Can Continuous Blood Pressure Monitoring Be Risky?

Ōura Health, maker of the sleek ring that tracks sleep, stress, and fitness, has formally petitioned the FDA for clearance to continuously monitor blood pressure through its optical sensors. If approved, the Ōura Ring would become one of the most well-known consumer wearables not worn on the wrist to provide continuous, clinically validated blood pressure readings.

The petition is an impressive leap forward for the company and for wearable technology. For decades, blood pressure has been a static snapshot taken in a clinic, once or twice a year, often under fluorescent lights and leading to patient anxiety. (I have yet to meet someone who is not at least somewhat bothered by the cuff that normally reads blood pressure.) Continuous, real-world monitoring will reveal the rhythms of blood pressure as people go about their lives: at work, under stress, asleep, or recovering from exercise.

As exciting as this step is, the rise of continuous biometric surveillance also surfaces profound questions about accuracy, accessibility, and who really owns the torrent of data these devices generate.

Hypertension is deadly and it is common, affecting nearly half of U.S. adults. In 2023, high blood pressure was a primary or contributing cause of 664,470 U.S. deaths.

Despite its prevalence, hypertension is often referred to as a silent killer precisely because most people have it checked only once or twice a year. Devices capable of continuous, validated monitoring could change that equation. The potential clinical advantages are huge:

Early detection and intervention. Subtle changes in baseline pressure could trigger earlier adjustments to medication or lifestyle before heart damage occurs.

Personalized, longitudinal insight. Instead of relying on "white-coat" readings, clinicians could see trends across days or weeks, distinguishing stress spikes from sustained hypertension.

Patient engagement. Real-time feedback could drive behavior change. With appropriate education, patients may make the connection between certain behaviors -- like if last night's cocktail or poor sleep elevated morning blood pressure. It's possible those data points and connections could be more motivating than a lecture during an annual checkup. Remote monitoring and equity. For rural or mobility-limited patients, data sharing with clinicians could extend care beyond clinic walls.

Research and prediction. Millions of anonymized data points could feed algorithms that would better predict cardiovascular events or contribute to a better understanding of the interaction between sleep, diet, and vascular health.

Ōura signals the future of preventive cardiology: ambient medicine, where health data quietly flows in the background, alerting us before crises strike.

First, when every heartbeat and glucose fluctuation is visible, data noise can masquerade as disease. Even medically trained users struggle to interpret variability; false alarms can cause unnecessary testing or anxiety. Clinicians face another burden: data deluge. Integrating continuous readings into already-strained workflows risks overwhelming primary care physicians and specialists. The signal-to-noise ratio will determine whether these devices improve care or just create clutter.

We also risk widening certain health disparities. High-quality wearables still cost hundreds of dollars and require smartphones and internet access. Without public health support, these technologies may serve mostly the affluent, not the populations at highest cardiovascular risk. (Perhaps Ōura could follow the lead of internet service providers, which, in partnership with local and state governments, often strive to provide more affordable options for lower-income families.)

Finally, sensors and algorithms have biologic blind spots. Optical signals can behave differently depending on skin tone, body type, or movement, leading to uneven accuracy across diverse users. Even with FDA oversight, we must ensure validation studies truly reflect the populations who will use these devices.

Continuous monitoring produces more than health insight; it generates an ocean of data. The typical wearable collects not only physiologic metrics, but also location information, device metadata, and behavioral cues, all of which are immensely valuable. These metrics have the potential to aid clinical research, but couldn't they also be sold for profit?

For Ōura Health, that question has become more prescient given their recent partnership with Palantir, a data management and analytics firm. Founded by Peter Thiel in 2003, Palantir now has close ties to the Trump administration and the Department of Defense. Reports state Thiel named the company after the crystal ball in the Lord of the Rings, which was used to spy on enemies.

Privacy: Few consumer devices are fully covered or strictly regulated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA). A breach or resale of identifiable biometric data is a matter of when, not if. Ambiguous ownership: Most terms of service grant the company control over secondary data use. Commercial exploitation: Data may inform targeted marketing or even future insurance decisions. While companies can assure consumers they do not use personal information for these purposes, data breaches could wreak havoc or future company owners could have alternative plans.

Algorithmic bias: Datasets dominated by certain demographics may train models that systematically misinterpret signals in other populations.

Consumers may click "accept" without realizing their resting heart rate, stress levels, menstrual cycles, and sleep cycles could become commercial commodities.

Despite concerns, patients and providers could also gain from large-scale data aggregation. Potential benefits include: a population-level understanding of disease progression and lifestyle impact; faster drug and device development through real-world evidence; and predictive modeling for early disease detection.

