You want to track your blood pressure regularly but the trek to the local pharmacy to use a blood pressure cuff is inconvenient. So, when a smartphone app comes along that boasts its readings are as accurate as the traditional machine, requiring users to simply input gender, height, weight, and birthdate to get instant BP readings, it seems like a life saver. Online reviews speak to its quality.
Aura’s ads promised that its Instant Blood Pressure (IBP) app “could be used to replace around-the-arm cuffs and would be just as accurate as the traditional device.” The problem is, according to the FTC, “studies demonstrate clinically and statistically significant deviations between the App’s measurements and those from a traditional blood pressure cuff.” And the glowing customer reviews? Aura’s president and owner, Ryan Archdeacon, and co-founder and Board Chair Archie Giroux, allegedly wrote favorable reviews for the product without disclosing any conflict of interest.
And that made the FTC’s blood boil. According to an FTC complaint, California-based Aura Labs Inc. sold the IBP app online for between $3.99 and $4.99. Between June 2014 and June 2015, Aura’s sales of the IBP came to more than $600,000 in “ill-gotten gains.” Under the terms of the FTC’s December, 2016 settlement, Aura and its owner are prohibited from making any claims about the apps’ health efficacy, and they must divulge any material connections between Aura Labs and endorsers. The $595,945 fine was suspended due to the company’s inability to pay.
Or, you don’t want to drink and drive and need a convenient way to tell you if you’ve over-imbibed. In a similar case, the FTC said an app that garnered fame on television’s Shark Tank as an accurate way to assess blood alcohol content (BAC) didn’t do the trick. Breathometer Original attached to a smartphone through a jack. Consumers would then blow into a hole in the device. Five seconds later, the smartphone would display what the company represented in its advertising was the user’s precise BAC. Not only that, the company said that the Breathometer Original would also “provide guidance on when you will be Back to ZeroTM - or likely sober.” Original was sold through a variety of major outlets online at a manufacturer’s suggested retail price of $49.99. Original began shipping in in mid-2013, and had gross sales of $3.1 million as of March 2016.
Breeze, the Bluetooth-enabled version of Original, sold for $99.99. Gross sales of Breeze from mid-2014 through March 2016 totaled approximately $2 million. Breeze not only also possessed the same accuracy issues of the Original app, but had serious additional defects. According to the FTC complaint, “In late 2014, Breathometer learned of accuracy problems with Breeze devices: they eventually degraded and “suffered from downward “drift” in BAC calculations.” And, while Breathometer became aware of the problem in 2015 and tried to correct the issue, it failed to notify consumers of the problem until 2016 and had no way to recalibrate the app once it had been installed on users’ phones.
Under the terms of the settlement with the FTC, Breathometer has agreed to inform its customers of the apps’ defects and issue full refunds. CEO Charles Yim is prohibited from making any claims about Breathometer’s accuracy unless it can be substantiated by tested and approved National Highway Transportation Safety Administration specifications.
Smartphone apps that purport to provide reliable physical or health-related information are proliferating. But early evidence, such as a 2013 study published in the Journal of Medical Internet Research, suggests app accuracy claims aren’t supported by the facts. Moreover, depending on those claims, the app makers may just face concerns by another regulatory agency, the Food and Drug Administration (FDA). Advances in algorithms linked to sound clinical data truly hold the promise of innovative health care benefits to consumers. However, it’s especially important to remember that any type of health-related claim must be backed up by competent and reliable scientific evidence, and that information suggesting that the apps are inaccurate or degrade need to be communicated to consumers. Companies that produce health-related apps need to take these obligations very much to heart. If they don’t, they may just be in for some big headaches.