The company touted its heart-tracking feature as proof that the watch can help people proactively manage their health. “The Apple Watch has become the intelligent guardian for your health,” Apple chief operating officer Jeff Williams, who oversees the development of the Apple Watch, said in the company’s presentation of new Apple products this week.
Onstage at the event at Apple headquarters, American Heart Association president Ivor Benjamin said that products such as Apple Watch offer “deeper health insights” that can promote longer, healthier lives. The technology used to flag potential heart problems is more complex — and closer to what physicians use in diagnostic tests — than the heart rate trackers used now by Apple, Fitbit and other wearable device makers.
The FDA has cleared Apple’s device as a Class II medical device, meaning that it is intended to diagnose or treat a medical condition and poses a minimal risk to use. (Other Class II devices include some powered wheelchairs and pregnancy kits, according to the FDA website.) In its letter to Apple clearing the feature, the FDA listed as a risk factor the potential for mistakenly flagging a problem, prompting unneeded treatment.
Physicians say the watch could be good for patients who have irregular heart rhythms but may not realize it. Some people who have atrial fibrillation, the condition for which the watch is screening, don’t always have noticeable symptoms. In an ideal situation, someone who doesn’t know they have a problem could get a warning from their watch and take that data to their doctor.
But there is also concern that widespread use of electrocardiograms without an equally broad education initiative could burden an already taxed health-care system. Heart rhythms naturally vary, meaning that it’s likely that Apple Watch or any heart monitor could signal a problem when there isn’t one — and send someone running to the doctor for no reason.
“People are scared; their heart scares them,” said John Mandrola, a cardiologist at Baptist Health in Louisville. “That leads to more interaction with the health-care system.”
An extra visit to your doctor may not sound like a bad thing, but Mandrola said it would potentially lead to another round of tests or even unnecessary treatment if there are other signs that can be misinterpreted.
And doctors might wind up facing a crowd of anxious Apple Watch users getting false signals — something physicians have already had to deal with as fitness trackers that monitor heart rates have become popular.
“I’ve had to tell patients: Just take off the Fitbit and don’t look at the data,” said Gregory Marcus, a cardiologist and director of clinical research in cardiology at the University of California San Francisco. But he recognizes there could be positive medical and financial outcomes from a watch-triggered doctor visit — especially if the ECG is accurate enough to allow for a diagnosis without the need for other tests.
“It’s too early to tell from a public health perspective whether the costs will outweigh the benefits,” Marcus said. There are many other factors, such as someone’s general health or age, that affect whether an irregular heartbeat needs to be treated, he said. Those must be evaluated by a physician to find the right approach for each patient.
What could help calm anxiety, he said, would be more general education about conditions such as atrial fibrillation. “Generally, physicians talk about these things among themselves,” he said. “Perhaps this movement into the consumer realm means educating the public about these issues, as well.”
Marcus — whose Health eHeart study is evaluating how technology can help patients — and Mandrola say they are optimistic about how data collected from Apple Watch from people who’ve opted in to studies can help researchers. But for those who wear the watch and get spooked by an alert, the concern that the warnings will cause unnecessary anxiety is real.
“I see patients; I see normal people come in, and most people are scared out of their wits,” Mandrola said. With the widespread appeal of the Apple Watch, he said, that’s only likely to increase. “You could get a tsunami of people coming in.”