NYT Report: Apple Watch ‘should not be considered a medical device’

The new electrocardiogram-equipped Apple (NSDQ:AAPL) Watch should not be considered a medical device, according to a new report from the New York Times.

The article, written by Indiana University School of Medicine pediatrics professor Aaron Carroll, calls into question the downsides of the newly released device and the potential for both false positives and false negatives.

Carroll acknowledged the possible positives of the device, including the ability for physicians to monitor patients from a distance and diagnosing heart problems in individuals that would possibly go undetected, but said that “just because something seems like a good idea doesn’t mean it is.”

“No screening test is perfect,” Carroll wrote in the Times article. “In general, we would like people who are sick to have a positive screening result, and people who are well to have a negative result. Unfortunately, people who are sick sometimes have a negative result. Those are false negatives. People who are well sometimes have a positive result. Those are false positives.”

Both outcomes are worrisome, Carroll suggested in the report. He added the false negatives may cause someone who needs medical help to not seek it, but said that because “relatively few people have serious, undiagnosed arrhythmias with no symptoms” that it wasn’t a major concern.

False positives, however, end up costing time time, money and emotional distress, according to the Times report.

“The health care system is already busy, if not overloaded. No physician wants to field calls from patients who have no problems. Such patients will require visits and further testing, and will potentially receive interventions. They’ll generate bills and harms without benefits,” Carroll wrote.

Carroll said that the watch’s “irregular rhythm” notification feature is likely to generate “many false positives.” He added that before the watch won clearance, the FDA reviewed data collected by the Stanford Heart study for 266 individuals who received irregular rhythm notifications, and said that most of them had been wrong.

“The study wasn’t peer reviewed, so we don’t know for sure, but this was also a population for whom atrial fibrillation might be more common than in those who might use the watch. People who buy the latest Apple watch will most likely be younger, healthier, wealthier and more plugged into the health care system – and less likely to remain undiagnosed,” he wrote for the Times.

He went on to suggest that one of the major problems with the device is that the people who would benefit most are least likely to get it, according to the report.

“If we truly believed this was a medical test beneficial to the general population, insurance should pay for it. No one is suggesting that should happen,” Carroll wrote for the Times.

He went on to suggest that experts generally aren’t in support of universal cardiac monitoring, and that the US Preventive Services Task Force issued a “D” recommendation for screening asymptomatic adults at low risk, according to the report.

The suggestions were based on good research, Carroll said in the Times article. He added that a randomized controlled trial of ECG screening for heart problems “did not demonstrate that such screening offered any benefits in reducing desk or the risk of heart attacks or stroke in middle-aged people,” and that the ECG scans were “much more robust” than the Apple Watch will provide.

“I happen to own an Apple Watch. I find the other functions useful and fun. I even enjoy aspects of the activity monitoring. But I’m under no illusion they will help me lose weight or exercise more or improve my heart health. I own one because I want it, not because I need it. That’s the same criterion you should use, too,” Carroll wrote.

Last month, Apple unveiled the Series 4 Watch, which features on-board electrocardiogram scanning technology.

The post NYT Report: Apple Watch ‘should not be considered a medical device’ appeared first on MassDevice.

from MassDevice https://ift.tt/2QHcgEm