Regulation of artificial intelligence in healthcare: Clinical Laboratory Improvement Amendments (CLIA) as a model

To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI). We identify overlap in the quality management requirements for laboratory testing and clinical AI. We propose modifications to the CLIA model that could make it suitable for oversight of clinical AI. In national discussions of clinical AI, there has been surprisingly little consideration of this longstanding model for local technology oversight. While CLIA was specifically designed for laboratory testing, most of its principles are applicable to other technologies in patient care. A CLIA-like approach to regulating clinical AI would be complementary to the more centralized schemes currently under consideration, and it would ensure institutional and professional accountability for the longitudinal quality management of clinical AI.