Nearly half of all American adults own smartphones, according to a Pew survey published on March 1, 2012, and with smartphones and other mobile devices come apps–application software that allows the phones and devices to perform specific tasks. Apps allow users to do everything from play games to read news updates to check their bank accounts. A growing number of apps are health-related, running the gamut from helping consumers lose weight to helping doctors monitor test results to, in one notable case, allowing an amputee to control her prosthetic limb. However, many health apps make impossible claims and others carry with them substantial risks. The Government is finally taking baby steps to regulate the mobile health (or mHealth) industry.
Food and Drug Administration (FDA)
The FDA recently announced a list of topics on which it plans to issue proposed guidance in 2013. It included Mobile Medical Applications on the “A-list” of final guidance topics that it plans to issue. It issued draft guidance on the subject on July 21, 2011, but Congressional legislation nearly placed a moratorium on issuing further guidance. However, the Food and Drug Administration Safety and Innovation Act (FDASIA) (P.L. 112-144), which became law on July 9, 2012, removed that language.
In its draft guidance, the FDA proposed to treat certain mobile medical apps, which include apps for smartphones, tablets, and other mobile devices, as medical devices. It planned to regulate only those apps that are (1) used as accessories to FDA-regulated medical devices or (2) transform mobile platforms into regulated medical devices. The first category includes mobile apps that are connected to and serve as extensions of medical devices by controlling the device or “displaying, storing, analyzing, or transmitting patient-specific” data. Examples include apps that allow for the remote display of data from a bedside monitor or apps that utilize a mobile platform to control the inflation and deflation of a blood pressure cuff. The second category includes apps that utilize physical attachments to allow platforms to function as medical devices, such as apps that allow for the attachment of electrocardiograph (ECG) electrodes to read and evaluate signals. The FDA further included apps that analyze patient-specific data and produce patient-specific results in response, such as apps that calculate medication dosages. Proposed regulation would exclude apps that provide reference materials, such as textbooks, that do not include patient-specific information; wellness apps, such as dietary logs, that may make suggestions for improving health, but do not in any way attempt to cure or treat specific illnesses; clerical apps; apps that are not specific to the medical field; and electronic health record (EHR) or personal health record systems.
Apps would be classified as Class I, II, or III medical devices. Class I devices are subject to general controls. Class II devices are additionally subject to special controls and generally require premarket notification subject to section 510(k) of the Food, Drug and Cosmetic Act, which requires manufacturers to notify the FDA of their intent to market a medical device at least 90 days in advance of marketing. This allows the FDA to determine whether the appropriate class for the device and whether a similar device exists. Class III, in addition to being subject to various controls, requires Premarket Approval by the FDA. Mobile Medical App manufacturers would also be required to report adverse events and corrections made to reduce health risks to the FDA.
Federal Trade Commission (FTC)
Clearly, the FDA guidelines are narrowly tailored to specific types of medical devices. But what about all of the other apps that consumers can download in a matter of minutes? Click on “Health & Fitness” while visiting Apple’s App Store and you’ll be presented with 240 apps that likely don’t fall into the categories targeted by the FDA, most of which involve weight loss, pregnancy tracking and prep, and exercise. The FTC might become involved.
The FTC investigates fraudulent and unfair business practices that affect consumers, including false advertising. In September, 2011, the FTC settled with the marketers of two mobile medical apps that claimed to treat acne with light emitted from mobile devices. The marketers claimed that Acne App and Acne Pwner treated acne when screens were held next to affected areas of the skin, despite the fact that the light emitted by mobile devices is not in the right spectrum to provide any kind of light therapy. Other apps, for example, claim to treat Seasonal Affective Disorder (SAD) with phones with maximum light intensities of 200 lux, despite the fact that SAD therapy requires 2,000 lux in two-hour sessions. Other fraudulent apps claim to cure and treat diseases, sometimes in the form of oversimplified versions of effective treatments.
The FTC has not pursued additional cases. It did publish a guide entitled, “Marketing Your Mobile App,” to provide developers with truth-in-advertising and privacy guidelines. However, many of the guidelines are simply bits of common sense advice, such as “Tell the truth about what your app can do,” and “Disclose key information clearly and conspicuously.”
A year and a half after the FDA issued its proposed guidelines, there is still no regulatory framework in place. However, the FDA is increasingly issuing 501(k) clearances to mobile medical app manufacturers. Only time will tell whether the agency will issue final guidance in 2013 and whether other agencies become involved in the effort to clear the market of subpar apps.