With The AW4, Apple Started The Revolution In Wearable Healthcare

The next time you glance at your watch, it may tell you a lot more than just the time.

With the recent announcement of FDA approval for the first-ever consumer wearable health device – the electrical heart rate sensor embedded within the new Apple Watch 4 – lawmakers have begun paving the way for an entirely new industry of consumer-based healthcare devices. The significance of Apple’s De Novo clearance cannot be overstated (more on that below), and it foretells of a growing intersection between wearables, personal health, and the healthcare industry itself, which could drastically change the way we approach patient engagement and care.

In fact, these changes have been brewing for a long time, and the new Apple Watch serves as a lens through which we can explore how new digital health technologies and the increasing involvement of traditionally consumer technology giants will shape the future of health.

Data Details From Off The Cuff

The first and most obvious change wearable technologies such as the Apple Watch bring to consumer care is one that has revolutionized countless other industries in recent years: access to big data. With its ECG sensor and app, the Apple Watch provides unique patient data surrounding atrial fibrillation, or AFib, an irregular heart rhythm that can lead to heart conditions such as blood clots, stroke, and heart failure. Currently, about 2.7 million people (1 percent of Americans) have AFib. Compare this to the fact that Apple is expected to ship 71.5 million smartwatches by 2021, and that’s a lot of previously unattainable data that could change the way we approach population health and medical research.

According to Boca Raton, Fla., cardiologist Stephen Servoss, M.D., M.Sc., F.A.C.C., “As the accuracy of the Apple Watch 4 is carefully assessed following its release to consumers, it will be important to utilize the device as an indicator that further medical evaluation is required, rather than a definitive means of diagnosis.”

And in fact, previous versions of the watch are already doing just that. While the watch isn’t intended to monitor people who have previously been diagnosed with AFib (insert a resounding “yet” here), Stanford’s Apple Heart Study has already begun compiling heart health data from older Apple Watch models. The aim is to determine if heart rate data can be used to preemptively identify irregular heart rhythms and conditions, and while the study will officially end in January 2019, there’s no doubt that the device has already saved lives by encouraging wearers who have detected an irregularity in their heart rate to get checked out.

Apple has also announced a similar partnership with medical device company Zimmer Biomet, whose aim is to better understand how patients should prepare for, and recover from, common knee and hip replacement procedures. Zimmer Biomet CEO Bryan Hanson called the study “one of the largest evidence-gathering clinical studies in orthopedic history,” and hopes that it will shed light on why recovery times vary drastically for patients undergoing orthopedic surgery.

This capability stems from the watch’s step and movement tracking features, which are also being used for a new purpose: fall detection. The watch’s new algorithms can analyze wrist trajectory and impact acceleration and will send the wearer an alert if a fall is detected. If the alert isn’t dismissed or the watch senses the wearer has not moved for a minute or more, it will automatically contact emergency services and the person’s emergency contact. Orthopedic surgeon Dr. Jason Weisstein of Colorado Center of Orthopaedic Excellence and medical director of orthopedics at Modernizing Medicine envisions how the watch’s capabilities could be extended to improve remote patient monitoring and care:

“Around one out of four elderly individuals will sustain a fall. Those individuals who are at risk for fall will have a quicker way to get help by leveraging this new technology,” shares Dr. Weisstein. “Traditionally, people who have fallen have to wait for someone to come to their aid, or a necklace-like device needs to be manually activated to call for help. This new Apple device would eliminate any delay in getting help and expedite care.”

The wealth of information wearable devices can gather is unprecedented – and will only continue to grow as adoption reaches market saturation. These examples foretell of the countless other ways wearable health technology may affect clinical research and the unimaginable insights we could gain into how our daily actions affect our overall well-being.

An Apple A Day Keeps The Doctor…On Call?

Wearable health devices could also change the way we interact with doctors, schedule appointments, and approach acute care. Telemedicine has long been on the horizon for the healthcare industry, but low adoption has meant that many of its fabled benefits, such as reduced costs, have failed to come to fruition. The burgeoning wearable health market could be another step in the right direction toward more widespread adoption of virtual care.

So far, virtual medicine has been chiefly used for consultations and check-ins, but as the adoption of wearable devices increases, virtual patient monitoring through integrated health devices will change what is possible. Some of the largest populations that could benefit from the increasing use of telemedicine are rural and aging patients, who are often unable to overcome the burden travel places on receiving consistent care. Instead, remote patient monitoring through wearables, combined with intermittent telehealth checkups, could help to preemptively identify chronic conditions among these populations.

Other market dynamics are further aligning to promote telehealth adoption, most notably CMS’ 2019 Physician Fee Schedule and Quality Payment Program, which proposes to incentivize remote patient monitoring and telehealth programs through improved reimbursements for physicians. These proposed regulations – which will be decided in November – could create the perfect environment for telemedicine to take off, as adoption would be driven by both consumer use of wearables and physician incentives.

The (Regulatory) Elephant In The Room

Of course, as with any healthcare innovation, overcoming regulatory hurdles is still a challenge – but one that seems to be fading. According to a recent interview with Bloomberg, FDA Commissioner Scott Gottlieb says the institution is ready to make the healthcare market more “accessible to nontraditional manufacturers, or traditional technology manufacturers that haven’t before entered the medical space.” With the burgeoning wearable market, it’s the right time for the FDA to take a look at the complex and prohibitive U.S. medical device approval process and consider simplifying it to promote innovation in this space.

The Apple Watch’s rapid approval could have something to do with this new, lighter touch the FDA is promising for wearable medical devices. However, classifying the Apple Watch as a De Novo device – meaning that it’s a fundamentally new kind of product – certainly helped with the company’s lightning-fast approval, which took less than 30 days and came just 24 hours before the watch’s launch. It remains to be seen how the FDA will approach approval of subsequent devices in this space.

One thing is for sure, however – even if the Apple Watch isn’t technically De Novo (wearable EKGs do, in fact, already exist) the wearable health industry certainly is, and only time will tell how the regulatory process will shape up – not to mention the innovations they’ll bring about for consumer-centric healthcare.

Joe Harpaz

Joe Harpaz

President and Chief Operating Officer

Joe Harpaz serves as President and Chief Operating Officer of Modernizing Medicine. In his role, Joe leads growth and scale at Modernizing Medicine as the company aims to deliver best in class product and customer experience to make a true difference in healthcare tech.

Joe has over 20 years of experience in building and leading high growth B2B software businesses that operate in complex and regulated industries. He’s known for his ability to lead and inspire large organizations while driving innovation and growth at scale. Learn more about Joe here. 


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