---

Image

---

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.

BACKGROUND

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.

• Date and Time
• Webcast Meeting Link
• Preliminary Agenda
• Registration
• Contact
• Resources

DATE and TIME

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

WEBCAST MEETING LINK

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.

PRELIMINARY AGENDA

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

TIME	EVENT	PRESENTERS
10:00 a.m.	Welcome	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.	Break
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.	Lunch
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.	Break
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.	Adjourn

 

REGISTRATION

Registration is closed as of May 3, 2021.

CONTACT

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]

RESOURCES

• Patient-generated health data information
• FDA Patient Engagement Advisory Committee
• 2018 PEAC Meeting Materials

---