date:
2023-09-11
Scope
Main Technical Content: This document specifies the ethical principles, general provisions, informed consent, use of health and medical data, intellectual property protection, conflict of interest, benefit sharing, ethics committees, and ethical review related requirements for the sharing of health and medical data. This document applies to trials, development, and international and domestic scientific research cooperation conducted using health and medical data. According to the sources of the collected data, this document mainly applies to the following data with sharing and reuse plans: - Data generated from biomedical research involving humans, including clinical trials, referred to as research data; - Medical business data intended for research, including health checkups, clinical diagnosis and treatment, nursing data, management data, and health economics data, referred to as business data. This document also applies to data from the aforementioned sources that have been collected and are shared or reused (also known as reuse or secondary use) for public welfare purposes beyond the scope of the initial research and the original collection purposes, including the following two scenarios: - Sharing and reusing research data that has been completed; - Sharing and using medical business data that has been collected for research purposes. This document applies to entities or institutions that use community-based active health platforms for medical data sharing or use requirements, including: - Medical research or healthcare service institutions; - Universities, medical institutions, and R&D enterprises involved in medical research; - Testing institutions, third-party organizations, or platforms that provide data sharing and services; - Other institutions involved in data sharing and use; - Data not applicable to national security or confidentiality or data that are not allowed to be shared according to laws and regulations; - Traditional eth