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Accelerating Innovation in Ophthalmic Digital Health: New Frontiers for Medical Devices

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The proportion of Americans with smartphones has grown to 77% since the iPhone was introduced in 2007, and more than 2 million applications (apps) are available for download.1 Smartphones, tablets,… Click to show full abstract

The proportion of Americans with smartphones has grown to 77% since the iPhone was introduced in 2007, and more than 2 million applications (apps) are available for download.1 Smartphones, tablets, and wearables are portable computing systems equipped with hardware for advanced image processing; highresolution photograph, video, and audio capture; biometric sensors; and wireless communication. These features can create powerful platforms for medical applications. In parallel, previously nondigital medical devices are now becoming part of the “internet of things” as embedded “smart” technology adds connectivity and computational power. The Federal Food, Drug, and Cosmetic Act defines a medical device as anything that is not a drug but is intended for diagnosis, treatment, or prevention of disease.2,3 This includes certain types of software.1 A consumer computing platform can be transformed into a medical device that meets this definition using software and/or hardware extensions. Software, apps, accessories, digital devices, and analog medical devices with embedded processors meeting this definition will be referred to herein as digital health technology. Digital health technology has the potential to augment telemedicine, personalized health data collection, home health care, and disease monitoring, aiding with screening, diagnosis, and treatment. In eye care, a number of mobile apps are designed to capture ophthalmic data including visual function and anatomic images both in the clinic and elsewhere. Digital health technology creates innovative opportunities to improve patient care but also raises important public health considerations.

Keywords: digital health; accelerating innovation; health; medical devices; health technology

Journal Title: JAMA Ophthalmology
Year Published: 2017

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