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J&J and Apple Begin Enrollment for Heartline Study
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J&J and Apple Begin Enrollment for Heartline Study

The study is designed to explore if the Heartline Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection of atrial fibrillation.

In the past few years, Apple has greatly increased its presence in healthcare. The Cupertino, CA-based company has received FDA nods for apps associated with its technology and has found itself in several clinical trials.

Most recently, the tech giant is seeing some movement in its partnership with Johnson & Johnson’s Janssen Pharmaceutical unit.

The companies just opened enrollment for the Heartline Study, which is designed to explore if the Heartline Study app on iPhone and heart health features on Apple Watch can improve health outcomes, including reducing the risk of stroke, with earlier detection of atrial fibrillation (AFib).

Heartline was announced a little more than a year ago. Participation in the study will span a total of three years with two years of active engagement, followed by one year of additional data collection. During the active engagement period, participants will receive heart health education, wellness tips, surveys, and questionnaires across multiple topics related to overall heart health in the app each week.

To enroll in the Heartline Study, individuals must be age 65 or older, a U.S. resident, have Original (traditional) Medicare, own an iPhone 6s or a later model, and agree to provide access to their Medicare claims data.

“We are looking to secure up to 150,000 participants in the study,” a spokesperson for J&J told MD+DI. “Through this important collaboration with Apple, we are pioneering new models that we hope can break down some of the most common barriers to participation in clinical studies and make them faster and more cost-effective, so that we can deliver innovative solutions more quickly to the people who need them.”

The companies said through the app-based approach, the study will enable participants to engage in the study remotely, right from their iPhone and in some cases an Apple Watch, rather than travel to a clinical trial site. This approach to conducting a clinical trial, if successful, could potentially save time and cost.

Breakout healthcare moment

Apple’s breakout moment in healthcare occurred when the company won a nod from FDA in September of 2018 to offer an ECG app, a software-only mobile medical application that can classify whether there are signs of AFib, and another software-only mobile medical app analyzing pulse rates for irregular rhythms.

Since that time, Apple has made a number of forays into research and clinical studies. Late last year, Apple deepened its medical research commitment with three new studies. The company even found a partner in Zimmer Biomet to use the Apple Watch and iPhone to change the patient journey for knee and hip replacement surgeries.

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