Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing

Current regulatory frameworks for artificial intelligence-based clinical decision support (AICDS) are insufficient to ensure safety, effectiveness, and equity at the bedside. The oversight of clinical laboratory testing, which requires federal- and hospital-level involvement, offers many instructive...

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Bibliographic Details
Published in:NPJ digital medicine 2024-12, Vol.7 (1), p.359-6
Main Authors: Herman, Daniel S., Reece, Jenna T., Weissman, Gary E.
Format: Article
Language:English
Subjects:
639/705/1042
639/705/258
639/705/794
692/700/139/1420
692/700/1538
706/648/453
Biomedicine
Biotechnology
Comment
Medicine
Medicine & Public Health
Online Access:Get full text
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Summary:Current regulatory frameworks for artificial intelligence-based clinical decision support (AICDS) are insufficient to ensure safety, effectiveness, and equity at the bedside. The oversight of clinical laboratory testing, which requires federal- and hospital-level involvement, offers many instructive lessons for how to balance safety and innovation and warnings regarding the fragility of this balance. We propose an AICDS oversight framework, modeled after clinical laboratory regulation, that is deliberative, inclusive, and collaborative.
ISSN:2398-6352
2398-6352
DOI:10.1038/s41746-024-01369-1