Evaluating New Ophthalmic Digital Devices for Safety and Effectiveness in the Context of Rapid Technological Development.

Key PointsQuestionHow could ophthalmic digital devices be evaluated for safety and effectiveness to streamline innovation? FindingsThis Special Communication from a workshop on ophthalmic digital devices comprising regulators, health care practitioners, researchers, medical device firms, mobile application developers, patients, and other stakeholders concluded that because of the risks associated with automation are substantially increased in rapidly progressive diseases, criterion standards and expert graders are critically important in the evaluation of automated systems and telemedicine platforms. Training at all levels is important for the safe and effective operation of digital health devices, and to promote cybersecurity and protect patient privacy. MeaningWith appropriate validation against criterion standards, physician oversight, and robust cybersecurity protocols, digital health technology could improve screening and treatment of ophthalmic diseases and improve access to care. This Special Communication from The Ophthalmic Digital Health Workshop discusses the challenges of balancing providing patients with the most current innovations in ophthalmic digital health and maintaining appropriate safety and efficacy screening. ImportanceThe US Food and Drug Administration's medical device regulatory pathway was initially conceived with hardware devices in mind. The emerging market for ophthalmic digital devices necessitates an evolution of this paradigm. ObjectivesTo facilitate innovation in ophthalmic digital health with attention to safety and effectiveness. Evidence ReviewThis article presents a summary of the presentations, discussions, and literature review that occurred during a joint Ophthalmic Digital Health workshop of 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, the American Society of Retina Specialists, the Byers Eye Institute at Stanford and the US Food and Drug Administration. FindingsCriterion standards and expert graders are critically important in the evaluation of automated systems and telemedicine platforms. Training at all levels is important for the safe and effective operation of digital health devices. The risks associated with automation are substantially increased in rapidly progressive diseases. Cybersecurity and patient privacy warrant meticulous attention. Conclusions and RelevanceWith appropriate attention to safety and effectiveness, digital health technology could improve screening and treatment of ophthalmic diseases and improve access to care.