The Concept of ‘Wellness’ is Losing Its Significance in Health Technology

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Recently, I’ve been pondering Oura’s new venture into the political arena. The Oura Ring has long been a favorite among influential figures, but it seems to have found a new home on Capitol Hill. A recent article highlighted how the smart ring company is lobbying lawmakers for reduced regulations on wearables. Specifically, Oura is proposing a new classification for low-risk wearable health features, which would exempt them from the FDA’s clearance process.

Oura’s CEO, Tom Hale, first laid out this idea in a Wall Street Journal op-ed last December. He argues that wearables don’t fit neatly into the FDA’s existing regulatory categories, which separate health tech into wellness and medical devices.

Hale raises a valid point. The distinction between wellness and medical devices is often murky. The FDA defines wellness features as those intended for educational or entertainment purposes, meaning they don’t require oversight. Features like step counts, sleep tracking, and resting heart rates fall into this category. Conversely, medical devices are broadly defined as tools meant to diagnose, treat, prevent, or mitigate health conditions, classified by risk levels. For instance, a tongue depressor is low-risk, while a pacemaker is high-risk. Wearables typically occupy a gray area, considered low to moderate risk, especially when it comes to advanced features that resemble diagnostic tools.

In 2018, Apple made waves by introducing an EKG sensor in the Apple Watch Series 4, transforming smartwatches from luxury fitness trackers into potentially life-saving devices capable of flagging atrial fibrillation. This feature, along with others, required FDA clearance due to its implications for medical treatment. While the Apple Watch itself isn’t classified as a medical device, it includes features that the FDA deems necessitate closer examination for safety.

The challenge lies in the arduous process of obtaining FDA clearance. Wearable manufacturers often face stringent accuracy testing and must ensure compliance with HIPAA to protect health data. This process can take years and cost millions, resources that smaller companies may lack. At CES 2026, I encountered a wearable solution for premature ejaculation that took six years and multiple funding rounds to gain FDA clearance, resulting in a lot of health tech that never sees the light of day.

To sidestep this regulatory maze, many wearable companies label their features as wellness-related. This often leads to either watered-down insights or prolonged timelines for new features to hit the market.

I can understand Hale’s push for a digital health screener category. He describes it as “software features that can alert users to potential issues without making diagnoses.” Ideally, this new classification would come with “clear guidelines,” straightforward labeling, and performance standards for accuracy and reliability.

However, from a consumer perspective, FDA clearance already provides similar assurances. FDA-cleared health features come with disclaimers stating they aren’t intended to diagnose conditions or replace medical advice. The proposed change seems to suggest 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. “Consumers shouldn’t have to navigate the complexities of FDA categories. They want reliable, accurate products that are easy to use and help improve their health. Ultimately, it’s up to companies like Oura to collaborate with the FDA to clarify what these products do and expedite their availability.”

Bloomfield emphasizes that Oura’s approach isn’t about skimping on accuracy testing. The company plans to continue publishing accuracy metrics for transparency. The goal is to blend some medical device rigor with the flexibility of lower-risk classifications to keep pace with the rapid evolution of health tech.

“One of the main points here is that technology is advancing so quickly that the FDA often struggles to keep up,” Bloomfield notes.

I have my reservations. Does introducing a third classification genuinely clarify the distinction between wellness and medical devices? I frequently find myself explaining this difference to readers, and even seasoned tech enthusiasts often confuse FDA clearance with FDA approval. The former applies to moderate-risk medical devices, while the latter pertains to high-risk classes and drugs. Adding another ambiguous classification makes me uneasy, especially in an era where wellness influencers can easily spread misinformation.

Wearable-induced health anxiety is also a genuine concern. I’ve often discussed the downsides of overwhelming users with countless metrics. This is particularly true for features that detect subtle conditions like atrial fibrillation or sleep apnea. Research shows that 20% of wearable users experience “intense fear and anxiety” upon receiving irregular heart rhythm notifications, while 15% feel “anxious, scared, or concerned” after abnormal heart rate alerts. In one case, a 70-year-old smartwatch user took 916 EKG readings in a year due to anxiety triggered by their device.

Some might argue that anxious individuals should simply avoid wearables, but that perspective overlooks the marketing narratives that suggest these devices could save lives or enhance longevity. Most people want to avoid death for as long as possible—what’s a little anxiety if a gadget promises to help?

It’s also concerning to see the narrative that wearables empower individuals to “take control” of their health. This idea was popularized by RFK Jr. last year, who expressed hope that every American would eventually wear one. While self-quantification can be beneficial, it’s not a substitute for professional medical care. Even with the potential benefits of faster innovation and continuous monitoring, it’s unsettling to consider relaxed regulations at a time when we expect wearables to do more.

In my conversations with various doctors, most appreciate the potential of wearables, especially in research. However, many remain skeptical about false positives. Even if everything were perfect, integrating wearable data into a diagnosis or treatment plan isn’t always straightforward. I began noticing health issues after tracking my data with a Fitbit in 2014, but it took 11 years and six doctors to finally receive proper diagnoses and a treatment plan. My experience is far from unique.

I’m not suggesting that Oura is wrong for highlighting a legitimate issue with the current clearance process, nor am I saying their proposal is inherently flawed. However, I believe regulation isn’t the sole problem. Effective regulation relies on accurately distinguishing low-risk health features. The more pressing concern is whether we’re losing clarity in communicating the difference between wellness and medical devices.

Who gets to make that judgment? Medical experts, well-funded lobbyists, or wellness influencers who promote questionable health practices? Tech companies may aim to improve public health, but they are ultimately driven by investor interests.

A recent incident with Whoop illustrates this dilemma. The company recently doubled its lobbying efforts and launched a blood pressure feature, which the FDA flagged as misleading and requiring clearance. Whoop argued it was a wellness feature, but my review found it fell into a confusing gray area. Providing blood pressure estimates could mislead users into thinking they have hypertension, prompting unnecessary actions based on a presumed diagnosis, despite disclaimers stating it wasn’t a diagnostic tool. In January, the FDA updated its guidance, indicating that blood pressure features could be acceptable if they were purely informational.

When I asked Bloomfield about this, he acknowledged the updated guidance was a positive step but noted that much discussion remains before it becomes a reality. He pointed out that this was the first update to FDA guidance on this category since 2019. Oura is particularly interested in discussing the ability for digital screening features to specify what they’re flagging. For instance, Oura’s Symptom Radar feature must remain vague under current guidelines, stating only, “We’re detecting early signs of changes in your health,” rather than directly indicating illness. Bloomfield believes that while this vagueness is still useful, more specificity could enhance screening.

“This is an area where even experts have differing opinions,” he says. “We’re all trying to navigate this together… Healthcare is a collaborative effort, and we need to work together to ensure we do the right thing for everyone.”

While much of what Bloomfield says resonates, I firmly believe it’s crucial for consumers to understand the distinction between “wellness” and medical features. Reflecting on all this, it’s evident that change is necessary. The concept of wellness is already precarious, and I worry it won’t be long before it loses its significance entirely.