By REBECCA ROBBINS @rebeccadrobbinsNOVEMBER 14, 2019

SAN FRANCISCO — Apple (AAPL) on Thursday launched three observational studies — focused on mobility, menstruation, and hearing — that each aim to enroll hundreds of thousands of people and monitor them virtually using their own iPhones and Apple Watches.

Amid rising concern about health data privacy, the tech giant has vowed not to sell the data collected from the studies. Apple will allow participants to control which types of information they share and to delete data within 24 hours of their collection. The company may, however, use the collected study data to refine its algorithms; for example, it could mine for correlations between heart rate data and activity data — how many steps you take, how often you stand, or how often you exercise — to try to improve the notifications it sends Apple Watch users who have an irregular heart rhythm or a high heart rate.

The studies, plans for which were first announced in September, represent an emerging, and ambitious, approach to medical research. Unlike traditional models that recruit study enrollees with the help of flyers and physicians, Apple’s studies will bring in participants a different way: via the Research app, newly available for download in Apple’s app store.

For all three studies, enrollees must be at least 18 years old, or a few years older, depending on their state of residence; they’ll be prompted to re-consent to the research after two years. Apple has set aggressive enrollment targets for each study:

• The Apple Heart and Movement Study aims to enroll 500,000 people over the next five years. To sign up, participants must have an Apple Watch to record their workouts and daily movement.
• The Apple Women’s Health Study wants 1 million people to sign up over the next 10 years. To be eligible, participants must have menstruated at least once in their life. They’ll be asked to track their menstrual cycles and answer regular survey questions.
• The Apple Hearing Study aims to enroll 150,000 people over the next two years. Participants will be asked to complete hearing tests, while their Apple devices will detect and measure loud noises in their environment.

Apple, the sole sponsor of all three studies, will partner on them 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.

The studies are being billed as observational — meant to monitor people rather than serve them with an intervention — although the hearing health study has an interventional component. For that study, researchers plan to randomly divide participants into two groups — one that gets notifications when loud noise is detected, and the other that gets no notification — to see if they behave differently when it comes to future noise exposures.

Apple’s launch of the three studies on the Research app is an extension of the ResearchKit initiative, launched in 2014, to allow academic and industry researchers to use Apple’s code as a template to build their own apps to recruit participants for their own studies. One of the apps built this way was for the Apple Heart Study, in which Apple enrolled more than 419,000 people.

The results of that study, run in partnership with Stanford University researchers, were unveiled at a big cardiology meeting this past March; they showed that the Apple Watch can detect important heart rhythm changes. All told, 0.5% — or 2,161 people — were informed that they might have atrial fibrillation, an arrhythmia that raises risk for stroke and other conditions.

Correction: An earlier version of this story provided incorrect enrollment targets for the Apple Heart and Movement Study and the Apple Women’s Health Study.

About the Author

Rebecca covers the life sciences industry in the Bay Area. She is the co-author of the ewsletter STAT Health [email protected]@rebeccadrobbins