Frequently Asked Questions for the Home as a Health Care Hub
In April 2024, the FDA’s Center for Devices and Radiological Health (CDRH) launched the Home as a Health Care Hub, to reimagine the home as an integral part of the health care system, with the goal of advancing access to medical device technologies with the potential for better health outcomes for all people in the United States.
The information provided below may be useful to patients, caregivers, medical device developers, and health care providers.
On this page:
- Why did CDRH launch the Home as a Health Care Hub Initiative?
- What is the Home as a Health Care Hub Idea Lab?
- How was the Idea Lab developed?
- What is the goal of the Idea Lab?
- What is Lilypad™ and why was it developed?
- How will developers access Lilypad™ to aid in their research and development?
- What does the Home as a Health Care Hub initiative mean for patients?
- What parts of the home can a developer see in the Lilypad™?
Why did CDRH launch the Home as a Health Care Hub?
In 2023, the FDA requested public comment and held a Patient Engagement Advisory Committee (PEAC) meeting to better understand how the FDA can facilitate access to medical devices that are designed to be safe and effective when used in the home. PEAC members stressed the criticality of ensuring devices work well in the home, taking into consideration where people live and the specific challenges they may face at home. Additionally, CDRH heard from the public that developers need additional direction from the FDA on how to demonstrate the safety and effectiveness of home-use medical devices.
The Home as a Health Care Hub initiative and the Idea Lab are a step towards addressing this feedback.
What is the Home as a Health Care Hub Idea Lab?
The Idea Lab is intended to provide a tangible look into the challenges and constraints of people navigating their medical conditions in their daily lives and provide a space for innovators to think about how current and future technology can help people optimize their health where they live.
The Idea Lab includes:
- Fictional personas representing a range of people who live with diabetes in affordable housing.
- Lilypad™ - a free software that allows users to virtually enter the world of people living with diabetes in affordable housing.
- Considerations for Innovators.
- Research and Insights from the Home as a Health Care Hub initiative.
We invite others to share their ideas on what the future state could look like. Email us at HealthHomeHub@fda.hhs.gov.
How was the Idea Lab developed?
CDRH contracted with architectural firm HKS, Inc., Inc. to develop the Idea Lab. The Idea Lab is built on research. The process to develop the Idea Lab was person-centered, evidence-based, and interdisciplinary.
It began with discovery, including:
- Insights gathered from conversations with patients, caregivers, health care providers, device and consumer tech innovators.
- Field research with site visits to two settings of low-income housing.
- Literature review of clinical needs and technology solutions for people living with diabetes, along with housing design considerations and affordable housing requirements.
HKS, Inc. interviewed patients and care partners, health care providers, and medical device developers to help summarize these findings. This informed the design of the virtual spaces and representative patient personas that are incorporated into the Lilypad™ virtual experience.
What is the goal of this Idea Lab?
This Idea Lab is intended to catalyze innovators across fields to:
- Design health and wellness solutions centered on the person that meet people where they live, work, and play.
- Create new solutions for people living with diabetes and other chronic conditions.
- Unlock opportunities to link design to improved health outcomes.
- Leverage the emerging technology ecosystem.
- Address barriers to adoption.
- Imagine the home becoming the nexus of health, accessible for all.
You can learn more about the development of this Idea Lab in the Executive Summary.
What is Lilypad™ and why was it developed?
Lilypad ™ is a virtual reality (VR) prototype of various home environments of people with low-income status and are living with diabetes. The virtual reality experience provides a look into the challenges and constraints of people navigating their medical conditions in their daily lives.
CDRH started with homes of people living with diabetes as a test case. We chose people living with diabetes as a test case given the prevalence and burden of disease, the importance of medical devices and lifestyle in managing the condition and preventing comorbidities, and the mobilized patient organizations and provider groups that are well-positioned to contribute to solutioning.
The Lilypad™ prototype of different homes environments are the beginning of the conversation. Lilypad™ is intended to:
- Help device developers consider novel design approaches.
- Offer providers opportunities to educate patients and extend care options, generating discussions on value-based care models.
- Open opportunities to bring clinical trials and other evidence generation processes to underrepresented communities through the home.
CDRH is committed to fostering innovation that improves public health. The Home as a Health Care Hub initiative is intended to stimulate solutions that improve evidence generation and seamlessly integrate medical devices and health care, prevention, and wellness into people's lives, leading to a longer, better quality life for all.
How will developers access Lilypad™ to aid in their research and development?
Developers can download the complete Lilypad™ VR experience from our website. Developers will also find instructions on how to use the VR and incorporate and test their own devices within the VR experience.
What does the Home as a Health Care Hub initiative mean for patients?
The ultimate goal of the Home as a Health Care Hub initiative is to help address the health and wellness needs of all Americans, including underserved patient communities.
In the United States, health care has focused on the needs of the system - hospitals, clinics, providers, and payers - rather than the person. This has contributed to significant health care costs and 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-income neighborhoods are more likely to experience worse health outcomes.
Focusing care and clinical evidence generation on people where they live can help to address challenges faced by patients. Home-use medical devices, including digital health technologies, can enable a shift in the way care is delivered to meet the needs of the person rather than the system. Models that have examined care delivery at home have found high patient satisfaction, good adherence, and potential cost savings to the health care system.
While many people use medical devices in their homes today, 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. For example, a person living with diabetes and the complications of their condition may use multiple devices at home like a glucose monitor, an insulin pump, and a home dialysis machine.
Through the Home as a Health Care Hub initiative and Idea Lab, CDRH hopes to generate discussions about integrated care approaches through medical devices and opportunities to bring clinical trials and other evidence generation processes to all patients.
What parts of the home can a developer see in the Lilypad™?
The Lilypad™ prototype of different home environments focus on the critical rooms in the home that are in most housing units, including a single-family home, mobile home, and an apartment. This includes the entryway, living space (kitchen/dining/living), bedroom, and bathroom.
Contact
For more information about the Home as a Health Care Hub, please email HealthHomeHub@fda.hhs.gov.