2 big announcements came out around CES that shined a light on all the pomp and circumstance that you hear at a show like CES and the Digital Health Summit. The first was Lumosity’s $2 million in refunds to settle Federal charges with the FTC for deceptive marketing practices.
The FTC commented:
“Lumosity preyed on consumers’ fears about age-related cognitive decline, suggesting their games could stave off memory loss, dementia, and even Alzheimer’s disease,” said Jessica Rich, director of the FTC’s Bureau of Consumer Protection. “But Lumosity simply did not have the science to back up its ads.”
The company said in a statement that the FTC’s charges and the resulting settlement stem from “marketing language that has been discontinued” and that the company’s focus “has not and will not change.”
The lawsuit filed in federal court this week claims that the wrist-based activity tracker is consistently misrecording users’ heart rates by a “very significant margin.” It also takes aim at Fitbit commercials with slogans like “Every Beat Counts” and “Know Your Heart.”
“Far from ‘counting every beat,’ the PurePulse Trackers do not and cannot consistently and accurately record wearers’ heart rates during the intense physical activity for which Fitbit expressly markets them,” the lawsuit states.
Here’s Fitbit’s response:
Fitbit stands behind our heart rate technology and strongly disagrees with the statements made in the complaint and plans to vigorously defend the lawsuit.
Some of you might have read my article where I wrote that Fitbit’s data isn’t clinically relevant. The challenge is that they give the impression that it is clinically relevant. It’s a fine line you walk when you don’t want to take the time and spend the money to do the clinical studies and FDA clearance that’s needed to make clinical claims. Anecdotal results isn’t enough. Plus, the media can take and make whatever claims they want even if you are very careful with your words.
This discussion is going to become really important as clinically relevant devices that have gone through the clinical studies and can make the claims start to hit the market. It just takes years for these studies to see the light of day. Many would argue that it’s not fast enough. They’re right. It takes forever, but you’re walking a fine line in the claims you make while you wait for the results to be published.
While we wait, Doctors will continue to use and share these various digital health solutions and offer their first hand experience using the products. It’s just a really hard balancing act when the company starts to promote these stories.
Watch for this discussion to really come into focus in 2016. Count on legislation which clarifies what’s acceptable and what’s not as well.