FDA-led Workshop Puts Focus on Ophthalmic Digital Health

Ophthalmic Digital Health

The workshop on Ophthalmic Digital Health, a collaboration of the Food and Drug Administration and a host of medical societies that aims to explore safety and effectiveness issues of digital health in the ophthalmology space, is slated for Monday, October 23, in Gaithersburg, MD. Registration deadline for both in-person attendance and the webcast is Tuesday, October 17.

The full agenda and information on registering can be found here.

The panel will start with a welcome from Malvina Eydelman, MD, director, division of ophthalmic and ear, nose, and throat devices at the FDA, and conclude with comments by FDA commissioner Scott Gottlieb, MD.

A statement on the FDA’s website says the workshop will facilitate patients’ and providers’ access to and use of safe and effective ophthalmic digital health options. The one-day workshop is for physicians, investors, and entrepreneurs interested in learning how digital health fits into ophthalmology. The workshop agenda covers wireless medical devices, mobile medical apps, health IT, telemedicine, medical device data systems, medical device interoperability, software as a medical device, and cyber security. 

“Everybody has a vested stake in understanding this better, and frankly engaging in a dialog, and that’s the beauty of the workshop: that it’s not a series of lectures,” says workshop panel co-moderator Mark S. Blumenkranz, MD, H.J. Smead Professor of Ophthalmology at the Byers Eye Institute at Stanford University, one of the co-sponsors. “I think it’s very convenient to have people go devote eight hours and at the end of that time you really are much better informed on an area that is pretty technical, and the regulations are codified and carry the force of law, if you will.” Dr. Blumenkranz, an early player in the digital health space as co-founder of Digisight, made the comments in a recent OIS Podcast.

How Workshop Came About

Dr. Blumenkranz explains the workshop came about when a group of people interested in the possibilities of digital health, and concerned about the risks and challenges, decided to bring together key stakeholders to answer questions crucial to better understanding digital health.

Those questions can range from the nature of the mobile device to risk, regulatory pathway, and safety implications, Dr. Blumenkranz says. Safety issues include not only mechanical or electrical harm, or photic injury, but also cyber security and privacy, including Health Insurance Portability and Accountability Act considerations. Workshop sessions will focus on regulation of digital health, medical device data systems, and telemedicine, advanced analytics, and machine learning in ophthalmology. Panels will explore safety and effectiveness concerns and risk-mitigating safeguards and methods.

Who should be interested in attending the conference? Says Dr. Blumenkranz, “All stakeholders, payers, clinicians, healthcare systems, medical device manufacturers, traditional manufacturers who are developing a mobile strategy, small companies and entrepreneurs, and academics. What we want to do is get the best minds, and the people who are most interested, and put them all together.”

Participating co-sponsors along with Byers Eye Institute are the American Academy of Ophthalmology, the American Academy of Pediatrics, the American Association for Pediatric Ophthalmology and Strabismus, the American Society of Cataract and Refractive Surgery, and the American Society of Retina Specialists.