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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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2023
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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. |
format | Online Article Text |
id | pubmed-10582217 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
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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