Initiative aims to better position agency to address health care needs by moving care into the home setting
FOR IMMEDIATE RELEASE
April 23, 2024
The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH) and Michelle Tarver, M.D., Ph.D., deputy director for transformation at CDRH
Clinical care is undergoing an evolution that has been accelerated over the last few years by the COVID-19 public health emergency. Health care has primarily been centered on health care systems and their components—hospitals, clinics, providers, and payers. However, many challenges persist, such as primary care physician and specialist shortages, significant increases in health care costs, higher chronic disease prevalence rates, and often the inability to meet the health care needs of millions of people who have no or limited access to health care systems. People from various racial and ethnic minority populations and those who live in rural communities and lower-income neighborhoods are impacted the most by these system challenges, which furthers health disparities across the nation.
Today, the U.S. Food and Drug Administration is announcing the launch of a new initiative, Home as a Health Care Hub, to help reimagine the home environment as an integral part of the health care system, with the goal of advancing health equity for all people in the U.S. While many care options are currently attempting to use the home as a virtual clinical site, very few have considered the structural and critical elements of the home that will be required to absorb this transference of care. Moreover, devices intended for use in the home tend to be designed to operate in isolation rather than as part of an integrated, holistic environment. As a result, patients may have to use several disparate medical devices, some never intended for the home environment, rather than interact with medical-grade, consumer-designed, customizable technologies that seamlessly integrate into an individual person's lifestyle.
The FDA's Center for Devices and Radiological Health (CDRH) has contracted with an architectural firm that intentionally designs innovative buildings with health and equity in mind, to consider the needs of variable models of a home and tailor solutions with opportunities to adapt and evolve in complexity and scale.The hub will be designed as an Augmented Reality/Virtual Reality (AR/VR)-enabled home prototype and is expected to be completed later this year.
This partnership includes collaboration with patient groups, health care providers, and the medical device industry to build the Home as a Health Care Hub. This prototype will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical device developers, policy makers, and providers to begin developing home-based solutions that advance health equity. Existing models that have examined care delivery at home have found great patient satisfaction, good adherence, and potential cost savings to health care systems. By beginning with dwellings in rural locations and lower-income communities, the planned prototype will be intentionally designed with the goal of advancing health equity.
The FDA is using diabetes as an example health condition for the hub prototype given the impacts over the lifecycle of someone living with this condition. According to the Centers for Disease Control and Prevention (CDC), over $300 billion per year was spent on medical costs for diabetes in the U.S. in 2022. This is a 35% increase over the past decade, which is disproportionately borne by underserved communities and communities of color. Diabetes is a condition that impacts most major organs and can result in significant morbidity and early mortality, including cardiovascular disease, kidney failure, blindness, and amputations.
To increase access to health care and maximize health outcomes, it is critical that the delivery of personalized care has people at the center. By shifting the care model from systems to people, the health care system can triage scarce resources to those with the most urgent and critical needs and tailor personalized care for those managing chronic conditions. The Home as a Health Care Hub prototype is the beginning of the conversation—helping device developers consider novel design approaches, aiding providers to consider opportunities to educate patients and extend care options, generating discussions on value-based care paradigms, and opening opportunities to bring clinical trials and other evidence generation processes to underrepresented communities through the home.
As a part of CDRH's strategic priority to advance health equity, CDRH continues to support innovation that addresses health equity by moving care, as well as prevention and wellness, into the home setting. CDRH is committed to fostering innovation that improves public health by launching the Home as a Health Care Hub effort to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people's lives, leading to a longer, higher quality life for all.
Additional Resources:
- CDRH Strategic Priorities and Updates
