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).
Join our upcoming free 2-day public meeting to help contribute to this work!
You’ll have the opportunity to share insights that will help guide the development of new resources – and walk away with a better understanding of PGHD implementation during medical device development and clinical studies.
Meeting details:
June 26, 2024 | 11am – 3pm ET
June 27, 2024 | 11am – 3pm ET
Free. Open to the public.
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
