Academic journal article Journal of Law, Technology and the Internet

The FDA Guidance Document for Medical Mobile Apps and Its Impact on Innovation: Bringing the Promise of a New Way to Look at Medicine Closer, or Pushing It Further?

Academic journal article Journal of Law, Technology and the Internet

The FDA Guidance Document for Medical Mobile Apps and Its Impact on Innovation: Bringing the Promise of a New Way to Look at Medicine Closer, or Pushing It Further?

Article excerpt

INTRODUCTION

Six years after the launch of the iPhone, it is almost impossible to conceive what our lives would be like without our mobile devices. (1) And, regardless of your field of interest, chances are "there's [at least] an app for that." (2) According to Portio Research, 1.2 billion people used mobile apps worldwide in 2012 and approximately 4.4 billion people will be using mobile apps by 2017. (3) While the total number of apps currently out on the market is hard to calculate, there are over 1,600,000 mobile apps only between Apple's App Store and Google's Play Store. (4)

Mobile apps are no longer limited to games, but have also become players in fields such as education and medicine. The World Health Organization defines mobile health as "medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices." (5) There are currently over 43,000 healthcare related apps in the iTunes store alone, (6) and, according to Research2Guidance, 500 million people will be using healthcare mobile applications in 2015 globally. (7)

This Note critiques the guidance document released by the Food and Drug Administration ("FDA") in connection with the medical mobile apps it intends to regulate and the regulations that govern medical mobile apps. Specifically, the main argument of this Note is that, while the document is clearly a step in the right direction, significantly more guidance, focused on the characteristics of this new field, such as the rapid change of mobile technology, and on the transformational impact on healthcare of health IT in general and mHealth in particular, should follow soon. Part I provides an overview of the guidance document, with a focus on the FDA's attempt to find the right balance between regulating apps that could potentially be harmful, and trying to promote innovation. Part II reviews the FDA regulations for medical devices in general, which the FDA used in its guidance document for medical mobile apps. Part III discusses ambiguities in the guidance document, the difficulties mobile app developers may encounter in trying to comply with it, the huge gap between the ability of conventional medical device manufacturers and that of medical mobile app manufacturers to go through the premarket approval process, and how the way the FDA intends to regulate medical mobile apps may ultimately impact innovation in the field. Part IV looks at potential solutions to improve the current regulations and strike the balance between ensuring safety and supporting innovation, and argues for a change in the way the FDA approaches regulation of mobile medical apps, which should incorporate a clear reflection of a field that is constantly evolving at a very fast pace, with very different players than the traditional medical device manufacturers, and for which a 40-year old framework is simply outdated.

I. THE PROBLEM: MOBILE APPS AS MEDICAL DEVICES

A. Mobile Apps.

The Federal Food, Drug, and Cosmetic Act defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or... intended to affect the structure or any function of the body." (8)

Before the world could even comprehend the idea of mobile apps as medical devices, the first mobile apps were built by handset manufacturers and carriers, and were part of the pre-installed software stack. And while people who bought the same headset used to have the same exact device, no two people today have the same exact mobile phone because as soon as they get the device they are able to customize it based on their needs, interests and preferences. …

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