Doctors Incorporate Apple Watch in Medical Practices Despite Lack of FDA Approval

Doctors incorporate Apple Watch, recommended by your doctor, as a life-saving tool. The watch helps you monitor heart rate and rhythm. It also tracks other important health metrics like activity levels, sleep patterns, and blood oxygen levels. You can send the data collected by your watch directly to your doctor. This monitoring and information sharing gives you confidence, knowing your doctor can keep a close eye on your heart health.

Expanding Use in Medical Research

There is an expanding body of research on the informal use of the Apple Watch in medical care, despite the availability of other approved devices for tracking the same metrics. Dr. Rod Passman, a cardiologist and professor of medicine at Northwestern Medicine in Chicago, notes, “Not a week goes by in my clinic without someone coming in and saying, ‘My Apple Watch indicates I have an abnormal heart rhythm.

Dr. Rod Passman, a cardiologist at Northwestern Medicine, highlights the growing trend of patients using Apple Watch for medical insights, acording to WSJ Subscription

NIH-funded Study on Blood-thinning Medication

Passman is leading a six-year, NIH-funded study involving 85 research centers nationwide and collaboration with Apple. The study aims to determine if data from the Apple Watch can be used in an app to reduce the time patients with atrial fibrillation need to spend on blood-thinning medications. Currently, such patients must take these medications continuously, despite the associated risks. The hope is that with the Apple Watch detecting episodes of atrial fibrillation, patients will only need to take these drugs for 30 days following an episode. Passman and his team obtained an FDA exception allowing them to use the watch to alert diagnosed atrial fibrillation patients of irregular heartbeats.

Doctors Recommending Apple Watch

Doctors integrate Apple Watch into medical practices, despite lacking FDA approval for monitoring atrial fibrillation episodes. Patients are advised to purchase an Apple Watch for this purpose, despite its unapproved status for those with a history of atrial fibrillation. The watch is FDA-approved to notify users without prior atrial fibrillation of ongoing episodes, but only if they declare no history of the condition. According to an FDA spokesperson, healthcare providers can use approved devices off-label if deemed medically suitable. This practice allows flexibility in medical decision-making for individual patient needs.

Popularity and Compliance

Doctors prefer the Apple Watch due to its simplicity, affordability, and widespread availability—Apple shipped about 40 million watches in 2023 alone, and even more in previous years. Adherence is a significant issue with medical-monitoring devices, and the consumer appeal of the Apple Watch helps improve compliance. One study of nearly 200 individuals found they wore the watch four out of five days, averaging more than 14 hours per day. This compares favorably to adherence rates for other treatments, such as medication and exercise, which often fall short of doctors’ recommendations.

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Research into New Applications

These factors have sparked extensive research into using the watch’s data in new ways. Researchers have shown that the Apple Watch might assess stress levels, track and improve post-surgery recovery, and monitor children’s heart health. Pedro Velmovitsky, who led a study on using the Apple Watch and other consumer health monitors to evaluate stress, suggests these devices could eventually become the gold standard for stress research, potentially leading to new public health interventions to treat stress.

Challenges and Future Prospects

Interestingly, recent research on new applications for the Apple Watch has not come from Apple itself. The company has faced challenges in enhancing the watch’s health-monitoring capabilities. Issues include the accuracy of sensors and potential patent battles. Apple halted sales of some watch models last year due to a dispute with medical-technology company Masimo over blood-oxygen sensing. Many off-label uses of the Apple Watch are possible because it continuously gathers activity and heart-rate data, and can perform an electrocardiogram when initiated by the user. This data can then be exported and analyzed independently of Apple.

Abundant Data for Continuous Monitoring

Compared to traditional methods of studying patients, the continuous monitoring by the Apple Watch generates an abundance of potentially useful data, says Dr. Corinna Zygourakis, a neurosurgeon studying the watch’s use in post-spinal surgery monitoring. For Dr. Ruud Koster, a 72-year-old cardiologist in Amsterdam and Apple Watch user, no sophisticated algorithm was needed. Koster, a cardiologist for 50 years, noticed an abnormality in his ECG after a workout, indicating a potential silent ischemia. Continuous monitoring with his watch led to a timely visit to his doctor, resulting in bypass surgery to fix constricted heart arteries. Without his Apple Watch, he might not have discovered this life-threatening issue in time.

The Issue of False Positives

One major challenge with the Apple Watch data is false positives, potentially alarming users unnecessarily. Koster notes that millions of wearables could prompt unnecessary medical tests due to health alerts. Consequently, regulators carefully assess medical devices before approving their claims for accuracy.

Ongoing Research and Apple’s Role

Passman’s trial has been ongoing for 10 months, recruiting 550 participants out of a planned 5,000. Apple engineers provide access to heart-rate data, which is typically restricted for app developers. Passman emphasizes that Apple defers medical use recommendations to clinicians and researchers.

Apple’s Commitment to Health

Apple’s investment in health is evident with a growing team of cardiologists and heart-rhythm specialists onboard. In a 2023 health report, Apple COO Jeff Williams outlined the company’s goal to develop science-based technology. This technology aims to equip users with comprehensive health information and act as a health guardian. At a recent developers’ conference, Apple introduced software updates for Watch OS 11, including a new “Vitals” app. However, despite these advancements, there are limits to what Apple should do in health alert logic, as noted by Passman.

Future of Apple Watch in Health Monitoring

Successful navigation of sensor accuracy and patent challenges could empower Apple Watch data to diagnose and monitor health conditions. Further advancement in health-monitoring devices like the Apple Watch hinges on user engagement in self-tests and data sharing. This involvement is crucial for developing systems that can automatically evaluate health data.

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