Since the first Apple Watch, health monitoring has been one of Apple’s core features. In 2015, Apple released ResearchKit, a software infrastructure built specifically for medical researchers, that allows app developers to develop coding libraries for healthy apps on iPhones and Apple Watches. Apple has since launched apps for asthma, heart disease, diabetes, breast cancer and Parkinson’s.
In 2018, when the Apple Watch Series 4 was released, it introduced electrostat image monitoring, which alerts users when the watch detects a suspected atrial fibrillation. One user said the Apple Watch tested him for atrial fibrillation and asked him to seek emergency medical attention in a timely manner, only to be diagnosed.
Recently, however, Mayo’s clinical researchers have questioned Apple’s health monitoring capabilities: The device’s abnormal pulse detection capabilities can over-consume medical resources.
“According to guidelines from medical institutions and physicians, only 11.4 percent of patients were diagnosed with clinically significant cardiovascular outcomes after medical evaluation, a finding that showed a high false positive rate,” Mayo clinical researchers wrote in the paper. “
“False positive screening results can lead to overuse of medical resources and increase anxiety between those monitored,” researchers at the Mayo Clinic said in the Journal of the American Medical Association. “
Retrospective studies of clinical data also showed that a significant proportion of these participants used the Apple Watch feature that was “inconsistent with FDA guidelines.” Pulse abnormality monitoring is available on all Apple Watch devices, but it’s not the ECG atrial fibrillation monitoring feature that came with the previous 4-generation watch.
Of the 264 patients who were included in the study, 15.5 percent had clear medical records showing that pulse abnormalities alerted them. The rest refers to the Apple Watch and the detected abnormal pulse, but does not explicitly mention that users received generated alerts, which the researchers say may have been caused by incomplete documentation or the patient’s manual use of the Apple Watch’s heart monitoring app.
Overall, 11.4% of patients received clinically viable diagnoses. Among recorded patients who received the alert, the diagnosis rate rose slightly to 15%.
For patients who experienced abnormal pulse alerts and required medical evaluation, seven patients (95 percent confidence interval, 3.5-14.5) needed to be evaluated to determine a clinically viable diagnosis of cardiovascular disease, the researchers wrote. “In 15 asymptomatic patients, they showed up after an abnormal pulse alarm, and only one was diagnosed with a clinically operational cardiovascular diagnosis with a number of 15 (95 percent confidence interval, 2.9-286.5).
It is also worth noting the group of patients included in the analysis. Twenty-two percent of patients had atrial fibrillation, and 8.7 percent were under the age of 22 — both cases excluding them from FDA guidelines on atrial fibrillation.
“We encourage stricter access controls to ensure that actual use complies with FDA guidelines,” the researchers wrote.
The researchers looked at the clinical records of all clinics, including the “Apple Watch” (n s 598), between December 6, 2018 and April 2, 2019. After excluding 64 people who refused to use their records for research, the researchers manually examined the remaining records and excluded another 270 people who did not recommend using the smartwatch’s abnormal pulse detection function.
In the remaining 264 patients, the researchers extracted demographic and clinical characteristics of the patients concerned and evaluated and final diagnosed them. Diagnosis of atrial fibrillation, atrial paracetasis, atrial conduction block, intrinsic titration, cerative fibrillation and roomal tration are considered “clinically actionable cardiovascular diagnosis”.
Irregular heart rate monitoring was re-approved by the FDA and launched in late December 2018 with Apple’s electrostartogram feature.
At the time, Apple produced a set of data showing that the Apple Watch’s irregular notification features were very consistent with the way electrocardogram stickers were worn. But the FDA and other agencies point out that unnecessary medical testing can be a risk to new features, and there is always a gap between ideal and reality.
“The fda and Apple must carefully consider the consequences of screening for asymptomatic atrial fibrillation directly to consumers, including excessive medical resource use due to false positive screening results and inadequate research,” the researchers wrote. “
It’s worth noting that the researchers don’t have a conflict of interest with Apple, but the Mayo Clinic does have a partnership with Apple’s rival, Consumer Cor, a provider of electro-electrograms.
The researchers further clarified that neither the Mayo Clinic nor Alive Cor were involved in the study.