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Among all the features of the Apple Watch 4, the most discussed is probably its ability to perform an electrocardiogram or an ECG. An ECG (also called ECG) is usually performed by placing electrodes on the skin to detect electrical changes resulting from the heartbeat. The Apple Watch 4 includes both the possibility of performing an ECG and detecting irregular heart beats, but a cardiologist wondered if the application was accurate enough to perform these tests safely.
First, a point to keep in mind: Neither the ECG nor the irregular heartbeat pickup software are currently incorporated into the product. Apple has not given a date for when they will arrive. The second point, the lack of discussion, is that some physicians themselves are cautious about the kind of information that these applications will provide and how useful they will be. They have good reasons to be.
Whenever you test a medical condition (and the Apple Watch 4 passively monitors one), you need to tackle the risk of false positives and false negatives. A false positive is a test result indicating that you have a problem when you do not do it. A false negative is a test result indicating that you have no problem when you make. Both can lead to death or, at the very least, suboptimal or incomplete medical treatment for an ongoing illness.
Most of the news about the new medical monitoring of Apple Watch 4 focused on the question of what Apple was proposing, but not on the evidence presented to the FDA for the possibility of offering this feature, such as the highlights a new article from HealthNewsReview. Apple collected data from 588 people for its ECG application and 226 people with atrial fibrillation.
For the ECG application, the FDA received data showing that the Apple Watch could not rank about 1 out of 10 rhythm. Of the rest, 98.3% of the time, people with atrial fibrillation were correctly detected, while 99.6% of people were correctly identified as do not to have an AFib if they did not have one.
The irregular heartbeat monitor was not as accurate. In this mode, 226 patients were followed with an ambulatory cardiac monitor for six days. 41.6% of patients had an episode during this period. Of the 41.6% of patients who had an episode, Apple Watch 4 caught an event in 78.9% of cases. However, these two measures are subject to two important caveats: the data were not peer-reviewed and, in these cases, clinicians already knew which individuals had fibrillation problems. auricular and which are not. A percentage or two of incorrect pricing applies to millions of people when you consider the size of Apple's global market.
"The big problem with this finding is that this population has a prevalence of atrial fibrillation probably 100 times greater than Apple's target market," said Venkatesh Murthy, MD, a cardiologist at the University of Michigan. "This is not good, however, the main caveat is that we still lack most of the information needed to be sure of how this experiment was performed, so we are just guessing.
There are also questions about the overall process used to check the health software in the first place. Apple is part of a program to accelerate the certification of health software, but the FDA rules for device approval in this context appear to be rather weak. The FDA goes so far as to declare that "the demonstration of [safety and effectiveness] does not necessarily require a survey / clinical study. This is a startling statement from the organization following highly publicized tarnishes like Theranos, where a company valued at billions of dollars has basically lied about its products and their ability to transform the blood test market for several years until all of his activity turned out to be based on lies and the company imploded.
It's an open question as to whether this type of surveillance is useful to most people or not. Nor is it an innocuous question when the price of healthcare is skyrocketing. It is not so much that the Apple Watch 4 can detect a potentially fatal problem, but that it will unnecessarily send people to expensive specialists (or even to increasingly expensive PCPs). The problem with the return to surveillance narration is that there are already real examples of features like this one that can save lives. Discussions about the perceived need for care, whether people should go to the doctor in a given situation and the long-term price inflation of care in the US medical system (all extremely complex topics to start with) are even more difficult to obtain. On the one hand, you have loads of facts and figures and on the other hand, you have compelling personal essays with headlines such as, "How Apple Watch saved my life". But that does not make the points irrelevant.
Buy an Apple Watch 4 watch if you want it and use the ECG and AFib monitoring capabilities if it gives you some peace of mind, but never make the mistake of thinking it's a cardiologist. it's on the market and better tests can be done. This is not as good as testing the device in blinded studies initially, but it will answer a few questions about the accuracy of this feature.
Now read: The Apple Watch Series 4 watch will consolidate the Apple Smartwatch dominance, the expected notebook growth, and the FDA approves the EKG heart monitor for Apple Watch
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