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Stronger Data Governance and Reliability Standards Needed for Wearables to Power Tech-Enabled Care

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Dr. Lucienne Marie Ide , 2025-11-09 14:18:00

The push for expanded use of wearable devices and wider data collection in healthcare, at first glance, appears to be a logical next step for the industry. Though slow to adapt at first, healthcare has notably accelerated its adoption of technology over the past few years. As barriers such as high costs, interoperability issues, and regulatory hurdles fell away, innovations like robotics, AI, and telemedicine were integrated into patient care and medical research. 

Now accustomed to the advantages technology can bring, the landscape should be poised to embrace the next advancement. Whether that turns out to be increased usage of wearables that expedite the collection of personal medical data, as proposed by the Department of Health and Human Services, remains to be seen. Outfitting all Americans with insight-gathering wearables in the next four years isn’t an all-inclusive solution to the nation’s healthcare challenges, though it’s reasonable to expect that parts of the plan could become a reality. If it comes to fruition, a host of ethical and practical concerns must first be addressed to ensure the process is safe and effective. 

Care is only as accurate as the data it’s based on

HHS Secretary Robert F. Kennedy Jr.’s call for widespread public adoption of wearable healthcare technologies preceded the White House’s July announcement of a new private health tracking system. The program, slated to launch early next year, would facilitate the upload of medical records into systems and apps run by private tech companies. While the idea of placing more emphasis on data to improve care is laudable, true improvements are reliant on accurate, trustworthy information. Basing decisions, research initiatives or policy development on unreliable or erroneous data will only lead to ineffective care and programs. 

The degree of accuracy associated with wearable-generated health data can vary widely depending on the device, the wearer, and the type of metric. The devices may offer useful trend data, but raw data isn’t always dependable. Often, the information provided probably isn’t something on which the wearer would want a physician to base treatments or a care plan. Apple’s recent announcement that the new Apple Watch will notify users of concerning high blood pressure patterns over a 30-day period shows the company is moving closer to true medical-grade wearables by first addressing consumer awareness. This “concerning trend” alert would, in theory, prompt users to monitor their blood pressure at home or schedule an assessment with their medical provider.   

I occasionally use the ECG app on my smartwatch to monitor my heart rate and rhythm. Despite activating it correctly, I’ve found it’s not unusual to receive inaccurate readings caused by poor signal quality. As a physician, I understand the nuances and implications behind these readings, so I don’t find inconclusive results as concerning as someone outside of healthcare might. For users without a medical background, such readings could be unsettling and may even prompt an unnecessary trip to the hospital — only to be told that smartwatch data should be interpreted with caution. Technology should enhance, not replace, professional care. In this sense, consumer-focused technology is an “and,” not an “or.”

Wearables play an important role in wellness and lifestyle improvements

Though not intended for use as a medical-grade device, wearables are excellent for tracking wellness metrics and contributing to healthy lifestyle changes. A Journal of Medical Internet Research study found that 64% of users reported improved health outcomes when they utilized data insights provided by their devices. Any improvement in health is beneficial, so if a smartwatch proves useful in maintaining a fitness routine and a balanced lifestyle, then it’s worth the personal investment.

When used for their intended purposes, wearables offer many advantages. And while they do generate enormous amounts of health data, it’s still not reliable or standardized enough to stand alone as a tool for managing chronic disease. Substantial progress has been made, though, thanks to the development of policies like the 21st Century Cures Act, which required greater interoperability across EHRs so patients could more easily access their own data. However, those regulations applied to clinical systems and didn’t extend to data from other channels, like consumer apps and devices. 

Similarly, the “Kill the Clipboard” roadmap unveiled in July is intended to modernize data exchange by eliminating paper forms and manual data collection. This effort to facilitate the seamless storage and accessibility of patient data emphasizes the use of digital-first workflows and interoperability, building on Cures Act provisions such as mandating standardized APIs and prohibiting information blocking. Initiatives like these lay the foundation for consumer-generated data to eventually flow into clinical systems in a way that’s usable and compliant. Patients stand to benefit from the convenience these changes would afford, but it shouldn’t come at the expense of patient privacy and security.

Use of data collection for research must not compromise trust and privacy

There’s no question that large datasets are essential to advance medical research and answer critical health questions. Leveraging the insights responsibly helps to identify trends, improve public health responses, and speed the development of new treatments. However, patient trust hinges on transparency into how that data is collected, stored and shared. Everyone deserves the confidence of knowing their information is being handled ethically. The collaborative element of the administration’s new health tracking system could improve data flow, but concerns around privacy, consent, and potential misuse make it difficult to determine whether the benefits outweigh the risks.

To shift wearables from wellness tools to useful drivers of disease management, the data they generate must be as trustworthy as it is plentiful. Clear frameworks that govern how information is gathered and used are needed, along with standards for the accuracy and reliability of devices. Interoperability rules, like those already in place for certified medical devices, should apply to all consumer health technologies. Safeguarding data with strong privacy protections is fundamental to maintaining patient trust, which is the top priority at all times. The future of healthcare technology is brightest when innovation is combined with evidence to build systems that strengthen — not strain — relationships between patients and their providers. 

As a supplement to comprehensive care, wearables can absolutely contribute to better wellness, but they won’t be the sole determining factor. Fully integrating the devices into care delivery is possible, but will require time and a firm commitment from the healthcare and tech industries to establish standards that verify the reliability of wearables and the data generated.

Photo: LDProd, Getty Images


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Lucienne Marie Ide, M.D., PH.D., is the founder and Chief Executive Officer of Rimidi, a digital health company that supports healthcare providers in the delivery of remote patient monitoring and chronic disease management with EHR-integrated software, services, and connected devices. She brings her diverse experiences in medicine, science, venture capital, and technology to bear in leading Rimidi’s strategy and vision. Motivated by the belief that we can do so much better as individuals, in industry, and in society. After completing her internship in Obstetrics and Gynecology at UPMC, Dr. Ide left clinical medicine to join the ranks of healthcare entrepreneurs who are trying to revolutionize an industry.

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