Last month, the Federal Trade Commission (FTC) announced settlements that prohibit the marketers of two mobile apps – “MelApp” and “Mole Detective” – from continuing to claim that their apps can detect symptoms of melanoma.

According to the FTC, MelApp and Mole Detective “purported to calculate [a] mole’s melanoma risk as low, medium, or high,” based on photos and other information uploaded by users.  The FTC charged that the marketers of the apps “deceptively claimed the apps accurately analyzed melanoma risk and could assess such risk in early stages,” without “adequate evidence to support such claims.”

The settlements (see here and here) prohibit the marketers from, among other things, claiming that their apps can detect or diagnose melanoma, unless the representation is non-misleading and supported by “competent and reliable scientific evidence” based on human clinical testing that meets standards generally accepted by experts in the field.

The FTC cast the settlements as a reminder that “[t]ruth in advertising laws apply in the mobile market place.” It warned app developers and marketers that they “must have scientific evidence to support any health or disease claims that they make for their apps.”

These settlements are also a reminder that numerous federal entities actively regulate and oversee the telehealth industry.  Telehealth providers and technology developers may be familiar with FDA and CMS, but several other agencies also implement and enforce federal law relevant to health care-related technology, including HHS Office of Civil Rights (privacy and HIPAA), the Department of Justice (accessibility under the Americans with Disabilities Act, among other things), and of course the FTC (advertising and other consumer protection policies).

 

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Covington Digital Health Team

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with…

Stakeholders across the healthcare, technology and communications industries seek to harness the power of data and information technology to improve the effectiveness and efficiency of their products, solutions and services, create new and cutting-edge innovations, and achieve better outcomes for patients. Partnering with lawyers who understand how the regulatory, IP, and commercial pieces of the digital health puzzle fit together is essential. Covington offers unsurpassed breadth and depth of expertise and experience concerning the legal, regulatory, and policy issues that affect digital health products and services. To learn more, click here.