2021 Federal Wearables Summit

The Future of Wearable Sensors in Health Monitoring: Putting the Patient at the Center of a Multidisciplinary Community

October 08, 2021

2021 Federal Wearables Summit Photograph

Advances in electronics, data science, behavioral science, systems biology and sensor technologies have enabled the development of a wide range of personal wearable health and activity monitoring devices, some of which are earning clear roles in healthcare. At the recent 2021 Federal Wearables Summit, medical care providers, researchers, engineers, data security specialists, regulators, and insurers, among others joined with multiple federal agencies to discuss the development of these smart technologies and what questions remain before they have a bigger role in health care and public health.

The event was hosted by BARDA’s Division of Research, Innovation and Ventures (DRIVe). Along with DRIVe, the Defense Threat Reduction Agency, Defense Advanced Research Projects Agency, Defense Innovation Unit and the National Institutes of Health (NIH) co-sponsored the online conference, which took place August 31, 2021.

Existing technologies already have the potential to enable wearables capable of giving us early identification of infection, insight into our body’s response to treatment when we’re sick and alerts when additional treatment may be needed. Wearables also offer the opportunity to monitor recovery from illness after we’ve left a health care setting.

These are among the reasons that wearables are poised to revolutionize health monitoring and care not only for infectious diseases but also for cancer care, diabetes, maternal health, and senior health. The future of wearables is a suite of enabling technologies to detect a variety of diseases and monitor health generally.

However, the devices are not yet developed to the point that they can be adopted widely for health care or public health uses. At the 2021 Federal Wearables Summit, panelists addressed needed improvements such as ease-of-use and the ability of new devices to feed data into existing health data systems.

During the summit, hundreds of participants joined distinguished speakers and panelists to discuss the benefits and challenges of wearables in health monitoring and to share how these devices can integrate with, and potentially improve, a person’s lifestyle and medical care. Many people already use fitness trackers to help stay active, but future wearables could extend this technology to help detect early signs of impending illness and empower proactive decisions about our activities and health care.

Presenters highlighted the public’s and the federal government’s common interest in wearables. These technologies could help people stay healthier and out of hospitals and reduce the burden on rehabilitative care facilities. Wearables also have the potential to advance health equity and close gaps in medical care for underserved groups. Those outcomes greatly benefit patients, health care providers, insurance companies, the government, and communities at-large. However, wearable devices and applications need work if they are to be used by more people.

Speakers focused on what may be an obvious but nonetheless overlooked consideration: how users and other stakeholders interact with the devices and the data they collect. Developing health interventions requires – or should require - engagement with users from the outset.

One presenter gave several examples where device designers were surprised by patient feedback, suggesting that the patient perspective was not reflected well enough in the initial design. For instance, some people may be more willing to have a visible device than an awkward bulge under their clothing. A wrist device may work for one group, but a lanyard might be better for others.

Dr. Steve Xu, assistant professor at Northwestern University School of Medicine and CEO of Sibel Health and Sonica Health, captured a significant aspect of the challenge in an adapted quote from former Surgeon General C. Everett Koop: “Wearables don’t work in patients who don’t wear them.” (Koop, who was surgeon general from 1981 to 1989, famously said, “Drugs don’t work in patients who don’t take them.” He died in 2013 at age 96.)

Wearables that easily integrate with a person’s lifestyle will be used more readily, and will be more effective at changing behavior, than wearables a person must adapt to using, said Dr. Wendy Nilsen from the National Science Foundation, urging a user-centered design approach. Another presenter cited an example of a patient who developed her own diabetes management technology because solutions offered by the medical device industry did not work for her.

BARDA’s DRIVe recognizes the importance of creating health technologies through a user-centered research and development process. By putting users at the center, we naturally surround them with the multidisciplinary community needed to design and develop effective solutions from the beginning.

Understanding who benefits from these devices and the mountains of data they potentially collect is also important. Patients must know how their data is being used, and healthcare professionals need to know how the data is collected, analyzed, and shared. And, everyone must know that personal health information is adequately protected.

Dr. Marion Couch, chief medical officer of Cambia Health Solutions, said that to get payers on board, wearables must demonstrate value through quantifiably better health outcomes. That’s the starting point.

For healthcare practitioners to embrace wearables or data derived from them, practitioners must be included in the development process, along with healthcare institutions, insurance companies and other healthcare payers. For providers to integrate wearables data into routine medical practice, health care institutions must support them by putting the infrastructure in place to store and work with the data. For patients to adopt wearables, the devices must be covered by insurance or other health care payers or supported by direct-to-consumer or other sustainable business models, and healthcare professionals must be compensated for using the devices and the data in medical practice.

BARDA scientist Šeila Selimović along with Tiffani Bailey Lash, Dana Wolff-Hughes, and Andrew Weitz of the NIH noted federal funding opportunities for wearables development. Bakul Patel, director of the FDA’s Digital Center of Excellence, encouraged developers to reach out to the Food and Drug Administration to determine how their wearable device may be regulated and for help through the regulatory process

ABOUT the Team:

The Division of Research, Innovation and Ventures (DRIVe) team investing in health wearables includes a diverse set of experts in sensor development, medical device design, data science, immunology, and clinical practice. More information is available at https://drive.hhs.gov/wearables_summit.htm/.

Last Updated: October 08, 2021

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