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Wearable Medical Devices and the Future of Health Informatics

January 15, 2019

In the fall of 2018, Apple released its Apple Watch Series 4 models, the first consumer smartwatches that double as wearable medical devices thanks to their ability to generate an electrocardiogram test (ECG or EKG), which can inform you about your heart health. This release pushed the boundaries of wearable technology in healthcare and earned Apple a De Novo classification from the U.S. Food and Drug Administration (FDA).1

The ECG app utilizes electrodes built into the Digital Crown as well as an electrical heart rate sensor in the back crystal of the watch, so that when users touch the Crown the app can classify a heart rhythm after 30 seconds of use.

According to Apple, the app demonstrated 99.6% sensitivity when classifying if the heart is beating in a normal pattern, and 98.3% sensitivity when detecting signs of atrial fibrillation (AFib), a heart condition that can increase the risk of stroke, heart failure and other complications.2

Apple isn’t the only company trying their hand at wearable health technologies. On January 7, Withings introduced multiple wearables with ECG capabilities. And while they’re still waiting for FDA approval, they don’t actually need it to begin selling their watches and positioning their brand in this rapidly developing market.3

But what does the availability of this technology really mean for consumers and healthcare providers? Below, we explore the advantages and drawbacks of wearable health technology and patient-generated data.

Is Wearable Health Technology Helping or Hindering?

For many in the health informatics (HI) and healthcare industries, the development of an ECG app built into a consumer wearable device is a large step forward in the journey toward the Internet of Things for healthcare. However, there’s also a healthy dose of skepticism from some, like Kent State Professor John Sharp, who sees challenges for the future of “connected health.”

This advancement in wearable health technology opens the door for myriad possibilities, but it also leaves many unanswered questions. For healthcare providers, the biggest challenges will likely be acceptance and adoption. “The two reasons for this have been the lack of evidence of digital health effectiveness and the fear that [users] will be overwhelmed by the amount of data,” says Sharp. This fear was voiced on the very day the ECG app was announced, with Bay Area cardiologist Ethan Weiss tweeting “I can’t figure out if today is the best day in the history of cardiology or the worst.”4

The Apple Watch Series 4 has a feature that allows consumers to export a PDF of their heart monitoring data to their physicians. This feature will likely change the dialogue between healthcare providers and patients as well as provide physicians with valuable patient insights. But there’s also the fear that these PDFs will become a needle in a haystack in already crowded Electronic Healthcare Records (EHR) system.

The ECG app will generate a significant amount of cardiac related data, but for the medical community, it remains to be seen how well the software can distinguish between actual AFib and false alarms. Consequently, physicians are bracing themselves for an influx of concerned patients, as the app has the ability to both catch actual worrying cardiac episodes that might have otherwise gone unnoticed and create undue alarm.5

How Hi Can Help

As tempting as it may be to focus on the massive influx of data and the short-term challenges and limitations it presents, this healthcare development does show promise in the long term. This is where Professor Sharp sees HI providing solutions, specifically from those involved in analytics. “They can help develop more usable dashboards for physicians which help them identify potential problems from patient generated health data (data from apps and devices) and drill down into detailed data from those patients,” says Sharp. He also points out that researchers in HI can help design studies that track the everyday use of technology in healthcare and help determine how upgrades and new devices impact it.

When dealing with the influx of patient-generated information, Sharp notes that “There are informatics solutions now available to analyze vast amounts of data from wearables [such as] artificial intelligence tools to identify monitor readings which are trending towards areas of concern.” He also says that utilizing “the expertise of health informatics professionals in data analytics can help providers understand the flood of data from digital health devices to better interpret their meaning.”

It remains to be seen which processes healthcare providers will begin to put into place in order to make new heart monitoring data actionable. However, it’s likely that HI professionals will find advanced solutions to efficiently collect the data, sort through it, find the most important and useful data, and incorporate it in the EHR.

Initial Results

For all the potential glitches and hiccups that are expected with the launch of an ECG machine that lives on your wrist, the Apple Watch Series 4 and its ECG app already appear to be benefiting consumers just weeks after its December 6 launch.

Otherwise healthy people who have never suspected that they were living with AFib have reported receiving the AFib alert from their watches, going to ERs to have their heart checked, and having doctors confirm that they do indeed have an irregular heartbeat.6

But even with these early detections, most doctors are still taking these readings with a grain of salt. After all, this wrist-worn ECG won’t give as much information as a traditional 12-lead EKG, and its reliability remains to be seen. But with almost 700,000 cases of undiagnosed AFib in the U.S. alone7 and the ability of HI professionals to provide solutions to the biggest challenges facing this new technology, the future for patient-generated data from wearable devices looks hopeful.

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