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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.
The Oura Ring has a Symptom Radar feature that falls in the gray area between wellness and medical 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.
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