• 国家药监局综合司 国家卫生健康委办公厅
  • 国家药监局综合司 国家卫生健康委办公厅

Research on the Construction of Security Risk Review Indicator System for Foreign-funded Medical Practices in China

Corresponding author: Meng Yanchen, myanchen@ccmu.edu,cn
DOI: 10.12201/bmr.202507.00045
Statement: This article is a preprint and has not been peer-reviewed. It reports new research that has yet to be evaluated and so should not be used to guide clinical practice.
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    Abstract: Objective:To construct a foreign-funded medical safety risk review evaluation index system for the regulatory needs in the context of expanding the opening up of Chinas medical service industry, in order to achieve a dynamic balance between opening up and safety and prevent systemic risks; Methods:Using a combination of the Delphi method and hierarchical analysis method, 21 senior experts from the fields of management of healthcare institutions, health policy, health jurisprudence and public safety were invited to participate in the construction of the indexes. Statistical quantities such as expert authority coefficient, coordination coefficient and content validity were used to ensure the scientificity of the indicators, and the hierarchical analysis method was used to quantify the weights of the indicators and derive the analysis results; Results: the positive coefficients of the two rounds of expert consultation were greater than 95%, and the expert authority coefficient was 0.897; the expert Kendall coordination coefficients were 0.178 and 0.182, respectively, with P<0.001, and the differences were all statistically significant. Through two rounds of expert correspondence, the evaluation index system of foreign-funded medical hospital safety risk review constructed by 4 first-level indicators, 12 second-level indicator systems and 38 third-level indicators of functional safety, medical safety, biosafety and information security was finalized; Conclusion: Through a multi-dimensional risk assessment framework, the system provides quantitative tools for the review and dynamic supervision of foreign medical access, which can support the policy synergy of “high level of openness and high level of security”and help modernize the governance capacity of Chinas medical service industry.

    Key words: Foreign-funded hospitals,Opening-up of Medical Services,Health Governance Security; ; 

    Submit time: 14 July 2025

    Copyright: The copyright holder for this preprint is the author/funder, who has granted biomedRxiv a license to display the preprint in perpetuity.
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    1 2025-05-29

    bmr.202507.00045V1

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Li Aozhe, Lv Yixing, Luo Haoyu, Meng Yanchen. Research on the Construction of Security Risk Review Indicator System for Foreign-funded Medical Practices in China. 2025. biomedRxiv.202507.00045

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