Artificial intelligence related safety issues associated with FDA medical device reports
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.
Authors
- Seth Krevat (ORCID: https://orcid.org/0000-0002-0167-8791)
- Raj M. Ratwani (ORCID: https://orcid.org/0000-0002-8623-6123)
- Allan Fong (ORCID: https://orcid.org/0000-0002-7550-1569)
- Jessica L. Handley
Institutions
- Georgetown University (US)
- MedStar Georgetown University Hospital (US)
- MedStar Health (US)
Publication Details
- Journal
- npj Digital Medicine
- Published
- 2024-12-03
- DOI
- https://doi.org/10.1038/s41746-024-01357-5
- Citations
- 9
- Primary Topic
- Artificial Intelligence in Healthcare and Education
- Type
- article
- Field-Weighted Citation Impact
- 1.08
Funders
- MedStar Health Research Institute
- Agency for Healthcare Research and Quality