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JMIR Res Protoc2024;13e48156.July 11, 2024Journal Article

AI as a Medical Device Adverse Event Reporting in Regulatory Databases: Protocol for a Systematic Review.

Aditya U Kale1,2,3,4, Riya Dattani5, Ashley Tabansi6, Henry David Jeffry Hogg7, Russell Pearson8, Ben Glocker9,10, Su Golder11, Justin Waring12, Xiaoxuan Liu1,2,3,4, David J Moore13, Alastair K Denniston1,2,3,4
1Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.
2University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom.
3NIHR Birmingham Biomedical Research Centre, Birmingham, United Kingdom.
4NIHR Incubator for AI and Digital Health Research, Birmingham, United Kingdom.
5Springer Nature Group, London, United Kingdom.
6School of Chemistry, Food and Pharmacy, University of Reading, Reading, United Kingdom.
7Population Health Science Institute, Faculty of Medical Science, Newcastle University, Newcastle, United Kingdom.
8Medicines and Healthcare Products Regulatory Agency, London, United Kingdom.
9Kheiron Medical Technologies, London, United Kingdom.
10Department of Computing, Imperial College London, London, United Kingdom.
11Department of Health Sciences, University of York, York, United Kingdom.
12Health Services Management Centre, University of Birmingham, Birmingham, United Kingdom.
13Institute of Applied Health Research, University of Birmingham, Birmingham, United Kingdom.
PubMed PMC DOI PDF

Abstract

BACKGROUND: The reporting of adverse events (AEs) relating to medical devices is a long-standing area of concern, with suboptimal reporting due to a range of factors including a failure to recognize the association of AEs with medical devices, lack of knowledge of how to report AEs, and a general culture of nonreporting. The introduction of artificial intelligence as a medical device (AIaMD) requi…

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