Apple Watch Heart Study Involved 400,000 Participants

Stanford Medicine has published more details about the future of the Heart Study program it conducted in partnership with Apple, in which it attempted to reliably detect atrial fibrillation in Apple Watch wearers.

The condition, which is characterized by an irregular heartbeat, often remains hidden because many people don't experience symptoms. Atrial fibrillation can increase the risk of stroke and heart failure.


According to Stanford, the study involved 400,000 participants, making it the the largest screening program for atrial fibrillation ever conducted. A paper has also been published in the American Heart Journal describing the unique design of the clinical trial.

Enrollment began in late 2017 and closed in August. Although some participants were informed in September that their participation in the study was complete, Stanford says it will continue to collect and collate data until early next year, which is consistent with Apple's original announcement.
"We hope this study will help us better understand how wearable technologies can inform precision health," said Lloyd Minor, MD, dean of the School of Medicine. "These new tools, which have the potential to predict, prevent and manage disease, are finally within our reach."
The FDA cleared two Apple Watch medical apps in September. One app uses data from the Apple Watch Series 4 to take an ECG by touching the button on the side of the device. The second app uses data from an optical sensor available on the Apple Watch Series 1 and later to analyze pulse data and identify irregular heart rhythms indicating atrial fibrillation. The Apple-Stanford Heart Study used the second app.

Each year in the United States alone, atrial fibrillation results in 130,000 deaths and 750,000 hospitalizations, according to the Centers for Disease Control and Prevention. The CDC estimates that the condition affects between 2.7 million and 6.1 million people. In addition, another 700,000 people may have undiagnosed atrial fibrillation.


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Apple Watch Owners Can Participate in Apple Heart Study to Identify Irregular Heart Rhythms

Apple today announced it has launched a ResearchKit-based Apple Heart Study app, which uses the Apple Watch's heart rate sensor to collect data on irregular heart rhythms and notify users who may be experiencing atrial fibrillation.


As part of the study, if an irregular heart rhythm is identified, participants will receive a notification on their Apple Watch and iPhone, a free consultation with a study doctor and an electrocardiogram (ECG) patch for additional monitoring.
"Every week we receive incredible customer letters about how Apple Watch has affected their lives, including learning that they have AFib. These stories inspire us and we're determined to do more to help people understand their health," said Jeff Williams, Apple's COO. "Working alongside the medical community, not only can we inform people of certain health conditions, we also hope to advance discoveries in heart science."
To calculate heart rate and rhythm, the Apple Watch's sensor uses green LED lights flashing hundreds of times per second and light-sensitive photodiodes to detect the amount of blood flowing through the wrist.

Apple is partnering with Stanford University's School of Medicine to perform the research.
"Through the Apple Heart Study, Stanford Medicine faculty will explore how technology like Apple Watch's heart rate sensor can help usher in a new era of proactive health care central to our Precision Health approach," said Lloyd Minor, Dean of Stanford University School of Medicine. "We're excited to work with Apple on this breakthrough heart study."
While heart arrhythmias aren't always symptoms of a serious disease, atrial fibrillation is a leading cause of stroke, which can lead to death. Many people don't experience symptoms, so it often goes undiagnosed.

The Apple Heart Study is rolling out on the App Store in the United States today to customers who are 22 years or older and have an Apple Watch Series 1 or later. The app itself requires an iPhone running iOS 11 or later.

Apple says the study is not intended for people who already have atrial fibrillation or atrial flutter during the enrolment process.

This announcement follows news that AliveCor has received FDA approval to sell its medical-grade Kardia Band for Apple Watch, which can detect abnormal heart rhythm and atrial fibrillation, in the United States.


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Apple Considered Buying Medical Clinic Startup Crossover Health

Apple considered purchasing medical clinic startup Crossover Health as part of its push into healthcare, reports CNBC. Apple is said to have participated talks with the healthcare company up until recently, but after months of discussion, no deal materialized.

According to its website, Crossover Health works with major companies to provide employees with on-site medical clinics. Some of its existing customers include Facebook, Microsoft, LinkedIn, Square, and Apple, with many of these companies offering on-campus medical care.


Citing three sources with knowledge of the talks, CNBC says it's not clear why no acquisition ultimately happened between the two companies. Apple also talked to One Medical, another startup that offers patient clinics in several different cities.

Whether Apple would use such a startup to develop public-facing actual medical clinics or use existing facilities to sell products and gather data is not known.
The discussions about expanding into primary care have been happening inside Apple's health team for more than a year, one of the people said. It is not yet clear whether Apple would build out its own network of primary care clinics, in a similar manner to its highly successful retail stores, or simply partner with existing players.
Apple has made serious inroads into medical care with the introduction of CareKit and ResearchKit. CareKit is aimed at helping app developers create health-related apps to allow consumers better access to healthcare data, while ResearchKit is aimed at helping medical professionals develop studies to further medical research using data gathered from Apple customers.

Apple is said to be aiming to make the iPhone a "one-stop shop" for medical info, offering a centralized way to store all of a person's health data.

In the past, Apple CEO Tim Cook has said that health is an area that interests Apple because it's where hardware, software, and services can come together into "something that's magical." "We believe that health is something that is a huge problem in the world," said Cook in 2016. "We think it is ripe for simplicity and sort of a new view, and we'd like to contribute to that."


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