On Monday, the Federal Trade Commission levied fines against the marketers of two mobile health applications over misleading claims that the apps could be used to diagnose and assess the risk of melanoma, the Washington Post‘s “The Switch” reports.
Background on Apps
Mole Detective and MelApp were on sale between 2011 and 2012 and claimed to be able to calculate consumers’ risk of melanoma by analyzing pictures of their moles. According to “The Switch,” both apps recommended that users visit a doctor if they had actual concerns (Tsukayama, “The Switch,” Washington Post, 2/23).
An FTC review of the apps’ advertising found that the marketers had “deceptively claimed the apps accurately analyzed melanoma risk and could assess such risk in early stages,” noting that both lacked sufficient evidence to support their claims, Health Data Management reports (Slabodkin, Health Data Management, 2/24).
Mary Engle, FTC’s associate director for advertising practices, said the advertisements suggested that the apps could be used as diagnostic tools, which could harm consumers. Engle said, “You need a trained dermatologist to make that assessment.”
Under the settlements:
- Health Discovery Corp., the marketer for MelApp, will pay $17,063; and
- New Consumer Solutions, developer and initial marketer of Mole Detective, will pay $3,930.
The settlement also bars the marketers from claiming that the apps can “accurately detect or diagnose symptoms of melanoma,” according to “The Switch.”
Both marketers have agreed to the settlements (“The Switch,” Washington Post, 2/23).
Pending FTC Action
FTC is still pursuing action against L Health — a separate, British marketing firm that acquired Mole Detective — and the company’s owner, Avi Lasarow, who refused to settle with FTC (Dolan, MobiHealthNews, 2/23).
Lasarow said that when he acquired Mole Detective, its original developer Kristi Zhulke Kimball said the app had not violated any advertising laws. According to Lasarow, L Health did not use any new marketing material and the app “always stated that it should be used for educational purposes only and must not replace a doctor visit.” Lasarow added that the app was taken offline “[o]nce FTC started its investigation” (“The Switch,” Washington Post, 2/23).
Jessica Rich, director of FTC’s Bureau of Consumer Protection, said, “Truth in advertising laws apply in the mobile marketplace,” adding, “App developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps” (Health Data Management, 2/24).
Separately, Maureen Ohlhausen, an FTC commissioner, dissented from the commission’s majority decision.
She said that while she agrees apps should have substantial scientific evidence to back up their claims, “[h]ealth-related apps need not be as accurate as professional care to provide significant value for many consumers” and therefore should not be subject to “overly stringent substantiation requirements.” However, she noted that app developers and marketers must make clear the “limitations” of their apps (MobiHealthNews, 2/23).
Meanwhile, Bradley Merrill Thompson — general counsel for the mHealth Regulatory Coalition — said it was surprising that FTC, rather than FDA, took action against the apps’ marketers. “In this particular case, to me it seems relatively clear that the app is a medical device, and yet FTC still took the lead,” he said, adding, “I agree that FTC has the right to enforcement, but the silence from FDA is somewhat deafening” (Health Data Management, 2/24).
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