What if patients could learn their hypertension risk using a device they already own?<\/p>\n
In a country where about half of adults<\/a> have hypertension (chronic high blood pressure) but less than 10%<\/a> get all their recommended screenings, this is an exciting idea. A 2023 study<\/a> estimates that expanding home blood pressure monitoring could reduce heart attacks, strokes, and save an average of $7,794 in healthcare costs per person over 20 years.<\/p>\n Unfortunately, that promise hasn\u2019t yet met its potential. It\u2019s being held back by technological limits and a lack of clear guidelines and standards for consumer wearables, experts tell Healthcare Brew.<\/p>\n \u201cPart of the problem is that we\u2019re now entering this area where there\u2019s this blurred line: Is this a medical device, or is it meant just for fun?\u201d Jordana Cohen, associate professor of medicine and epidemiology at the University of Pennsylvania, told us.<\/p>\n Digging into data. Oura Health<\/a> and Google are currently gathering data on detecting hypertension with their wearables, and the Apple Watch launched a hypertension alert feature in September.<\/p>\n The Apple Watch doesn\u2019t directly measure blood pressure, however. Instead, an AI algorithm analyzes readings from the watch\u2019s heart sensors and extrapolates, per Apple\u2019s February 2025 application for FDA clearance. It\u2019s been cleared by the FDA \u201cto identify patterns that are suggestive of hypertension.\u201d<\/p>\n The device flagged 41% of people with undiagnosed hypertension in a clinical study, but it missed 59% of them, according to a Feb. 9 JAMA analysis<\/a> of data submitted by Apple to the FDA, coauthored by Cohen. In comparison, high-quality office blood pressure measurements correctly diagnosed 71% of people who were previously undiagnosed with hypertension, per a 2023 study<\/a>.<\/p>\n Although the FDA reviews device performance data, it doesn\u2019t require blood pressure devices to conduct standardized testing. Clearance does not necessarily mean a device is \u201caccurate enough for clinical use,\u201d per a December scientific statement<\/a> from the American Heart Association (AHA) coauthored by Cohen.<\/p>\n Navigate the healthcare industry<\/p>\n Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.<\/p>\n While it\u2019s \u201camazing\u201d this watch may inform some people who wouldn\u2019t have otherwise known they had high blood pressure, its results show it\u2019s \u201cnot medical grade,\u201d Cohen said.<\/p>\n Nonetheless, she\u2019s encountered several patients who reply to their hypertension diagnosis with \u201cWell, my watch didn\u2019t alert me!\u201d<\/p>\n Zooming out. To be fair, Apple\u2019s website says not everyone with hypertension will get a notification. And the watch has been great at minimizing false positives. Only 8% of people without hypertension were falsely flagged as being at risk of hypertension, the JAMA study notes.<\/p>\n