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. and Scott, Philip and Ordish, Johan and South, Matthew and Thomas, Mark and Jones, Caroline and Lacey‐Bryant, Sue (2023) 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. Learning Health Systems. ISSN 2379-6146

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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.

Item Type: Article
Additional Information: ** Article version: VoR ** From Wiley via Jisc Publications Router ** History: received 12-05-2023; rev-recd 20-07-2023; accepted 27-07-2023; epub 25-08-2023. ** Licence for VoR version of this article: http://creativecommons.org/licenses/by-nc/4.0/
Uncontrolled Keywords: medical device regulation, knowledge libraries, mobilising computable biomedical knowledge, learning health systems, computable knowledge
Subjects: R Medicine > RA Public aspects of medicine > RA0421 Public health. Hygiene. Preventive Medicine
Z Bibliography. Library Science. Information Resources > ZA Information resources > ZA4050 Electronic information resources
Divisions: Institutes and Academies > Institute of Management and Health > Business, Finance and Management
SWORD Depositor: JISC Publications Router
Depositing User: JISC Publications Router
Date Deposited: 31 Aug 2023 12:15
Last Modified: 30 Oct 2023 11:09
URI: https://repository.uwtsd.ac.uk/id/eprint/2549

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