Overview

The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH), the American Academy of Ophthalmology (AAO), the American Academy of Pediatrics (AAP), the American Association for Pediatric Ophthalmology and Strabismus (AAPOS), the American Association 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”.

Attend the Ophthalmic Digital Health Workshop scheduled Monday, October 23, 2017 from 8 a.m. – 6 p.m. at the Holiday Inn Gaithersburg located at 2 Montgomery Village Ave., Gaithersburg, MD 20879.

Topics will include patient and caregiver perspectives to help inform best practices in evaluating ophthalmic medical devices and attain patient-centric outcomes.

The workshop will allow providers and other stakeholders in ophthalmic digital health to discuss ways to:

·         Improve access,

·         Reduce costs,

·         Make medicine more personalized for patients.

The use of technology such as smart phones and internet applications, not only change the way we communicate, but provide innovative ways for us to screen for diseases as well as diagnose and monitor our eye health, giving us greater access to information. Together these advancements lead to a convergence of people, information, technology, and connectivity to improve health care and health outcomes.

The objective of this workshop is to discuss factors to consider when evaluating the safety and effectiveness of digital health devices 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.

Focusing on Ophthalmic Digital Health

Ophthalmic medical devices have the ability to connect to and communicate with other devices or systems and digital innovation of these features and devices is dynamic.

Many stakeholders are involved in ophthalmic digital health activities, including patients, health care practitioners, researchers, traditional medical device industry firms, and firms new to FDA regulatory requirements, such as mobile application developers.

FDA’s Center for Devices and Radiological Health (CDRH) and the co-sponsors of this workshop, are excited for these advances and the convergence of ophthalmic medical devices with connectivity and consumer technology. The workshop’s objective is to inform practical approaches that balance benefits and risks of:

·         wireless medical devices

·         mobile medical apps

·         health IT

·         telemedicine 

·         medical device data systems 

·         medical device interoperability 

·         software as a medical device (SaMD), and

·         cybersecurity