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Foundational Considerations for Artificial Intelligence Using Ophthalmic Images
Affiliation:1. Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa;2. Center for Devices and Radiological Health, Office of Health Technology 1, United States Food and Drug Administration, Silver Springs, Maryland;3. Center for Devices and Radiological Health, Digital Health Center of Excellence, United States Food and Drug Administration, Silver Springs, Maryland;4. Byers Eye Institute at Stanford, Stanford University School of Medicine, Palo Alto, California;5. Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan;6. Japanese Vitreous Retina Society, Osaka, Japan;7. Department of Ophthalmology, University of Wisconsin, Madison, Wisconsin;8. Innovation Ventures, University of California, San Francisco, San Francisco, California;9. Department of Pediatric Endocrinology, Johns Hopkins University School of Medicine, Baltimore, Maryland;10. Computational Health Informatics Program, Boston Children’s Hospital, Boston, Massachusetts;11. Department of Biomedical Informatics, Harvard Medical School, Boston, Massachusetts;12. Department of Dermatology, Stanford University School of Medicine, Stanford, California;13. National Eye Institute, Bethesda, Maryland;14. Division of Pediatric Cardiac Anesthesia, Department of Anesthesiology, Stanford University School of Medicine, San Francisco, California;15. Center for Biomedical Ethics, Stanford University School of Medicine, San Francisco, California;16. Department of Elecrical and Computer Engineering, University of Iowa, Iowa City, Iowa;17. Department of Biomedical Engineering, University of Iowa, Iowa City, Iowa;18. Division of Vascular and Endovascular Surgery, Universify of California San Francisco, California;1. Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa;2. Center for Devices and Radiological Health, Office of Health Technology 1, United States Food and Drug Administration, Silver Springs, Maryland;3. Center for Devices and Radiological Health, Digital Health Center of Excellence, United States Food and Drug Administration, Silver Springs, Maryland;4. Byers Eye Institute at Stanford, Stanford University School of Medicine, Palo Alto, California;5. Department of Ophthalmology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan;6. Japanese Vitreous Retina Society, Osaka, Japan;7. Department of Ophthalmology, University of Wisconsin, Madison, Wisconsin;8. Innovation Ventures, University of California, San Francisco, San Francisco, California;9. Department of Pediatric Endocrinology, Johns Hopkins University School of Medicine, Baltimore, Maryland;10. Computational Health Informatics Program, Boston Children’s Hospital, Boston, Massachusetts;11. Department of Biomedical Informatics, Harvard Medical School, Boston, Massachusetts;12. Department of Dermatology, Stanford University School of Medicine, Stanford, California;13. National Eye Institute, Bethesda, Maryland;14. Division of Pediatric Cardiac Anesthesia, Department of Anesthesiology, Stanford University School of Medicine, San Francisco, California;15. Center for Biomedical Ethics, Stanford University School of Medicine, San Francisco, California;16. Department of Elecrical and Computer Engineering, University of Iowa, Iowa City, Iowa;17. Department of Biomedical Engineering, University of Iowa, Iowa City, Iowa;18. Division of Vascular and Endovascular Surgery, Universify of California San Francisco, California;1. Department of Ophthalmology, University of Washington, Seattle, Washington;2. Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, The State University of New York, Buffalo, New York;3. Department of Ophthalmology, Byers Eye Institute, Stanford University, Palo Alto, California;4. Veterans Affairs Palo Alto Health California System, Palo Alto, California;5. The Vision Research Center, Wills Eye Hospital, Philadelphia, Pennsylvania;6. Roger and Angie Karalis Johnson Retina Center, Seattle, Washington;1. Casey Eye Institute, Oregon Health & Science University, Portland, Oregon;2. Cornea & Refractive Surgery, Aravind Eye Hospital, Madurai, India;3. Cornea & Refractive Surgery, Aravind Eye Hospital, Chennai, India;4. Cornea & Refractive Surgery, Aravind Eye Hospital, Coimbatore, India;5. Cornea & Refractive Surgery, Aravind Eye Hospital, Tirunelveli, India;6. Francis I. Proctor Foundation, University of California, San Francisco, San Francisco, California;7. Ophthalmology, Kaiser Permanente Redwood City Medical Center, Redwood City, California;1. Division of Epidemiology and Clinical Applications, National Eye Institute, National Institutes of Health, Bethesda, Maryland;2. Emmes Corporation, Rockville, Maryland;3. Age-Related Eye Disease Study 2 Research Group;1. Gavin Herbert Eye Institute, University of California, Irvine School of Medicine, Irvine, California;2. Illinois Eye and Ear Infirmary, University of Illinois College of Medicine at Chicago, Chicago, Illinois;3. Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts;4. Vanderbilt Eye Institute, Vanderbilt University Medical Center, Nashville, Tennessee;5. Ophthalmic Surgeons and Consultants of Ohio, Columbus, Ohio;6. Ophthalmic Plastic Surgery, Lions Eye Institute, Department of Ophthalmology, Albany Medical Center, Albany (Slingerlands), New York;7. Department of Ophthalmology, McGovern Medical School at University of Texas Health Science Center, Houston, Texas;8. Cullen Eye Institute, Baylor College of Medicine, Houston, Texas;1. University of Maryland School of Medicine, Baltimore, Maryland;2. Physicians Eye Care Center, Columbia, Maryland;3. Elman Retina Group, Baltimore, Maryland
Abstract:
Keywords:Artificial intelligence  Augmented intelligence  Clinical standards  Clinical trial  Cornea  Ethics  FDA  Glaucoma  Oculoplastics  Regulation  Retina  Safety  imaging  non-maleficence  equity  autonomy  patient benefit  health disparities  population health  clinical outcome  validation  explainability  validability  transparency  population achieved sensitivity  vernacular medicine  scalability  AI"}  {"#name":"keyword"  "$":{"id":"kwrd0075"}  "$$":[{"#name":"text"  "_":"artificial intelligence  CCOI"}  {"#name":"keyword"  "$":{"id":"kwrd0085"}  "$$":[{"#name":"text"  "_":"Collaborative Community on Ophthalmic Imaging  CT"}  {"#name":"keyword"  "$":{"id":"kwrd0085a"}  "$$":[{"#name":"text"  "_":"computed tomography  DICOM"}  {"#name":"keyword"  "$":{"id":"kwrd0085d"}  "$$":[{"#name":"text"  "_":"Digital Imaging and Communications in Medicine  FDA U  S  "}  {"#name":"keyword"  "$":{"id":"kwrd0095"}  "$$":[{"#name":"text"  "_":"Food and Drug Administration  FPOAI"}  {"#name":"keyword"  "$":{"id":"kwrd0095z"}  "$$":[{"#name":"text"  "_":"Foundational Principles of Algortihmic Interpretation Workgroup of the Collaborative Community for Ophthalmic Imaging  Washington  DC  GPU"}  {"#name":"keyword"  "$":{"id":"kwrd0095zd"}  "$$":[{"#name":"text"  "_":"graphics processing unit  ISO"}  {"#name":"keyword"  "$":{"id":"kwrd0095zc"}  "$$":[{"#name":"text"  "_":"International Organization for Standardization  MRI"}  {"#name":"keyword"  "$":{"id":"kwrd0095zj"}  "$$":[{"#name":"text"  "_":"magnetic resonance imaging  PAS"}  {"#name":"keyword"  "$":{"id":"kwrd0105"}  "$$":[{"#name":"text"  "_":"population-achieved sensitivity  SaMD"}  {"#name":"keyword"  "$":{"id":"kwrd0115"}  "$$":[{"#name":"text"  "_":"Software as a Medical Device
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