Public Workshop - Ophthalmic Digital Health, October 23, 2017
The Food and Drug Administration (FDA), the American Academy of Ophthalmology (AAO), the American Academy of Pediatrics (AAP), the American Association for Pediatric Ophthalmology and Strabismus (AAPOS), the American Society of Cataract and Refractive Surgery (ASCRS), the American Society of Retina Specialists (ASRS) and Stanford Medicine, Byers Eye Institute will co-sponsor a one day workshop entitled, "Ophthalmic Digital Health". The objective of this workshop is to discuss factors to consider when evaluating safety and effectiveness of ophthalmic digital health as well as ways to improve their safety and effectiveness. This workshop will facilitate patients and providers access to and use of safe and effective ophthalmic digital health options.
Date, Time and Location
This meeting will be held October 23, 2017, beginning at 8:00 a.m. - 5:00 p.m. at the following location:
Holiday Inn Express, Gaithersburg
2 Montgomery Village Avenue
The Grand Ballroom
Gaithersburg, MD 20879
The meeting will be webcast and registration is required.
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:
| Time | Title | Speaker |
|---|---|---|
| 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 |
| 8:35 A.M. | FDA Perspectives on Ophthalmic Mobile Medical Applications and Telemedicine | Ronald Schuchard, Ph.D. |
| 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; Leslie Bottorff; David Morrison, MD; Darius M. Moshfeghi, MD; Maria A. Woodward, MD, MS; Ingrid E. Zimmer-Galler, MD |
| 11:50 A.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 Reite; Eitan Sharon, PhD |
| 4:05 P.M. | MODERATOR SUMMARIES FOR PANEL 1, 2, AND 3 | Moderators from each Panel |
| 4:35 P.M. | CONCLUDING REMARKS | |
| 4:45 P.M. | FDA COMMISSIONER'S REMARKS | Scott Gottlieb, MD |
| 5:00 P.M. | ADJOURN |
Registration to Attend the Workshop
Registration is $295 (in-person) and $245 (webcast) for members of the American Academy of Ophthalmology (AAO), the American Academy of Pediatrics (AAP), the American Association for Pediatric Ophthalmology and Strabismus (AAPOS), the American Society of Cataract and Refractive Surgery (ASCRS), the American Society of Retina Specialists (ASRS) and Stanford Medicine, Byers Eye Institute; and $495 (in-person) and $445 (webcast) for non-members and available on a first-come, first-served basis. Persons interested in attending this workshop must register online. The deadline for online registration is October 17, 2017. There will be no onsite registration on the day of the public workshop. Early registration is recommended because facilities are limited.
To register for the public workshop, please visit Ophthalmic Digital Health Workshop: Agenda and Registration. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, telephone number, and membership in the cosponsoring organizations. If there are any questions with registration, please contact Bobbi Hahn, Program Manager, Center for Organizational Management, 2025 Woodlane Drive, St. Paul, Minnesota 55125, 651-731-2944 / 800-284-3937, E-mail: cfom@cfom.info. Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.
If you require special accommodations due to a disability, please contact Susan Monahan, Office of Communications, Education, and Radiation Programs, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, susan.monahan@fda.hhs.gov.
Contact Us
For questions regarding workshop content please contact:
Michelle Tarver, M.D., Ph.D., Ophthalmologist / Epidemiologist, Division of Ophthalmic and Ear, Nose, and Throat Devices (DOED), Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 66, Rm 2504, Silver Spring, MD 20993, 301-796-6884, email: michelle.tarver@fda.hhs.gov.