By Christopher Rowland, The Washington Post, 6 December 2018
|Jeff Williams, Apple's chief operating officer, says the tech|
giant's latest smartwatch "is the ultimate guardian for
your health." (Marcio Jose Sanchez/AP)
The contradiction sums up the deeper questions raised by the introduction of a mass-market monitoring tool for the heart. Apple’s products are designed to inspire, with clean designs and seamless operation. But health care is messy and unpredictable.
The latest gadget worn on the wrist is simply not accurate enough to handle the task of assessing serious medical conditions, according to health officials. It’s mostly a gateway for conversations with your doctor, and Apple’s detailed setup screens for the new watch are loaded with warnings and explanations, including one that informs people with atrial fibrillation that the Apple Watch app is not for them.
But even those who have not been diagnosed with the condition might be unduly alarmed by the app’s warnings.
“What’s going to be a bigger problem is these false positives and people with normal hearts who have intermittent fibrillation” and who do not require treatment, said Eric Topol, a cardiologist and director of the Scripps Research Translational Institute. He said those potential false positives probably will lead to cardiac stress tests, unnecessary use of blood thinning medications and even unwarranted catheterizations.
“At the least we’re going to see a lot of engendered anxiety and, at worst, it will be beyond anxiety,’’ Topol said. “Its value is if it’s used only in the right people — not for 20-year-olds who have an Apple Watch.’’
The takeaway for Silicon Valley is that the Apple Watch signifies substantial strides in health care and is forging a path to the future. But the revolution in medicine and wearable tech is not yet here.
There are possibilities for future advances, such as gathering electrical signals from the heart in real time, at the precise moment when a patient feels ill or a fluttering heart. Storing that data and sending it to a doctor will lead to better options for patients and doctors, said Ben Scirica, a cardiovascular specialist at Brigham and Women’s Hospital in Boston.
“The potential to really understand somebody’s disease is enormous,’’ Scirica said. “I think this is the beginning of a real sea change in how physiologic and biologic data can be collected outside traditional care settings.’’
But potential false positives for atrial fibrillation are a significant issue in the new app. The Food and Drug Administration cleared it for use even though, in a clinical study, 20 percent of the time the watch’s warning of atrial fibrillation was not confirmed by an EKG patch the study subject also was wearing.
Apple said, of that 20 percent, nearly all were classified as “clinically relevant arrhythmias,’’ indicating they warrant attention.
A separate app that Apple released Thursday, an electrocardiogram that displays heart rate when you put your finger on the watch crown for 30 seconds, is more accurate, according to figures that Apple released. It does not work well if it’s wet or if your skin is wet from rain or perspiration. Apple recommends holding your arm still on a table or leg to get an accurate reading. It is available for download only on the Apple Watch Series 4. This app carries no warning for people diagnosed with atrial fibrillation.
Neither the atrial fibrillation detection nor the electrocardiogram are meant for use by people under 22 years old, according to the FDA’s approvals, which is the threshold for a pediatric medical device requiring a separate approval.
Because of so many complexities, multiple setup screens for the apps guide consumers through the context and nuance of normal heartbeat, irregular heartbeat, and the risks of stroke and other cardiovascular maladies.
Apple, which declined to comment for this story, appears to be aware of the challenges.
The company was criticized for appearing to put marketing before medical accuracy in September when it unveiled its latest watch and the heart monitoring apps with this dramatic proclamation by chief operating officer Jeff Williams: “Apple Watch Series 4 is the ultimate guardian for your health.’’
Thursday’s release of the apps contained came with no hyperbole.
The setup screens are loaded with warnings, including statements that the watch cannot detect heart attacks, it cannot detect strokes, and it is not always on the lookout for signs of atrial fibrillation.
If you check a circle saying you have already been diagnosed with atrial fibrillation, you land on a screen that says this app is not for you.
The company’s news release on Thursday contained a statement about the limitations of the technology from the president of the American College of Cardiology, C. Michael Valentine.
“The idea that wearables can be used by both patients and their health care providers to manage and improve heart health holds promise and should also be approached with caution,’’ he said, “to ensure information and data are used responsibly and in concert with other evidence-based tools and guidelines.”
Observers say Apple laid the groundwork with the FDA to develop an approval pathway for its heart apps before submitting its medical device application on Aug. 14. The FDA cleared it for marketing less than a month later, the day before Apple’s Sept. 12 unveiling.
The uncommonly speedy device review was taken as a signal that the FDA is highly receptive to wearable tech that empowers consumers.
Apple also is among a handful of companies in a group working to develop rules for future rapid approvals of health-care software.
“It’s going to help a lot of digital health companies,’’ said lawyer Bethany J. Hills, who head’s the FDA practice at law firm Mintz Levin.
But for skeptics, the fast approval for the Apple heart apps was an unsettling indication that the agency is not sufficiently scrutinizing consumer tech that does not perform as well other devices on the market.
“There are a lot of tech companies that are focused on the consumer-grade medical device,’’ said Bradley Merrill Thompson, a Washington lawyer at Epstein Becker Green who represents clients before the FDA.
He said the Apple apps are not designed for sick people but rather for the “worried well’’ who want to monitor their biological signals.
“There’s probably a big market for it. I don’t doubt the economics of it,’’ Thompson said. “I’m just not sure of the public health imperative behind it.’’