MacWorld: Developers of the Apple Watch app Cardiogram worked with researchers leading the University of California San Francisco’s Health eHeart study to develop a ResearchKit-based study of their own called mRhythm. On Thursday, Cardiogram and UCSF’s cardiology division are presenting the results of that 14-month study, which collected more than 100 million heart rate data points from more than 6,000 Apple Watch users. Cardiogram developed a machine learning-powered algorithm that can detect atrial fibrillation, which is often asymptomatic.
Cardiogram’s algorithm was tested against an in-hospital test called cardioversion. Patients experiencing atrial fibrillation, which affects one in four people in their lifetime and causes 25 percent of all strokes, wore an Apple Watch while undergoing cardioversion to compare outcomes. Both segments, the cardioversion test and the Apple Watch’s heart rate data, were blinded against whether the patients’ heart rates were normal or abnormal, then sent to Cardiogram’s algorithm. The results: the Apple Watch data detected atrial fibrillation 97 percent of the time.
Apple has been communicating privately with the FDA for years about medical devices and so far the FDA has taken a light touch to Apple but these issues are coming to a head. As with the regulation of DNA tests, the regulation of these devices is going to raise important free speech issues. It’s one thing to ensure that the devices do what they say they do at reasonable accuracy (measure heart rate, identify genes etc.) but regulating what advice may be given on the basis of such readings is problematic. Can the FDA regulate a website that says go see your doctor if your heart rate monitor exhibits these particular readings? Why is an app that tells you the same thing any different?
Hat tip: Samir Varma.