Apple is inserting its presence into our lives once more, this time via a medical application. Apple is partnering with a group of clinicians at Stanford, as well as telemedicine vendor American Well, to test whether Apple Watch’s heart rate sensor can detect abnormal heart rhythms in a cohort of patients.
The announcement coincided as Apple unveiled its newest version of the Apple Watch with wireless connectivity, reports Dr. Mark McKenna.
It’s unlikely the FDA will classify the Apple Watch as a medical device. But the Apple Watch could serve as a useful screening tool for high-risk patients — if its heart rate monitor proves to be sufficiently sensitive and accurate. Millions of people at risk for blood clots, strokes and other complications will benefit from the tool.
American Well’s CEO Roy Schoenberg stated that telemedicine companies are working closely with wearable makers. If a problem is detected, he said, “the best route forward is to put a health care professional out in front.”
American Well is among the multiple companies already providing apps for the iPhone so that provide a connection with a doctor in just minutes.
97% accuracy in UCSF studies
Apple Watch has already been used in studies to screen for heart rhythm abnormalities. Earlier this year, a start-up called Cardiogram released the results, in partnership with University of California, San Francisco clinicians. Cardiogram created the heartbeat measurement app.
In their study, researchers found 97 percent accuracy in detecting the most common abnormal heart rhythm when paired with an AI-based algorithm, explains Dr. S. Mark McKenna.
The 6,158 participants were recruited through the Cardiogram app on Apple Watch. They were participating in the UCSF Health eHeart study and most had normal EKG readings. However, 200 of the participants had been diagnosed with paroxysmal atrial fibrillation (abnormal heartbeat).
Engineers were able to “train” a neural network to identify these abnormal heart rhythms from the Apple Watch heart rate data.
This data is based on a preliminary algorithm — but provides a promising medium to identify and prevent stroke due to atrial fibrillation, which is the most common cause. Specialists estimate that two-thirds of those strokes can be prevented with relatively inexpensive drugs.
Our aging population is most prone to stroke risk, and has increasingly adopted Fitbits and Apple Watches, so there is potential to save lives with an atrial fibrillation app.
Cardiogram and UCSF will continue the eHealth study and further validate the deep neural network “against multiple gold standards, incorporating the results into the Cardiogram app itself, and investigating the ability to detect health conditions beyond atrial fibrillation,” according to Cardiogram.
Greg Marcus, a cardiac electrophysiologist at UCSF who was involved with the Cardiogram study, said Apple benefits from the real-time access to raw data from its heart rate sensor. “That’s potentially more powerful,” he said, than the signals that third-party developers can access through Apple Watch.
Tim Cook weighs in on heart health applications
Apple’s Tim Cook hinted at the company’s interest in heart health applications in a recent interview with Fortune magazine, says Dr. Mark McKenna.
“We started working on the Apple Watch several years ago,” he said, and one goal was “performing some measurements of your health that people were not measuring, at least continually. Like your heart. Very few people wore heart monitors. We’re extremely interested in this area. And yes it is a business opportunity.”
Cook described the medical health activity market as the “largest or second largest component” of the economy.
Apple has hired Sumbul Desai, a star on Stanford’s digital health team working on projects related to Apple Watch. Apple has been in talks with developers and hospital industry groups about bringing clinical data, such as lab and allergy results, to its devices.
Another Apple app in the works
Apple is rumored to be working on an Apple Watch sensor to monitor glucose levels through skin contact instead of a skin prick. While there has not been a formal announcement, Tim Cook was spotted wearing a prototype glucose monitor that would connect to the Watch, says Dr. Mark McKenna.
Apple has already filed for a patent covering several medical apps that would apply to the Apple Watch. The patent, titled, “electronic device that computes health data,” describes a device that comprises a camera, an ambient light sensor and a proximity sensor to measure and calculate health data. The patent was recently granted.
These actions suggest that Apple has far broader plans for its Watch. Getting FDA approval is another matter, as the FDA’s classification for medical devices involves regulatory hoops that Apple might not want to jump through.
FDA approval would likely be a difficult process for both the FDA and Apple, working around platform regulations — iPhone, Apple Watch or other Apple devices. Tim Cook has stated that his plans don’t go beyond creating a fitness and heart rate sensor to the Watch for that reason. Nevertheless, the FDA is providing guidance on Apple’s heart research study.
Industry experts predict that Apple might create two versions of the Watch – one for general use, another for medical tracking uses.
This isn’t the only medical device app, adds Dr. Mark McKenna. Smartphone-enabled mobile EKG readers have made great strides in recent years. The Mayo Clinic has added an EKG reader to the back of a smartphone and uses the Kardia app to determine abnormal heart rhythm. Their studies have determined it was as good as other EKG devices used in the doctor’s office.