The term “wearable” and “health and fitness trackers” have entered into frequent public discourse. However, these vague designations rightly confuse the general public, blurring what should be a clear distinction between consumer-based and medical-grade devices. With the advent of the new Apple watch series 4, which has unveiled three health-related features—fall detection, atrial fibrillation (AFib) detection, and a simplified electrocardiogram (ECG)–the distinction blurs further.
Can the Apple watch diagnose AFib? Can it tell if you’re having a heart attack? In case you didn’t know, the answer to both is a resounding “no.” The Apple watch does not enable a sufficient degree of accuracy and reliability to designate it a medical-grade wearable, and it cannot be used for the purposes of diagnosing a medical condition.
Right now, the inherent value of the Apple watch lies in the market that it opens up for medical-grade wearables. By raising awareness of possible health issues and normalizing user engagement with a wearable device, the Apple watch is paving the road for medical-grade wearables that can step in where the watch leaves off.
Medical-grade wearables will facilitate professional diagnoses and the opportunity for effective chronic disease management through increased patient adherence and engagement. Next-generation medical wearables will strive to incorporate more patient vital signs to increasingly diagnose a wider range of conditions, while striving for the same degree of comfort and accuracy that current wearables bring.
Limitations of AFib detection & ECG test
The entire Apple ECG test takes just 30 seconds. While a user wears the watch on the wrist and touches their finger to the digital crown on the app, the watch performs the test using the electrodes built into the reverse side. The signal quality from the electrodes are subject to reliability issues, since hairs on the wrist or small movements of the finger could distort the results.
So, while the Apple watch ECG test can pick up the most obvious heart rhythm abnormalities, it can’t be used to accurately detect more subtle or infrequent ones. The Apple watch is also designed to detect AFib, which is the most common form of arrhythmia, or abnormal heart rhythm. AFib is particularly dangerous because it can cause a stroke and, in fact, an estimated 15% of strokes are the result of untreated AFib.
What staggers in the face of this reality is that AFib is a manageable condition, and with early detection and treatment, patients can avoid life-threatening consequences.
The Apple watch detects heart rate by using special lights on the back of the watch that shine onto the skin of the wearer’s wrist. Other sensors detect subtle changes in the light coming back and measure differences in blood flow which directly correlate to the wearer’s heartbeat. The watch will raise a red flag and alert the wearer if it detects a pattern of irregularity that matches AFib enough times. In order to accurately diagnose an arrhythmia, doctors need to continuously monitor a patient’s ECG for a minimum of a full day, to capture any and all symptoms accurately and comprehensively.
Arrhythmias are notoriously difficult to detect and can be intermittent, so detection and diagnosis are improved through long-term continuous monitoring.
Mobile cardiac telemetry (MCT) devices that provide real-time monitoring of a patient’s heart rhythm over a longer period of time, such as Bioflux, are vital for AFib detection. MCT devices are the only heart monitoring devices that provide complete arrhythmia detection and offer the highest diagnostic yield at 61 percent, compared to Event monitors at 23% and Holter monitors at 24%.
Where the Apple watch brings value
Apple’s watch brings two primary value drivers to consumers: it raises awareness of possible health issues, and it fosters greater user engagement, which can lead to long-term behavioral and lifestyle changes. Although the Apple watch does not have the necessary accuracy and reliability from which to make a medical diagnosis, it is a useful device inasmuch as it can alert the wearer to a possible cardiac issue that has previously gone unnoticed, long before visible and detrimental symptoms begin to manifest.
This is particularly important for younger wearers who might have congenital problems, as early detection can save precious time during which a course of treatment can be implemented for maximum effectiveness. A physician could then prescribe a medical wearable device–which is accurate to within 90-95% or higher–to monitor the patient’s heart rhythm and to make a real diagnosis. Thus, the Apple watch is a potent segue into the medical wearables market, and wearers of the Apple product constitute a considerable segment of the population that can potentially benefit from a medical wearable in the future.
Wearables that constantly collect metrics and provide direct feedback to wearers foster greater user engagement, which can translate to positive long-term behavioral and lifestyle change. What the Apple watch is accomplishing here is to make user engagement through wearables rote for a large subset of the population.
This again eases the road for medical wearables, which are also beginning to incorporate the same opportunities for users to engage and obtain live feedback from their devices. As the number of patients with chronic diseases increase, so will the need to monitor these patients remotely, especially through medical-grade wearables that collect accurate and real-time patient-generated health data (PGHD).
When it comes to chronic disease, patients are often required to make significant behavior and lifestyle changes. These changes—which can encompass diet, exercise, and medication adherence—are subject to very little clinical control. Rather, their effectiveness is predicated on the patient’s own proactive behavior. Patients need constant guidance and self-reflection to succeed at managing a chronic condition, which cannot be provided adequately through sporadic office visits.
Medical-grade wearables can help create a system of effective disease management that empowers both patients and physicians with vital data and greater personal agency.
Where will wearables go next?
Despite its inherent limitations, the Apple Watch Series 4 is symptomatic of a greater movement in the medical wearables market, which will find its most compelling expression in the collection of vital signs: pulse, respiratory rate, oxygen saturation, blood pressure, and blood sugar (glucose) levels.
Taken in isolation or in combination, these vital signs can say a lot about a person’s general health, and they can serve as key indicators in the diagnosis of certain conditions. When combined with pulse detection, for example, low oxygen saturation readings could help identify sleep apnea. Like AFib detection, detecting sleep apnea has the potential to guard against life-threatening conditions, as sleep apnea is often an early precursor for cardiac problems. In fact, obstructive sleep apnea increases the risk of heart failure by 140%, the risk of stroke by 60%, and the risk of coronary artery disease by 30%.
Likewise, future medical wearables that could accurately collect blood pressure and glucose level measurements without cuffs and blood samples, respectively, would constitute a significant scientific breakthrough. Future wearable devices will aspire to collect a wide range of patient biometrics with high precision and minimal discomfort, driving higher adoption.
Another factor that will greatly influence the adoption of wearables will be found in reimbursement and subsidies. Health and fitness wearables attract health insurers who see these devices as a way to incentivize customers to get more exercise and maintain healthier lifestyles. Aetna, for instance, has given away more than 500,000 Apple watches to its customers this year. The insurance provider plans to pre-load the watches with apps that it co-develops with Apple.
The apps could remind wearers to take required medications on time, or prompt them to refill prescriptions. Once medical insurance companies start to realize that they can benefit from customers who are actively taking care of their own health, they will be more inclined to subsidize medical-grade wearables.
The Centers for Medicare and Medicaid Services (CMS) has unbundled CPT code 99091 to enable eligible practitioners to receive separate reimbursement for time that is spent on collecting and interpreting remote patient health data that is digitally stored and transmitted to a provider. By recognizing remote patient monitoring services for separate payment, CMS is encouraging widespread implementation of medical-grade wearables.
Once medical wearables become fully reimbursable, their general use in medical practice will be assured. Right now, the Apple watch series 4 is offering a consumer-based platform that makes quick, convenient, and metric-guided health awareness a reality. Armed with useful information, consumers can take their results to a health practitioner for professional diagnostics–and in some cases, for a medical-grade wearable experience.
Waqaas Al-Siddiq is founder and CEO of Biotricity.
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