The new Apple Watch 4 has an electrocardiogram (ECG or EKG) feature that is ‘cleared’ but not approved by the Food and Drug Administration (FDA).
Having this seal of approval lends the product consumer trust – but comes with limits that don’t apply to products that are FDA approved – the true regulatory gold standard.
Apple’s health technology has clearance from the FDA for people over 22 to use it, but, technically, no one younger than that should have the device.
What’s more, the Apple ECG is not intended for people who have been diagnosed with atrial fibrillation – the group at greatest risk of the heart rhythm abnormalities the feature is meant to detect.
The audience – and Apple loyalists worldwide – are only so thrilled about the new tech ‘because they don’t know anything about the science of screening for diseases in a population with a very low prevalence of that disease,’ says Dr David Brown, a Washington University, St Louis cardiologist.
Apple COO Jeff Williams introduced the Apple Watch 4’s EKG feature to fanfare – but cardiologists aren’t so sold on the feature they fear will return false positives
An electrocardiogram is a crucial diagnostic tool for heart disease and arrhythmias.
In a hospital or clinic setting, the test monitors the heart’s electrical activity through electrode sensors placed on the chest and, sometimes, limbs.
It is also the go-to diagnostic tool for medics responding to a suspected heart attack.
And now the FDA has cleared it as part of a trendy wearable for anyone – as long as they are over 22 and don’t have the most common heart rhythm problem.
The previous mode of the Apple Watch was already equipped with a heart rate monitor that tracks the wearer’s usual heart rate during various states of activity and notifies them if something is off, given whatever activity they seem to be doing.
Screening sounds good, but it’s really part of this misconstrued ‘quantified self’ movement
Dr David Brown, Washington University St Louis cardiologist
And in December 2017, the FDA approved the KardiaBand, an add-on for the device that gave it ECG capabilities.
Now, that technology is fully integrated into stock Apple Watches.
And people are very excited about it, as was evident from the cheers, whistles and applause that erupted the moment Apple COO uttered the word ‘electrocardiogram’ on stage at the company’s September 12 event.
Notably, atrial fibrillation is a problem of old age, becoming increasingly prevalent in people from their 60s to 70s to 80s, and so on.
‘I don’t know too many 80-year-olds that want or have Apple Watches. It’s the 30-year-olds who are generally healthy and wealthy who are wearing an unproven device for atrial fibrillation,’ says Dr Brown.
Their risks are so low, but the monitoring so constant, that he is concerned there will be a a surge in false-positives from the new Apple Watches.
‘You can imagine a 30-year-old, on a Saturday night, gets a notification from the Watch [to take an ECG], Googles it, and finds out they’re at risk for a stroke,’ says Dr Brown.
‘They’re going to end up in a clinic or ER, distracting doctors from patients in need of attention, getting unnecessary tests, and then they’re told to go home because there’s nothing wrong.’
Studies – including one from Stanford University, which has now partnered with Apple for an ongoing heart study – have shown that the device is 98 percent accurate.
But the watch will only instruct a wearer to take an ECG if Apple’s heart rate sensors detect unusual activity.
Though there have been reports of the previous, simpler heart monitor saving the lives of people who didn’t realize they were in cardiac distress, there are plenty of accounts of false alarms, too.
I don’t know too many 80-year-olds that want or have Apple Watches. It’s the 30-year-olds who are generally healthy and wealthy who are wearing an unproven device for atrial fibrillation
For example, the final moments of last year’s NFL playoff game between the Minnesota Vikings and the New Orleans Saints were so dramatic that the heart rates of fans on couches across the country went suddenly from slow and steady to speeding and erratic, setting off all the watches’ bells and whistles.
Those fans, of course, were not in medical distress, simply in emotional distress or elation, depending on who they were cheering for.
And even if the sensors are only incorrect one or two percent of the time, that could mean false positives for many people, Dr Carter pointed out.
The Stanford study involved under 600 patients. Last holiday quarter alone, Apple sold eight million watches. If they had the new watch, and just one percent of them gave false positives, that would still be 80,000 people making panicked trips to the ER, unnecessarily.
‘Screening sounds good, but it’s really part of this misconstrued “quantified self” movement,’ says Dr Brown.
‘[The Apple Watch] is not tested in terms of its effect on any kind of health outcomes; it’s just that the device and it’s algorithm work.’
That is the essence of what it means for it to have FDA clearance, but not approval.
The device is safe, it does what it claims to with reasonable accuracy, but that doesn’t mean the FDA has confidence it will reduce the rate of heart arrhythmias among Americans.
Yet, ‘it’s a stamp of approval from a lay person’s perspective of the device,’ says Dr Brown.
‘They’re going to see that, and the president of the American Heart Association endorsing this as a way to potentially improve health outcomes without any data, and it would be silly to believe those two things will help them.’
He adds that it is ‘telling’ that the new Apple Watch is not cleared – much less approved – to be used by people who have already been diagnosed with atrial fibrillation.
‘Is it that Apple doesn’t want the liability of having their device used in people that have a much higher risk? If they’re so certain that it’s more than 98 percent accurate, you’d think they’d want it used in people at risk of problems,’ Dr Brown says.