Artificial intelligence related safety issues associated with FDA medical device reports

Jessica L Handley; Seth A Krevat; Allan Fong; Raj M Ratwani

doi:10.1038/s41746-024-01357-5

Artificial intelligence related safety issues associated with FDA medical device reports

NPJ Digit Med. 2024 Dec 3;7(1):351. doi: 10.1038/s41746-024-01357-5.

Authors

Jessica L Handley¹, Seth A Krevat^{1

2}, Allan Fong³, Raj M Ratwani^{4

5}

Affiliations

¹ MedStar Health National Center for Human Factors in Healthcare, Washington, DC, USA.
² Georgetown University School of Medicine, Washington, DC, USA.
³ MedStar Health Center for Bioinformatics and Data Science, Washington, DC, USA.
⁴ MedStar Health National Center for Human Factors in Healthcare, Washington, DC, USA. Raj.M.Ratwani@medstar.net.
⁵ Georgetown University School of Medicine, Washington, DC, USA. Raj.M.Ratwani@medstar.net.

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.

Abstract

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