The regulation of mobile medical applications

TLDR

The rapidly expanding number of mobile medical applications can transform patient‑provider relationships by improving turnaround time and reducing costs, but the FDA issued guidance in 2013 to regulate them and protect consumers, distinguishing regulated from non‑regulated apps based on marketing claims and addressing concerns such as OS and app updates. The article aims to explain the essence of FDA guidance by providing examples and evaluating its impact on academia, industry, patients, and clinicians. The authors illustrate the guidance through examples and assess its impact on key stakeholders. The assessment shows that awareness and incorporation of the guidelines can accelerate commercialization, while obstacles and future directions are identified.

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.