{"title":"自主人工智能的监督:从护士从业者作为医师扩展者的经验教训。","authors":"Walker Morrell, Carmel Shachar, Anthony P Weiss","doi":"10.1093/jlb/lsac021","DOIUrl":null,"url":null,"abstract":"<p><p>The development of autonomous artificial intelligence (A-AI) products in health care raises novel regulatory challenges, including how to ensure their safety and efficacy in real-world settings. Supplementing a device-centered regulatory scheme with a regulatory scheme that considers A-AI products as a 'physician extender' may improve the real-world monitoring of these technologies and produce other benefits, such as increased access to the services offered by these products. In this article, we review the three approaches to the oversight of nurse practitioners, one type of physician extender, in the USA and extrapolate these approaches to produce a framework for the oversight of A-AI products. Under the framework, the US Food and Drug Administration would evaluate A-AI products and determine whether they are allowed to operate independently of physician oversight; required to operate under some physician oversight via a 'collaborative protocol' model; or required to operate under direct physician oversight via a 'supervisory protocol' model.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2022-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d5/3e/lsac021.PMC9366091.pdf","citationCount":"0","resultStr":"{\"title\":\"The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders.\",\"authors\":\"Walker Morrell, Carmel Shachar, Anthony P Weiss\",\"doi\":\"10.1093/jlb/lsac021\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The development of autonomous artificial intelligence (A-AI) products in health care raises novel regulatory challenges, including how to ensure their safety and efficacy in real-world settings. Supplementing a device-centered regulatory scheme with a regulatory scheme that considers A-AI products as a 'physician extender' may improve the real-world monitoring of these technologies and produce other benefits, such as increased access to the services offered by these products. In this article, we review the three approaches to the oversight of nurse practitioners, one type of physician extender, in the USA and extrapolate these approaches to produce a framework for the oversight of A-AI products. Under the framework, the US Food and Drug Administration would evaluate A-AI products and determine whether they are allowed to operate independently of physician oversight; required to operate under some physician oversight via a 'collaborative protocol' model; or required to operate under direct physician oversight via a 'supervisory protocol' model.</p>\",\"PeriodicalId\":56266,\"journal\":{\"name\":\"Journal of Law and the Biosciences\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2022-08-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/d5/3e/lsac021.PMC9366091.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Law and the Biosciences\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/jlb/lsac021\",\"RegionNum\":2,\"RegionCategory\":\"哲学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2022/7/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"ETHICS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Law and the Biosciences","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/jlb/lsac021","RegionNum":2,"RegionCategory":"哲学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2022/7/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"ETHICS","Score":null,"Total":0}
The oversight of autonomous artificial intelligence: lessons from nurse practitioners as physician extenders.
The development of autonomous artificial intelligence (A-AI) products in health care raises novel regulatory challenges, including how to ensure their safety and efficacy in real-world settings. Supplementing a device-centered regulatory scheme with a regulatory scheme that considers A-AI products as a 'physician extender' may improve the real-world monitoring of these technologies and produce other benefits, such as increased access to the services offered by these products. In this article, we review the three approaches to the oversight of nurse practitioners, one type of physician extender, in the USA and extrapolate these approaches to produce a framework for the oversight of A-AI products. Under the framework, the US Food and Drug Administration would evaluate A-AI products and determine whether they are allowed to operate independently of physician oversight; required to operate under some physician oversight via a 'collaborative protocol' model; or required to operate under direct physician oversight via a 'supervisory protocol' model.
期刊介绍:
The Journal of Law and the Biosciences (JLB) is the first fully Open Access peer-reviewed legal journal focused on the advances at the intersection of law and the biosciences. A co-venture between Duke University, Harvard University Law School, and Stanford University, and published by Oxford University Press, this open access, online, and interdisciplinary academic journal publishes cutting-edge scholarship in this important new field. The Journal contains original and response articles, essays, and commentaries on a wide range of topics, including bioethics, neuroethics, genetics, reproductive technologies, stem cells, enhancement, patent law, and food and drug regulation. JLB is published as one volume with three issues per year with new articles posted online on an ongoing basis.