Duke Institute for Health Innovation, Duke University, Durham, NC 27701, United States.
Division of Research, Kaiser Permanente, Oakland, CA 94612, United States.
J Am Med Inform Assoc. 2024 Jun 20;31(7):1622-1627. doi: 10.1093/jamia/ocae119.
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.
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.
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.
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.
揭示医疗保健提供组织（HDO）在遵循美国食品和药物管理局（FDA）关于临床决策支持（CDS）软件使用的最终指南时所面临的紧迫困境。
我们以脓毒症为例，强调了美国 6129 家医院必须权衡的患者安全和法规遵从性之间的取舍。
脓毒症 CDS 仍在广泛常规使用。没有经过 FDA 批准作为医疗器械的商业化可用的脓毒症 CDS 系统。没有公开披露任何 HDO 因监管合规问题而关闭脓毒症 CDS。也没有公开披露 FDA 对 HDO 使用未经医疗器械批准的脓毒症 CDS 采取执法行动的情况。
我们提出了多种政策干预措施，旨在缓解当前的紧张局势，使 HDO 能够利用人工智能来改善患者护理，同时解决 FDA 对产品安全性、有效性和公平性的关注。
