Foundational Considerations for Artificial Intelligence Using Ophthalmic Images.

Journal: Ophthalmology
Published Date:

Abstract

IMPORTANCE: The development of artificial intelligence (AI) and other machine diagnostic systems, also known as software as a medical device, and its recent introduction into clinical practice requires a deeply rooted foundation in bioethics for consideration by regulatory agencies and other stakeholders around the globe.

Authors

  • Michael D Abramoff
    Department of Ophthalmology and Visual Sciences, The University of Iowa, Iowa City, IA.
  • Brad Cunningham
    Center for Devices and Radiological Health, Office of Health Technology 1, United States Food and Drug Administration, Silver Springs, Maryland.
  • Bakul Patel
    Center for Devices and Radiological Health, Digital Health Center of Excellence, United States Food and Drug Administration, Silver Springs, Maryland.
  • Malvina B Eydelman
    Center for Devices and Radiological Health, Office of Health Technology 1, United States Food and Drug Administration, Silver Springs, Maryland.
  • Theodore Leng
    Department of Ophthalmology, Byers Eye Institute at Stanford, Palo Alto, CA, USA.
  • Taiji Sakamoto
    Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan. tsakamot@m3.kufm.kagoshima-u.ac.jp.
  • Barbara Blodi
    Department of Ophthalmology, University of Wisconsin, Madison, Wisconsin.
  • S Marlene Grenon
    Innovation Ventures, University of California, San Francisco, San Francisco, California; Division of Vascular and Endovascular Surgery, Universify of California San Francisco, California.
  • Risa M Wolf
    Department of Pediatric Endocrinology and Diabetes, Johns Hopkins University School of Medicine, Baltimore, MD.
  • Arjun K Manrai
    Department of Biomedical Informatics, Harvard Medical School, Boston, MA 02115, USA.
  • Justin M Ko
    Department of Dermatology, Stanford University School of Medicine, Stanford, California.
  • Michael F Chiang
    National Eye Institute, National Institutes of Health, Bethesda, Maryland.
  • Danton Char
    Division of Pediatric Cardiac Anesthesia, Department of Anesthesiology, Stanford University School of Medicine, San Francisco, California; Center for Biomedical Ethics, Stanford University School of Medicine, San Francisco, California.