GAITHERSBURG, MD – With the rise of digital health technologies, stakeholders gathered at an FDA workshop on Monday to examine factors to consider when evaluating safety and effectiveness of ophthalmic digital devices.
The workshop covered 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.
During the opening remarks, Jeffrey E. Shuren, director of the Center for Devices and Radiological Health at the FDA, spoke about the challenges of regulating software as a medical device.
“Not only do we need to think about a different paradigm for digital health technologies, but we need a different way to approach it,” Mr. Shuren said. “The traditional model of government acting in a command and control fashion does not work well here. We have to do this collaboratively … We need to establish a forum or multiple forums where we can bring together the interested stakeholders to work collaboratively and proactively to address common challenges and even unique challenges of the various stakeholder groups through a collective responsibility approach.”
Mr. Shuren said the FDA regulatory paradigm was designed around hardware technologies, even as they evolved to have software.
“So hardware technologies, while they have rapid innovation, it's more on the order of months to sometimes years. And in very competitive spaces, we'll see next-generation technology about every 18 months,” Mr. Shuren said. “And [hardware technologies’] impact on patients tends to be very direct and observable. You can see changes to the structure or the function, or measurable biological or physiological parameters. And the knowledge that's generated about one device is often transferable to other devices within that category.”
Mr. Shuren said when dealing with software, specifically ophthalmic digital health technologies, there are unique characteristics that need to be considered.
“The innovation cycles are much faster. There are new challenges like cyber security. You can't just look at software and have a good understanding of what it's going to do. And when you go ahead and test it, the impact may not be so direct on patients’ health. These may be impacts on cognitive and behavioral aspects of the patient or the clinician. And what you understand for one software program isn't necessarily transferable for other technologies, even when they have similar functionality. So it's a very, very different kind of beast,” he said.
The workshop, entitled "Ophthalmic Digital Health,” was co-sponsored by several ophthalmic societies, including 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, and Byers Eye Institute.
For more information on the workshop or to access the webcast, visit http://www.cfom.info/meetings/OphthalmicDigitalHealth/index.html