Wyatt Jeremy C, Scott Philip, Ordish Johan, South Matthew, Thomas Mark, Jones Caroline, Lacey-Bryant Sue
School of Primary Care, Population Sciences and Medical Education University of Southampton Southampton UK.
Institute of Management and Health University of Wales Trinity Saint David Lampeter Wales UK.
Learn Health Syst. 2023 Aug 25;7(4):e10386. doi: 10.1002/lrh2.10386. eCollection 2023 Oct.
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.
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.
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.
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.
了解在英国，可计算生物医学知识库中的知识对象何时可能会被作为医疗器械进行监管。
一份简报分发给了一个由25人组成的多学科小组，成员包括监管机构人员、律师以及其他对器械监管有见解的人士。召开了一次为期一天的研讨会，讨论与我们的目标相关的问题。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。
本文报告了这些讨论情况，并描述了英国器械监管机构可能会如何对待可计算生物医学知识库中可能存储的不同类型的知识对象。虽然我们关注的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。我们包括一个表格，考察了2011年博克斯瓦拉所描述的四个知识层面中每一个层面的影响，并提出了一个额外的层面。
如果一个知识对象被描述为可直接用于医疗目的以提供决策支持，那么它通常会在英国“作为医疗器械的软件”的监管范围内。然而，如果知识对象由一种算法、一组规则、伪代码或其他不可直接执行且其开发者未声称可用于医疗目的的表示形式组成，那么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推理方法。
