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  4. Virtual Public Meeting – Home as a Health Care Hub – Stakeholder Listening Session; July 25, 2024 - 07/25/2024
  1. Medical Devices News and Events

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) announced a virtual public meeting, “Home as a Health Care Hub – Stakeholder Listening Session”. The purpose of this meeting was 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 virtual meeting was held on July 25, 2024, from 12:00 noon – 4:00 p.m. (ET).

WEBCAST

Recording Link: 
https://fda.zoomgov.com/rec/share/m01HQLsZOwvdGthtt9zj5jxOzuJ3E3A6utkamG7STbrgQQEucdKsS_NMCWihOIbJ.Lhmo7RjB8B6UgD0k

AGENDA

Speakers Bios

Time Subject Name of Speaker
MC: Ankurita Datta
12:00 - 12:35pm Opening Remarks

FDA
Dr. Robert Califf

Participating Organizations
Julianne Lally, Breakthrough T1D
Mark Leahey, Medical Device Manufacturers Association (MDMA)
Sharmila Sandhu, American Occupational Therapy Association (AOTA)
Charles D Henderson, American Diabetes Association (ADA)
Gary Shapiro, Consumer Technology Association (CTA)
Scott Whitaker, Advanced Medical Technology Association (AdvaMed)
12:35 - 12: 45 pm  Setting the Stage for the Initiative - the Importance of Health Equity with Diabetes as an Example Dr. Jeff Shuren, FDA
12:45 - 12:55 pm  Designing and Building with Health Care Needs in Mind Joanna Frank, Center for Active Design
12:55 - 1:05 pm Overview of Home as a Healthcare Hub Initiative Dr. Upali Nanda, HKS
1:05 - 1:30 pm  Panel Discussion with Audience Q&A

Moderator: Dr. Matthew Diamond, FDA

Julianne Lally, Breakthrough T1D
Dr. Nuha Ali El Sayed, American Diabetes Association (ADA)
Sabrena McCarley, American Occupational Therapy Association (AOTA)
Joe Kiani, Medical Device Manufacturers Association (MDMA)
René Quashi, Consumer Technology Association (CTA)
Dr. Susan Alpert, Advanced Medical Technology Association (AdvaMed)
Deborah Wingler, HKS
1:30 - 1:45 pm Break  
1:45 - 2:20 pm Open Public Comments on Barriers & Opportunities with Bringing Health Care Home Public Presentations
2:20 - 3:35 pm Perspectives from Members of the Ecosystem on Delivering Health Care in the Home

Arianna Gehan, Daia 
Dr. Courtney Lias, FDA
Dr. Martin Mendoza, CMS

Andrew Cleeland, Fogarty Institute
Casper de Clercq, Norwest Venture Partners 
Dr. Ricky Choi, Samsung
 
Dr. Joel Brill, Predictive Health
Dr. Jesse Ehrenfeld, AMA
3:35 - 3:55 pm Panel Discussion with Audience Q&A 

Moderator: Dr. Michelle Tarver, FDA

Arianna Gehan, Daia 
Dr. Courtney Lias, FDA
Andrew Cleeland, Fogarty Institute
Casper de Clercq, Norwest Venture Partners 
Dr. Ricky Choi, Samsung 
Dr. Joel Brill, Predictive Health
Dr. Jesse Ehrenfeld, AMA 
Dr. Upali Nanda, HKS
3:55 - 4:00 pm Closing Remarks Dr. Michelle Tarver, FDA

COMMENTS

Please submit your comments regarding the workshop to https://www.regulations.gov, Docket No. FDA-2024-N-2780 by August 23, 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

 

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