Effectiveness of federal regulation of mobile medical applications.

• Author: Kilker, Sarah Jean

INTRODUCTION

Steve Jobs hated the design of the health-monitoring devices used to treat him during his final days. (1) In posthumous homage to its founder, Apple released the Health app, powered by the HealthKit developer framework, as part of its iOS 8 operating system update and its new iPhone 6 release in September of 2014. (2) HealthKit allows the Health app to access third party apps and wearable devices. (3) Although the Health app--as a mobile medical application ("app")--could arguably fit the mold of a medical device subject to Food and Drug Administration ("FDA") regulation, Apple managed to escape such regulation of its product. This Note discusses the reasons this occurred. (4)

A myriad of medical smartphone apps are available in the app market. (5) Apple's foray into the market triggered a surge in apps that are compatible with the Health app. (6) As a result, mobile health applications are becoming more integrated into Americans' everyday lives.

Samsung, a fierce competitor in the smartphone market, is also touting the health and wellness features of its Galaxy S5. (7) The Galaxy S5 is the first smartphone with a built-in heart rate monitor. (8) Samsung included SHealth software, similar to Apple's Health app, which is compatible with the Galaxy S5 pedometer. (9) The Galaxy S5 also connects to Samsung Gear Fit, a wristband that provides personalized real-time information on the progress and results of a workout using the device's optical heart rate sensor, similar to the Apple Watch. (10)

These are just two examples of how mobile health is expanding from basic pedometers and informative medical apps into more complex interactive programs and apps. It is understandable that governmental regulation has not been able to adequately keep pace with mobile medical technology. (11) The rapidly growing popularity of smartphones in the consumer market has triggered aggressive investment in mobile health, sometimes referred to as "mHealth." (12) Some of the mHealth investment money goes toward the development of medical apps. (13) Technology companies are rolling out sophisticated applications for computers and smartphones that can perform a wide variety of tasks; from basic monitoring of personal health statistics to complex medical testing and diagnosis, including a pregnancy test app that utilizes a smart phone's Bluetooth, (14) an app that monitors blood pressure, (15) and even an app that can conduct a urinary analysis. (16)

Due to the rapid growth and advancement of technology, uncertainty has emerged as to whether some of the medical apps on the market should be considered medical devices, which are subject to stringent regulation by the FDA. (17) The FDA issued final guidelines regarding the regulation of medical apps in September of 2013 and updated the guidance in February 2015, but it has not issued formal regulations. (18)

Mobile technology is an integral part of daily life in the United States; as of January 2014, 90% of adults in the United States owned a cell phone, and 64% of adults owned a smartphone. (19) Almost 20% of smartphone users in the United States have at least one application on their device that helps them track or manage their health and have used such an app in the past year. (20) By some estimates, 500 million users worldwide will use one or more of these apps within the year. (21) And by 2018, more than 50% of the 3.4 billion smartphone and tablet users worldwide will have downloaded a medical health app. (22)

Relevant to this Note, smartphones and medical apps are becoming increasingly popular among healthcare professionals. Nearly eighty percent of physicians use smartphones as part of their medical practice. (23)

And eighty-five percent of physicians use medical applications as part of their practice. (24)

This Note proceeds as follows. Part I examines the development of mobile medical health applications and regulation in countries with comparable mobile-app use, and then explores the evolution of the FDA's position regarding the regulation of such apps. Part II analyzes and critiques current and conceivable regulatory strategies by the federal government, as well as private regulatory organizations such as the United States Pharmacopeial Convention and the Health on the Net Foundation. Part III argues that current FDA regulations are insufficient and suggests a peer reviewer or other organization may be better suited to assess the usability of apps and offer usage guidelines for consumers. Part III also discusses three proposed models for regulation of mobile medical apps. This Note argues that a regulatory approach that includes a peer review system and a non-profit organization that specializes in mobile medical technology will be more efficient and useful to monitor mobile medical apps than the current FDA guidelines.

