The Federal Trade Commission has taken action against two melanoma detection apps: MelApp and Mole Detective. Some of the marketers behind the apps have agreed to settle with the FTC, while two additional marketers of Mole Detective have refused. Total settlements for the two apps came to just north of $20,000. Both apps claim to provide an "automated analysis of moles and skin lesions for symptoms of melanoma and increase consumers’ chances of detecting melanoma in its early stages", according to the FTC.
This move was not unprecedented. In 2011 the FTC took similar action against two acne apps.
Here's how the FTC summed up each of the melanoma app's claims:
Advertising for MelApp stated that it 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.”2 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,” using “shape recognition software.”
Mole Detective was first developed by Kristi Kimball and her company, New Consumer Solutions in January 2012, according to the FTC. In August of that year, UK-based Avrom “Avi” Lasarow and his company, L Health, took over the app. The app cost as much as $4.99 at one time. Kimball and her company agreed to settle and will pay $3,930. Lasarow refused so the agency is pursuing litigation against him and his company.
Health Discovery Corporation launched MelApp in 2011 for $1.99, according to the FTC. Its settlement is similar to Kimball's. As part of it, the company will not make claims about detecting melanoma or its risk factors or even that their app increases a user's chance of detecting melanoma unless the claim is not misleading and backed up by reliable scientific evidence. The company must pay $17,963.
"I don't know about you, but I'm starting to see a trend," Bradley Merrill Thompson of Epstein Becker Green wrote MobiHealthNews in an email. "It seems as though FTC enforcement sidesteps all of the dicey issues associated with FDA jurisdiction. Honestly, though, I still find the strategy curious. In this particular case, to me it seems relatively clear that the app is a medical device, and yet FTC still took the lead. Indeed, these can be very high risk apps. I agree that FTC has the right to enforcement, but the silence from FDA is somewhat deafening."
One FTC commissioner -- Maureen Ohlhausen dissented from the majority in issuing the complaints against the two app companies.
Commissioner Ohlhausen agreed that apps must have substantial scientific backing in order to make claims, but she believed the complaints as written seem to be asking app developers to do more to prove their claims than is necessary.
"This approach concerns me," she wrote. "Health-related apps have enormous potential to improve access to health information for underserved populations and to enable individuals to monitor more effectively their own wellbeing, thereby improving health outcomes. Health-related apps need not be as accurate as professional care to provide significant value for many consumers. The [FTC] should not subject such apps to overly stringent substantiation requirements, so long as developers adequately convey the limitations of their products. In particular, the [FTC] should be very wary of concluding that consumers interpret marketing for health- related apps as claiming that those apps substitute for professional medical care, unless we can point to express claims, clearly implied claims, or extrinsic evidence. If the Commission continues to adopt such conclusions without any evidence of consumers’ actual interpretations, and thus requires a very high level of substantiation for health-related apps, we are likely to chill innovation in such apps, limit the potential benefits of this innovation, and ultimately make consumers worse off."