Regulation of artificial intelligence in healthcare: Clinical Laboratory Improvement Amendments (CLIA) as a model.

IF 4.7 2区医学 Q1 COMPUTER SCIENCE, INFORMATION SYSTEMS

Journal of the American Medical Informatics Association Pub Date : 2024-12-06 DOI:10.1093/jamia/ocae296

Brian R Jackson, Mark P Sendak, Anthony Solomonides, Suresh Balu, Dean F Sittig

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引用次数: 0

Abstract

Objectives: To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI).

Materials and methods: We identify overlap in the quality management requirements for laboratory testing and clinical AI.

Results: We propose modifications to the CLIA model that could make it suitable for oversight of clinical AI.

Discussion: In national discussions of clinical AI, there has been surprisingly little consideration of this longstanding model for local technology oversight. While CLIA was specifically designed for laboratory testing, most of its principles are applicable to other technologies in patient care.

Conclusion: A CLIA-like approach to regulating clinical AI would be complementary to the more centralized schemes currently under consideration, and it would ensure institutional and professional accountability for the longitudinal quality management of clinical AI.

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目的评估调整现有技术监管模式（即临床实验室改进修正案（CLIA））以适用于临床人工智能（AI）的潜力：我们确定了实验室检测和临床人工智能质量管理要求的重叠之处：结果：我们建议对 CLIA 模式进行修改，使其适用于临床人工智能的监督：在有关临床人工智能的全国性讨论中，令人惊讶的是，很少有人考虑这一长期存在的本地技术监督模式。虽然 CLIA 是专门针对实验室检测而设计的，但其大部分原则都适用于患者护理中的其他技术：结论：类似于 CLIA 的临床人工智能监管方法将对目前正在考虑的更为集中的计划起到补充作用，并将确保临床人工智能纵向质量管理的机构和专业责任。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of the American Medical Informatics Association 医学-计算机：跨学科应用

CiteScore

14.50

自引率

7.80%

发文量

230

审稿时长

3-8 weeks

期刊介绍： JAMIA is AMIA''s premier peer-reviewed journal for biomedical and health informatics. Covering the full spectrum of activities in the field, JAMIA includes informatics articles in the areas of clinical care, clinical research, translational science, implementation science, imaging, education, consumer health, public health, and policy. JAMIA''s articles describe innovative informatics research and systems that help to advance biomedical science and to promote health. Case reports, perspectives and reviews also help readers stay connected with the most important informatics developments in implementation, policy and education.