During the announcement of the Apple Pulse Watch Series 6, the company added its latest element – the Blood Oxygen Monitor – in addition to the slate of its existing health features.
“Apple Pal and Watch are already a powerful health tool with apps that measure heart rate and heart rhythm,” said Apple’s VP of Health, Sumbul Ahmed Desai. “And now adding oxygen to the blood brings another value to health for users.”
Features on the Apple Pull Watch that track heart rate and heart rhythm, however, are the main differences from Blood Oxygen Oxygen Monitor: Heart-tracking features are cleared by the Food and Drug Administration (FDA), and not Oxygen Monitor. Apple Play underwent a lengthy, comprehensive process to develop and validate the EKG feature, so that the watch could detect a condition called atrial fibrillation. It doesn’t have to do the same thing for a pulse oximeter.
Blood oxygen monitors or pulse oximeters are considered class II medical devices by the FDA. Generally, any company that wants to sell one in the United States must submit documents to the agency that confirm that its product is already working on other versions of the same product in the market. However, one task is the same: if the company says the product is for entertainment only or for general “well-being”, they don’t have to go through that process. They cannot claim to be able to diagnose or treat a medical condition, but they can put it up for sale.
That’s the way Apple went down the aisle. They do not say that their monitors can diagnose any disease, only that they provide that information. Other health-focused applications and smart ches have taken a similar approach by advancing the FDA process. “If you’re just providing information, they’re not regulating it,” says Matt Granan, an assistant professor of health care at the University of Pennsylvania’s Wharton School. Digital health products are so ubiquitous, and so many new products come on the market every year that it would be difficult for the FDA to review them all. “They have to think about how they can allocate their own resources,” Grenen says.
The agency takes action, however, when companies want to use the apps to influence someone’s medical care. EKG facility falls under that category. It is considered for a specific medical purpose: flagging an abnormal heart rhythm. “This is to interpret and manage a potentially life-threatening situation,” says Michael Matheny, co-director of the Center for Public Health Improving at Wonderbilt University’s Informatics Center.
As part of the FDA clearance process for EKG, Apple had to provide and publish data that showed the feature could, in fact, flag artery fibrillation. Doctors and specialists were able to examine the information, and there are dozens of published research studies examining closely how the clock can detect really dangerous heart rhythms.
Because the Pulse Ox Xmeter is just a product of well-being, Apple Play didn’t need to release any of that information. While searching for data showing how well the Apple Pulse Watch pulse oximeter works compared to other devices in the methane market, he couldn’t find much. “It was for me,” he says. Fictional reports from people testing the Apple Pulse Watch have found that the pulse oximeter feature is not accurate and can be difficult to use.
The difference between a facility used for health and a facility used for medical care is important – one has been cleared by specialists, and the other has not. That clarity isn’t obvious to those who buy products like the Pulse Watch, especially when it slows down the marketing line – such as when Apple compared the heart monitoring features on the Pulse directly to the new Pulse Oximeter. “Often patients and consumers do not really understand the difference. So they will start using the device and rely on the information, ”says Matheny.
It becomes more complicated when different applications that fall under different categories are in the same product, Grenen says. “It’s confusing to think that one feature on the device is medical grade, and another feature, which looks like it’s medical, isn’t really.”
Granlin says the DA bridge is not the last product of some of the features that have been cleared by the FDA and others that are classified as wellness tools. “I think we’re going to see a lot in it. The pieces of technology will have multiple capabilities and some will be tested more than others. “
