The FTC steps up enforcement of misleading software and mobile app promotional claims as FDA deregulates low-risk health IT devices.
In recent weeks, the Federal Trade Commission (FTC) has taken several enforcement actions against companies that make misleading promotional claims for their software and mobile medical applications. Interestingly, this increased FTC enforcement activity has taken place concurrent with the Food and Drug Administration’s (FDA’s) deregulation of low-risk health IT devices. Although the FDA retains jurisdiction over the labeling and promotion of standalone software and mobile applications that make disease- or medical-related claims, these recent activities suggest that the FDA may be deferring to the FTC’s overlapping authority over the advertising and promotion of such products.
In January 2015, the FTC filed a complaint and proposed consent order against Focus Education, LLC, charging that the company and its officers violated the Federal Trade Commission Act (FTC Act) by making false or unsubstantiated claims that the ifocus system permanently improves children’s focus, memory, attention, behavior, and/or school performance, including in children with attention deficit hyperactivity disorder (ADHD). The proposed order prohibits the company and its principals from making unsubstantiated claims about the benefits, performance, or efficacy of products or services that supposedly alter the brain’s structure or function; improve cognitive abilities, behavior, or academic performance; or treat or reduce the symptoms of cognitive disorders, including ADHD.
In February 2015, the FTC announced enforcement actions against two melanoma-detection applications or “apps”: MelApp and Mole Detective. The two apps claim to increase consumers’ chances of detecting melanoma by analyzing pictures of moles and skin lesions taken with smartphones. The FTC’s complaint against MelApp states that the company made advertising claims that the product used “patent protected state-of-the-art mathematical algorithms and image-based pattern recognition technology to analyze the uploaded image [of a skin lesion]” to “provide a risk analysis of the uploaded picture being a melanoma” and “assist in the early detection of melanoma.” Advertising for Mole Detective stated that it “is the first and only app to calculate symptoms of melanoma right on the phone” and that it could “analyze your mole using the dermatologist ABCDE method and give you a risk factor based on the symptoms your mole may or may not be showing,” “increase the chance of detecting skin cancer in early stages,” and “save lives through the early detection of potentially fatal melanoma by helping you check and track your moles.”
Marketers for both apps have agreed to settlements with the FTC that prohibit them from making any claims that the apps can accurately detect or diagnose symptoms of melanoma. MelApp’s marketer, Health Discovery Corp., consented to a $17,063 fine as part of its settlement. Mole Detective’s developer and original marketer, New Consumer Solutions, consented to a $3,930 fine. The FTC is pursuing a judgment against a separate British marketing firm, which has not elected to settle with the FTC.
The FTC’s recent enforcement actions against health IT marketers have taken place at the same time that the FDA has been evaluating its role in regulating low-risk software and mobile medical apps. The FDA has faced increased pressure from industry, consumers, and Congress to deregulate health-related apps. For example, several bills have been introduced over the last two years that seek to exempt certain software from FDA regulation. In response, the FDA has taken several actions to deregulate certain low-risk health IT devices, including the following:
Through deregulation, the FDA has responded to industry’s desire to increase the availability of mobile and other technologies that will enable consumers to better manage their health and communicate with healthcare providers. Although the FDA has emphasized that it intends to continue to regulate higher risk mobile apps that meet the definition of “device,” it appears to have deferred to the FTC in the recent cases discussed above.
To date, the FTC’s new pattern of enforcement appears to be consistent with FDA’s policies concerning the types of mobile medical apps subject to regulation. For example, FDA stated in its Mobile Medical Application guidance document that apps that “analyze an image of a skin lesion using mathematical algorithms, such as fractal analysis, and provide the user with an assessment of the risk of the lesion” would be subject to FDA regulation.
We will continue to monitor events in this area to assess whether this represents a trend or is unique to these few cases.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact any of the following Morgan Lewis lawyers:
. 80 Fed. Reg. 4575 (Jan. 28, 2015) (Focus Education, LLC, Analysis of Proposed Consent Agreement to Aid Public Comment).
. 80 Fed. Reg. 11437 (Mar. 3, 2015) (Health Discovery Corporation, Analysis of Proposed Consent Agreement to Aid Public Comment).
. 80 Fed. Reg. 11437 (Mar. 3, 2015) (In the matter of FTC v. Lazerow et al., File # 132-3210).
. See, e.g., SOFTWARE Act, H.R. 3303, 113th Cong. (2013).
. FDA, Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices (Feb. 9, 2015).
. FDA, Guidance, “Mobile Medical Applications,” at 28 (Sept. 25, 2013, updated Feb. 9, 2015).