The New York Attorney General's office announced today that it has settled with three mobile health apps around alleged misleading claims and irresponsible privacy practices. The apps include Adidas subsidiary Runtastic; MIT Media Lab spinoff Cardiio, and Matis, maker of "My Baby's Beat", an app that claims to monitor a fetus's heartbeat using the iPhone microphone.
“Mobile health apps can benefit consumers if they function as advertised, do not make misleading claims, and protect sensitive user information,” New York Attorney General Eric Schneiderman said in a statement. “However, my office will not hesitate to take action against developers that disseminate unfounded information that is both deceptive and potentially harmful to everyday consumers.”
MobiHealthNews reached out to the app developers for comment, but they either couldn't be reached by press time or declined to comment for this story.
Cardiio is an MIT Media Lab spinoff that was also a member of one of Rock Health's first accelerator classes. The company makes an app that uses the smartphone's camera to measure heart rate.
Even though the company spun out of the MIT Media Lab and its technology is licensed from MIT, that doesn't constitute an endorsement from MIT, something the New York AG office says Cardiio claimed. Schneiderman's office also said that Cardiio hadn't tested their app on users who had engaged in vigorous exercise, despite marketing it to those users. The company has since made its validation studies available on its website.
Runtastic is an Austrian fitness app company that was acquired by Adidas in 2015. Similar to Cardiio, the AG office says the app has not been tested or validated for those engaged in vigorous exercise, despite being targeted at them.
Mantis, an Israeli company, had perhaps the most serious charges against it, with the AG office accusing the company of making claims that would require FDA clearance.
"Although Matis exhorted consumers to use My Baby’s Beat rather than a fetal heart monitor or Doppler, it never conducted, for example, a comparison to a fetal heart monitor, Doppler, or any other device that had been scientifically proven to amplify the sound of a fetal heartbeat," the New York AG office said in a statement.
On its website, Matis previously described the app as "a unique, state-of-the-art, iPhone application that monitors a fetus’s heartbeat during pregnancy, using only the iPhone / iPad microphone, WITHOUT ANY ACCESSORY!" Now the site calls it "a unique IOS application that allows you to listen to your baby's heartbeats and other sounds", adding that "the app uses only the device’s microphone, with no accessory required." The company currently advertises the app as "a bonding experience" for mothers and babies and stresses that it is not an FDA-cleared medical device.
Update: Since this story was posted, Matis posted a statement to its website about the settlement, defending the app's scientific basis, reiterating that it has never advertised itself as a medical device, and affirming that it now meets New York's "very high standards". Read the statement here.
According to the AG office, the settlement also involved the privacy policies for all three apps, requiring affirmative consent to the policy (rather than having it be opt-out) and full disclosure of what information is collected and how it's used.
Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in regulatory law for digital health, pointed out that this action sets an interesting precedent, since it highlights the sheer number of potential enforcers developers in the health space need to consider.
"This is interesting, because yet again we have an agency other than FDA weighing in on what it thinks is misleading advertising," he told MobiHealthNews in an email. "Over the last several years, we've seen the FTC pursue mobile app companies on the basis of unsupported claims in the medical realm. Indeed it has pursued claims that would likely fall under FDA regulation. But the federal government doesn't have a monopoly on regulating advertising, even for health-related products. Most states have agencies that oversee advertising within their state, even though much of the advertising is done broadly across the states. This means software developers have to think about potentially all 50 states, and whether an enforcer in any state might take offense at their claims. Clearly at least the New York Attorney General is not relying on the federal government – either the FDA or FTC – to take appropriate actions."