Steps Toward Health Data Standards for Wearables

Fitness trackers and smartwatches now regularly gather personal health data like heart rate and steps taken per day. A proliferation of studies suggest this information can lead to productive health outcomes. Doctors and healthcare professionals, naturally, want to be in the loop in advising and monitoring their patients' fitness. Bridging the gap between personal tech and clinical practice, however, is still a real challenge.

Industry groups and standards bodies have begun quantifying wearable devices' capabilities via the IEEE P360 standard for wearable consumer electronic devices and Consumer Technology Association (CTA) standards for step counting, heart rate, and sleep tracking.

Although some of these technical standards have been available for five years, consensus has been slow to form on how to incorporate such data into clinical standards and practice. That shortcoming is now changing, though, thanks to formal partnerships between the American College of Cardiology (ACC), the CTA, and health data platform developer Evidation Health.

Beyond those partnerships, Evidation, the CTA, and Boston-based professional association the Digital Medicine Society (DiMe) are building initiatives around what Evidation CEO Deborah Kilpatrick calls the "behaviorome"—meaning, everyday behaviors from which data can be captured, contextualized, and acted upon.

In a recent Evidation webinar, John Rumsfeld, MD, former chief innovation and science and quality officer at the ACC, said the organization's innovation program has focused on "moving healthcare to be delivered in a different way than we have for the last 50 or 60 years," he said. "It is really exciting but a daunting challenge to take that on, and we know we can't do it alone."

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To that end, the ACC and Evidation have partnered on Achievement for Heart Health, a pilot program, announced last December, that collects and analyzes health data of people diagnosed with heart failure who have been invited to participate. As of May 25, the program had enrolled 474 participants—who've contributed data from self-reporting surveys and device data stored on Evidation's Achievement platform. (Sixty-one percent of the participants have a connected wearable device.) Patients are then supplied with personalized educational material from the ACC's CardioSmart program to share with their clinicians.

Bray Patrick-Lake, Evidation's senior director of strategic partnerships, is also a cardiac patient.

"I've been the patient who has dragged in all of my data, which is largely uninterpretable," she said. "If you only go in to the doctor's office every 12 weeks or 6 months or once a year, what is happening outside the clinic is really lost. This is a way of diarizing that and bringing that information in, and hopefully we can shorten the time it takes to get the patient on the right treatment. ...

"If we are serious about running a true learning healthcare system," she continued, "based on measuring how healthy we can keep people as opposed to what we can do for them once they get sick, we have to figure out how to not only inject these newly created enormous flows of data, but we also have to be able to trust that we know what they mean."

There's certainly room for improvement in the patient population, Patrick-Lake said. Of the approximately 84 percent of program participants who take medication, 53 percent say their medication provided no additional benefit or even made them feel worse.

"This partnership made great sense because there is evidence that shows only 30 percent of heart failure patients are on guideline-directed medical therapy," Patrick-Lake said. "And that is a huge opportunity to improve someone's quality of life."

Beyond the pilot, which is Evidation's first such health program, Anusha Narayan, the company's vice president of strategic marketing, said the company hopes to build incrementally on the work it is doing now with the ACC.

"Our goal is not to generate specific sets of evidence," Narayan said, "but to facilitate that interaction and contextualize the data individuals are generating outside the clinic in a way that renders it more useful than it is today."

“We have to figure out how to not only inject these newly created enormous flows of data, but we also have to be able to trust that we know what they mean."

The collaboration between the ACC and the CTA, announced in May, is also the technology association's first with a medical society, according to Kerri Haresign, the CTA's director of technology and standards. Through the partnership, she said, experts from the technology and healthcare sectors will offer guidance for device manufacturers on how to communicate the capability of individual products to clinicians, and in turn support those clinicians' efforts to recommended the appropriate devices to their patients.

"This work with the ACC is really at the core of our mission, where we want to increase the use of digital health technologies to improve outcomes, lower costs and enhance patients' experiences," Haresign said. "There is a communications gap between the technology companies and the practitioners, and that's one of the things we're hoping to address with this project."

She said the project's timeline calls for a best practices document to be released by end of this year. The document, she said, will concern devices like trackers that are used for prevention, devices like blood pressure monitors used for screening, and devices used for health management or treatment of diagnosed conditions.

The ACC partnerships with Evidation and the CTA are part of a larger trend of the health and technology communities coalescing into a functional ecosystem, according to DiMe CEO Jennifer Goldsack. DiMe, for example, announced the creation of the Digital Health Measurement Collaborative Community at the end of May, nearly concurrent with the ACC-CTA announcement. The collaborative, which counts both Evidation and the CTA as members, aims to both increase digital health literacy and to integrate data from consumer trackers into electronic health records.

"We have to get out of the cycle of individual initiatives and pilots," Goldsack said. "If we are serious about running a true learning healthcare system, based on measuring how healthy we can keep people—as opposed to what we can do for them once they get sick—we have to figure out how to not only inject these newly created enormous flows of data, but we also have to be able to trust that we know what they mean."