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BMC Med. 2012 May 8;10:46. doi: 10.1186/1741-7015-10-46.

The regulation of mobile health applications.

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  • 1University of Colorado, Anschutz Medical Campus, College of Nursing, 13120 East 19th Avenue, Aurora, Colorado 80045, USA.


In July 2011, the United States Food and Drug Administration issued draft guidance concerning the regulation of mobile medical applications (applications on a wireless device that are used as accessories to medical devices or to convert a mobile platform to a medical device). While the suggestion of regulation is rooted in patient safety, concerns about limits on innovation and discovery as well as the evolving nature of both mobile health and current healthcare delivery have emerged. This article discusses the prevalence of mobile health, the context of regulation concerning mobile medical applications, and implications for the future.

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