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New studies launched of Apple Watch’s health-monitoring abilities

SAN FRANCISCO — Apple (AAPL) on Tuesday announced that it’s launching three research studies that will assess the Apple Watch’s capabilities in monitoring women’s medical conditions, hearing health, and mobility signals like heart rate and walking pace.

It’s the latest sign of Apple’s rising profile and ambition as a player in medical research — centered around a consumer gadget that has yet to demonstrate that it offers widespread health benefits for individuals or the population at large.

Apple will partner on the studies with the National Institutes of Health and the American Heart Association, as well as leading academic medical institutions including the Harvard T.H. Chan School of Public Health and Brigham and Women’s Hospital in Boston, and the University of Michigan.

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The three planned projects, slated to start enrolling participants later this year, are observational studies, rather than randomized controlled trials. At least at the start, they will be conducted entirely virtually, with no in-person visits. They will have the following goals:

The women’s health study will make use of the Apple Watch’s recently announced feature to allow women to track their menstrual periods. The goal is to use those data to inform screening and patients’ risk for conditions such as polycystic ovary syndrome, infertility, and osteoporosis.
The study on hearing health will rely on the Apple Watch’s new hearing monitoring features. The idea is to collect data over time to understand how the loud noises and sounds people are exposed to in everyday life can affect their long-term hearing health. Apple said it would share these data with the World Health Organization.
The mobility study will use the wearable to collect data on people’s heart rate, walking pace, and how many flights of stairs they’ve climbed. It will then analyze those data to probe connections to hospitalizations, falls, cardiovascular health, and quality of life.

This isn’t the first major medical research effort for Apple. The company previously enrolled more than 400,000 people in its Apple Heart Study conducted in partnership with Stanford University researchers. The results of that study were unveiled at a major cardiology meeting this past March; they showed that the Apple Watch can spot important heart rhythm changes. All told, 0.5 percent — or 2,161 people — were told that they might have atrial fibrillation, an arrhythmia that increases the risk of stroke and other conditions.

Dr. Sumbul Desai, Apple’s vice president for health, unveiled the news on stage at a big press event in Silicon Valley on Tuesday morning. She said the Apple Heart Study results were so encouraging that it pushed Apple executives to launch the new research.

Apple did not specify enrollment targets for any of the three studies, nor did it specify how long researchers would follow participants. Those details will be announced closer to the launch date of the studies, Desai told STAT in an interview on Tuesday afternoon.

Desai also said that Apple has been working closely with the investigators at the academic medical partners for each study to determine the specific endpoints that the research will be powered to assess.

Desai said that consumers who use an Apple Watch will be able to sign up to participate in the new studies via a new Research app that will be available for download in the Apple Store later this year. Just like with any other research study, the app will map out specific inclusion and exclusion criteria that will dictate whether would-be participants can join the study, Desai told STAT.

Apple, of course, is in the business of selling Apple Watches, and having more research to support the idea that they could help monitor health could help drive revenue. But Desai demurred when asked by STAT how the research studies might help Apple make money.

“There isn’t a monetary driver behind what we’re doing,” Desai said. She likened the research to other features, like Apple’s Screen Time monitoring tool designed to address concerns around smartphone addiction, that Apple builds with the customer in mind.

Rather, Desai said, “we have partners that we’re working with that are really interested in understanding how technology can be used to really impact people’s behavior and health in these three areas, and that’s what we’re really exploring.”

At Apple’s event on Tuesday morning, the company played an emotional, slickly produced video featuring testimonials from consumers who’d used the Apple Watch in their own health crises.

There was a runner whose Apple Watch called 911 when he took a fall that left him unconscious, and a pregnant woman whose Apple Watch told her she had an elevated heart rate and sent her to the hospital for an emergency C-section. “It’s not something you think of, your watch saving your life,” one customer says in a voiceover.

To be sure, the Apple Watch is not an unproven intervention; it got FDA clearance last year for its irregular-heart-rhythm alert, as well as for an electrocardiogram feature to measure heart activity. But as Politico reported earlier this year, some cardiologists have been troubled by the way Apple has marketed the health features of the Apple Watch.

Asked about that criticism, Desai told STAT that Apple has not heard such feedback from physicians.

“We’ve never marketed that something has saved someone’s life,” Desai said. “We’ve shared stories that customers have shared with us where they may have said that, but we have not ever marketed that as being the benefit to expect from the features.”

Desai added: “We know there’s no perfect test, there’s no perfect screening, there’s no perfect diagnostic… We have been very specific about the claims we’ve made about those features, and we take that very seriously.”