基于人工智能技术的医疗诊断软件测试和监测方法学

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论证。2016年，全球对基于人工智能技术开发医疗诊断软件的公司的投资额为8000万美元，2017年为1.52亿美元，并预料还将继续增长。软件公司的积极活动必须符合现有的临床、生物伦理、法律和方法学原理和标准。在国家和国际范围，基于人工智能技术的软件还没有统一的测试和监测标准和协议。

该研究的目的是开发一种通用方法，用于测试和监测基于人工智能技术的医疗诊断软件，以提高其质量和在实际医疗中的应用。

材料和方法。在分析阶段，对PubMed和eLIBRARY数据库进行了文献综述。实用阶段包括 在《使用创新计算机视觉技术进行医学图像分析并进一步应用于莫斯科市医疗系统的实验》框架内批准所开发的方法学，并将其进一步应用于莫斯科的医疗保健系统。

结果。我们开发了一套基于人工智能技术的医疗诊断软件测试和监测方法学，旨在提高该软件的质量，并将其应用于实际医疗保健中。该方法学包括7个阶段：自我测试、功能测试、校准测试、技术监测、临床监测、反馈和改进。

结论。该方法学的显著特点是对软件进行周期性的监测和改进，从而不断提高其质量；对软件性能结果并医生参与软件评估提出详细要求。该方法学可使软件开发人员在各个领域取得优异成绩并展示成就，也可使用户在通过独立、全面质量控制的程序中做出明智、自信的选择。

作者简介

Yuri A. Vasiliev

Moscow Center for Diagnostics and Telemedicine

Email: VasilevYA1@zdrav.mos.ru
ORCID iD: 0000-0002-0208-5218
SPIN 代码: 4458-5608

MD, Cand. Sci. (Med.)

俄罗斯联邦, Moscow

Anton V. Vlazimirsky

Moscow Center for Diagnostics and Telemedicine

Email: VladzimirskijAV@zdrav.mos.ru
ORCID iD: 0000-0002-2990-7736
SPIN 代码: 3602-7120

MD, Dr. Sci. (Med.)

俄罗斯联邦, Moscow

Olga V. Omelyanskaya

Moscow Center for Diagnostics and Telemedicine

Email: OmelyanskayaOV@zdrav.mos.ru
ORCID iD: 0000-0002-0245-4431
SPIN 代码: 8948-6152
俄罗斯联邦, Moscow

Kirill M. Arzamasov

Moscow Center for Diagnostics and Telemedicine

Email: ArzamasovKM@zdrav.mos.ru
ORCID iD: 0000-0001-7786-0349
SPIN 代码: 3160-8062

MD, Cand. Sci. (Med.)

俄罗斯联邦, Moscow

Sergey F. Chetverikov

Moscow Center for Diagnostics and Telemedicine

Email: ChetverikovSF@zdrav.mos.ru
ORCID iD: 0000-0002-3097-8881
SPIN 代码: 3815-8870

Cand. Sci. (Engin.)

俄罗斯联邦, Moscow

Denis A. Rumyantsev

Moscow Center for Diagnostics and Telemedicine

编辑信件的主要联系方式.
Email: x.radiology@mail.ru
ORCID iD: 0000-0001-7670-7385
SPIN 代码: 8734-2085
俄罗斯联邦, Moscow

Maria A. Zelenova

Moscow Center for Diagnostics and Telemedicine

Email: ZelenovaMA@zdrav.mos.ru
ORCID iD: 0000-0001-7458-5396
SPIN 代码: 3823-6872
俄罗斯联邦, Moscow

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1. JATS XML
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2. 图1。关于测试和监测基于人工智能技术的医疗诊断软件的方法。

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3. 图2。有图像的基于人工智能技术软件成果的主要组成部分：基准作品示例。

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4. 图3。有DICOM SR的基于人工智能技术软件成果的主要组成部分：基准作品示例。

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5. 图4。基于人工智能技术的软件另一系列的截图：不符合基本功能要求的严重不符合项。

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6. 图5。图片说明叠置：不符合基本功能要求的严重不符合项。

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7. 图6。校准测试协议书的示例。

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8. 图7。基于人工智能技术的软件运行监测内部报告表格。

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9. 图8。“胸部X射线照相术”模式软件的技术缺陷动态变化。

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10. 图9。技术监测报告的示例。

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11. 图10。假阴性（没有右肺下叶亚段膨胀不全的 定位）：不符合基本诊断要求的非严重不符合项。

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12. 图11。用户界面反馈窗口的内容。

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