Artificial intelligence related safety issues associated with FDA medical device reports.
cross_sectional · Level IV
Where this comes from
- Record sourced from PubMed, PMID 39627534.
- Also identified by DOI 10.1038/s41746-024-01357-5 and PMC identifier 11615200.
- Licence recorded as CC BY-NC-ND.
- Because redistribution is not established, this page shows the abstract only. Follow the links below for the full text.
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.