Tech juggernaut Apple’s splashy September announcement that it had received FDA clearance to market the Apple Watch Series 4 as a device capable of conducting electrocardiograms (ECGs) signals a serious foray into medical devices. But while physicians agree the technology has potential, several have expressed concern it could create unnecessary paranoia among users.
FDA Commissioner Scott Gottlieb enthused at length about the development in a statement, saying that the two mobile medical apps on-board allow consumers to take a more active role in their own health. The over-the-counter ECG app monitors heart rhythms and can alert wearers of the presence of atrial fibrillation (AFib). A second app is described as an “irregular heart rhythm notification feature” that analyzes pulse rate to identify episodes of irregular heart rhythms suggestive of AFib.
FDA’s sign off-on the technology offers consumers nominal reassurance that findings are accurate, one physician said.
“When you’re talking about potentially notifying someone that they have a very serious medical condition…I do think that federal regulators need to be involved, just as they are with consumer genetic testing kits and so forth,” said Ford Vox, a physician who specializes in rehabilitation medicine. “It’s really our line of defense with regards to these technologies that could theoretically harm consumers.”
Securing FDA’s endorsement is also indicative of the seriousness of Apple’s entrée into the medical space, evolving from so-called “vanity health metrics”—how many steps we take, etc.—to “something that empowers us to manage our health a little bit more proactively,” said Angela Radcliffe, general manager for trial solutions at the marketing firm PulsePoint.
Moreover, the clearance speaks to the way the technology may evolve. Apple, to maintain good standing with the agency, should be committed to honing its algorithm to avoid unnecessarily panicking people, while spurring developers to innovate around the new heart monitoring platform.
Nevertheless, the potential for paranoia is real, experts say. Greg Marcus, a cardiologist and director of clinical research at the University of California San Francisco, said he worries that the apps could lead to unnecessary healthcare utilization, layering additional burdens on already overworked doctors.
“I think there are some patients or individuals for whom this device will be useful,” he said. But, “there will no doubt be some individuals who suffer unneeded anxiety, and will probably experience unneeded physician visits because of what they will find. We don’t know yet the way it will ultimately fall.”
Vox is similarly skeptical, citing false alarms as his number one concern. Diagnosis of AFib is an evolving science, and empowering consumers with that info will undoubtedly result in some issues. Specifically, he said he was surprised to learn that the device will now automatically contact emergency services (utilizing Siri) if it senses immobility after a fall—another new feature.
“It’s going to be very bad news for Apple if there’s a rash of stories from small hamlets across the country about overburdened ambulance services going out for Apple Watch [wearers],” Vox said. “Apple must have supreme confidence that this technology is super accurate. We’ll see how that works out.”
Will the harms ultimately outweigh the benefits, or vice versa? C. Seth Landefeld, a physician and member of the U.S. Preventive Services Task Force, said USPSTF looked at whether screening with ECG for AFib in asymptomatic older people does more damage than good. As of now, he told MM&M, universal AFib screening isn’t recommended. More data are still needed.
The medical apps’ clearance was based on two data sets, according to STAT, one consisting of 588 patients, roughly half of whom had permanent or persistent AFib (this cohort was studied to ensure the app’s ability to properly classify rhythm recordings), and a second cohort of 226 participants who had received at least one notification that they may have AFib and who were tracked to see if they really did have it (as detected by an ambulatory cardiac monitor). Neither data set had been peer-reviewed, though.
“There’s very little research on wearable devices such as Apple Watch [Series] 4, or on other new technologies that would allow much more frequent monitoring,” Landefeld added. Traditionally, ECGs were obtained either at a doctor’s office or a public health event.
Wearables, he said, are changing the screening landscape—for the better or not he isn’t sure.
One company, AliveCor, had already offered a similar FDA-cleared ECG app, and it seems likely that more tech companies will follow their lead. “I think this is potentially the beginning of this foray into actual healthcare,” Marcus said.
Meanwhile, tech companies need to be aware that drowning physicians in patient data is not helpful. “Physicians are already overworked, and don’t have as much time as they would like to spend with each of their patients,” Marcus said. “A step that’s going to be necessary to really make good use of this incredibly valuable data…is to figure out the data-management aspect.”
Another important factor in considering the usefulness of the collected data is that Apple Watch wearers tend not to be the same population of people concerned about AFib. The former tend to be young, healthy, and affluent, meaning it’s unlikely that consumers will be buying the device strictly for its ECG capabilities, Vox said.
Marcus agreed. “It’s likely that people who use Apple Watch are more fitness savvy, wealthier, with greater access to care, and potentially at lower risk for some of the diseases that would be of interest,” he said.
AFib specifically is more common in older people, those with high blood pressure, heart failure and various other maladies. Theoretically, the ECG could help doctors make the diagnosis of other arrhythmias. But even those would still require a physician to verify the diagnosis.
“I would say even if the algorithm flags the presence of AFib, that it needs to be overread by a trained physician before a final diagnosis is made,” Marcus said.