Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety.

IF 4.7 2区医学 Q1 COMPUTER SCIENCE, INFORMATION SYSTEMS

Journal of the American Medical Informatics Association Pub Date : 2024-06-20 DOI:10.1093/jamia/ocae119

Mark P Sendak, Vincent X Liu, Ashley Beecy, David E Vidal, Keo Shaw, Mark A Lifson, Danny Tobey, Alexandra Valladares, Brenna Loufek, Murtaza Mogri, Suresh Balu

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引用次数: 0

Abstract

Objectives: Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software.

Materials and methods: We use sepsis as a case study to highlight the patient safety and regulatory compliance tradeoffs that 6129 hospitals in the United States must navigate.

Results: Sepsis CDS remains in broad, routine use. There is no commercially available sepsis CDS system that is FDA cleared as a medical device. There is no public disclosure of an HDO turning off sepsis CDS due to regulatory compliance concerns. And there is no public disclosure of FDA enforcement action against an HDO for using sepsis CDS that is not cleared as a medical device.

Discussion and conclusion: We present multiple policy interventions that would relieve the current tension to enable HDOs to utilize artificial intelligence to improve patient care while also addressing FDA concerns about product safety, efficacy, and equity.

查看原文本刊更多论文

加强人工智能在医疗机构中的应用：兼顾合规性和患者安全。

目标：揭示医疗机构（HDOs）在美国食品药品管理局（FDA）临床决策支持（CDS）软件使用最终指南中面临的紧迫困境：我们以败血症为案例，强调了美国 6129 家医院必须在患者安全和合规性之间做出权衡：结果：脓毒症 CDS 仍在广泛、常规使用。目前还没有商业化的脓毒症 CDS 系统被 FDA 批准为医疗设备。没有公开披露过 HDO 因合规问题而关闭脓毒症 CDS 的情况。也没有公开披露美国食品及药物管理局对使用未被批准为医疗设备的败血症病理诊断系统的人类发展组织采取执法行动：我们提出了多种政策干预措施，以缓解当前的紧张局势，使人类发展组织能够利用人工智能改善患者护理，同时解决 FDA 对产品安全性、有效性和公平性的担忧。

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.