{"title":"一般健康产品和管制设备之间的界限:策略和影响。","authors":"David A Simon, Carmel Shachar, I Glenn Cohen","doi":"10.1093/jlb/lsac015","DOIUrl":null,"url":null,"abstract":"<p><p>Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a flexible approach that allows firms to manufacture a 'general wellness product' ('GWP') without being subject to regulation typically applied to 'devices' that diagnose or treat a disease or condition. Using currently available medical products and devices from across a spectrum of diseases, we describe how firms can use this existing regulatory framework to develop innovative products by 'skating the line' between mostly unregulated GWPs and regulated devices. On the one hand, we find that skating the line offers a variety of benefits, including potential improvements to product development, innovation, and patient access to medical technologies. On the other hand, we show that this technique has potential costs to patient safety, competition, and data sharing. Skating the regulatory line between GWP and devices, in other words, offers important benefits but is not without risks. Any further regulatory action to address such risks should be careful to leave significant unregulated space for product development.</p>","PeriodicalId":56266,"journal":{"name":"Journal of Law and the Biosciences","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2022-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/98/51/lsac015.PMC9280986.pdf","citationCount":"7","resultStr":"{\"title\":\"Skating the line between general wellness products and regulated devices: strategies and implications.\",\"authors\":\"David A Simon, Carmel Shachar, I Glenn Cohen\",\"doi\":\"10.1093/jlb/lsac015\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a flexible approach that allows firms to manufacture a 'general wellness product' ('GWP') without being subject to regulation typically applied to 'devices' that diagnose or treat a disease or condition. Using currently available medical products and devices from across a spectrum of diseases, we describe how firms can use this existing regulatory framework to develop innovative products by 'skating the line' between mostly unregulated GWPs and regulated devices. On the one hand, we find that skating the line offers a variety of benefits, including potential improvements to product development, innovation, and patient access to medical technologies. On the other hand, we show that this technique has potential costs to patient safety, competition, and data sharing. Skating the regulatory line between GWP and devices, in other words, offers important benefits but is not without risks. Any further regulatory action to address such risks should be careful to leave significant unregulated space for product development.</p>\",\"PeriodicalId\":56266,\"journal\":{\"name\":\"Journal of Law and the Biosciences\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.5000,\"publicationDate\":\"2022-07-14\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/98/51/lsac015.PMC9280986.pdf\",\"citationCount\":\"7\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Law and the Biosciences\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/jlb/lsac015\",\"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/lsac015","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}
Skating the line between general wellness products and regulated devices: strategies and implications.
Health technology is advancing at a rapid clip, with many of these technologies appearing on consumer products like smartphones and tablets. Federal regulators have responded to these changes with a flexible approach that allows firms to manufacture a 'general wellness product' ('GWP') without being subject to regulation typically applied to 'devices' that diagnose or treat a disease or condition. Using currently available medical products and devices from across a spectrum of diseases, we describe how firms can use this existing regulatory framework to develop innovative products by 'skating the line' between mostly unregulated GWPs and regulated devices. On the one hand, we find that skating the line offers a variety of benefits, including potential improvements to product development, innovation, and patient access to medical technologies. On the other hand, we show that this technique has potential costs to patient safety, competition, and data sharing. Skating the regulatory line between GWP and devices, in other words, offers important benefits but is not without risks. Any further regulatory action to address such risks should be careful to leave significant unregulated space for product development.
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.