FDA launches initiative to advance home healthcare models, devices

April 24, 2024 - The United States Food and Drug Administration (FDA) has launched a new initiative to support the development of home healthcare models and home-based solutions that bolster health equity.

Called the Home as a Health Care Hub, the initiative’s primary goal is to “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.,” wrote Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health (CDRH) and Michelle Tarver, MD, PhD, deputy director for transformation at CDRH, in an online statement.

According to Shuren and Tarver, healthcare provider organizations increasingly use the home as a clinical care site; however, new protocols and devices are necessary to transfer care out of healthcare facilities successfully. For instance, many devices currently used in home-based healthcare settings are not explicitly designed for these settings, showing a lack of medical-grade devices designed to be part of integrated home healthcare models.

Thus, the FDA’s CDRH will bring together patient groups, healthcare providers, and medical device developers to build the Home as a Health Care Hub. The hub aims to serve as a lab where these stakeholders can discuss and develop models and devices intended for home-based use in ways that accelerate health equity. The center plans to use the hub to help medical device developers and providers consider new device designs and opportunities to extend care options and drive discussions around value-based care models. The center also aims to provide underrepresented communities access to clinical trials and other research opportunities through the hub.

“To increase access to health care and maximize health outcomes, it is critical that the delivery of personalized care has people at the center,” Shuren and Tarver wrote. “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.”

Further, the CDRH has contracted with an architectural firm to develop the hub as an augmented reality/virtual reality (AR/VR)-enabled home prototype. It is slated to be completed later this year.

At-home care options are driving healthcare provider interest across the industry. In fact, a survey of 116 clinicians conducted last June reveals that a majority (81 percent) would like to see their organization’s investment in care-at-home initiatives increase over the next year or two.

Not only that, but 70 percent of survey respondents also said care-at-home services enhance access to care, and 55 percent said offering care-at-home programs could help increase satisfaction in their current role.

However, respondents noted that technology support in the home (77 percent) and logistics support for technology, including delivery, pickup, and reprocessing of devices (73 percent), were significant hurdles to care-at-home program implementation.

Support for policies that expand at-home care options, like the hospital-at-home model, is growing alongside clinical evidence of their efficacy.

In 2020, the Centers for Medicare & Medicaid Services launched the Acute Hospital Care at Home (AHCaH) waiver to ease inpatient care challenges amid the COVID-19 pandemic. As of April 22, 322 hospitals across 37 states have been approved for the waiver. However, the waiver is slated to expire at the end of 2024.

Research published earlier this year revealed that hospital-at-home programs are associated with low mortality, skilled nursing facility use, and readmission rates one month after discharge. The study included data for 5,132 patients receiving hospital-at-home care under the waiver.

At 30 days post-discharge, the group’s mortality rate was 3.2 percent, the rate of skilled nursing facility use was 2.6 percent, and the readmission rate was 15.6 percent.

In March, more than 65 healthcare organizations sent a letter urging Congress to extend the waiver program for at least another five years.