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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  1. Home Health and Consumer Devices

Home as a Health Care Hub

 

Images of people using medical devices at home.

 

Imagine a home that is customized for a person’s health care needs. In this home, medical devices blend into the space and are effortless to use. The person who lives here has first-class health care, right in their own home. This ideal living space is the future vision behind Home as a Health Care Hub. Home as a Health Care Hub aims to elevate the science of personal health and wellness by putting people at the center of their own care.

The FDA's Center for Devices and Radiological Health (CDRH) has contracted with the architectural firm HKS, Inc., to reimagine the home as an integral part of the health care system. Virtual reality prototypes of the home are expected to be completed by the end of 2024. This person-centric approach aspires to empower individuals from all walks of life to contribute to their own diagnosis, treatment, and health outcomes by fostering innovation and connection among the devices that monitor their health– seamlessly and privately. It also allows for the treatment of medical conditions as well as personalizes strategies for prevention and wellness to be delivered in the comfort of the home.

Home as a Health Care Hub

The Home as a Health Care Hub reimagines 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. The FDA and the contracted architectural firm HKS, Inc. are collaborating with patient groups, health care providers, and the medical device and consumer technology industry to build virtual reality prototypes of the home. These prototypes will serve as an idea lab, allowing for innovative solutions and frameworks to be developed.

Advancing Health Equity

The Home as a Health Care Hub is informed by public feedback. As part of CDRH’s 2022-2025 Strategic Priority focused on advancing health equity, the FDA requested public comment on approaches to facilitate access to medical devices designed to be safe and effective when used in the home.

Medical device and consumer technology developers, policy makers, and providers may use the findings from this initiative to develop home-based solutions that can advance health equity by moving care, as well as prevention, wellness, and evidence generation into the home setting. These prototypes will be realistically designed and scaled to reflect the needs of people living in lower-resource communities.

Background

While many care options are currently attempting to use the home as a virtual clinical site, few have considered what will be required for this change. Devices for use in the home are often designed to operate in isolation rather than as part of an integrated, holistic environment. Patients may have to use several different medical devices, some never initially designed with the home environment in mind, rather than being able to use medical-grade, consumer-designed, customizable technologies that seamlessly integrate into an individual's lifestyle.

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, and higher chronic disease prevalence rates. The result is 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-resource neighborhoods are impacted the most by these system challenges, which furthers health disparities across the nation.

 

Four icons demonstrating the evolution of clinical care: Growing Patient Base; Shrinking Provider Network; Contraction of Care Facilities; Decreased Reimbursement

 

Get Involved

Share your thoughts, ask questions, and receive updates. Email us at HealthHomeHub@fda.hhs.gov.

Events

Virtual Public Meeting – Home as a Health Care Hub – Stakeholder Listening Session July 25, 2024

Share your ideas on aspects to consider in developing the Home as a Health Care Hub prototypes for all people in the U.S.

Frequently Asked Questions

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