Congress Must Update FDA Regulations for Medical AI
Scott Gottlieb
Abstract
This JAMA Forum discusses pending legislation in the US House and Senate and the history of the “firm-based approach” the US Food and Drug Administration (FDA) could use when regulating artificial intelligence (AI) medical devices to augment patient care.
Topics & Concepts
Food and drug administrationLegislationMedical deviceAdministration (probate law)Drug approvalHouse of RepresentativesMedicinePolitical scienceBusinessLawMedical emergencyDrugPharmacologyLegislatureBiomedical engineeringArtificial Intelligence in Healthcare and EducationHealth Systems, Economic Evaluations, Quality of LifeEthics in Clinical Research