Evaluation and Regulation of Medical Artificial Intelligence Applications in China.
- Author:
Mao YOU
1
;
Yue XIAO
1
;
Han YAO
2
;
Xue-Qing TIAN
1
;
Li-Wei SHI
1
;
Ying-Peng QIU
3
Author Information
- Publication Type:Journal Article
- Keywords: health technology assessment; medical artificial intelligence; regulatory sandbox
- MeSH: Artificial Intelligence/legislation & jurisprudence*; China; Humans; Algorithms
- From: Chinese Medical Sciences Journal 2025;40(1):3-8
- CountryChina
- Language:English
- Abstract: Amid the global wave of digital economy, China's medical artificial intelligence applications are rapidly advancing through technological innovation and policy support, while facing multifaceted evaluation and regulatory challenges. The dynamic algorithm evolution undermines the consistency of assessment criteria, multimodal systems lack unified evaluation metrics, and conflicts persist between data sharing and privacy protection. To address these issues, the China National Health Development Research Center has established a value assessment framework for artificial intelligence medical technologies, formulated the country's first technical guideline for clinical evaluation, and validated their practicality through scenario-based pilot studies. Furthermore, this paper proposes introducing a "regulatory sandbox" model to test technical compliance in controlled environments, thereby balancing innovation incentives with risk governance.
