IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes

Tuesday, July 28, 2020 from 10:00 am to 02:00 pm

Event Details

Tuesday, July 28, 2020 from 10:00 am to 02:00 pm

The U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and the UCSF-Stanford Center of Excellence in Regulatory Science & Innovation (CERSI) is pleased to present:

IMPACT Bootcamp: Navigating the Journey from Digital Health Technologies to Meaningful Patient Outcomes

 An online course presented by FDA to serve the digital health and medical technology community

Tuesday, July 28, 2020 | 10 am to 2 pm Pacific Time

Online Course - Delivered Virtually by FDA Staff

Information, Agenda and Registration:

Are you a digital health innovator? Are you building sensors, wearables, or other digital health tools to be used in clinical trials to capture information about how patients feel, function, or survive?

Join the U.S. Food and Drug Administration and the UCSF-Stanford CERSI for an immersive mini-bootcamp, being held virtually and in a condensed format due to the COVID-19 pandemic. Be empowered to navigate the Digital Health Technology development and evaluation journey from patient needs assessment, to product development and validation tailored to supporting the context of use, to measuring patient outcomes and preferences. The hands-on training will provide an opportunity for early-stage innovators to become fluent with terminology and aware of regulatory considerations and resources, thus enabling innovators to have more informed interactions with regulators, improve their evidence generation, and bring safe and effective medical technologies into the healthcare system in a timely manner. The emphasis of this bootcamp will be on Digital Health Technologies used to facilitate assessment of patient outcomes in clinical trials (i.e., Clinical Outcome Assessments (COAs)).

Key Words: Digital Health Technologies (DHTs), Digital Biomarkers, Clinical Outcome Assessments (COAs), Patient-Reported Outcomes (PROs), Performance Outcomes (PerfOs), Observer-Reported Outcomes (ObsROs), Patient Preference Information (PPI)

Learning Objectives:

  • Develop high-level understanding of the regulation of medical devices and use vocabulary used by FDA when communicating about patient outcome measurements and DHTs.
  • Describe important considerations for development, validation, and use of DHTs and outcome measurement tools for regulatory purposes.
  • Discuss DHTs used for remote acquisition of clinical data and describe regulatory considerations for their development.
  • Differentiate between PPI and PROs, and describe how PPI can inform on unmet needs and tool development.
  • Develop practical expertise applying bootcamp concepts to cases relevant as an innovator developing and bringing medical technologies to the market.


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