The Federal Trade Commission (FTC) has announced that they’ve settled charges of deceptive marketing against the makers of Instant Blood Pressure app, Aura Labs Inc.

We first came across this app in 2014 and Dr. Iltifat Husain described in detail the dubious claims made by this health app as well as the potential harms to patients. Dr. Timothy Plante, a general internal medicine fellow at Johns Hopkins (and colleague of mine), went on to demonstrate just how inaccurate Instant Blood Pressure was in a clinical study published in JAMA Internal Medicine earlier this year.

To briefly recap, Instant Blood Pressure claimed to measure blood pressure by having users place their finger over their smartphone camera with the microphone on their chest. We’ve gone over how it works and critical pitfalls in past articles. All of that aside, the central problem here was that Instant Blood Pressure implied that it could accurately measure blood pressure without independent or peer-reviewed validation. Despite that, we now know based on the FTC documents that Aura Life made over $600,000 from Instant Blood Pressure.

The FTC clearly agreed with that assessment. In their press release, they stated:

Although Defendants represent that the Instant Blood Pressure App measures blood pressure as accurately as a traditional blood pressure cuff and serves as a replacement for a traditional cuff, in fact, studies demonstrate clinically and statistically significant deviations between the App’s measurements and those from a traditional blood pressure cuff.

The FTC also highlighted the fact that Aura Life officers left positive reviews of Instant Blood Pressure in the app store.

In the settlement with the FTC, Aura Life is prohibited from making any claims that their app can actually measure blood pressure without proof. Interestingly, the settlement goes on to describe what would be considered proof:

For purposes of this Section, competent and reliable scientific evidence shall consist of human clinical testing of such product that is sufficient in quality and quantity, based on standards generally accepted by experts in the relevant field, when considered in light of the entire body of relevant and reliable scientific evidence, to substantiate that the representation is true. Such testing shall conform to actual use conditions, include a representative range of blood pressures and representative groups of subjects, and be conducted by researchers qualified by training and experience to conduct such testing. In addition, all underlying or supporting data and documents generally accepted by experts in the relevant field as relevant to an assessment of such testing as described in the Section entitled “Preservation of Records Relating to Competent and Reliable Human Clinical Tests or Studies” must be available for inspection and production to the Commission.

For claims about impact of the app on health-related outcomes, the FTC additionally requires:

…tests, analyses, research, or studies (1) that have been conducted and evaluated in an objective manner by qualified experts; (2) that are generally accepted by qualified experts to yield accurate and reliable results; and (3) that are randomized, double-blind, and placebo-controlled human clinical testing of the Device, when qualified experts would generally require such human clinical testing to substantiate that the representation is true.

The FTC is setting the evidence bar for health apps that make really any health-related claims, making it clear that they intend to take a close look at supporting data. This action is only the latest in a series that the FTC has taken against deceptive health apps and likely won’t be the last. With the FDA having decided to keep focused on a small sliver of high risk health apps & digital health devices, this action makes it clear that there will be some rules of the road for the rest of the digital health ecosystem.

Sources: FTC Press Release, FTC Complaint & Settlement