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  5. Virtual Public Meeting - Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices - 05/04/2021 - 05/04/2021
  1. Workshops & Conferences (Medical Devices)


Event Title
Virtual Public Meeting - Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices
May 4, 2021

May 4, 2021
10:00 AM - 4:00 PM ET
Illustration of a clipboard, stethoscope, smart watch, laptop, and glucose meter.

The U.S. Food and Drug Administration (FDA) is announcing a virtual public meeting entitled "Patient-Generated Health Data Throughout the Total Product Life Cycle of Medical Devices". The purpose of this meeting is to discuss patient-generated health data (PGHD) and its potential impact across the healthcare ecosystem.


As stated in the Office of the National Coordinator for Health Information Technology's webpage on Patient-Generated Health Data, PGHD includes health-related data that is created, recorded, or gathered by or from patients. Health and treatment history, biometric data, symptoms, and lifestyle habits can all be categorized as PGHD. The potential role of PGHD in the post-market surveillance of medical device safety was discussed during the FDA's Patient Engagement Advisory Committee (PEAC) meeting on November 15, 2018. The PEAC recommended additional discussions about the critical elements of this data and how it could be used across the medical device total product life cycle. To address those recommendations from the PEAC members, the FDA's Center for Devices and Radiological Health (CDRH) is hosting a meeting focusing on PGHD and its potential uses throughout the healthcare ecosystem. Sources of PGHD, data quality measures, interoperability, and potential impacts of the data in regulatory and healthcare settings will be discussed during this meeting.

This meeting is the intersection of CDRH efforts in patient science and engagement, real-world data and real-world evidence, and the Digital Health Center of Excellence.  The FDA invites stakeholders from the medical device industry, patient organizations, research organizations, healthcare professionals, payors, and other interested individuals to join this discussion and provide their individual opinions on the use of PGHD in medical device development, evaluation, and monitoring. The topic details are provided in the Preliminary Agenda below.


This meeting will be held on May 4, 2021, from 10:00 a.m. to 4:00 p.m. (ET) by webcast only.


To view the webcast, just click on this link: Patient-Generated Health Data Meeting then follow the registration instructions on the screen to sign in to the meeting.


This agenda is preliminary and subject to change. More information will be made available as presenters are confirmed.




10:00 a.m.


Christina Webber, PhD

Jeff Shuren, MD, JD

10:15 a.m.

Patient-Generated Health Data Foundations and Opportunities

Daniel Caños, MPH, PhD

Bakul Patel, MSc, MBA

Anne Hammer

10:45 a.m.

Data Governance and Management

Christina Mack, MSPH, PhD

Jimmy Tcheng, MD

Flora Sandra Siami, MPH

Mary Beth Ritchey, PhD

Chun-Ju (Janey) Hsiao, PhD

Danica Marinac-Dabic, MD, PhD, MMSc

Daniel Caños, MPH, PhD (moderator)

11:15 a.m.



11:25 a.m.

Patient-Driven Registries

Christina Webber, PhD

Sohini Chowdhury, MA

Ben Nowell, PhD

Pamela Gavin, MBA

Todd Durham, PhD

Anindita Saha, BSE (moderator)

12:40 p.m.



1:10 p.m.

Stakeholder Perspectives on Methods of PGHD Integration into the Healthcare Ecosystem

Elise Berliner, PhD

Stanley Huff, MD

Brandon Arbiter

Charles Rardin, MD

Andrea Coravos

Joseph Drozda, MD

Kevin Haynes, MSCCE, PharmD

Danica Marinac-Dabic, MD, PhD, MMSc (moderator)

2:25 p.m.



2:35 p.m.

Art and Science of Building Trust Among Stakeholders and Building Bridges Between Data Sources

C. Daniel Mullins, PhD

Vahan Simonyan, PhD

Claudia Grossmann, PhD

Joseph Ross, MD, MHS

Susan Moore, PhD, MSPH

Meg Doerr, MS

Stephanie Garcia, MPH

Michelle Tarver, MD, PhD (moderator)

3:50 p.m.

Closing Remarks

Michelle Tarver, MD, PhD

4:00 p.m.





Registration is closed as of May 3, 2021.


For questions regarding meeting content, please contact:

Christina Webber
Center for Devices and Radiological Health
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993

Email: [email protected]


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