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

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

BackgroundThe 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...

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Bibliographic Details
Main Authors: Aditya U Kale, Riya Dattani, Ashley Tabansi, Henry David Jeffry Hogg, Russell Pearson, Ben Glocker, Su Golder, Justin Waring, Xiaoxuan Liu, David J Moore, Alastair K Denniston
Format: Article
Language:English
Published: JMIR Publications 2024-07-01
Series:JMIR Research Protocols
Online Access:https://www.researchprotocols.org/2024/1/e48156

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https://www.researchprotocols.org/2024/1/e48156

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