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

Jeremy C. Wyatt Orcid Logo, Philip Scott Orcid Logo, Johan Ordish, Matthew South Orcid Logo, Mark Thomas, Caroline Jones Orcid Logo, Sue Lacey‐Bryant, (workshop participants)

Learning Health Systems, Volume: 7, Issue: 4

Swansea University Author: Caroline Jones Orcid Logo

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DOI (Published version): 10.1002/lrh2.10386

Abstract

Our aim was to understand when knowledge objects in a computable biomedical knowledge library were likely to be regulated as a medical device in the UK. A briefing paper was circulated, followed by a one-day workshop with 25 multi-disciplinary attendees, all of whom had insights into medical device...

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Published in: Learning Health Systems
ISSN: 2379-6146 2379-6146
Published: Wiley 2023
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URI: https://cronfa.swan.ac.uk/Record/cronfa64003
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spelling v2 64003 2023-07-31 Which computable biomedical knowledge objects will be regulated? Results of a <scp>UK</scp> workshop discussing the regulation of knowledge libraries and software as a medical device 8201817d55a832f7c23f406402904a2b 0000-0001-7632-9468 Caroline Jones Caroline Jones true false 2023-07-31 HRCL Our aim was to understand when knowledge objects in a computable biomedical knowledge library were likely to be regulated as a medical device in the UK. A briefing paper was circulated, followed by a one-day workshop with 25 multi-disciplinary attendees, all of whom had insights into medical device regulation. Following the workshop a discussion paper was drafted by the lead authors and circulated to other authors for their comments. This article is the result of those discussions, and sets out how UK medical device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While we focus on the anticipated approach of UK regulators, we suggest our analysis will also be relevant to the approaches taken by regulators elsewhere. Included is a table examining the implications for each of the four knowledge levels described by Boxwala in 2011, though we propose the inclusion of an additional level. We conclude that 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 is not directly executable, and the developers make no claim that it can be used for a medical purpose, it is unlikely to be subject to regulation. We anticipate similar reasoning to be applied by regulators in other countries with comparable regulatory regimes. Journal Article Learning Health Systems 7 4 Wiley 2379-6146 2379-6146 computable knowledge, knowledge libraries, learning health systems, medical device regulation, mobilising computable biomedical knowledge. 1 10 2023 2023-10-01 10.1002/lrh2.10386 COLLEGE NANME Hillary Rodham Clinton Law School COLLEGE CODE HRCL Swansea University Another institution paid the OA fee 2024-06-06T11:25:35.5121959 2023-07-31T17:29:43.2490310 Faculty of Humanities and Social Sciences Hilary Rodham Clinton School of Law Jeremy C. Wyatt 0000-0001-7008-1473 1 Philip Scott 0000-0002-6289-4260 2 Johan Ordish 3 Matthew South 0000-0002-3192-5853 4 Mark Thomas 5 Caroline Jones 0000-0001-7632-9468 6 Sue Lacey‐Bryant 7 (workshop participants) 8 64003__28455__9e3af1a7cc9f41eea7da010ad68eb42a.pdf 64003.pdf 2023-09-05T12:35:35.0622057 Output 781121 application/pdf Version of Record true © 2023 The Authors. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License. true eng http://creativecommons.org/licenses/by-nc/4.0/
title Which computable biomedical knowledge objects will be regulated? Results of a <scp>UK</scp> workshop discussing the regulation of knowledge libraries and software as a medical device
spellingShingle Which computable biomedical knowledge objects will be regulated? Results of a <scp>UK</scp> workshop discussing the regulation of knowledge libraries and software as a medical device
Caroline Jones
title_short Which computable biomedical knowledge objects will be regulated? Results of a <scp>UK</scp> 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 <scp>UK</scp> 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 <scp>UK</scp> 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 <scp>UK</scp> 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 <scp>UK</scp> workshop discussing the regulation of knowledge libraries and software as a medical device
author_id_str_mv 8201817d55a832f7c23f406402904a2b
author_id_fullname_str_mv 8201817d55a832f7c23f406402904a2b_***_Caroline Jones
author Caroline Jones
author2 Jeremy C. Wyatt
Philip Scott
Johan Ordish
Matthew South
Mark Thomas
Caroline Jones
Sue Lacey‐Bryant
(workshop participants)
format Journal article
container_title Learning Health Systems
container_volume 7
container_issue 4
publishDate 2023
institution Swansea University
issn 2379-6146
2379-6146
doi_str_mv 10.1002/lrh2.10386
publisher Wiley
college_str Faculty of Humanities and Social Sciences
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hierarchy_top_id facultyofhumanitiesandsocialsciences
hierarchy_top_title Faculty of Humanities and Social Sciences
hierarchy_parent_id facultyofhumanitiesandsocialsciences
hierarchy_parent_title Faculty of Humanities and Social Sciences
department_str Hilary Rodham Clinton School of Law{{{_:::_}}}Faculty of Humanities and Social Sciences{{{_:::_}}}Hilary Rodham Clinton School of Law
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description Our aim was to understand when knowledge objects in a computable biomedical knowledge library were likely to be regulated as a medical device in the UK. A briefing paper was circulated, followed by a one-day workshop with 25 multi-disciplinary attendees, all of whom had insights into medical device regulation. Following the workshop a discussion paper was drafted by the lead authors and circulated to other authors for their comments. This article is the result of those discussions, and sets out how UK medical device regulators are likely to treat the different kinds of knowledge objects that may be stored in computable biomedical knowledge libraries. While we focus on the anticipated approach of UK regulators, we suggest our analysis will also be relevant to the approaches taken by regulators elsewhere. Included is a table examining the implications for each of the four knowledge levels described by Boxwala in 2011, though we propose the inclusion of an additional level. We conclude that 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 is not directly executable, and the developers make no claim that it can be used for a medical purpose, it is unlikely to be subject to regulation. We anticipate similar reasoning to be applied by regulators in other countries with comparable regulatory regimes.
published_date 2023-10-01T11:25:36Z
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