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| 论医学人工智能时代的移动健康终端质控 |
| Quality control of mobile health platforms in the era of medical artificial intelligence |
| 投稿时间：2019-06-24 修订日期：2019-08-07 |
| DOI： |
| 中文关键词: 人工智能医疗器械 质量控制 移动健康终端 |
| 英文关键词: artificial intelligence medical device quality control mobile health platform |
| 基金项目:国家重点研发计划课题(2017YFC0111004) |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Objective: to study the requirement and issue with quality control of mobile health platform in the era of medical artificial intelligence. Methods: literature study is done on regulation documentations in China and other countries; information on verification and validation is collected from published review documents of smart medical device based on mobile health platform. Results: the requirement on quality control of mobile health platform is different between China and other countries. Compliance with medical electrical equipment is required in China, while USA accepts other standards. Conclusion: This paper discusses the impact of mobile health platforms on artificial intelligence medical device and clarifies the quality requirement of mobile health platforms so as to assure the safety and effectiveness of related artificial intelligence medical device. |
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