Lobbying Oura FDA benefits the Apple Watch if everyone is smart about the risks

Smart ring market leader Oura is trying to convince US lawmakers to loosen some regulations on health monitoring of wearable devices, which if successful will also benefit Apple. Users will just have to be careful what they do with the data.

Products that are sold must meet regulatory requirements, and this is something that Apple is very familiar with with its product line. However, if one wearable company’s work leads to change in the United States, it could directly benefit Apple’s own products as well.

Smart ring maker Oura has ramped up its efforts to make a good impression on the US government in 2025. Politics report details. In addition to giving out smart rings to Olympic athletes, she increased the lobbying budget.

While she spent just $40,000 in 2024, in 2025 that number exceeded $1 million.

This effort has not gone unnoticed, Oura is popular in Washington and the Department of Defense is its biggest customer. Lawmakers have also sought to protect Ouru from rivals in India and China, even though it is a Finnish company.

His latest focus is on US political decisions, with his sights set on the Food and Drug Administration’s medical classification.

Currently, the FDA regulates wearables as either a general wellness product with little oversight or as a medical device. Hardware designated as a medical device would require additional safety and efficacy reviews, which consumes time and resources.

Oura CEO Tom Hale wrote an op-ed in December urging the FDA and Congress to create an exemption for wearables that would help them avoid the dreaded medical-grade classification. He insists there should be a third category for “digital health screeners”, designed for devices that warn of health problems without making an actual diagnosis.

The op-ed apparently helped because the FDA changed its rules so that wearable devices can warn users to seek a more thorough medical evaluation from a doctor. It also opened the door to devices that measure blood pressure and blood sugar levels without necessarily requiring a medical device to be approved in advance.

Oura isn’t done yet, as she has called on lawmakers in Congress to make changes to the law to make it clear what features should be allowed without needing expanded approval.

It may come here, too, as Rep. Troy Balderson (R-Ohio), chairman of the House Digital Health Committee, is working on legislation in this area. Balderson said the legislation is meant to create an environment for wearables to expand and be more innovative.

Risky business

The discussion of legislatively giving companies the freedom to create new features without having to go through a rigorous review process is generally framed as a pro-innovation initiative. Even so, such a policy brings risk.

The purpose of FDA reviews is to ensure that if a device claims to measure a health-related statistic, it does so reliably. When it comes to monitoring vital data points about the body, such as blood glucose, an incorrect reading can cause the user to react in a truly life-threatening way, or not react when they really need to.

In February 2024, the FDA stated that non-invasive glucose monitoring has not yet been approved due to concerns about inaccuracy. He cautioned that patients should not purchase devices specifically for this purpose and should continue to use direct blood monitoring.

Apple has long been rumored to be testing glucose monitoring features with a view to adding it to the Apple Watch in the future.

So far, this has only really manifested itself on the Apple Watch in the form of the Dexcom continuous glucose meter, not the technology manufactured by Apple.

The FDA already has to deal with problematic technology when it comes to glucose monitoring. In December, the FDA warned consumers against using certain sensing devices that have been linked to at least seven deaths and more than 700 serious injuries.

The faulty devices supplied incorrect data to users, who then treated their condition based on this faulty data. In these reported cases, this has resulted in users unintentionally harming themselves, sometimes fatally.

Even so, it’s better to get some data to work with than no data at all. As we’ve seen many times before, the Apple Watch didn’t actually make a diagnosis, but encouraged users to seek professional help with its various health warnings.

All this without it being exclusively a medical device. However, it requires users to be smart about what data they see.

Oura is not the only company lobbying for change, but not everyone is following the same line. Rival wearable maker Whoop was pleased with the FDA’s changes to the physiological metrics rules for wearable devices, but did not support the creation of an entirely new “digital health screener” category.

Alex Vannoni, vice president of healthcare at Whoop, urged “caution” when considering creating an unregulated and undefined category for this purpose.

Apple (device) daily…

Oura’s attempts to convince the US government to steer clear of wearables has the potential to affect more than just Oura or smart rings in general. This could apply to many other wearables.

For Apple, of course, this would cover the Apple Watch range, as well as heart rate monitors like the AirPods Pro 3 and Beats Powerbeats Pro 2.

There’s also the oft-rumored Apple Ring, a smart ring that’s been repeatedly rumored but still hasn’t made it to market. Depending on the rumor you read, it could provide anything from limited health tracking to gesture recognition.

Currently, the Apple Watch would benefit primarily from changes in classification based on the FDA or Congress.

While it wasn’t needed for every feature, like the introduction of blood oxygen sensing in the Apple Watch Series 6, other features had to jump through more regulatory hoops.

Its inclusion of an EKG in the Apple Watch Series 4 was groundbreaking, but FDA approval arrived less than 24 hours before its launch. It was a similar story for the atrial fibrillation feature, which was approved hours before Apple’s WWDC 2022 keynote.

Securing features like these and hypertension alerts requires much more documentation, research, and evidence gathering to submit to the FDA for review. Even then, there is no guarantee that the FDA will provide a quick enough response, nor will it necessarily grant this approval.

The reclassification would free Apple from those restrictions and make it easier to roll out features for consumers.

If it had already been adopted, Apple would surely have brought features like non-invasive glucose monitoring to the Apple Watch by now, instead of continuing long-term development before release.

Care is still needed

Oura may have its way, helping Apple and others develop health-based features and bring them to market faster. However, this can put users’ lives at risk if not implemented with the right safeguards.

While companies in this space may be incentivized to bring new features due to reduced levels of regulatory oversight, this is a big risk. Although companies can anticipate an increase in potential lawsuits based on the data these features bring, users may end up paying the ultimate cost if they’re not careful.