Regulatory Frameworks for Development and Evaluation of Artificial Intelligence-Based Diagnostic Imaging Algorithms:

David B Larson1, Hugh Harvey2, Daniel L Rubin3

  • 1Vice Chair, Education and Clinical Operations, Department of Radiology, Stanford University School of Medicine, Stanford, California.

Summary

Regulatory frameworks for artificial intelligence (AI) diagnostic algorithms need improvement. We propose enhancements for AI development and evaluation to ensure safety and effectiveness for wider adoption in healthcare.