将内部问责制嵌入医疗机构,以便在医疗实践中安全、有效、合乎道德地实施人工智能:梅奥诊所案例研究

Brenna Loufek MS , David Vidal JD , David S. McClintock MD , Mark Lifson PhD , Eric Williamson MD , Shauna Overgaard PhD , Kathleen McNaughton JD , Melissa C. Lipford MD , Darrell S. Pardi MD
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引用次数: 0

摘要

医疗机构正在以越来越快的速度构建、部署和自我管理数字医疗技术(DHT),包括人工智能。这一范围需要专业知识和高质量的基础设施,以确保影响患者护理的技术在其整个生命周期内都是安全、有效和合乎道德的。本文旨在介绍梅奥诊所嵌入内部问责制的方法,作为其他医疗机构寻求负责任地实施人工智能 DHT 的方法的案例研究。梅奥诊所的目标是通过以下方式为创新者提供支持和授权:(1)培养内部技能和专业知识;(2)建立集中审查委员会;(3)使开发和部署流程与法规、标准和最佳实践保持一致。2022 年,梅奥诊所成立了 "软件作为医疗器械审查委员会"(简称 "委员会"),这是一个由医生和领域专家组成的独立机构,代表组织为创新者提供 DHT 的监管和风险缓解建议。自此,数百个数字医疗产品团队从这一职能中受益,该职能旨在使负责任的创新与法规和最先进的质量管理实践保持一致。其他医疗机构也可以利用这一框架建立类似的内部问责机构。作为标准持续改进实践的一部分,梅奥诊所仍有机会不断改进其方法,并提高董事会的代表性。
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Embedding Internal Accountability Into Health Care Institutions for Safe, Effective, and Ethical Implementation of Artificial Intelligence Into Medical Practice: A Mayo Clinic Case Study
Health care organizations are building, deploying, and self-governing digital health technologies (DHTs), including artificial intelligence, at an increasing rate. This scope necessitates expertise and quality infrastructure to ensure that the technology impacting patient care is safe, effective, and ethical throughout its lifecycle. The objective of this article is to describe Mayo Clinic’s approach for embedding internal accountability as a case study for other health care institutions seeking modalities for responsible implementation of artificial intelligence–enabled DHTs. Mayo Clinic aims to enable and empower innovators by (1) building internal skills and expertise, (2) establishing a centralized review board, and (3) aligning development and deployment processes with regulations, standards, and best practices. In 2022, Mayo Clinic established the Software as a Medical Device Review Board (The Board), an independent body of physicians and domain experts to represent the organization in providing innovators regulatory and risk mitigation recommendations for DHTs. Hundreds of digital health product teams have since benefited from this function, intended to enable responsible innovation in alignment with regulation and state-of-the-art quality management practices. Other health care institutions can adopt similar internal accountability bodies using this framework. Opportunity remains to iterate on Mayo Clinic’s approach in alignment with advancing best practices and enhance representation on The Board as part of standard continuous improvement practices.
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Mayo Clinic Proceedings. Digital health
Mayo Clinic Proceedings. Digital health Medicine and Dentistry (General), Health Informatics, Public Health and Health Policy
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