Stronger data governance and reliability standards needed for wearable devices to power technology-enabled care

At first glance, the push for expanded use of wearable devices and broader data collection in healthcare seems like a logical next step for the industry. Although slow to adapt at first, healthcare has significantly accelerated technology adoption in recent years. As barriers such as high costs, interoperability issues, and regulatory hurdles have disappeared, innovations such as robotics, AI, and telemedicine have been integrated into patient care and medical research.

Now accustomed to the benefits that technology can bring, the landscape should be ready to accommodate the next advances. It remains to be seen whether this will translate into increased use of wearable devices that speed the collection of personal medical data, as the Department of Health and Human Services is proposing. Equipping all Americans with information-gathering wearable devices over the next four years is not a comprehensive solution to the nation’s health problems, although it is reasonable to expect that parts of the plan will become a reality. For this project to be successful, a multitude 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 is based on

HHS Secretary Robert F. Kennedy Jr.’s call for widespread public adoption of wearable health technologies preceded the White House’s July announcement of a new private health tracking system. The program, scheduled to launch early next year, would make it easier to upload medical records into systems and applications run by private technology companies. While the idea of ​​placing more emphasis on data to improve care is laudable, real improvements depend on accurate and reliable information. Basing decisions, research initiatives, or policy development on unreliable or flawed data will only lead to ineffective care and programs.

The level of accuracy associated with wearable-generated health data can vary significantly depending on the device, user, and metric type. Devices can offer useful trend data, but raw data is not always reliable. Often the information provided is probably not something the wearer would want a doctor to base a treatment or plan of care on. Apple’s recent announcement that the new Apple Watch will notify users of high blood pressure trends over a 30-day period shows that the company is moving closer to true medical-grade wearables by first addressing consumer awareness. This “worrying trend” alert would, in theory, prompt users to monitor their blood pressure at home or schedule an evaluation with their medical provider.

I occasionally use the ECG app on my smartwatch to monitor my heart rate and rhythm. Despite enabling it correctly, I have found that it is not uncommon to receive inaccurate readings due to poor signal quality. As a physician, I understand the nuances and implications of these readings. So I don’t find inconclusive results as concerning as someone outside the health sector might. For users without medical training, such readings could be unsettling and could even result in an unnecessary trip to the hospital – only to be told that the smartwatch data should be interpreted with caution. Technology should enhance, not replace, professional care. In this sense, consumer-centric technology is an “and,” not an “or.”

Wearables play an important role in improving well-being and lifestyle

Although not intended for use as medical-grade devices, wearable devices are excellent for tracking wellness metrics and contributing to healthy lifestyle changes. A study from the Journal of Medical Internet Research found that 64% of users reported improved health outcomes when using information 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 the personal investment is worth it.

When used for their intended purpose, wearables offer many benefits. And even though they generate enormous amounts of health data, it is still not sufficiently reliable or standardized enough to constitute a chronic disease management tool on its own. Substantial progress, however, has been made through the development of policies such as the 21st Century Cures Act, which required greater interoperability between EHRs so that patients could more easily access their own data. However, these regulations applied to clinical systems and did not extend to data from other channels, such as consumer apps and devices.

Similarly, the “Kill the Clipboard” roadmap unveiled in July aims to modernize data exchange by eliminating paper forms and manual data collection. This effort to facilitate seamless storage and accessibility of patient data emphasizes the use of digital-first workflows and interoperability, building on provisions of the Cures Act such as requiring standardized APIs and prohibiting information blocking. Initiatives like these lay the foundation for consumer-generated data to ultimately flow into clinical systems in a usable and compliant manner. Patients will benefit from the convenience these changes would provide, but this should not come at the expense of patient privacy and safety.

Use of data collection for research purposes must not compromise trust and confidentiality

There is no doubt that large data sets are essential for advancing medical research and answering critical health questions. Leveraging this information responsibly helps identify trends, improve public health responses, and accelerate the development of new treatments. However, patient trust depends on transparency around how this data is collected, stored and shared. Everyone deserves to know that their information is being handled ethically. The collaborative element of the administration’s new health tracking system could improve data flow, but concerns about privacy, consent and potential abuse make it difficult to determine whether the benefits outweigh the risks.

To move wearable devices from wellness tools to useful disease management engines, the data they generate must be as reliable as it is abundant. Clear frameworks governing how information is collected and used are needed, as well as 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. Protecting 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 brighter when innovation is combined with evidence to create systems that strengthen – not strain – the relationships between patients and their providers.

As a complement to comprehensive care, wearables can certainly contribute to better well-being, but they will not be the only determining factor. Fully integrating devices into care delivery is possible, but will require time and a strong commitment from the healthcare and technology sectors to establish standards verifying the reliability of wearable devices and the data generated.

Photo: LDProd, Getty Images

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