Patient Science and Engagement Updates from CDRH

News, updates, and upcoming events from CDRH's Patient Science and Engagement Program

If your email program has trouble displaying this email, view as a webpage. Patients are experts in their conditions and offer valuable information to the U.S. Food and Drug Administration (FDA) about living with the condition and its treatments. Patient input can significantly impact the development, evaluation, and monitoring of medical devices. Discover how the FDA's Center for Devices and Radiological Health (CDRH) puts patients first with its Patient Science and Engagement Program. Patient Engagement and Digital Health Artificial Intelligence and Imaging Patients shared their perspectives on this emerging technology during a February 2020 workshop on the Evolving Role of Artificial Intelligence in Radiological Imaging. Device developers at the meeting commented on how helpful the patients' insights were to their product development considerations. Read more Digital Health Center of Excellence "Establishing the Digital Health Center of Excellence is part of the FDA's work to ensure that the most cutting-edge digital health technologies are rapidly developed and reviewed in the U.S." -Dr. Stephen Hahn, Former FDA Commissioner The new Digital Health Center of Excellence in CDRH aims to advance health care by fostering safe, effective and high-quality digital health innovation. Connecting and building partnerships with patients is critical to that goal, and the Center of Excellence encourages input from patients on topics of interest. Read more Patient Engagement Advisory Committee 2020 - Virtual "Despite the global challenges with the COVID-19 public health emergency… the patient's voice won't be stopped, and if anything, there is even more reason for it to be heard." -Dr. Jeff Shuren, CDRH Center Director Patients, caregivers, patient organizations, and experts met together with FDA staff and others in October 2020 for a virtual discussion on artificial intelligence and machine learning.  The committee discussed the diversity of the patients included in the datasets on which the software "learns," components of the device information shared with patients, and factors that impact patient trust in the technology.  Read more Patient Science Meetings and Workshops In 2021, CDRH will host a workshop on Patient-Generated Data. Check the next issue of this newsletter or the Patient Engagement Advisory Committee page for details. The Patient Science and Engagement Program hosted two virtual public meetings in fall 2020. Using Patient Preference Information (PPI) in Medical Device Regulatory Decisions Discussions addressed potential applications, challenges, and opportunities associated with using patient preference information (PPI) beyond the regulatory decision. Read More Patient-Reported Outcomes (PROs) and Medical Device Evaluation: Benefit-Risk and Beyond Panel discussions focused on the use of patient-reported outcomes (PRO) throughout the health care ecosystem. Read More Contact Patient Science and Engagement If you have questions about interacting with the patient engagement team at CDRH, email CDRH_PatientEngagement@fda.hhs.gov.

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