The FDA's willingness to engage companies like Ōura is encouraging; it shows the agency recognizes that wearables are fast becoming quasi-medical devices. But regulatory rigor must evolve alongside innovation. Clinical validation and consumer convenience are not mutually exclusive, but without thoughtful policy, one will eclipse the other.

Standardize accuracy benchmarks. The FDA should establish clear, population-inclusive accuracy thresholds for wearable blood pressure and metabolic sensors that are effective across skin tones, body types, and comorbidities. Establish transparent data-use labeling. Just as nutrition labels disclose ingredients, device packaging and app onboarding should disclose who owns the data, where it is stored, and how it may be used or sold.

Expand HIPAA-like protections. Physiologic data collected outside clinical settings must enjoy the same legal protections as data collected in hospitals or practices.

Provide incentives for equitable access. Governments and private payers should consider subsidies or reimbursement models for validated wearables when used for chronic disease management.

Prioritize interoperability and clinician usability standards. Continuous-monitoring data must flow into electronic health records in a digestible, actionable format -- we need summaries, not raw streams.

Establish independent audit and certification. Similar to cybersecurity audits, third-party reviewers should regularly evaluate device performance, algorithm updates, and privacy practices, publishing results for clinicians and consumers.

These steps will not stifle innovation -- they will sustain it by building trust. Without public confidence, even the most advanced device will end up in a drawer.

Ōura Health's move toward continuous blood pressure monitoring is more than a technological milestone; it demonstrates where healthcare is headed.

We are moving from episodic measurement into continuous surveillance, from reactive medicine to proactive insight.

That journey can save lives, but only if we design the roadmap with intention. Continuous does not have to mean intrusive; personalized does not have to mean devoid of ethical responsibilities. The true measure of success will not be how many data points are collected, but in how responsibly we interpret, protect, and democratize that information.

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For health items whether BP or weight, respiration, O2, trends and lots of aggregate data prevail. Frequency of collection just means more data.

(Barring of course extreme cases like hypotension or radically low O2 that need immediate care)

when every heartbeat and glucose fluctuation is visible...

I like the data stream of CGM, nutritionally extremely educational and life changing for the better.

Expect next year a CKM, Continuous Ketone Monitor... already available outside the US, including Canada. Hope to grab some of those...

Not meaning to go off topic too much, the interesting issue to me is “who owns the data”.

Not just on this issue of BP monitoring. But, the information being collected on us by the cornucopia of electronic devices and gadgets that dominate modern life.
Very few it seems are totally benign and completely self contained. Too many collect and share with sources largely unknown to us information that they observe or process.

Continuously worrying about anything and everything is more debilitating to your health than most other factors you can control.

JMO

--- "Continuously worrying about anything and everything is more debilitating to your health than most other factors you can control. JMO"

Not just your opinion, for it is shared by many including my bride and me.

Throughout modern Western life as we read it in media, there seem two basic themes: "Fear!" And "fear not." We ascribe to the latter.

These little devices are just anxiety inducement machines. Filling the uneducated with dread and fear every time their individual vital signs deviate from the “laboratory norm”.

We need a few good old-fashioned doctors (almost extinct now) to go around and hit people in the head with their reflex hammers and remind people to go live and stop worrying. There are people who need such monitoring and for them it is beneficial. For the vast majority, they do not.

One famous medical researcher has claimed that the introduction of MRI scanning has caused untold mischief (in addition to being overused) in that it often detects clinically insignificant abnormalities (incidentalomas) which often lead to further tests and unnecessary treatments.

It has been suggested to me by medical professionals that the BP should be checked multiple times a day. Nope, I check it 2 or 3 times a week. If I relax for 10-15 minutes and it is normal (as defined by me, not the desired “normal” that keeps creeping down) I’m good. I noticed it was creeping up so I got back to walking 3-4 times a week. Seems to do the trick.

I told them, I’m satisfied and I am NOT going to become obsessed with it.

I bought mine in a store and use it every morning. For some reason I tend to get lower readings at the Red Cross when I give blood or at the doctor’s office. So much for a doctor’s office being more stressful. I figure that their machines are probably more accurate.

Algorithmic bias: Datasets dominated by certain demographics may train models that systematically misinterpret signals in other populations. Yeah, but Master told me to breath in through my nose and out my mouth, deeply, twice...then reset.

...which often lead to further tests and unnecessary treatments.

Yes, but it pads out the bottom line (profit) just fine. Since the 'Plandemic' forced most doctors to choose between ethics or retaining their licenses I suspect the rest of Pandora's box of mischief has been unleashed...overcharging perhaps being the least of it.

The older I get the more I hate being right.

You other Hypertensive people: mine is a crapshoot every reading despite carefully tailored medication, good diet and exercise. One more thing I studiously DON'T worry about.

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