Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 39672919.
- Also identified by DOI 10.1038/s41746-024-01369-1 and PMC identifier 11645404.
- 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
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.