Review of 2013-2014 Mobile Medical Applications: Regulatory Challenges and Precedents

Authors

  • Jordan David Shapiro Intersect | Editor in Chief Dept. of Bioengineering, Stanford University, Undergraduate Dept. of Management Science and Engineering, Stanford University, Masters
  • Sheila Muschellack
  • Kian Ameli

Keywords:

mobile medical applications, mobile medical devices, biodesign, regulation, FDA, global, mHealth, mobile health, entrepreneurship

Abstract

This project aims to offer a review of mobile medical apps and the most important changes that happened in this sector in 2013 and 2014. We start with a discussion about the regulation of these devices in the United States, the European Union, and Brazil. 2013 was a significant year because of the publication of important guidelines about regulation and classification of mobile apps as medical devices. We further discuss how the manufacturers look at the requirements of safety and efficiency and how they are assessing these outcomes. Next, we explore the value proposition of mobile medical applications. Finally, we explore three case studies of mobile medical applications; one intended for imaging diagnostics, called ResolutionMDTM, by Calgary Scientific Inc., another, MyVisonTrackTM, by Virtual Art and Science, Inc., and a third, unregulated application from GN ReSound called ReSound SmartTM. The information for this project was mainly gathered using secondary research. For this purpose, we used databases, medical, business and mobile health reports, medical journals, and medical and mobile health websites. The time frame for data was mainly between 2010 and 2014, with only one reference each from 2002, 2004, and 2008. As the world becomes increasingly more mobile and moves to a value-based healthcare system, mobile medical applications offer a huge opportunity to provide cost-effectiveness, patient empowerment and good health outcomes. 2013 and 2014 were significant years for the first steps of the regulatory agencies towards more structured guidance on this matter, but health application developers seemingly have yet to fully understand the importance of providing safer and more efficient apps to patients and providers.

Author Biography

  • Jordan David Shapiro, Intersect | Editor in Chief Dept. of Bioengineering, Stanford University, Undergraduate Dept. of Management Science and Engineering, Stanford University, Masters
    Jordan Shapiro is a junior at Stanford University majoring in Bioengineering with a minor in Modern Languages (Spanish and Mandarin Chinese). Jordan is also a coterminal master's degree student in the Department of Management Science & Engineering. In addition to his role as Editor in Chief for Intersect, Jordan serves at Class President to the Stanford Class of 2015 and as President of the Stanford Israel Alliance. Jordan's work on campus include roles as a campus tour guide manager and an oral communication tutor. In his free time, he enjoys reading science fiction and practicing Taekwondo.

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Published

2014-11-28

Issue

Vol. 8 No. 1 (2014)

Section

Research Articles

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