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《中国工程科学》 >> 2022年 第24卷 第1期 doi: 10.15302/J-SSCAE-2022.01.021

人工智能独立医用软件监管研究

1.浙江数字医疗卫生技术研究院,杭州 311100;

2.浙江大学医学院附属第一医院,杭州 310003

资助项目 :中国工程院咨询项目“人工智能在医药健康领域应用发展战略研究”(2019-ZD-06) 收稿日期: 2021-06-30 修回日期: 2021-11-10 发布日期: 2022-02-22

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摘要

科学的监管体系可以促进新兴事物的蓬勃和规范化发展。人工智能(AI)独立医用软件是人工智能时代赋能医疗健康领域的重要产物。随着人工智能的深入发展,人工智能独有的黑盒算法及自主学习能力引起了巨大的监管挑战。AI 独立医用软件的监管需要与时俱进,为最大程度降低人工智能医疗软件不良事件发生率和风险影响,我们亟待寻求更为科学合理的监管应对方案。对此,本文从AI 技术特征监管应对出发,针对算法变更管理、质量控制、安全追溯等监管上存在的痛点和难点问题梳理了国内外AI 独立医用软件相关监管制度和支撑资源的现状。分析总结了我国AI 独立医用软件监管在制度层面、支撑资源层面仍面临的一些问题与挑战,并针对上市后监管短板提出了措施建议:系统完善AI 独立医用软件监管制度,深化AI 独立医用软件监管支撑体系。以期能够为进一步完善我国AI 独立医用软件科学监管提供参考。

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