Strengthening the use of artificial intelligence within healthcare delivery organizations: balancing regulatory compliance and patient safety.

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

Abstract

OBJECTIVES: Surface the urgent dilemma that healthcare delivery organizations (HDOs) face navigating the US Food and Drug Administration (FDA) final guidance on the use of clinical decision support (CDS) software.

Authors

  • Mark P Sendak
    Duke Institute for Health Innovation, Durham, NC, United States.
  • Vincent X Liu
    3 Division of Research, Kaiser Permanente, Oakland, California.
  • Ashley Beecy
    Division of Cardiology, Department of Medicine, Weill Cornell Medicine and NewYork-Presbyterian, New York, NY, USA.
  • David E Vidal
    Center for Digital Health, Mayo Clinic, Rochester, MN 55905, United States.
  • Keo Shaw
    DLA Piper, Washington, DC 20004, United States.
  • Mark A Lifson
    Center for Digital Health, Mayo Clinic, Rochester, MN.
  • Danny Tobey
    DLA Piper, Dallas, Texas, USA.
  • Alexandra Valladares
    Duke Institute for Health Innovation, Duke University, Durham, NC 27701, United States.
  • Brenna Loufek
    Center for Digital Health, Mayo Clinic, Rochester, MN 55905, United States.
  • Murtaza Mogri
    Division of Research, Kaiser Permanente, Oakland, CA 94612, United States.
  • Suresh Balu
    Duke Institute for Health Innovation.