An Apple a Day…

With the news of Apple’s September announcement now permeating society, many are left with more questions about healthcare than Apple’s new devices. While many previously thought about Apple as a modern, consumer tech company, their reveal of the Apple Watch 4’s ECG feature that has a stamp of FDA clearance has certainly made their foray into the med-tech industry a big splash. As a company dedicated to the use and development of technology in order to better prevent, diagnose, and treat heart disease, we’ve teamed up to give you the good, the bad, and the ugly about the new Apple Watch and what it means for you.

There are several devices out there that do similar things to the Apple Watch 4’s ECG feature. The companies that produce such devices fall into 2 categories: 1) Medical Devices; 2) Consumer Wearables.

Medical device companies such as AliveCor have been making heart rhythm monitors that people can purchase outside of the medical setting for years. AliveCor’s product line is validated and carries FDA clearance to detect abnormal heart rhythms such as atrial fibrillation, also known as AFib. Although their most popular – and older – iPhone case is easy and affordable, it was their newer KardiaBand, an Apple Watch band with ECG capability, that is much more similar to Apple’s new tech. AliveCor’s products are marketed at both consumers and healthcare providers.

Consumer wearables are those that would typically be categorized as part of the wellness industry as opposed to the healthcare industry, like medical devices. Companies such as FitBit have dominated this industry with fitness trackers and heart rate monitors. Nayan Jain, CTO at Heartbeat Health, says,

“Wellness devices like the Fitbit are intentionally marketed to consumers that want to be seen as living an active lifestyle. I see them as a fashion statement, more or less a signal to the world that says, ‘I am wearing this device to tell you that I’m health conscious.’”

From a doctor’s perspective, the interesting thing about Apple’s device is that it has the allure and perceived reliability of a medical device with the sex appeal of a wearable. The Apple Heart Study, a collaborative study between Apple and Stanford University, is looking at how good the Apple Watch is at identifying AFib, the most common abnormal heart rhythm. They allowed anyone with an Apple Watch who was over 22 years old to participate and had anyone that the watch identified as having an irregular heart rhythm wear an already approved heart rhythm monitor to confirm or refute the diagnosis made by the watch.

What got the FDA to clear this tech is that out of 588 people’s data, half of whom already had known AFib, the Apple Watch was able to interpret 90% of the ECGs it obtained. Furthermore, it correctly diagnosed 98.3% of people known to have AFib and correctly diagnosed normal heart rhythms 99.6% of the time. That’s all fine and dandy, but what’s a little worrisome is that while the ECG app did quite well, Apple also tested an irregular rhythm notification that was correct in identifying AFib only 41.6% of the time when compared to the standard heart rhythm monitor people got after the Apple notification. For those in this group that were wearing the Apple Watch and the monitor at the same time, this app was only correct 78.9% of the time. This is all according to a report from HEALTHNEWSREVIEW.ORG based on data obtained from Quartz and STAT from the FDA. The key point is that the ECG app is different than the irregular rhythm monitor app and one is clearly more accurate than the other.

Some might think that it’s great that this device is picking up on a lot of people who might not know they had AFib and could potentially prevent a lot of complications that would have happened from it going undiagnosed such as heart failure and stroke. The excitement is tempered when you think about how many people who wouldn’t have sought medical attention and are otherwise healthy will now be flooding the healthcare system with potentially false positive diagnoses based on what their watch told them though.

Currently, there are somewhere between 3 and 6 million people in the US with AFib according to the CDC, which costs the US about $6 billion per year. If you add in a whole new group of people seeking medical care for a finding on their watch, it’s hard to predict whether that would ultimately result in healthcare system savings or astronomical expenditures that may or may not actually improve outcomes.

When asked what the biggest breakthrough is with regards to the ECG feature, Jain says,

“Awareness. The Apple Watch was not the first consumer device to offer the ECG or heart rate tracking. It is the first to offer a health sensor in a device that we check everyday. It is a daily reminder that asks us to be mindful of our symptoms and lets technology into our lives to check our health when we forget. I think the ECG will get people thinking about their heart health and how important it is to living a full life. Given the time we spend online and connected, it is important that health monitoring is included.”

So you may ask yourself, what happened to AliveCor in all of this? Well, Vic Gundotra, AliveCor’s CEO and a former Google executive, said in a report to Business Insider that while Apple may have reported something unexpected, AliveCor has been bringing this technology to consumers for 7 years already. Gundotra said, “We love that Apple is validating AFib; just wait until you see what AliveCor is going to do next.”

All that said, we can’t deny Apple’s go-big-or-go-home approach. The medical community is looking forward to seeing what would usually be referred to as post-marketing surveillance, or clinical data of something widely available in large numbers to see how it actually affects the healthcare system and heart health. The tech community is also looking forward to large data sets of the device in use because as Jain puts it, “Artificial intelligence (AI) depends on access to data.” He notes that just how Apple has used our data to make recommendations for our personal interests through Siri, perhaps “they can use it to help us make better decisions around our health using AI.”

Holter and Wearables

So is Apple taking a step toward replacing cardiologists? We think this is unlikely and not just because we’d like job security. Being a doctor is about compiling and analyzing data to make and manage diagnoses, which AI will ultimately become very good at. It’s also about the personal connections, the trusting relationships, and the perception of things outside of traditional data sets. Vinod Khosla, a venture investor in Silicon Valley, believes that technology will ultimately replace about 80% of diagnostic work, leaving doctors (humans) to focus on the 20% left that largely represents the humanistic aspects of medicine. We believe that technology has the ability to be synergistic with traditional doctoring, improving our ability to help patients live longer, healthier lives. Despite that, in a Twitter poll of almost 300 people of an online community of Cardiologists and health professionals (#CardioTwitter), 71% said they would not recommend the new Apple Watch 4 to aid in the diagnosis and monitoring of heart rhythm disorders.

The concept of consumer tech blending with AI to improve healthcare is exciting, whether you’re a fan of the Apple Watch or not. Let’s face it… the healthcare and technology industries are closely related. Harnessing the power of one to help the other may be a 2 + 2 = 5 type situation. We look forward to seeing how this evolving medical wearable industry impacts actual patient care by analyzing our own data after the update with the ECG feature is launched to the public later this year. If you want to join us, send us your Apple Watch ECGs and heart rate data! Perhaps this Apple a day won’t keep the doctor away, but it may very well bring you and your doctor closer together.

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