Wearables require stronger data governance and reliability standards to drive technology-enabled care

At first glance, the push for widespread use of wearables 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 over the past few years. Innovations such as robotics, artificial intelligence, and telemedicine are being integrated into patient care and medical research as barriers such as high costs, interoperability issues, and regulatory hurdles disappear.

Now that you're used to the advantages technology brings, you should be ready for the next advancement. Whether this will lead to increased use of wearable devices to speed up the collection of personal medical data, as proposed by the Department of Health and Human Services, remains to be seen. Equipping all Americans with wearable devices that gather insights over the next four years is not a comprehensive solution to the nation's health care challenges, although it is reasonable to expect that parts of the plan may become a reality. If results are to be achieved, a number of ethical and practical issues must first be addressed to ensure the process is safe and effective.

Care is only as accurate as the data on which it is based

Ahead of the White House's July announcement of a new private health tracking system, U.S. Department of Health and Human Services Secretary Robert F. Kennedy Jr. called for widespread public adoption of wearable health care technology. The program, set to launch early next year, will help upload medical records into systems and applications run by private technology companies. While the idea of ​​placing a greater emphasis on data to improve care is laudable, real improvements rely on accurate, trustworthy information. Decisions, research plans, or policy development based on unreliable or erroneous data will only lead to ineffective care and planning.

The accuracy associated with health data generated by wearable devices can vary significantly depending on the device, wearer, and metric type. These devices may provide useful trend data, but the raw data is not always reliable. Often, the wearer may not want the doctor to base a treatment or care plan on the information provided. Apple's recent announcement that the new Apple Watch will notify users about high blood pressure patterns within 30 days shows that the company is moving toward a truly medical-grade wearable device by first addressing consumer awareness. In theory, this “worrying trend” alert would prompt users to monitor their blood pressure at home or schedule an evaluation with a medical provider.

I occasionally use the EKG app on my smartwatch to monitor my heart rate and rhythm. Despite activating it correctly, I found it was not uncommon to receive inaccurate readings due to poor signal quality. As a doctor, I understand the nuances and meaning behind these readings, so I don't find inconclusive results like someone outside of health care might. For users without a medical background, such readings can be disturbing and may even lead to 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-centric technology is an “and” rather than an “or.”

Wearable devices play an important role in health and lifestyle improvements

While wearables are not intended to be used as medical-grade devices, they are great for tracking health metrics and facilitating healthy lifestyle changes. A study in the Journal of Medical Internet Research found that 64% of users said their health improved when they took advantage of data insights provided by their devices. Any improvement in health is beneficial, so if a smartwatch proves to be helpful in maintaining fitness habits and a balanced lifestyle, it may be worth the personal investment.

Wearable devices have many advantages when used for their intended purpose. While they do generate large amounts of health data, it is still not reliable or standardized enough to stand alone as a tool for managing chronic disease. However, substantial progress has been made thanks to policies like the 21st Century Cures Act, which requires greater interoperability between EHRs so that patients can more easily access their data. However, these regulations apply to clinical systems and do not extend to data from other sources, such as consumer apps and devices.

Likewise, the Unclipboard roadmap unveiled in July aims to modernize data exchange by eliminating paper forms and manual data collection. This effort to promote seamless storage and accessibility of patient data emphasizes the use of digital-first workflows and interoperability, building on Cures Act provisions such as mandating the use of standardized APIs and prohibiting information blocking. Initiatives such as these lay the foundation for consumer-generated data to eventually flow into clinical systems in a usable and compliant manner. Patients will benefit from the convenience these changes bring, but not at the expense of patient privacy and safety.

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

There is no doubt that large data sets are critical to advancing medical research and answering critical health questions. Responsible use of these insights can help identify trends, improve public health responses, and accelerate the development of new treatments. However, patient trust depends on transparency in how data is collected, stored and shared. Everyone should have confidence knowing their information is being handled ethically. Collaborative elements of the government'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 transform wearables from health tools into useful drivers of disease management, the data they generate must be both rich and reliable. A clear framework is needed to govern how information is collected and used, as well as standards for the accuracy and reliability of equipment. 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 and is always a top priority. The future of health care technology is brightest when innovation is combined with evidence to build systems that strengthen—not strain—the relationship between patients and their providers.

As a complement to comprehensive care, wearables can definitely promote better health, but they are not the only determining factor. Fully integrating devices into care delivery is possible, but it will take time and a strong commitment from the healthcare and tech industries to establish standards for validating wearable devices and the reliability of the data they generate.

Photo: LDProd, Getty Imagess

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