Home as a Health Care Hub - Understanding the Need
CDRH launched Home as a Health Care Hub in response to the changing needs of health care and feedback from the public. The Home as a Health Care Hub initiative supports CDRH’s focus on advancing innovative medical devices that support increased access to health care, as well as prevention and wellness.
On this page you’ll find:
Health Care is Changing
Clinical care is undergoing an evolution that has been accelerated over the last few years by the COVID-19 pandemic. Many challenges persist, such as primary care physician and specialist shortages, significant increases in health care costs, and high 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 who live in rural communities and lower-resource neighborhoods are impacted the most by these challenges, which furthers health disparities across the nation.
The delivery of health care has traditionally been centered around health care systems and their components—hospitals, clinics, providers, and payers – rather than on the person. Moving care and clinical evidence generation beyond traditional touchpoints of healthcare delivery, such as to the home, can help address challenges faced by patients. Home use medical devices, including many digital health technologies, can play a critical role in transitioning health care from a system level to person centered. Home as a Health Care Hub seeks to change that dynamic and serve as a catalyst for medical devices that are designed for consumers, blend into the home, and seamlessly integrate into a person’s lifestyle.
Public Feedback
In our September 2023 Patient Engagement Advisory Committee meeting and July 2024 listening session, participants told us it was important to consider where people live and the challenges they may face at home in the development and evaluation of medical devices to be used at home.
Home as a Health Care Hub incorporates firsthand the patient voice by exploring home barriers as described by patients themselves and the reality of their home experience, as well as takes into consideration the perspectives of health care providers and medical device companies.
Why Diabetes
Diabetes is an example of a condition that poses a nuanced range of clinical and lifestyle needs and offers a comprehensive use case. Diabetes and complications from diabetes can affect many different parts of the body and have significant impact on circulation, skin, dental, hearing, and vision.
Multiple device types are involved in diabetes care, from management tools such as glucometers, continuous glucose monitors, insulin pumps and injectables to mobility assistance devices such as wheelchairs, and orthotic walkers. Moreover, research suggests that diabetes impacts children and adults and disproportionally affects racial and ethnic minorities, low-income and rural populations in the U.S.
People living with diabetes represent a wide spectrum of needs. While some patients can adapt and manage their diabetes at home, such care requires active involvement from patients as well as their care partners, health care team, and others in their support network. There is a potential to bring digital technology and home environments together to better address the health care needs of people with diabetes. By taking diabetes and low resource environments as a use-case, the Lilypad™ seeks to make homes the hub for health in the most demanding scenarios. If devices can be developed for these scenarios, they can potentially be scaled to different health care and home environment scenarios with ease.
Get Involved
Home as a Health Care Hub wants to hear from you. Share your thoughts, ask questions, and receive updates. Email us at HealthHomeHub@fda.hhs.gov.
Join the innovators who are developing the solutions for tomorrow.
Organizations that Contributed to Development of the Idea Lab
- Advanced Medical Technology Association (Advamed)
- American Diabetes Association (ADA)
- American Occupational Therapy Association (AOTA)
- Breakthrough T1D
- Consumer Technology Association (CTA)
- HKS, Inc.
- Medical Device Manufacturers Association (MDMA)