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Join FDA and DiMe during a 2-day virtual event to help advance the use of PGHD to support improved trials, medical device development products, and regulatory science!

Join the Virtual First Care Coalition to shape a healthcare system that's intentionally designed with patients at the center.

Public Workshop

Using patient-generated health data in medical device development: Case examples of implementation throughout the total product lifecycle

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:
  • Better trials: Data from diverse participants by building trust and centering the patient voice

  • Better health products: Medical device development inspired and informed by patient experience

  • Better regulatory science: Consistent and meaningful patient-centered health measures, measurement standards for product authorization

Sign up for DiMe’s monthly newsletter to be the first to hear how this work progresses!

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