Agenda & Registration
Note: Red text below indicates an active link to the information presented at the workshop
Agenda: This workshop covers ophthalmic digital health topics including wireless medical devices; mobile medical apps, health IT, telemedicine, medical device data systems, medical device interoperability, software as a medical device (SaMD), and cybersecurity. The tentative program agenda is as follows:
| 7:55 A.M. | FDA Welcome: Malvina B. Eydelman, MD |
| 8:05 A.M. | Welcome from Cosponsoring Organizations |
| American Academy of Ophthalmology (AAO): Michael Xavier Repka, MD | |
| American Association for Pediatric Ophthalmology and Strabismus (AAPOS): Derek T. Sprunger, MD |
American Society of Retina Specialists (ASRS): Mark S. Humayun, MD, PhD
Stanford Medicine Byers Eye Institute: David Myung, MD, PhD
8:10 A.M. Accelerating Innovation To Encourage New Frontiers in Ophthalmic Digital Health: Zach Bodnar, MD
8:20 A.M. The Regulation of Digital Health: Bakul Patel, MBA
8:35 A.M. FDA Perspectives on Ophthalmic Mobile Medical Applications and Telemedicine: Ronald Schuchard, PhD
8:50 A.M. Medical Device Data Systems: Krishna Yeshwant, MD, MBA
9:00 A.M. Telemedicine in Ophthalmology: Paul P. Lee, MD, JD
9:10 A.M. Telemedicine Diagnostic Challenges for Retinopathy of Prematurity: R. V. Paul Chan, MD
9:20 A.M. Telemedicine Diagnostic Challenges for Diabetic Retinopathy: Ingrid E. Zimmer-Galler, MD
9:30 A.M. Advanced Analytics in Ophthalmology: Michael Chiang, MD
9:40 A.M. Machine Learning in Ophthalmic Diagnostics: Linda M. Zangwill, PhD
9:50 A.M. The Patient Interface with Digital Health: John Reites
10:00 A.M. Question/Answer
10:20 A.M. BREAK
10:35 A.M. PANEL 1: Safety and effectiveness concerns when a digital health device provides information as an aid for diagnosis and the assets, threats, and vulnerabilities to be considered and identified (Questions 1 & 4)
MODERATORS: Natalie A. Afshari, MD & Mike T. Trese, MD
PANELISTS: Dimitri Azar, MD, MBA; Leslie Bottorff, MBA; David Morrison, MD; Darius M. Moshfeghi, MD; Maria A. Woodward, MD, MS; Ingrid E. Zimmer-Galler, MD
11:50 P.M. LUNCH
12:50 P.M. PANEL 2: Safety and effectiveness concerns for an ophthalmic digital health device used in a clinical or non-clinical environment and the assets, threats, and vulnerabilities to be considered and identified (Questions 2 & 4)
MODERATORS: Mark S. Blumenkranz, MD; Ken Nischal, MD
PANELISTS: Michael Abramoff, MD, PhD; Michael Chiang, MD; Michael H. Goldbaum, MD; Quinton Oswald; Linda M. Zangwill, PhD
2:20 P.M. BREAK
2:35 P.M. PANEL 3: Effective safeguards and methods for mitigating the risks for an ophthalmic digital health device and the assets, threats, and vulnerabilities to be considered and identified (Questions 3 & 4)
MODERATORS: Mark S. Humayun, MD, PhD; Derek T. Sprunger, MD
PANELISTS: Lama Al-Aswad, MD, MPH; Nitin Karandikar, MD, PhD; David Myung, MD, PhD; John Reites; Eitan Sharon, PhD
4:05 P.M. MODERATOR SUMMARIES FOR PANEL 1, 2, AND 3
4:35 P.M. CONCLUDING REMARKS
5:00 P.M. ADJOURN