• 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

Study on the safety impact and countermeasures of medical artificial intelligence products on patients

Corresponding author: dongtingting, d18256050927@163.com
DOI: 10.12201/bmr.202012.00004
Statement: This article is a preprint and has not been peer-reviewed.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: In recent years, medical artificial intelligence products have developed rapidly, the requirements for patient safety services have become more stringent. Based on Avedis Donabedian’s structure-process-result theory, this paper constructs a framework for the impact of medical artificial intelligence products on patient safety. From the four perspectives of medical artificial intelligence companies, medical institutions, health technicians, and the government, this paper takes medical imaging auxiliary diagnosis system, surgical robots, rehabilitation robots, and telemedicine as examples to analyze the adverse effects of medical artificial intelligence products on patient safety. Finally, relevant countermeasures are put forward,it provides management methods and theoretical basis for related units to improve the patient safety guarantee system.

    Key words: patient safety; medical artificial intelligence; medical risks; influencing factors; countermeasures

    Submit time: 25 December 2020

    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 2020-12-17

    bmr.202012.00004V1

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dongtingting. Study on the safety impact and countermeasures of medical artificial intelligence products on patients. 2020. biomedRxiv.202012.00004

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