The FDA has announced an initiative to reimagine the home environment as an integral part of the healthcare system and promote health equity for all Americans.
The new initiative, called “Home as a Health Care Hub,” seeks to address the longstanding disparities in healthcare access and outcomes using home-based care. FDA’s Center for Devices and Radiological Health (CDRH) said the move comes amidst a shifting clinical care landscape brought on by the COVID-19 pandemic.
In a joint statement, FDA CDRH Director Jeff Shuren and Deputy Director for Transformation Michelle Tarver said the healthcare system faces persistent challenges. These include shortages of healthcare professionals, rising costs and disparities in access that can affect more marginalized communities.
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When devices don’t operate together, the FDA says patients may have to use several disparate medical devices, some of which were never intended for the home environment. The goal is to have patients interact with medical-grade, consumer-designed, customizable technologies that can seamlessly integrate into a person’s lifestyle.
“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,” Shuren and Tarver said in a news release. “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.”
Collaborating to improve care
The agency has a contract with an architectural firm that designs innovative buildings with health and equity in mind and considers the needs of variable models of a home and tailors solutions that can adapt and evolve.
Using augmented reality/virtual reality (AR/VR), the prototype will be tailored to address the specific needs of diverse populations with an initial focus on rural and lower-income communities that are disproportionately affected by health disparities.
FDA’s CDRH is partnering with patient groups, healthcare providers and the medical device industry to co-create solutions that advance health equity. The prototype will serve as an “idea lab” to discuss design approaches, care options and value-based care paradigms.
The agency used diabetes as an example health condition for the hub prototype, given its impacts over someone’s lifetime. The condition has a significant impact on public health and a disproportionate burden on underserved communities and communities of color. According to the Centers for Disease Control and Prevention, over $200 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,” Shuren and Tarver said.
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By prioritizing chronic conditions like diabetes, the initiative aims to demonstrate the potential for home-based care to improve health outcomes and reduce healthcare costs. The agency stressed that the delivery of personalized care must have people at the center. The care model shift from systems to people will allow healthcare systems to triage scarce resources to patients with urgent and critical needs, and tailor personalized care for patients managing chronic conditions.
As part of its strategic priority to advance health equity, the FDA remains committed to supporting innovation in home-based care and prevention. Through the Home as a Health Care Hub initiative, the FDA seeks to empower individuals to take control of their health and well-being, ushering in a new era of personalized, accessible healthcare.
“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,” the agency said in a news release.
