Concepts in U.S. Food and Drug Administration Regulation of Artificial Intelligence for Medical Imaging.

Journal: AJR. American journal of roentgenology
Published Date: Jun 5, 2019

Abstract

Although extensive attention has been focused on the enormous potential of artificial intelligence (AI) technology, a major question remains: how should this fundamentally new technology be regulated? The purpose of this article is to provide an overview of the pathways developed by the U.S. Food and Drug Administration to regulate the incorporation of AI in medical imaging. AI is the new wave of innovation in health care. The technology holds promising applications to revolutionize all aspects of medicine.

Authors

  • Ajay Kohli
    Department of Radiology, Drexel University College of Medicine, Hahnemann University Hospital, 230 N Broad St, Philadelphia, PA 19102.
  • Vidur Mahajan
    Centre for Advanced Research in Imaging, Neurosciences and Genomics, New Delhi, India.
  • Kevin Seals
    Department of Radiology, University of California San Francisco, San Francisco, CA.
  • Ajit Kohli
    College of Osteopathic Medicine, Oklahoma State University, Tulsa, OK.
  • Saurabh Jha
    Department of Radiology, University of Pennsylvania, Philadelphia.

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