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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...

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Autores principales: Wyatt, Jeremy C., Scott, Philip, Ordish, Johan, South, Matthew, Thomas, Mark, Jones, Caroline, Lacey‐Bryant, Sue
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582217/
https://www.ncbi.nlm.nih.gov/pubmed/37860061
http://dx.doi.org/10.1002/lrh2.10386
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author Wyatt, Jeremy C.
Scott, Philip
Ordish, Johan
South, Matthew
Thomas, Mark
Jones, Caroline
Lacey‐Bryant, Sue
author_facet Wyatt, Jeremy C.
Scott, Philip
Ordish, Johan
South, Matthew
Thomas, Mark
Jones, Caroline
Lacey‐Bryant, Sue
author_sort Wyatt, Jeremy C.
collection PubMed
description 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.
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spelling pubmed-105822172023-10-19 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 Wyatt, Jeremy C. Scott, Philip Ordish, Johan South, Matthew Thomas, Mark Jones, Caroline Lacey‐Bryant, Sue Learn Health Syst Policy Analysis 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. John Wiley and Sons Inc. 2023-08-25 /pmc/articles/PMC10582217/ /pubmed/37860061 http://dx.doi.org/10.1002/lrh2.10386 Text en © 2023 The Authors. Learning Health Systems published by Wiley Periodicals LLC on behalf of University of Michigan. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Policy Analysis
Wyatt, Jeremy C.
Scott, Philip
Ordish, Johan
South, Matthew
Thomas, Mark
Jones, Caroline
Lacey‐Bryant, Sue
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Policy Analysis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10582217/
https://www.ncbi.nlm.nih.gov/pubmed/37860061
http://dx.doi.org/10.1002/lrh2.10386
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