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For the past week, I’ve been thinking about the fact that Oura has gone to Washington.
The Oura Ring has always had an influential clientele, but it’s apparently now a popular accessory in Capitol Hill. Earlier this week, Politico ran a story about how the smart ring maker is lobbying legislators for less wearable regulation. Specifically, the article notes that Oura has floated the idea of creating a “digital health screener” classification for so-called low-risk wearable and health features that would be exempt from the Food and Drug Administration’s clearance process.
Oura CEO Tom Hale actually outlined the idea in a Wall Street Journal op-ed back in December. In it, Hale contends that wearables don’t fit within the FDA’s current regulatory framework, which broadly divides health tech into two categories: wellness and medical devices.
He has a point. The line between wellness and medical devices isn’t as clear as it ought to be. Wellness features are generally defined by the FDA as for educational or entertainment purposes. As such, they don’t require oversight. For example, features like step counts, sleep quality, or your resting heart rate all fall under the wellness umbrella. The definition of a medical device is also broad. Generally, it refers to a device that is meant to help diagnose, treat, prevent, cure, or mitigate a disease, illness, or condition. They’re classified by risk levels. For example, a tongue depressor is a low-risk device, while a pacemaker is a high-risk one. Wearables typically live in a gray area between wellness and medical devices, and are considered to pose a low-to-moderate risk. Where things get tricky is advanced, diagnostic-adjacent features.
Back in 2018, Apple introduced an EKG sensor to the Apple Watch Series 4. It was a watershed moment in wearables history. Where smartwatches were once an expensive fitness tracking luxury, they morphed into potentially lifesaving devices because now the Apple Watch could potentially flag — though not diagnose — atrial fibrillation. That feature, and many since, required FDA clearance because it could potentially inform medical treatment. So while the Apple Watch in and of itself is not a medical device, it has features that the FDA has said require closer scrutiny to ensure safety.
The problem is that getting FDA clearance is a royal pain in the butt. Wearable makers often have to conduct strict accuracy testing and make sure features are HIPAA-compliant to ensure private, secure health data protocols. Those results have to be presented to the FDA for review. It can take years and several millions of dollars to obtain clearance — resources that smaller companies simply may not have. At CES 2026, I finally saw the taint bandaid — a wearable solution for premature ejaculation that took six years and required multiple rounds of funding to get FDA clearance. The result is you end up with a lot of health tech vaporware.
To avoid this regulatory quagmire, wearable makers often release features under the wellness moniker. That means either nerfing insights to the point where they’re not that useful or accepting that new features will take forever to get to market. If they make it to market.
So, I can see Hale’s point in advocating for a digital health screener category. In the op-ed, Hale describes this as “software features that can warn users of trouble but stop short of diagnoses.” Ideally, he says the new classification would have “clear guidelines” with straightforward labeling, explicit disclaimers, and performance standards for accuracy and reliability.
But, from the consumer standpoint, that’s what FDA clearance already does. FDA-cleared health features always come with warnings that they’re not intended to diagnose conditions or replace a doctor. Going through the process also requires companies to prove safety and accuracy. So what exactly is this difference being proposed here? Hale’s op-ed implies it’s a streamlined process to save companies time and money.
“From the consumer perspective, it should feel the same,” says Dr. Ricky Bloomfield, Oura’s chief medical officer. “We would never expect consumers to have to figure out what FDA categories mean and all that complexity. They just want a product that works reliably, that is accurate, easy to use and helps them improve their health. On the bottom line, it’s up to companies like Oura to work with the FDA to figure out the best path for these products so that we can be very clear about what they do and then get it to them as quickly as possible.”
Bloomfield went on to clarify that the process, in Oura’s view, isn’t meant to obscure or negate vigorous accuracy testing. He says that Oura would continue to publish accuracy metrics from their testing for transparency. Instead, it’s meant to combine some of the rigor of a medical device, with the ease of a lower-risk to accommodate all the ways health tech has evolved in the past decade.
“One of the main points here is that technology is moving so quickly that oftentimes, the FDA can’t move as quickly as the technology does,” says Bloomfield.
I have several concerns. Does adding a third classification actually clarify the difference between wellness and medical devices? I regularly have to explain the difference to readers, laypersons, and sometimes, even seasoned tech experts. I often see people conflating FDA clearance with FDA approval — the former is for moderate-risk medical devices, while the latter is for the highest-risk class and drugs. Adding a third, nebulously different classification? That makes me nervous in an age when wellness influencers often muddle facts but have an incredibly broad reach.
