Do you have AFib? That’s short for atrial fibrillation, an irregular heartbeat that as many as 6 million people in the United States may have, and it’s dangerous because AFib can create a blood clot that could cause a stroke. In fact, AFib is the leading cause of strokes. Trouble is, many people with AFib have no symptoms – such as palpitations or shortness of breath – and don’t know they have it. It’s also something that can come & go, often unnoticed by physicians unless it’s happening as they check your heart. AFib grows more common the older you get.
Apple has teamed up with researchers at Stanford University to see if a new app – called the Apple Heart Study App – can detect these arrhythmias so reliably that the Food & Drug Administration will approve using an app with the Apple Watch and iPhone as a medical device, a designation just given to the AliveCor KardiaBand, a band for the Apple Watch, which can produce an EKG on the watch by holding down a button, an EKG that you can send to a physician.
The difference is that Apple will be seeking FDA approval for an app which automatically detects and records AFib – whether the wearer knows it’s occurring or not, and without holding down a button for 30 seconds. To do that, they need adults with an Apple Watch (Series 1 or later) to download the heart study app and sign up.
The sensors on the back of the Apple watch are constantly reading your heart rate as blood flows through your wrist, and will be checking if the rhythms indicate AFib. The app will check 6 times before alerting the user with a buzz and a visual notification that their heart rhythm may be irregular. At that point the wearer will be connected by voice or video with a physician at America Well – a telemedicine provider – who will ask, among other things, if the person is having any symptoms, such as light-headedness or chest pain, and arrange for the person whose AFib was detected to wear a BioTelemetry ePatch monitor and the data collected goes to the Stanford study.
The study is expected to last about a year, looking at how the Apple app compares to the medical-grade ePatch as far as determining the correct heart rhythms, and if the app proves accurate enough, Apple will submit the data to the FDA to have an AFib monitoring app approved as a medical device. It’s not clear what other uses Stanford Medicine might put to the data, which will not include users’ names.
Apple CEO Tim Cook has made clear that they don’t want the watch itself to become a regulated medical device, as that would complicate future development of the Apple Watch, so they are planning to seek approval for just an app.
I was very interested in this study because I have had episodes of AFib or its almost as serious cousin, atrial flutter. And as with many people, I did not have any symptoms; in one instance my cardiologist picked it up during a routine annual check-up, which I get because of heart valve repair surgery more than 10 years ago.
Unfortunately, I cannot participate in this Apple/Stanford study because I already have a history of AFib, and in fact, no one with such a history will be included. But if you’re over 22 (and we presume anyone visiting Tech50+ is well over that age!) you can take part in the study. You need to have an Apple Watch and an iPhone, download the heart study app and apply to participate. There’s no charge for the app, nor monetary compensation for taking part in the study. But you may find out you’re one of the millions of people with undetected AFib, which means you can be treated to avoid a stroke. Payment enough, it seems to me.