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. 2019 Aug 1;137(8):939-944.
doi: 10.1001/jamaophthalmol.2019.1576.

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

Zachary M Bodnar  1 , Ronald Schuchard  2 , David Myung  1 , Michelle E Tarver  2 , Mark S Blumenkranz  1 , Natalie A Afshari  3 , Mark S Humayun  4 , Christie Morse  5 , Ken Nischal  6 , Michael X Repka  7 , Derek Sprunger  5 , Michael Trese  7 , Malvina B Eydelman  2
Affiliations

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

Zachary M Bodnar et al. JAMA Ophthalmol. .

Abstract

Importance: The 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.

Objectives: To facilitate innovation in ophthalmic digital health with attention to safety and effectiveness.

Evidence review: This 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.

Findings: 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. The risks associated with automation are substantially increased in rapidly progressive diseases. Cybersecurity and patient privacy warrant meticulous attention.

Conclusions and relevance: With appropriate attention to safety and effectiveness, digital health technology could improve screening and treatment of ophthalmic diseases and improve access to care.

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Figures

Figure.
Figure.
Device Development Cycle This illustration shows multiple places to incorporate safety checks in an agile development framework.
See this image and copyright information in PMC

References

    1. Pew Research Center. Mobile Fact Sheet. https://www.pewinternet.org/fact-sheet/mobile/. Published February 5, 2018. Accessed April 27, 2019.
    1. Stats IW. The Internet Big Picture: Internet World Stats, 2017. https://www.internetworldstats.com/stats.htm. Accessed April 27, 2019.
    1. Patel SN, Singh R, Jonas KE, et al. for the i-ROP Research Consortium. Inconsistencies in the diagnosis of aggressive posterior retinopathy of prematurity. J VitreoRetinal Dis 2017;1(3):181–186. doi:10.1177/2474126417691848 - DOI
    1. Winston PH. Lecture 12b: Deep Neural Nets. MIT OpenCourseWare. https://www.youtube.com/watch?v=VrMHA3yX_QI. Accessed April 27, 2019.
    1. Winston PH. Lecture 12a: Neural Nets. MIT OpenCourseWare. https://www.youtube.com/watch?v=uXt8qF2Zzfo. Accessed April 27, 2019.