is a senior reporter focusing on wearables, health tech, and more with 13 years of experience. Before coming to The Verge, she worked for Gizmodo and PC Magazine.
Few things scratch my brain like a good beef. Kendrick vs. Drake. Justin Baldoni vs. Blake Lively. On my beat, it’s usually two companies fighting over health tech patents. So-and-so copied a feature from so-and-so. The latest dispute on my radar is all about semantics. More specifically, the exact meaning of wellness.
Let me catch you up. On July 15th, the Food and Drug Administration (FDA) sent Whoop a letter. In it, the FDA declared that Whoop — maker of a niche fitness tracker favored by elite athletes — had crossed a line. Its new Blood Pressure Insights feature, the regulator said, was being marketed to customers without undergoing the proper clearance process.
In response, Whoop pulled out the W word: wellness.
In the world of health and wearable tech, “wellness” is sort of like a “get out of jail free” card. Some advanced health features, like EKGs and atrial fibrillation notifications, require regulatory clearance before consumers can use them. These features could be interpreted as diagnostic in nature or prompt a person to make a medical decision. Others, like step tracking and blood oxygen measurements, don’t require FDA oversight at all. They’re simply meant to make living a healthy life easier by helping you visualize certain measurable markers. Those features fall under the wellness umbrella. They’re “just for fun.”
Whoop’s Blood Pressure Insights feature, however, lies in murkier territory.
The way Whoop’s feature works is that a user takes readings with a regular blood pressure cuff for calibration. Once that process is complete, Whoop says its tracker uses metrics like “heart rate, heart rate variability, and blood flow patterns during sleep” to give an estimate of a person’s systolic and diastolic blood pressure each morning. The FDA contends that “providing blood pressure estimation is not a low-risk function” and that a blood pressure estimate inherently implies you’re diagnosing hypo- or hypertension. In a statement, Whoop says it “respectfully disagree[s]” and that this particular feature is more akin to tracking your sleeping respiratory rate. Under the wellness umbrella, Whoop argues it’s able to bring an innovative feature to the masses more quickly.
Whoop and the FDA both have points. It’s not a stretch to think that a user may get a few “high” blood pressure estimates, assume they have high blood pressure, and make health decisions informed by that assumption. At the same time, it’s clearly labeled as a beta feature, and similar “diagnostic adjacent” features are available without FDA regulation. I’ve lost count of how many sleep trackers claim to track “breathing disturbances.” That may not be explicitly marketed as a sleep apnea detection metric (that would require FDA clearance), but that’s semantics. The obvious reason to include it is to flag when a person might want to check themselves for sleep apnea.
The crux of it all is identifying high- and low-risk features for causing harm. Many cases are clear-cut. Natural Cycles, for example, is a period tracking app that claims you can use it as digital contraception using temperature data from wearables like the Oura Ring. It’s obvious that a regulatory body should vet a high-stakes feature like that. On the flip side, Samsung’s new Antioxidant Index feature for its Galaxy Watch 8 is a silly metric that tells you whether you’ve eaten enough fruits and veggies. Even if it’s inaccurate as hell (I was able to fool it by scanning a Cheez-It), it’s not likely to harm your health.
Oura is another wearable company that frequently lives in the gray area between wellness and medical tech. It recently partnered with Dexcom for OTC glucose monitoring, which is FDA-cleared. Photo: Amelia Holowaty Krales / The Verge
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