FDA Launches Health Care at Home Initiative

By MedTech Intelligence Staff
May 8, 2024


• Categories: 04-Product Design & Development, Hospital at Home, Patient Engagement, Regulatory

The FDA is launching a new initiative, the Home as a Health Care Hub, to help make health care in the home environment an integral part of the healthcare system, with the goal of advancing health equity for all people in the U.S.

The FDA’s Center for Devices and Radiological Health (CDRH) has contracted with an architectural firm that 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. CDRH is also collaborating with patient groups, healthcare providers, and the medical device industry to build the Home as a Health Care Hub.

“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,” shared Jeff Shuren, M.D., J.D., director of CDRH and Michelle Tarver, M.D., Ph.D., deputy director for transformation at CDRH. “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 prototype will serve as an idea lab to connect with populations most affected by health inequity and bring together 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,” stated Dr. Shuren and Dr. Tarver.

The FDA is using diabetes as an example health condition for the hub prototype. 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..

The FDA noted that by shifting the U.S. healthcare model from systems to people, the healthcare 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 this effort, as it is designed to:

• help device developers consider novel design approaches
• aid providers in educating patients and extending care options
• generate discussions on value-based care paradigms
• open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities through the home

Learn more here.