1. HISTORY

   1. Medical Apps

      Health and medical apps first emerged in the late 2000s by offering tools such as calorie counters and simple wearable devices like pedometers that were integrated with cell phone apps. (25) Medical apps have consistently grown in popularity, and large technology companies continue to invest in mobile health. (26)

      Mobile medical apps often utilize a smartphone's built-in features, like touch screens, cameras, lights, sounds, and wireless access, as well as software to process the data collected. (27) The information gathered can be presented to the user in an informative or even in a diagnosis-like format. Increasingly accessible and more affordable technology has allowed more people to access such applications but has also raised questions and concerns regarding safety and regulation.

      Some companies have developed devices that work in tandem with smartphones but do not require a mobile phone to operate. (28) For example, Scanadu, a Silicon Valley-based company that makes medical technology devices for consumers, created a device that can monitor and log the data of pulse, respiratory rate, blood pressure, temperature, and other vitals. (29) Because it is a standalone device, the FDA required Scanadu to seek further approval before the device goes onto the market. (30)

      Like standalone health devices, mobile phones can be used to engage in complex medical procedures through applications that work in conjunction with smartphone features and external tools and devices that plug into smartphones. Such features and programs on mobile phones may also be subject to the same discretionary review and regulation by the FDA as standalone devices. External devices that attach to the phone are particularly easy to peg for further review and approval, particularly if the application gives diagnostic-like data readings.

      One such app that offers the user a diagnosis is the Instant Heart Rate app. (31) The application can take the user's heart rate by allowing the user to place his or her finger over the camera for ten seconds. (32) Another app that utilizes a smartphone's built in features is BiliCam, which allows parents to check if their newborn has jaundice by taking a picture of a calibration card against their baby's skin. (33)

      Due to time and monetary constraints, mobile app developers do not want their apps to be subject to FDA and regulatory scrutiny. Whether a mobile app is a medical device is not as clear-cut as it is for a stand-alone medical device that is clearly designed for the purpose of diagnosis or treatment. Policy and regulation have yet to catch up with this evolving technology, creating a gray area encompassing such mobile health apps.

   2. History of FDA Involvement in Mobile Medical Apps

      The FDA is a federal agency that exists under the purview of the US Department of Health and Human Services. (34) The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, over-the-counter and prescription drugs, dietary supplements, and other food and medical products and devices available to consumers. (35) Pertinent to this Note, the FDA is empowered by Congress to enforce the Federal Food, Drug and Cosmetic Act, among other laws. (36) Notably, the FDA enforces section 361 of the Public Health Service Act and associated regulations, from which it derives its authority to regulate medical devices. (37) More specific statutory authority is exerted "over those mobile apps that meet the definition of 'device' in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)." (38)

      The FDA issued its first guidance regarding mobile medical applications in July of 2011, after soliciting public and stakeholder comments and opinions. (39) Those that responded "overwhelmingly supported a narrowly tailored, risk-based approach." (40) Industry stakeholders were eager for guidance from the FDA so they could proceed with research and development. (41) The FDA released this guidance in its report, Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff, in the Federal Register in September of 2013. (42)

      In the 2013 Guidance, the FDA attempted to define what factors make a mobile app a medical device, stating:

      Mobile apps that transform a mobile platform into a regulated medical device and therefore are mobile medical apps: These mobile apps use a mobile platform's built-in features such as light, vibrations, camera, or other similar sources to perform medical device functions (e.g., mobile medical apps that are used by a licensed practitioner to diagnose or treat a disease). (43) The FDA distinguished some types of apps they will regulate from some they will not. However, the Guidance leaves a considerable amount of discretion to the FDA. (44) FDA director Jeffery Shuren explained the FDA's stance on medical app regulation in a hearing before the Subcommittee on Health of the House Committee on Energy and Commerce, stating:

      Our mobile medical app policy is based on risk and functionality.

      For example, an electrocardiography...