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

Journal: Journal of the American Medical Informatics Association : JAMIA
Published Date:

Abstract

OBJECTIVES: To assess the potential to adapt an existing technology regulatory model, namely the Clinical Laboratory Improvement Amendments (CLIA), for clinical artificial intelligence (AI).

Authors

  • Brian R Jackson
    Department of Pathology, University of Utah, Salt Lake City, UT 84112, United States.
  • Mark P Sendak
    Duke Institute for Health Innovation, Durham, NC, United States.
  • Anthony Solomonides
    NorthShore University Health System, Research Institute, Evanston, IL, USA.
  • Suresh Balu
    Duke Institute for Health Innovation.
  • Dean F Sittig
    Center for Innovations in Quality, Effectiveness and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas, USA.