When Oura, the Finnish smart ring company, announced earlier this year that its device could screen for key cardiovascular markers, it joined a growing cohort of consumer wearable companies racing to transform everyday accessories into quasi-medical devices. But as these companies sprint ahead, a critical question looms over the industry: Who is watching the watchers on your wrist—and your finger?

The tension between innovation and regulation in digital health has never been more acute. Consumer wearable companies are increasingly marketing health-screening capabilities that would have required a visit to a doctor’s office just a decade ago. Yet the regulatory framework governing these devices remains a patchwork of guidelines that critics say is woefully inadequate for the speed at which the technology is evolving.

From Step Counters to Screening Tools: How Wearables Crossed the Medical Rubicon

As detailed in a recent deep analysis by The Verge, the evolution of consumer wearables from simple fitness trackers to health-screening instruments represents one of the most significant—and underexamined—shifts in modern healthcare. Companies like Oura, Apple, Samsung, and Withings are now offering features that detect atrial fibrillation, measure blood oxygen levels, track skin temperature variations as proxies for illness, and even screen for sleep apnea. These are not trivial wellness metrics. They are clinical indicators that physicians use to diagnose serious conditions.

The appeal is obvious. Continuous, passive health monitoring promises to catch problems early, reduce healthcare costs, and empower individuals with data about their own bodies. Oura’s ring, which has attracted a devoted following among health-optimization enthusiasts and Silicon Valley executives alike, exemplifies this trend. The company has secured FDA clearance for certain features, including its blood oxygen sensing capability, positioning itself as a legitimate player in the digital health arena. But as The Verge’s reporting underscores, FDA clearance for individual features does not mean the device as a whole is a regulated medical instrument—a distinction that most consumers are unlikely to appreciate.

The FDA’s 510(k) Pathway: A Regulatory Shortcut Under Scrutiny

The primary mechanism through which wearable companies bring health features to market is the FDA’s 510(k) clearance process. Unlike the more rigorous premarket approval (PMA) pathway required for high-risk medical devices, the 510(k) process allows companies to demonstrate that their product is “substantially equivalent” to a device already on the market. It is faster, cheaper, and far less burdensome—which is precisely why critics argue it is insufficient for devices that millions of people may rely on for health decisions.

When Apple received FDA clearance for its electrocardiogram (ECG) feature on the Apple Watch in 2018, it was a watershed moment. The clearance applied specifically to the ECG app’s ability to detect atrial fibrillation, not to the Apple Watch as a comprehensive cardiac monitor. Yet the marketing effect was unmistakable: consumers came to view the Apple Watch as a medical device. Oura has followed a similar playbook, obtaining clearances for discrete features while building a brand identity rooted in holistic health monitoring. The gap between what the FDA has actually evaluated and what consumers believe these devices can do is widening with each product cycle.

The Screening Problem: When Consumer Tech Delivers Clinical-Grade Anxiety

One of the most pressing concerns raised by digital health experts is the phenomenon of false positives—and the downstream consequences they create. A wearable device that flags a potential heart arrhythmia sends its wearer to a cardiologist. If the alert is accurate, that early detection could be lifesaving. If it is not, it generates unnecessary anxiety, costly follow-up testing, and additional strain on an already overburdened healthcare system.

The Verge’s analysis highlights this tension directly, noting that the proliferation of screening features in consumer wearables is effectively turning healthy people into patients—sometimes without clinical justification. Dr. Eric Topol, a cardiologist and digital health researcher at Scripps Research, has been vocal about both the promise and peril of this shift. While he has praised the potential of wearables to democratize health data, he has also cautioned that screening tools deployed at massive scale without adequate clinical validation can do more harm than good. The base rate problem in statistics—where a rare condition screened in a large, healthy population produces far more false positives than true positives—is not a hypothetical concern. It is a mathematical certainty.

