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Issue 5, 2014
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The regulation of mobile medical applications

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Abstract

The rapidly expanding number of mobile medical applications have the potential to transform the patient–healthcare provider relationship by improving the turnaround time and reducing costs. In September 2013, the U.S. Food and Drug Administration (FDA) issued guidance to regulate these applications and protect consumers by minimising the risks associated with their unintended use. This guidance distinguishes between the subset of mobile medical apps which may be subject to regulation and those that are not. The marketing claims of the application determine the intent. Areas of concern include compliance with regular updates of the operating systems and of the mobile medical apps themselves. In this article, we explain the essence of this FDA guidance by providing examples and evaluating the impact on academia, industry and other key stakeholders, such as patients and clinicians. Our assessment indicates that awareness and incorporation of the guidelines into product development can hasten the commercialisation and market entry process. Furthermore, potential obstacles have been discussed and directions for future development suggested.

Graphical abstract: The regulation of mobile medical applications

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Publication details

The article was received on 01 Nov 2013, accepted on 06 Dec 2013 and first published on 15 Jan 2014


Article type: Focus
DOI: 10.1039/C3LC51235E
Citation: Lab Chip, 2014,14, 833-840
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    The regulation of mobile medical applications

    A. K. Yetisen, J. L. Martinez-Hurtado, F. da Cruz Vasconcellos, M. C. E. Simsekler, M. S. Akram and C. R. Lowe, Lab Chip, 2014, 14, 833
    DOI: 10.1039/C3LC51235E

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