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?

• Author: Ciopraga, Ioana

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.

1. THE PROBLEM: MOBILE APPS AS MEDICAL DEVICES

   1. 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. (9) Nowadays, most of us also know someone who has built or is thinking about building an app. The change was driven by how mobile devices have evolved in terms of technology advancements, by manufacturers understanding the importance of giving access to the internal design of handsets, and by the emergence of proprietary platforms such as iOS and Android, on which developers can freely create apps not just for smartphones, but for a plethora of mobile devices. With over "one billion active smartphones and tablets [currently being active] globally, ... [analysts] expect [the number] to reach two billion in 2014." (10)

      Using mobile health related apps was a natural progression for today's consumers, who have been leveraging the Internet for years to look up medical information online. According to Pew Internet and America Life Project, 81% of American adults use the Internet, and 72% of Internet users looked online for health related information within the past year. (11) As of April 2012, 19% of smartphone owners had downloaded an app specifically to track or manage health. (12) We use our mobile devices to connect to our friends, our families, our business partners, so using them to connect to our healthcare providers and manage our health is only logical. As concluded by the GSM Association "[mHealth] solutions can help healthcare providers deliver better, more consistent, coordinated and more efficient healthcare, where and how it is needed, increase access to health services to remote or under-served communities and empower individuals to manage their own health more proactively and effectively." (13) By 2017, according to Research and Markets, half of the 3.4 billion smartphone or tablet users worldwide will use mobile health apps. (14)

      "[T]he use of mobile devices in the delivery of healthcare and in obtaining healthcare knowledge [has become] ubiquitous." (15) In light of the Affordable Care Act, mobile devices are also one of the most promising tools in achieving an important goal of Accountable Care Organizations (16), by reinforcing the best behavior in patients, reducing costs, and shifting the focus from just treatment to wellness and prevention. Mobile devices and the mobile apps they allow us to use are ideally suited to take healthcare outside of the hospital environment and begin a new age of remote medicine that has the potential to drive healthcare costs down while empowering the patients to become engaged in their health and wellness.

      In 2012, there were 828 companies in the high tech medical device industry, generating over $60 billion, and employing over 88,000 people, (17) and the top three companies (Medtronic, General Electric, and St. Jude Medical) controlled 32% of the market share. (18) By contrast, according to the Wall Street Journal, (19) the average app developer today is 29 years old or younger, 40% of app developers work alone, while 27% work at 2-3 person firms, with 34% making less than $15,000 from app development, 65% making less than $35,000, and only 12% making $100,000 or more.

   2. FDA Guidance.

      On September 25, 2013, the FDA released its final guidance document pertaining to mobile medical apps it intends to regulate. While the FDA acknowledges that "[m]obile apps are unleashing amazing creativity, and [it] intend[s] to encourage these exciting innovations," (20) its guidance regarding mobile medical apps may slow down or deter the very innovation it intends to encourage. A summary of the guidance is provided below.

      Most analysts welcomed the newly released guidance, as it brought much needed clarity compared to the draft guidelines released by the FDA back in 2011. (21) Morgan Reed, the executive director for the Association for Competitive Technology said that the new guidelines prove that the FDA "recognized that they aren't going to tell us how to innovate." (22) In theory, this should be good news for app developers and for the industry in general. However, the FDA applied the same approach it used in regulating medical devices in general to medical mobile apps, which could prove problematic and counterproductive in the long run. Part III discusses this in detail.

      1. Apps That Are Not Medical Devices

         The apps included under this category are apps that "could be used in a healthcare environment, in clinical care or patient management, but are not considered medical devices." (23) Since these apps are not considered medical devices, the FDA will not regulate them. The list of examples included in the guidance document (24) by the FDA indicates that the apps most likely to fall under this category are educational and informational, and are "not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease." (25) For example, these types of apps provide users and healthcare professionals with access to medical literature as well as commonly used reference information, can be training tools for healthcare providers, or help patients interact with their healthcare providers via different communications mechanism, as long as they are not intended specifically for medical use. If it simply informs or educates, a healthcare related mobile app is not considered a medical device, and the FDA will not regulate it.

      2. Apps That Are Medical Devices but over Which the FDA Will Exercise Enforcement Discretion

         In the case of apps that may be considered medical devices, but pose a low risk to patients, the FDA does not intend to enforce the requirements under the Food, Drug and Cosmetic Act. (26) These types of apps go beyond information or education, and are mostly apps that allow patients to self-manage their conditions, organize information related to their health, and communicate with their health care providers, as well as apps that automate simple tasks for health care providers. (27) The key characteristic of the apps included in this category is that they do not provide "specific treatment or treatment...