npj Digital Medicine (Dec 2024)

Artificial intelligence related safety issues associated with FDA medical device reports

  • Jessica L. Handley,
  • Seth A. Krevat,
  • Allan Fong,
  • Raj M. Ratwani

DOI
https://doi.org/10.1038/s41746-024-01357-5
Journal volume & issue
Vol. 7, no. 1
pp. 1 – 3

Abstract

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Abstract The Biden 2023 Artificial Intelligence (AI) Executive Order calls for the creation of a patient safety program. Patient safety reports are a natural starting point for identifying issues. We examined the feasibility of this approach by analyzing reports associated with AI/Machine Learning (ML)-enabled medical devices. Of the 429 reports reviewed, 108 (25.2%) were potentially AI/ML related, with 148 (34.5%) containing insufficient information to determine an AI/ML contribution. A more comprehensive approach is needed.