The three app developers are Cardiio, which sells an app claiming to measure heart rate; Runtastic, which sells an app claiming to measure heart rate and cardiovascular performance under stress; and Matis, which sells an app claiming to turn any smartphone into a fetal heart monitor.
The investigation found that all three companies marketed their apps without having sufficient evidence to back up their claims. For example, Cardiio and Runtastic did not test their apps’ accuracy on users who had engaged in vigorous exercise. Additionally, Cardiio implied MIT endorsed the app, which was not true.
The companies have cooperated with the Office of the Attorney General. They agreed to provide additional evidence of app testing as well as changed their privacy notices to more accurately reflect their practices, which includes collecting and sharing personally identifying information. The companies will also pay $30,000 in combined penalty fees to the Attorney General’s Office and post clear disclaimers noting their apps are not medical devices and not FDA approved.
More articles on health IT:
6 updates on the worldwide ransomware attack
Trump signs cybersecurity executive order: 3 things to know
Mayo Clinic, Sensely collaborate on patient assessment solution
