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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
Learning Health Systems
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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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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.
computable knowledge, knowledge libraries, learning health systems, medical device regulation, mobilising computable biomedical knowledge.
Faculty of Humanities and Social Sciences