Apple announced late Friday that Stanford Medicine had reported the results of the Apple Heart Study, the largest study ever of its kind, which enrolled over 400,000 participants from all 50 states in a span of only eight months.

Apple and Stanford created the study to evaluate Apple Watch’s irregular rhythm notification, which occasionally checks the heart's rhythm in the background and sends a notification if an irregular heart rhythm appears to be suggestive of atrial fibrillation (AFib). As part of the study, if an irregular heart rhythm was identified, participants received a notification on their Apple Watch and iPhone, a telehealth consultation with a doctor and an electrocardiogram (ECG) patch for additional monitoring.

Jeff Williams, Apple’s COO: "We are proud to work with Stanford Medicine as they conduct this important research and look forward to learning more about the impact of Apple Watch alongside the medical community. "We hope consumers will continue to gain useful and actionable information about their heart health through Apple Watch."

Stanford Medicine researchers presented their findings today at the American College of Cardiology’s 68th Annual Scientific Session and Expo. Study results showed 0.5 percent of the over 400,000 participants received an irregular heart rhythm notification, illustrating the feature’s ability to give a user important health information without creating unnecessary burden to their doctor’s schedule. Many participants sought medical advice following their irregular rhythm notification, using the information to have more meaningful conversations with their doctors.

SVP of Health Services Dr. Desai: "As physicians, we are always trying to find ways to offer patients health information that is meaningful to them for individualized care. Seeing medical research reflect what we’re hearing from consumers is positive and we’re excited to see Apple Watch helping even more consumers in the future while collaborating with the medical community to further research."

The next step for Apple and Apple Watch with ECG involves working with Johnson & Johnson in pragmatic clinical trial to track heart health called the "Heartline Study."   

Johnson and Johnson's HEARTLINE Study will bring together Johnson & Johnson’s health and behavioral science expertise and long heritage in treating cardiovascular disease with Apple’s technology expertise.

Emerging technology holds great potential to help identify people at risk for future disease and develop interventions to prevent disease before it occurs. Leveraging a new heart health app from Johnson & Johnson in combination with Apple Watch’s irregular rhythm notifications and ECG app, the HEARTLINE Study will investigate whether this technology can accelerate the diagnosis of AFib and improve outcomes including the prevention of stroke, as well as assess the impact of a medication adherence program.

The study will occur in the U.S. only, and will be designed as a pragmatic randomized controlled research study for individuals age 65 years or older.

In addition to contributing to the evolving science of digital health by helping researchers learn how to use emerging technology to better diagnose, treat and prevent heart conditions, participants will learn how to stay heart-healthy every day with heart health education and lifestyle tips.

Enrollment for the HEARTLINE Study will open in late 2019.

Additional Reading

1. Patently Apple posted a report back in February talking about Apple Watch and its ECG capability in a report titled "Apple's SVP of Health Services Dr. Desai is interviewed about Democratizing Patient Data and more."

2. STAT News (Larry Husten): "Beware the hype over the Apple Watch heart app. The device could do more harm than good"

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