Biotech
Aug. 28, 2014
Should there be an app for that health issue?
Increasingly, the marketplace has seen the creation and distribution of apps to manage personal health issues. The development, sale and use of these apps raise many regulatory, safety and efficacy concerns. By Tim O'Brien
Mobile apps are software programs that run on smartphones, accessories that attach to smartphones, or a combination of the two. Certain mobile apps meet the definition of medical devices and thus may be transformed into regulated medical devices, in particular if they are intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device. Increasingly, the...
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