A cardiac patient in Carlsbad sends their doctor in San Francisco a readout of their heart rate, courtesy of an Apple Watch. A New Yorker with hypertension texts with an Alabama health coach about data from their smart blood pressure cuffs. A person with diabetes snaps a photo of their dinner and uses an app to predict how it will impact their blood sugar.

Health care is undergoing a monumental shift toward remote patient monitoring — and a new class of patient-consumer is leading the charge, according to a new STAT report. The transformation — which began years ago as healthy people moved to optimize wellness and people with chronic conditions pushed for more convenient care — has taken on a more permanent tone amid the Covid-19 pandemic.

“Millions of Americans suddenly asked themselves, ‘Can I solve this care need without showing up in person?’” said Sean Duffy, chief executive officer and co-founder of Omada Health, a virtual diabetes care provider. “That consumer expectation change is going to be the thing that writes history the quickest.”

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Tech giants and virtual care companies alike are rushing to meet that demand.

For established companies like Apple, Amazon, and Alphabet, the exploding popularity of health tracking is a boon to their push to make sizable inroads in health. Those companies are courting the new patient-consumer with a device-first strategy, transforming their bestselling wearables into health tools with medical capabilities.

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Meanwhile, health tech companies like diabetes care providers Omada Health and Livongo are taking a platform-driven approach, catering to patients with remote monitoring programs that connect them with health professionals and provide useful data.

The tactic among tech giants

Tech companies are starting to chart their path to remote monitoring by transforming consumer gadgets to medical devices, with an eye on clinical evidence.

Apple was the first to enter the space this way, publishing a large and entirely virtual clinical study of its Apple Watch and embedded electrocardiogram, or EKG, which records the heart’s electrical signal. The study, which Apple brought to the Food and Drug Administration as part of its work to get the watch cleared as a medical device, showed the device could spot the heart condition atrial fibrillation, or A-fib. Fitbit, which was acquired by Google last year, is following the same path. The company launched a similar virtual study of its wearable in A-fib in May and plans to present the data to the FDA.

Even Facebook, which has yet to make its own wellness wearable, appears to be edging toward the heart monitoring space. In May, the social media giant formed a new team dedicated to health technology under the leadership of Yale cardiologist Freddy Abnousi and posted job ads for positions that include an expert in photoplethysmography, the same type of technology that Apple and Fitbit use for heart monitoring, and an expert skilled at interfacing with regulators like the FDA.

The tech- and consumer-driven shake-ups are already creating ripple effects throughout the health care system. Clinicians, for example, are increasingly being asked to interpret the results of Apple Watch EKGs in patients who are hesitant to come in for a visit during the pandemic.

“You’re really seeing a shift where it’s consumers and consumer electronics deciding things more than a doctor deciding which device to use,” said Ritu Thamman, cardiologist and assistant professor of medicine at the University of Pittsburgh School of Medicine. “We’re being pushed by the consumers themselves, and that’s creating the competition and the drive to create the best user experience.”

Still, by focusing on building out device capabilities — instead of creating comprehensive virtual health platforms that pair with devices — tech giants have created a new set of challenges. Without being connected to any sort of system, it remains unclear how, exactly, the devices will ultimately fit into a user’s care continuum. If Apple, Fitbit, and other big tech companies intend for their tools to remain relevant to users’ health for the long term, they’ll need to start integrating them with platforms that can help guide their care.

“Just because you have a watch that tells you things doesn’t mean you have remote monitoring. The platforms and the integration need to start,” said Mintu Turakhia, a cardiologist and executive director of Stanford Medicine’s Center for Digital Health.

Amazon’s new wearable, called Halo, may be a first step in this direction. Although the device does not currently have any medical diagnostic capabilities, it lets users share their body fat percentages with clinicians through an integration partnership with electronic medical record vendor Cerner.

The platform-first push by health tech companies

Virtual care businesses, in contrast to tech giants, are jumping into the health tracking space with a platform-centric strategy. Companies including Omada, as well as Alphabet subsidiaries Onduo and Verily, offer care delivery programs that harness remote monitoring hardware made by other companies and use fleets of faraway health coaches to help patients interpret and understand their data.

Those devices — which include Bluetooth-enabled weight scales, blood pressure cuffs, and glucose meters — are connected to the company’s platform, where clinicians and coaches take a patient’s data, contextualize it, and use it to offer advice or guide a person’s care. Unlike tech giants and medical device makers who acquire customers by selling devices, these companies acquire patients by way of partnerships with employers, insurers, and health plans.

 

But virtual care companies’ business models often rely on reimbursement or buy-in from health insurers or employers, meaning their success depends on being able to consistently demonstrate their effectiveness with research. And while many of these companies have published small and short term studies, academics and researchers say larger and more comprehensive research is needed.

“There’s very little clinical trial data” for remote devices, Turakhia said.

The rise of the patient-consumer is also placing new pressures on more traditional health care players, including established medical device makers. Industry stalwarts like Philips and General Electric, for example, are being forced to consider fundamental changes to their business structure aimed at better serving the patient-consumer instead of the hospital or clinic.

“We are definitely thinking about ways to reach outside hospital walls,” said Anders Wold, vice president and chief executive officer of clinical care solutions at GE Healthcare.

Regulators have begun to respond to these changes in recent months with a mix of temporary and permanent policies geared at making remote monitoring tools more widely accessible. For example, the FDA introduced a series of pandemic-era authorizations that increase patients’ ability to use remote health tracking tools at home, including the EKG-containing Apple Watch and Livongo’s glucose meters. And starting last year, the Centers for Medicare and Medicaid Services began reimbursing providers who use remote monitoring tools with new billing codes explicitly focused on remote health tracking, including codes that focus on weight and blood pressure.

If those changes are to have real sticking power, however, companies including tech giants and health tech providers will need to figure out how to make their devices an established, long-term component of the existing health care system, rather than simply a temporary or one-off solution.

“There are a lot of consumer devices out there with [FDA] clearance,” said Turakhia. “But when you’re talking about remote patient monitoring, you’re really talking about the whole system.”

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