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FTC Diagnosis: App Health Claims Need Life Support

By Sheila Millar on March 2, 2015
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Technology is advancing fast, but would you use an app to figure out if you had cancer? According the Federal Trade Commission (FTC), that’s just what two app developers were recommending, but the FTC said they lacked the evidence to back their claims up. The FTC entered into consent agreements with two companies, MelApp and Mole Detector, involving claims that their apps could detect melanoma (press release here, blog post here). The settlements are a reminder not only of the FTC’s interest in health claims, app advertising and privacy, but also the FTC’s view on when the likely perception of claims is so clear that extrinsic evidence isn’t necessary.

Among the developers’ claims were that the apps 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.” The settlements prohibit the developers from making any false melanoma detection claims, including representations without scientific substantiation that the apps detect or diagnose melanoma or risk factors of melanoma, or increase users’ chances of detecting melanoma in early stages. Here, competent and reliable scientific evidence must consist of blinded human clinical testing of the device that includes a range of lesions and is conducted by researchers qualified by training and experience to conduct such testing.

Republican Commissioner Maureen Ohlhausen dissented, suggesting that while she agrees with basic principles requiring substantiation, the Commission was imposing an unduly stringent substantiation burden on a relatively safe product. She opined that the Commission should have obtained extrinsic evidence on the question of whether consumers thought the app would match a dermatologist’s accuracy. So long as app developers convey the limitations of their products, there is no need to unduly restrict their ability to make claims.

The majority, on the other hand, felt that the app claims clearly conveyed to users that the app was just as good as going to the doctor.

As we have said previously in this blog, when it comes to evaluating advertising claims, it’s all about consumer perception. At least in this case, four out of five Commissioners agreed that they were capable of determining what consumers would take away from the ads without the need for extrinsic evidence.

Photo of Sheila Millar Sheila Millar

Sheila A. Millar is a partner at Keller and Heckman LLP, where she represents businesses and trade associations on a variety of public policy and regulatory issues, including privacy, data security, cybersecurity and advertising matters, as well as product safety issues. She has…

Sheila A. Millar is a partner at Keller and Heckman LLP, where she represents businesses and trade associations on a variety of public policy and regulatory issues, including privacy, data security, cybersecurity and advertising matters, as well as product safety issues. She has been involved in a variety of audit and compliance projects, including, among other issues, privacy and data security audits, and is experienced in providing crisis management legal support to a variety of national and international companies and associations.

Ms. Millar is a frequent speaker on regulatory and public policy matters, and has authored many articles. Ms. Millar is one of the vice chairs of the International Chamber of Commerce (ICC) Marketing and Advertising Commission, and chair of its Working Group on Sustainability, where she spearheaded the development of the ICC Framework Guides on Environmental Marketing Claims.

Ms. Millar is AV® PreeminentTM Rated by Martindale-Hubbell and for the eigth consecutive year was selected by her peers for inclusion in The Best Lawyers in America® 2018 for her work in practicing Advertising Law. She has also received the distinguished honor of Advertising Law “Lawyer of the Year” 2014 in Washington, DC by Best Lawyers®, and was awarded Advertising and Marketing Lawyer of the Year USA by Finance Monthly for their Finance Monthly Global Awards 2017.

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  • Posted in:
    Communications, Media & Entertainment
  • Blog:
    Consumer Protection Connection
  • Organization:
    Keller Heckman
  • Article: View Original Source

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