Making Sense of Data From Wearable Health Trackers
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In the 1960s, biophysicist Norman J. “Jeff” Holter commercialized a portable electrocardiogram — now known as a Holter monitor — which allowed patients with heart palpitations, a condition known as syncope (a medical term for fainting), or other cardiac issues to be monitored outside the clinic. It was an early but consequential response to the understanding that our diagnostic devices suffer from sampling bias: An ECG taken during a short visit to the doctor is a snapshot and might not reveal cryptic heart arrythmias. Suddenly, healthcare was in a new era, moving towards a future in which monitoring could occur outside of the walls of a hospital, quietly surfacing findings which may not have been brought to light until the patient suffered a more morbid outcome.
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In the 21st century, wearable monitoring has followed two paths: one that includes medical-grade devices, which are designed for clinical use; and another that includes consumer devices made by companies such as Fitbit, Samsung, Garmin, and Oura, which are often marketed as general wellness products. But advances in technology are beginning to blur the line between these categories.
Dexcom’s Stelo, the first over-the-counter continuous glucose monitor cleared by the Food and Drug Administration, brings a traditionally prescription-based device to direct consumer use. Apple’s HealthKit framework aggregates health records, lab results, and wearable data from third-party apps. WHOOP is similarly integrating wearable metrics with clinical blood testing through partnerships with labs such as Quest Diagnostics. As consumer-generated health data begins to resemble clinically measured biomarkers, medicine must develop standards for determining when those signals are accurate, interpretable, and useful enough to guide care. As a physician specializing in laboratory medicine, I think the prognostic value these consumer devices provide is supremely important as they creep into the clinic.
As wearable data begins to look like diagnostic information, it’s worth noting why these signals are not held to the same validation standards that medicine has applied to laboratory tests.
At the Consumer Technology Association’s CES show in January, then FDA Commissioner Marty Makary took the stage and announced that the agency was updating its guidance governing oversight of wearable technologies and AI-enabled devices in order to accelerate their speed to market. The FDA and CMS are also piloting two new programs, ACCESS and TEMPO, to allow insurance reimbursement for wearables designed to improve health for people with conditions such high blood pressure, diabetes, and depression. This will allow select digital health devices to be distributed while companies collect real-world data, rather than moving through the traditional regulatory pathway required for medical-grade devices. In March, the Advanced Research Projects Agency for Health, or ARPA-H, announced Delphi, a program to develop low-cost wearable and ingestible biosensors to continuously track biological signals that are more challenging to measure, including hormones, immune markers, and therapeutic drug levels.
These developments are very encouraging: Wearables can provide a lifeline for patients by making invisible physiology visible in everyday life. Patients have credited Apple Watch alerts with saving their lives after the device prompted them to seek care for previously unrecognized arrythmias. Continuous glucose monitors have also created a similar shift in metabolic health by helping users connect their food intake, sleep, exercise, and stress to real-time glucose patterns, including preliminary evidence for some modest benefits for those without diabetes. More broadly, wearables have been linked to an increase in physical activity. But as wearable data begins to look like diagnostic information, it’s worth noting why these signals are not held to the same validation standards that medicine has applied to laboratory tests.
Historically, diagnostic medicine has been governed by a clear validation framework. Hospital laboratories are...