Apple has expanded the scope of its smartwatch's electrocardiogram app, which can now be used as a replacement for an in-clinic ECG during the COVID-19 public health emergency.
The expansion takes advantage of guidance the Food and Drug Administration released to expand the availability of non-invasive remote patient-monitoring technologies during the COVID-19 pandemic, as part of an effort to allow physicians to treat patients remotely without needing them to visit a healthcare facility.
Under that guidance, physicians can use the Apple Watch's ECG app to support diagnosis of certain arrhythmias and manage related conditions while treating patients via telemedicine, according to Apple.
To support that expanded capability, patients can export a PDF of the ECG app's waveform recording and patient-reported symptoms to share with their physician. How that PDF is shared with a physician varies based on their electronic health record system; for physicians using Epic Systems Corp., Apple said it can be sent via messaging within a patient portal.
Apple stressed that while the ECG app can be used to measure and record a patient's heart rhythm, it should not be used to triage emergency situations, such as a suspected heart attack.
While there's ongoing research into whether fitness trackers—such as Apple Watch, Fitbit and other wearables that track heart rate—can be used to detect COVID-19, those studies are unrelated to the ECG app's capabilities allowable under FDA guidance.
"Healthcare professionals and patients shouldn't rely solely on the app to make clinical diagnoses or treatment decisions," reads a document from Apple. "Only a qualified provider should make a final interpretation and diagnosis of rhythms based on the ECG recording through the ECG app."
Apple made waves in the digital health world in 2018 when it announced its new Apple Watch would offer an FDA-cleared ECG app.
The app's algorithm has a 98.3% sensitivity and a 99.6% specificity for detecting atrial fibrillation, a type of irregular heart rhythm, according to a study completed that same year.
