For all the good the industry-leading Apple Watch family has done since the commercial release of the very first generation way back in 2015, there might be some unintended harm frequently caused by the universally praised health tracking tools to a significant number of unsuspecting users.
As you probably already know, the Apple Watch
has always included an optical heart sensor designed to detect pulse irregularities possibly signaling serious medical conditions the owners of the popular wearable devices may not be aware of prior to receiving an alert on their wrists. The 2018-released Series 4
model took the health monitoring capabilities of its forerunners to a whole new level by adding ECG technology to the equation.
This groundbreaking feature required FDA (Food and Drug Administration) clearance before it could actually be enabled for stateside use, but although Apple received the approval much faster than, say, Samsung
, one recent study highlights
a possible oversight in the certification process that can directly or indirectly lead to unnecessary patient anxiety and spending, as well as “excessive healthcare resource utilization.”
The heart rate monitor is not for everyone
This is obviously not something that Apple
likes to advertise very often given that the health tracking capabilities are undoubtedly the key selling point of the company’s hugely profitable Watches, but the FDA clearly stipulates that the abnormal pulse detection feature regularly used by pretty much everyone around the world is “not intended for people under 22 years of age” or “individuals previously diagnosed with atrial fibrillation.”
Instead, its explicit purpose is to identify potential signs of asymptomatic (also known as silent) atrial fibrillation in Apple Watch owners with no pre-existing heart problems, which is usually at the core of those dramatic stories of lives saved
that have been known to regularly make headlines
for the last few years.
The thing is far too many young and previously diagnosed Apple Watch wearers are often sent to the doctor to check for an illness that is either not there or doesn’t require immediate medical attention. Between December 2018 and April 2019, only 30 of 264 patients who visited Mayo Clinic sites in Minnesota, Arizona, Florida, Wisconsin, and Iowa after their smartwatches detected an irregular pulse received “new clinically actionable cardiovascular diagnoses of interest.”
The other 234 people basically wasted their and their doctors’ time, not to mention precious medical resources, while possibly incurring unnecessary expenses as well.
How can the FDA and Apple improve this aspect?
Although the conclusion of the recent study published in the prestigious Journal of the American Medical Informatics Association may seem quite clear, calling for the US Food and Drug Administration to “consider the unintended consequences of widespread screening for asymptomatic atrial fibrillation and use of the Apple Watch abnormal pulse detection functionality by populations in whom the device has not been adequately studied”, it’s unclear exactly how this problem can be fixed.
While no one ever expected the heart rate monitor and ECG capabilities of a $400 consumer device to be 100 percent accurate and infallible, a 10 percent or so success rate in detecting cardiac conditions “of interest” is without a doubt unacceptable.
At the same time, although pretty rigorous and well-documented, the new study pointing the finger at both Apple and FDA is itself not 100 percent trustworthy, failing to determine how many of the 264 aforementioned Mayo Clinic patients received automated heart rate alerts and how many performed manual pulse measurements on their own.
Furthermore, while the possible “overutilization of healthcare resources” sounds like a serious problem, it seems unlikely that the Apple Watch lineup could ever lead to that point in the real world. As highlighted by The Verge
, an older study concluded that under 1 percent of users received an abnormal pulse alert, which equates to a big but not medical system-paralyzing number.
Finally, as much stress and anxiety as a “false positive” ECG or heart rate result may cause for some people, that’s arguably a sacrifice worth making even if the Apple Watch “only” ends up saving one life every few months or so. Still, both Apple and the FDA could definitely do more to emphasize the purpose of the health monitoring tools available on your wrist, perhaps starting with some sort of a retail box label and those unsettling commercials
some people may wrongly consider to be uplifting.