哪些可计算的生物医学知识对象将受到监管?英国讨论知识库和软件作为医疗设备的监管的研讨会结果

IF 2.6 Q2 HEALTH POLICY & SERVICES
Jeremy C. Wyatt, Philip Scott, Johan Ordish, Matthew South, Mark Thomas, Caroline Jones, Sue Lacey-Bryant, workshop participants
{"title":"哪些可计算的生物医学知识对象将受到监管?英国讨论知识库和软件作为医疗设备的监管的研讨会结果","authors":"Jeremy C. Wyatt,&nbsp;Philip Scott,&nbsp;Johan Ordish,&nbsp;Matthew South,&nbsp;Mark Thomas,&nbsp;Caroline Jones,&nbsp;Sue Lacey-Bryant,&nbsp;workshop participants","doi":"10.1002/lrh2.10386","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Introduction</h3>\n \n <p>To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom.</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level.</p>\n </section>\n \n <section>\n \n <h3> Conclusions</h3>\n \n <p>If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as “software as a medical device.” However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries.</p>\n </section>\n </div>","PeriodicalId":43916,"journal":{"name":"Learning Health Systems","volume":"7 4","pages":""},"PeriodicalIF":2.6000,"publicationDate":"2023-08-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/lrh2.10386","citationCount":"1","resultStr":"{\"title\":\"Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device\",\"authors\":\"Jeremy C. Wyatt,&nbsp;Philip Scott,&nbsp;Johan Ordish,&nbsp;Matthew South,&nbsp;Mark Thomas,&nbsp;Caroline Jones,&nbsp;Sue Lacey-Bryant,&nbsp;workshop participants\",\"doi\":\"10.1002/lrh2.10386\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Introduction</h3>\\n \\n <p>To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusions</h3>\\n \\n <p>If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as “software as a medical device.” However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries.</p>\\n </section>\\n </div>\",\"PeriodicalId\":43916,\"journal\":{\"name\":\"Learning Health Systems\",\"volume\":\"7 4\",\"pages\":\"\"},\"PeriodicalIF\":2.6000,\"publicationDate\":\"2023-08-25\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/lrh2.10386\",\"citationCount\":\"1\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Learning Health Systems\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/lrh2.10386\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"HEALTH POLICY & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Learning Health Systems","FirstCategoryId":"1085","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/lrh2.10386","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
引用次数: 1

摘要

了解可计算生物医学知识库中的知识对象何时可能作为英国的医疗器械受到监管。一份简报分发给了一个由25人组成的多学科小组,其中包括监管机构、律师和其他对器械监管有深入了解的人。召开了为期一天的研讨会,讨论与我们的目标有关的问题。主要作者起草了一份讨论文件,并分发给其他作者征求他们的意见和贡献。本文报告了这些审议情况,并描述了英国设备监管机构可能如何处理可能存储在可计算生物医学知识库中的不同类型的知识对象。虽然我们的重点是英国监管机构可能采取的方法,但我们的类比和分析也将与其他地方监管机构采取的方法相关。我们包括一个表,检查Boxwala在2011年描述的四个知识水平中的每一个的含义,并提出了一个额外的水平。如果知识对象被描述为可直接执行用于医疗目的以提供决策支持,那么它通常在英国法规的范围内被称为“作为医疗设备的软件”。然而,如果知识对象由算法、规则集、,伪代码或其他不能直接执行的表示,并且其开发人员没有声称它可以用于医疗目的,它不太可能受到监管。我们预计其他国家的监管机构也会采用类似的理由。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device

Which computable biomedical knowledge objects will be regulated? Results of a UK workshop discussing the regulation of knowledge libraries and software as a medical device

Introduction

To understand when knowledge objects in a computable biomedical knowledge library are likely to be subject to regulation as a medical device in the United Kingdom.

Methods

A briefing paper was circulated to a multi-disciplinary group of 25 including regulators, lawyers and others with insights into device regulation. A 1-day workshop was convened to discuss questions relating to our aim. A discussion paper was drafted by lead authors and circulated to other authors for their comments and contributions.

Results

This article reports on those deliberations and describes how UK device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While our focus is the likely approach of UK regulators, our analogies and analysis will also be relevant to the approaches taken by regulators elsewhere. We include a table examining the implications for each of the four knowledge levels described by Boxwala in 2011 and propose an additional level.

Conclusions

If a knowledge object is described as directly executable for a medical purpose to provide decision support, it will generally be in scope of UK regulation as “software as a medical device.” However, if the knowledge object consists of an algorithm, a ruleset, pseudocode or some other representation that is not directly executable and whose developers make no claim that it can be used for a medical purpose, it is not likely to be subject to regulation. We expect similar reasoning to be applied by regulators in other countries.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Learning Health Systems
Learning Health Systems HEALTH POLICY & SERVICES-
CiteScore
5.60
自引率
22.60%
发文量
55
审稿时长
20 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信