Agenda & Registration

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:

7:50 A.M.  FDA Welcome: Malvina B. Eydelman, MD

7:55 A.M.  CDRH Efforts in the Digital Health Space: Jeffrey Shuren MD, JD
8:05 A.M.  Welcome from Cosponsoring Organizations
       American Academy of Ophthalmology (AAO): Michael Xavier Repka, MD
       American Academy of Pediatrics (AAP): David Bruce Granet, MD
       American Association for Pediatric Ophthalmology and Strabismus (AAPOS): Derek T. Sprunger, MD
       American Society of Cataract and Refractive Surgery (ASCRS): Natalie A. Afshari, 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; Pravin U. Dugel, 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

4:45 P.M.  FDA COMMISSIONER’S REMARKS: Scott Gottlieb, MD
5:00 P.M. ADJOURN
***Full panel questions available


Registration: Registration is now open!

Non-Members: (Live $495 and Webcast $445).

Members: (Live $295 and Webcast $245). Member affiliation will be verified. If you are unsure of your status, please contact the member organization directly.

American Academy of Ophthalmology (AAO)

American Academy of Pediatrics (AAP)

American Association for Pediatric Ophthalmology and Strabismus (AAPOS)

American Association of Cataract and Refractive Surgery (ASCRS)

American Society of Retina Specialists (ASRS)