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Frequently Asked Questions for the Home as a Health Care Hub

In April 2024, the FDA’s Center for Devices and Radiological Health (CDRH) launched 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.

The information provided below may be useful to patients, caregivers, health care facilities, and medical device manufacturers.

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Why did CDRH launch the Home as a Health Care Hub?

CDRH heard feedback from the public through the docket and from the (PEAC) meeting held in September 2023. This information helped inform the Home as a Health Care Hub initiative. In particular, PEAC members stressed it is critical not only to ensure devices will work well in the home when used by patients, but also to consider where people live and the challenges they may face at home.

The Hub initiative is a step toward addressing these concerns and is consistent with CDRH’s focus on advancing health equity.

How will CDRH implement the Home as a Health Care Hub?

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 Home as a Health Care Hub will design virtual reality prototypes of the home that are expected to be completed later in 2024.

This collaboration includes engagement with patient groups, health care providers, and the medical and consumer device industry. These prototypes will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for medical and consumer device developers, policy makers, and providers to begin developing home-based solutions that advance health equity.

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 improve evidence generation and seamlessly integrate medical devices and health care, prevention, and wellness into people's lives, leading to a longer, better quality life for all.

What does the Home as a Health Care Hub mean for patients?

Some programs exist for health care delivery to the home following hospital discharge, and these existing models have reported great patient satisfaction, good adherence, and potential cost savings to health care systems. With these goals in mind, and by beginning our Home as a Health Care Hub efforts with understanding homes in rural locations and lower-resource communities, the planned virtual reality prototypes of the home will be intentionally designed with the goal of addressing the health and wellness needs of these communities.

The Home as a Health Care Hub prototypes are 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 models, and opening opportunities to bring clinical trials and other evidence generation processes to underrepresented communities through the home.

What are the structural and critical elements of the home?

The Home as a Health Care Hub initiative focuses on the critical rooms in the home that are present in most housing units, whether a single-family home, mobile home, or an apartment. In addition, how those rooms are constructed could impact the safe and effective use of medical devices in the home. The initiative is examining opportunities to optimize how the home can integrate medical devices in health care, wellness, and evidence generation.

How will the Home as a Health Care Hub help medical devices integrate easily into a person's lifestyle?

As an example, someone living with diabetes and the complications of their condition may use multiple devices at home like a glucose monitor, an insulin pump, and a home dialysis machine. However, these devices may not all communicate with one another, may not be designed in a manner that encourages engagement, may not be customized to the person living with the condition, and may be identifiable by visitors to the home. By creating these virtual reality prototypes of the home, we hope to facilitate innovation in device design, spark solutions to address unmet needs, as well as foster discussions among device developers, policy makers, providers, patients, and regulators.

Contact

For more information about the Home as a Health Care Hub, please email HealthHomeHub@fda.hhs.gov.

Additional Resources

 
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