A new FDA program aims to develop strategies and guidelines for health systems delivering care in the patient’s home
Health systems are getting more help planning new remote patient monitoring (RPM) and acute care and hospital at home programs.
The U.S. Food and Drug Administration (FDA) has announced the launch of the Home as a Health Care Hub, a resource designed to help healthcare executives understand how to design programs that deliver care in the home setting. As part of this program, the FDA’s Center for Devices and Radiological Health (CDRH) is contracting with an architectural firm to explore how healthcare and health equity can be included in home design.
“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,” Jeff Shuren, MD, JD, director of the CDRH, and Michelle Tarver, MD, PhD, the CDRH’s deputy director for transformation, said in a press 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. 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 program builds on an intriguing trend in healthcare, in which health systems and hospitals are looking to shift more services out of the hospital, clinic, and doctor’s office and into the patient’s home. This includes RPM programs that enable care teams to monitor patients at home, either by gathering patient data at selected times or with continuous monitoring, and acute care and hospital at home programs that combine RPM, virtual care, and in-person care.
That transition isn’t so easy. While the consumer technology industry is seeing huge growth in wearables and smart devices that include healthcare uses, clinicians are wary of the reliability of data coming from these devices and don’t know how to use them. As well, while the home offers a new setting for healthcare delivery, clinicians need to better understand the both the challenges and the advantages of delivering healthcare in that setting.
“We have an untapped resource in the home,” Hon Pak, vice president and head of the digital health team at Samsung Electronics and a former Kaiser Permanente executive, said during a CES 2024 panel on this topic this past January in Las Vegas. “Fundamentally, we have to change the model” of how care is delivered.
The new program will also take aim at another key strategy in healthcare innovation: Addressing health inequity, or challenges to healthcare access and treatment caused by social drivers of health.
“This partnership includes collaboration with patient groups, healthcare providers, and the medical device industry to build the Home as a Health Care Hub,” Shuren and Tarver said in the press release. “This prototype will serve as an idea lab, not only to connect with populations most affected by health inequity, but also for 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 healthcare systems,” they added. “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.”
[Also read: Patient Experience Is Crucial to the Success of Hospital at Home.]
The two executives said the program is part of a redesign of healthcare to focus on the patient, with care plans that meet a patient’s needs and desired rather than a plan that forces the patient to adjust to new roles or routines. As such, care providers need to understand the environment around the patient.
“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,” they said.
The new will be unveiled sometime this year as an AR/VR prototype.
Eric Wicklund is the associate content manager and senior editor for Innovation at HealthLeaders.
KEY TAKEAWAYS
As health systems shift more services from the hospital, clinic, and doctor’s office to the home, providers need to better understand the patient’s home environment.
This includes understanding the benefits and challenges of the home setting, using devices and platforms that can capture reliable and relevant data, and addressing health inequity.
The FDA’s new Home as a Health Care Hub aims to give providers a resource to develop better home-based care programs, including RPM and acute care and hospital at home services.