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
{"title":"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","authors":"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","doi":"10.1016/j.mcpdig.2024.08.008","DOIUrl":null,"url":null,"abstract":"<div><div>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.</div></div>","PeriodicalId":74127,"journal":{"name":"Mayo Clinic Proceedings. Digital health","volume":"2 4","pages":"Pages 574-583"},"PeriodicalIF":0.0000,"publicationDate":"2024-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Embedding Internal Accountability Into Health Care Institutions for Safe, Effective, and Ethical Implementation of Artificial Intelligence Into Medical Practice: A Mayo Clinic Case Study\",\"authors\":\"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. 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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.</div></div>\",\"PeriodicalId\":74127,\"journal\":{\"name\":\"Mayo Clinic Proceedings. 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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.