Journal Article10.1002/lrh2.10386
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
Jeremy C Wyatt,Philip Scott,Johan Ordish,M. South,Mark Thomas,Caroline Jones,Sue Lacey‐Bryant +6 more
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TL;DR: The UK workshop discussed the potential regulation of computable biomedical knowledge objects as medical devices, but there is no consensus on the exact timing.
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Abstract: 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.
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Citations
Modelling clinical narrative as computable knowledge: The NICE computable implementation guidance project
Philip Scott,Michaela Heigl,Charles McCay,Polly Shepperdson,Elia Lima‐Walton,Elisavet Andrikopoulou,Klara Brunnhuber,Gary Cornelius,Susan Faulding,Ben McAlister,Shaun Rowark,Matthew South,Mark R. Thomas,Justin Whatling,John Williams,Jeremy C. Wyatt,Felix Greaves +16 more
TL;DR: The CAB aims to guide clinical decision support and other software developers to increase traceability, fidelity and consistency in supporting clinical use of NICE recommendations, and guide local practice audit and intervention to reduce unwarranted variation.
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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
Jeremy C Wyatt,Philip Scott,Johan Ordish,M. South,Mark Thomas,Caroline Jones,Sue Lacey‐Bryant +6 more
TL;DR: The UK workshop discussed the potential regulation of computable biomedical knowledge objects as medical devices, but there is no consensus on the exact timing.
3
References
Foundation models for generalist medical artificial intelligence
Michael Moor,O. Banerjee,Zahra F.H. Abad,Harlan M. Krumholz,Jure Leskovec,Eric J. Topol,Pranav Rajpurkar +6 more
TL;DR: Generalist medical AI (GMAI) as mentioned in this paper is a new paradigm for medical AI, which is capable of carrying out a diverse set of tasks using very little or no task-specific labelled data.
Drugs and Devices: Comparison of European and U.S. Approval Processes
TL;DR: In this paper, the similarities and differences in European and U.S. regulation of drugs and devices are explored, and challenges facing each of them are discussed, and some of the differences are discussed.
The GUIDES checklist: Development of a tool to improve the successful use of guideline-based computerised clinical decision support
Stijn Van de Velde,Ilkka Kunnamo,Pavel S Roshanov,Tiina Kortteisto,Bert Aertgeerts,Per Olav Vandvik,Signe Flottorp,Signe Flottorp +7 more
TL;DR: The GUIDES checklist can support professionals in considering the factors that affect the success of CDS interventions and may facilitate a deeper and more accurate understanding of the factors shaping CDS effectiveness.
New medical device regulations: the regulator's view.
Tom Melvin,Marina Torre +1 more
- 03 Jun 2019
TL;DR: The Medical Device Regulation (MDR) and the In Vitro Diagnostic Device (IVDR) regulations were introduced in Europe in May 2017 as mentioned in this paper, which will replace the current directives over the coming years.
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