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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.

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.


The virtual public meeting will be a live webcast and the link will be provided in your confirmation email. The link for the archived webcast will be posted to this web page for viewing after the meeting.


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

Time Event
10:00 a.m. Welcome
10:15 a.m. Patient-Generated Health Data (PGHD) Basics
10:45 a.m. Data Management
11:15 a.m. Break
11:25 a.m. Patient-Driven Registries
12:40 p.m. Lunch
1:10 p.m. Stakeholder Perspectives on Methods of PGHD Integration into the Healthcare Ecosystem
2:25 p.m. Break
2:35 p.m. Art and Science of Building Trust Among Stakeholders and Building Bridges Between Data Sources
3:50 p.m. Closing Remarks
4:00 p.m. Adjourn


If you wish to attend this virtual meeting, you must register by 4:00 p.m. on May 3, 2021. There is no fee to register for the meeting.

No dashes or spaces in phone numbers please.

Registrants will receive confirmation when requests for participation have been accepted, if applicable.

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, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 32, Silver Spring, MD 20993, 301-796-5661, Susan.Monahan@fda.hhs.gov.


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: Christina.Webber@fda.hhs.gov


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