The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) this week announced a new initiative aimed to help reimagine the home environment as an integral part of the health care system. The Home as a Health Care Hub prototype is intended to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into people’s lives and may:
- Help medical device developers consider novel design approaches.
- Aid providers to consider opportunities to extend care options and educate patients.
- Generate discussions on value-based care paradigms.
- Open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities.
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. 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.
To increase access to health care and maximize health outcomes, it is critical that the delivery of personalized care has people at the center. 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. 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.
Source: Story adapted from FDA Center for Devices and Radiological Health