Email updates

Keep up to date with the latest news and content from BMC Medicine and BioMed Central.

Journal App

google play app store
Open Access Commentary

The regulation of mobile health applications

Amy J Barton

Author affiliations

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

Citation and License

BMC Medicine 2012, 10:46  doi:10.1186/1741-7015-10-46

Published: 8 May 2012

Abstract

In July 2011, the United States Food and Drug Administration issued draft guidance concerning the regulation of mobile medical applications (applications on a wireless device that are used as accessories to medical devices or to convert a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.

Keywords:
Mobile medical applications; Regulation; Mobile health