DiMe and FDA are working to identify successful practices for using patient-generated health data (PGHD) and driving adoption of its use throughout the total product life cycle (TPLC).
We conducted a two-day public workshop – featuring nearly 45 speakers and 2,000 attendees – to explore the implementation of PGHD during medical device development and clinical studies. Insights from the workshop will now be used to develop a roadmap for using PGHD in TPLC and provide a vision for the future with better trials, health products, and regulatory science.
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Developing new resources
DiMe and FDA will use the information and insights shared during the public meeting to:
Gather case examples to demonstrate how PGHD can be implemented throughout the total product life cycle (TPLC).
Explore ways to use PGHD to help advance remote clinical trial data collection and support clinical outcome assessments
Demonstrate how PGHD can highlight the patient voice in the medical device ecosystem
They will also develop a roadmap for the use of PGHD in medical device TPLC and provide a vision for the future with:
Pamela Gavin
National Organization for Rare Disorders (NORD)
Anindita (Annie) Saha
FDA, Digital Health Center of Excellence
Tracy Gray
FDA
