This paper is in the following e-collection/theme issue:

Systematic Review Protocols (274) Safety and Error Prevention in Health (207) Artificial Intelligence (1466) Pharmacovigilance (140) Machine Learning (58) Health Care Quality and Health Services Research (276) Medical Device Adverse Events, Errors, Safety (17)

Published on in Vol 13 (2024)

This is a member publication of University of Birmingham (Jisc)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/48156, first published .
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

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

Authors of this article:

Aditya U Kale1, 2, 3, 4 Author Orcid Image ;   Riya Dattani5 Author Orcid Image ;   Ashley Tabansi6 Author Orcid Image ;   Henry David Jeffry Hogg7 Author Orcid Image ;   Russell Pearson8 Author Orcid Image ;   Ben Glocker9, 10 Author Orcid Image ;   Su Golder11 Author Orcid Image ;   Justin Waring12 Author Orcid Image ;   Xiaoxuan Liu1, 2, 3, 4 Author Orcid Image ;   David J Moore13 Author Orcid Image ;   Alastair K Denniston1, 2, 3, 4 Author Orcid Image
Article Authors Cited by (1) Tweetations (2) Metrics

Journals

  1. Yadav A, Pawar A, Shete A, Jadhav N, Kumbhar A, Jadhav N, Gejage S. Comparative analysis of medical device adverse event reporting forms forpatients and industries across various countries, and the introduction of a unified generic form for harmonization. Expert Review of Medical Devices 2025 View