Oura’s Ambitions and the Competitive Arms Race

Oura has been particularly aggressive in expanding its health-screening portfolio. The company, which raised $200 million in a Series C funding round in 2022 at a $2.55 billion valuation, has made clear that it views itself not merely as a consumer electronics company but as a health platform. Its latest generation ring includes sensors capable of measuring heart rate variability, respiratory rate, and blood oxygen saturation, with the company signaling ambitions to add even more clinical metrics in future iterations.

This ambition places Oura squarely in competition with Apple, which has invested billions in health technology research, and Samsung, which has integrated blood pressure monitoring into its Galaxy Watch lineup in select markets. Google, through its acquisition of Fitbit, is also pushing deeper into health screening. The competitive dynamics are driving a feature arms race in which each company seeks to outdo rivals with the next breakthrough health metric—a race that regulators are struggling to keep pace with.

What the FDA Can and Cannot Do in the Age of Software Updates

The regulatory challenge is compounded by the nature of modern wearable technology. Unlike a traditional medical device that is manufactured, cleared, and sold in a fixed configuration, a smartwatch or smart ring receives over-the-air software updates that can fundamentally alter its capabilities. A device that was sold as a fitness tracker can become a cardiac monitor with a single update. The FDA’s current framework was not designed for this reality.

The agency has taken steps to adapt. Its Digital Health Center of Excellence, established in 2020, is tasked with modernizing the regulatory approach to software-based health tools. The FDA has also developed the Predetermined Change Control Plan framework, which allows manufacturers to outline anticipated software changes at the time of initial clearance, theoretically enabling faster approval of updates. But these measures remain works in progress, and their effectiveness is unproven at scale. Meanwhile, companies continue to ship features that blur the line between wellness and medicine.

The Consumer Trust Equation and the Information Asymmetry

Perhaps the most consequential dimension of this debate is the information asymmetry between wearable companies and their customers. When a consumer sees that a device has received “FDA clearance,” they reasonably interpret that as a comprehensive endorsement of the device’s medical capabilities. In reality, the clearance may apply to a single, narrowly defined function, with significant limitations on its accuracy, the populations in which it has been validated, and the conditions under which it should be used.

This gap is not merely academic. It has real implications for how people make decisions about their health. A 35-year-old who receives a notification from their smart ring suggesting a possible cardiac irregularity may delay seeing a doctor because they trust the device’s “all clear” on subsequent readings. Conversely, they may flood emergency rooms with concerns triggered by algorithmic noise. Neither outcome serves the public health interest, and neither is adequately addressed by the current regulatory regime.

The Path Forward: Regulation That Matches the Pace of Innovation

Industry observers and health policy experts are increasingly calling for a more comprehensive regulatory framework—one that evaluates wearable health devices not feature by feature, but as integrated systems that shape consumer health behavior. Some have proposed a tiered classification system that would impose stricter requirements on devices marketed with health-screening claims, regardless of whether those claims are technically classified as “wellness” or “medical” under current FDA definitions.

Others argue that the solution lies not in more regulation but in better transparency. Requiring companies to publish detailed accuracy data, false positive rates, and population-specific validation studies in plain language accessible to consumers would, proponents say, allow the market to self-correct. The European Union’s Medical Device Regulation (MDR), which took full effect in 2021, offers a more stringent model that some U.S. policymakers have pointed to as a potential template.

What is clear is that the status quo is unsustainable. The wearable health industry is projected to exceed $60 billion in global revenue by 2027, according to estimates from Grand View Research. Millions of consumers are already making health decisions based on data from devices whose clinical validity has been only partially evaluated. The stakes—measured in lives, in healthcare costs, and in public trust—are too high for regulators to remain a step behind.

As Oura, Apple, and their competitors continue to push the boundaries of what a consumer device can detect, the question is no longer whether wearables will play a role in healthcare. They already do. The question is whether the systems meant to protect consumers can evolve as fast as the technology on their wrists and fingers.