Meeting | Virtual
Event Title
Virtual Public Meeting – Home as a Health Care Hub – Stakeholder Listening Session; July 25, 2024
July 25, 2024
- Date:
- July 25, 2024
- Time:
- 12:00 PM - 4:00 PM ET
SUMMARY
The Food and Drug Administration (FDA) is announcing a virtual public meeting, “Home as a Health Care Hub – Stakeholder Listening Session”. The purpose of this meeting is to discuss the home environment as an integral part of the health care system, including hearing stakeholder ideas on aspects to consider in developing the Home as a Health Care Hub prototype for all people in the U.S.
BACKGROUND
On April 23, 2024, the FDA announced a new initiative, Home as a Health Care Hub aimed to help 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 (https://www.fda.gov/medical-devices/medical-devices-news-and-events/fda-launches-health-care-home-initiative-help-advance-health-equity). As part of this initiative, the FDA's Center for Devices and Radiological Health (CDRH) has contracted with an architectural firm that designs innovative buildings with health and equity in mind, to consider the needs of variable models of a home and tailor solutions with opportunities to adapt and evolve in complexity and scale. The hub will be designed as virtual reality (VR)- prototypes of the home and is expected to be completed by the end of 2024. The FDA is using diabetes as an example health condition for the prototypes given the impacts over the lifecycle of someone living with this condition. The Home as a Health Care Hub prototypes are 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.
OBJECTIVES:
1. Share information about FDA’s newly launched Home as a Health Care Hub initiative
2. Solicit input from a broad set of stakeholders to inform future direction of the Home as a Health Care Hub initiative
3. Create a dialogue on the barriers and opportunities for the delivery of health care and the generation of clinical evidence in the home environment
DATE and TIME
This meeting will be held on July 25, 2024, from 12:00 noon – 4:00 p.m. (ET) by webcast only.
WEBCAST
The meeting will be webcast. A webcast link will be provided to all registrants in a confirmation email. The link for the archived webcast will be posted on the FDA webpage after the meeting.
PRELIMINARY AGENDA
The following meeting agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.
| Time | Subject | Name of Speaker |
|---|---|---|
| 12:00 - 12:35pm | Opening Remarks | FDA Remarks from Representatives of Organizations Participating on Initiative's Steering Committee |
| 12:35 - 12: 45 pm | Setting the Stage for the Initiative | FDA |
| 12:45 - 12:55 pm | Designing and Building with Health Care Needs in Mind | TBD |
| 12:55 - 1:05 pm | Overview of Home Prototype Project | HKS |
| 1:05 - 1:40 pm | Panel Discussion with Audience Q&A | FDA moderator Steering Committee members |
| 1:40 - 1:55 pm | Break | |
| 1:55 - 2:30 pm | Considerations for technology when it comes home | TBD |
| 2:30 - 3:30 pm | Stakeholder Listening Session on Barriers & Opportunities with Bringing Health Technology to the Home | Public Presentations |
| 3:30 - 3:55 pm | Panel Discussion with Audience Q&A | FDA moderator Steering Committee members |
| 3:55 - 4:00 pm | Closing Remarks | FDA |
REGISTRATION
If you wish to attend this public meeting and receive the link to live webcast, please register by 11:00 a.m. ET on July 25, 2024. For registration please visit, https://fda.zoomgov.com/webinar/register/WN_GVFoeds-SX-pJaAodpnUwA#/registration.
There is no fee to register for the public meeting. When registering, you must provide the following information:
(1) Name
(2) Title
(3) Affiliation, Company or Organization
(4) E-mail address
(5) Stakeholder Category (Academia, Clinical Providers, Consultant, Government, Industry, Patient or Caregiver, Home Designer or Builder, Payer, and Other)
Stakeholders interested in sharing ideas will be given 3 minutes to share their ideas and perspectives on Barriers & Opportunities with Bringing Health Technology to the Home. We are seeking perspectives from:
- Patients and Caregivers
- Clinical Providers
- Researchers and Academia
- Home Designers and Builders
- Medical Device and Consumer Technology Industry
- Payers
If you are interested in sharing your ideas and perspectives, please email Healthhomehub@fda.hhs.gov with “Home as a Health Care Hub Stakeholder Listening Session” in the subject line of your email by 12 noon ET July 12, 2024. Please include the following information in your email:
- Stakeholder group to which you belong
- Proposed talk title
- A few sentences that describe the perspective you propose to present on the barriers and opportunities associated with home as a health care hub. Individuals and organizations with common interests are urged to consolidate or coordinate jointly for sharing their ideas. Please note that statements related to off-label use of medical devices are not permitted. No commercial or promotional material will be permitted to be presented or distributed at the meeting.
- A recording (maximum 3 minutes) of your presentation in mp4 format.
FDA will do its best to accommodate requests to show recordings during the meeting; however, due to time constraints, not all recordings will be presented.
If you require special accommodations due to a disability, or need additional information regarding registration, please contact Susan Monahan, Office of Communication and Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.
COMMENTS
Please submit your comments regarding the workshop to https://www.regulations.gov, Docket No. FDA-2024-N-2780 by July 22, 2024.
Please refer to the Instructions for Submitting Comments to the docket to ensure that your feedback is received.
Please be advised that as soon as a transcript is available, it will be posted in the Dockets and accessible at https://www.regulations.gov.
CONTACT
For questions regarding this public meeting content, please contact:
Lindsay Lloyd
Office of the Center Director
Center for Devices and Radiological Health
10903 New Hampshire Ave.
Silver Spring, MD 20993
Email: Healthhomehub@fda.hhs.gov