Issue 5, 2014

The regulation of mobile medical applications

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

Article information

Article type
Focus
Submitted
01 Nov 2013
Accepted
06 Dec 2013
First published
15 Jan 2014

Lab Chip, 2014,14, 833-840

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

To request permission to reproduce material from this article, please go to the Copyright Clearance Center request page.

If you are an author contributing to an RSC publication, you do not need to request permission provided correct acknowledgement is given.

If you are the author of this article, you do not need to request permission to reproduce figures and diagrams provided correct acknowledgement is given. If you want to reproduce the whole article in a third-party publication (excluding your thesis/dissertation for which permission is not required) please go to the Copyright Clearance Center request page.

Read more about how to correctly acknowledge RSC content.

Social activity

Spotlight

Advertisements