论医学人工智能时代的移动健康终端质量控制

Discussion on Quality Control of Mobile Health Terminals in the Era of Medical Artificial Intelligence

目的:梳理医学人工智能时代的移动健康终端在质量控制方面的要求和问题。方法:查阅国内外监管政策文献,从国外公开的医疗器械审批资料中查询带有移动健康终端的智能化医疗器械在验证与确认环节开展的具体评价工作。结果:移动健康终端的质量评价要求在国内外存在差异,国内在电气安全方面主要参考医用电气设备,而美国可执行其他标准。结论:本文讨论了移动健康终端对人工智能医疗器械的影响,明晰了移动健康终端的质量评价思路,更好地保证基于移动健康终端的人工智能医疗器械的有效性和安全性。

Objective:To study the requirement and issues with quality control of mobile health terminals in the era of medical artificial intelligence.Methods:Regulation policy literatures of China and other countries were searched and reviewed.Specific evaluation of validation and verification of intelligent medical devices with mobile health terminals was collected from published review documents of medical devices of other countries.Results:The requirement of quality evaluation of mobile health terminals in China was different from that in other countries.Compliance with medical electrical equipment is required in China,while USA applies other standards.Conclusion:This paper discusses the impact of mobile health terminals on artificial intelligence medical device and clarifies the requirement of quality evaluation of mobile health terminals so as to ensure the safety and effectiveness of the artificial intelligence medical device based on mobile health terminals.