Wearable-induced health anxiety is also a real risk. In Optimizer, I’ve frequently written about the dark side of overloading people with dozens of biomarkers and metrics. That’s without factoring in features that flag hard-to-spot conditions like atrial fibrillation, sleep apnea, or hypertension. One study found that 20 percent of wearable users reported feeling “intense fear and anxiety” when receiving an irregular heart rhythm notification, while 15 percent reported feeling “anxious, scared, or concerned” when receiving abnormal heart rate alerts. In another, wearable anxiety spurred a 70-year-old smartwatch user into taking 916 EKG readings in a year.
Some people might say, “Well, anxious people should know better and avoid wearables,” but that’s disingenuous. The marketing narratives all say these devices might save your life. That they can help you live longer and healthier. They might even tell you when you’re about to get sick. Most people would like to avoid death for as long as humanly possible — what’s a little anxiety if a little gadget promises to make that possible?
It’s also alarming to see the narrative that wearables can help individuals “take control” of their health. It’s a concept that RFK Jr. touted widely last year after stating he hoped every American would eventually don a wearable. Self quantification can be helpful. However, it alone isn’t enough to “take control” of your health. Data is nice. You still have to see a doctor. Even if you consider the upsides — faster innovation, continuous monitoring for tricky-to-catch conditions — it’s unnerving to see suggestions for relaxed regulations at a time when we’re asking wearables to do more and more.
Speaking of doctors, I’ve spoken to several in my reporting over the years. The majority appreciate what wearables can do, especially in the research space. I’ve also spoken with plenty who are more skeptical and wary of false positives. But even if everything were perfect, incorporating wearable data into an actual diagnosis or treatment plan isn’t always a straightforward path. I began noticing health issues after I started tracking my data with a Fitbit in 2014. It took 11 years and six doctors for me to actually find proper diagnoses, a physician who took me seriously, and a treatment plan. Mine is far from an extraordinary story.
I’m not saying Oura’s wrong for pointing out a valid problem in the existing clearance process. I’m not even saying its proposal is a bad idea. I’m merely suggesting that perhaps regulation isn’t necessarily the main or only problem here. Good regulation hinges on accurately discerning what is and isn’t a low-risk health feature. To me, the bigger issue is whether we’re losing the plot on how to clearly communicate the difference between wellness and medicine.
Who gets to make that judgment call? Medical experts, lobbyists with deep pockets, or science-challenged wellness hacks who assert beef tallow is an adequate substitute for sunscreen? Tech companies that may want to help make the public healthier, but are ultimately beholden to investors?
I’ll point to a recent scenario with Whoop, another wearable company that Politico says has doubled its lobbying spending. Last summer, the company launched a blood pressure feature. The FDA sent a warning letter, saying the feature’s design was misleading and required clearance. Whoop countered saying it was a wellness feature. Reviewing the feature myself, it seemed to fall in a confusing gray area. Providing high or low blood pressure estimates could mislead customers into thinking they have hypertension (or hypotension). That could lead them to take certain actions, assuming a diagnosis, because Whoop’s marketing made it seem like its algorithm was scientifically validated. At the same time, there were clear disclaimers that this wasn’t a diagnostic tool. Then, in January, the FDA released further guidance saying blood pressure features were fine if they were just simply providing information — in other words, if it were for wellness purposes.
When I ask Bloomfield about this, he says the updated guidance was a step in the right direction but acknowledges that there’s still a lot of discussion left before this becomes a reality. For example, Bloomfield pointed out that January was the first time the FDA guidance on this category has been updated since 2019. One of the areas Oura’s interested in discussing further is the ability for digital screening features to actually name what they’re flagging. For example, Oura’s Symptom Radar feature has to remain vague under the current guidance. Instead of saying “Hey, you’re falling ill,” it can only say “We’re detecting early signs of changes in your health.” Bloomfield maintains that is still useful for consumers, but that a degree of specificity could be helpful for other screening.
“This is an area where even the experts have differing opinions on these things,” he says. “We’re all trying to figure this out together… Healthcare is a team sport and we need to work together to make sure we do the right thing for everyone.”
A lot of what Bloomfield says makes sense, though I strongly believe it’s important for the average consumer to understand what companies mean when they market something as a “wellness” feature versus a medical one. Mulling it all over, it’s clear something needs to change. Wellness as a concept has already been teetering on the edge. I’m afraid it won’t be long before it loses its meaning completely.
