Separating CES Wearable Hype from Clinical Value
Consumer electronics shows showcase hundreds of new health wearables each year, but most fail to deliver meaningful clinical outcomes. This article examines how to distinguish between marketing spectacle and devices that actually improve patient care, drawing on insights from clinicians and researchers who evaluate these technologies. Understanding the difference between impressive demonstrations and validated health data can save healthcare organizations from costly mistakes.
Prioritize Validated Endpoints Over Demos
At CES, I separate hype from clinical value by looking for evidence of validated endpoints, not model demos. The single signal I trust most is whether the wearable ties its claims to a cleared clinical indication or a peer-reviewed validation protocol, not just "AI accuracy."
The red flag is when companies show impressive dashboards but can't explain ground truth. If they can't answer what outcome was measured, against which gold standard, and over what population, it's marketing.
Example: wearables that reference FDA-cleared indications or published sensitivity and specificity ranges earn attention. Ones that only cite internal testing or "predictive insights" without clinical framing get filtered out fast.
Albert Richer, Founder, WhatAreTheBest.com
Judge By Clinically Meaningful Patient Outcomes
Start by judging wearable claims by patient outcomes, not flashy features. Look for proof of better symptoms, function, or quality of life, not just step counts or time on device. Check if the change meets a minimal clinically important difference, not just statistical noise. See whether trials compare the device to usual care and not only to nothing.
Pay attention to outcomes across age, race, and condition severity to spot gaps. Prefer peer-reviewed studies with clear methods and valid measures. Ask for published evidence that shows meaningful gains in outcomes patients value.
Demand Robust Privacy And Compliance
Trust grows when privacy, security, and rules are handled well. Confirm HIPAA or GDPR alignment and ask about data use, storage, and retention. Look for SOC 2 or ISO 27001 reports and recent penetration tests. Review how consent works, what third parties get data, and how breaches are handled.
Check the regulatory path, such as FDA clearance, De Novo, or a wellness claim, and ensure the marketing matches it. Verify that updates, components, and vendor partners are tracked and secure. Request security audits and regulatory letters before any purchase.
Prove Workflow Fit In EHR
True value shows up when the device fits the clinical workflow. Confirm that data flows into the EHR using standard APIs and shows up in the right chart spots. Make sure alerts are few, relevant, and easy to act on. Clarify who reviews data, when they act, and how work is routed and documented.
Test training needs, support plans, and time per patient to avoid hidden costs. Measure how the tool affects visit time and inbox load before broad use. Run a pilot in your EHR and demand a live demo with real cases.
Show Long-Term Adherence, Retention
Clinical impact fades if people stop using the device. Ask for six to twelve month adherence and retention, not just first month use. Check daily and weekly active use, dropout reasons, and time to disengage. Review design factors like comfort, battery life, and ease of charging that drive stickiness.
Look for human support, reminders, and coaching that follow behavior science and avoid fatigue. Confirm plans for device loss, breakage, and easy replacement to prevent gaps. Demand long-term engagement data and a clear plan to keep people using the tool.
Verify Reimbursement Path, Codes, Policies
Coverage and payment determine if a wearable can scale. Verify active CPT or HCPCS codes and confirm payer policies in writing. Check if prior auth is needed and how claims get processed by your revenue cycle. Model total cost, including devices, software, staffing, and replacements.
Estimate out-of-pocket costs and equity impact for patients with high deductibles. Explore value-based contracts that tie price to outcomes and limit risk. Ask payers for clear coverage decisions and a billing guide before deployment.