- Data from electronic health records (EHRs) provide new opportunities to inform medical product regulatory decision-making. Since the primary purpose of the EHR is to support care delivery, these data must undergo fitness-for-use assessments before they can be used for real-world safety and effectiveness analyses. This webinar will describe current practices and lessons learned from efforts to assess data quality and dataset suitability within the National Patient-Centered Clinical Research Network (PCORnet®), a large distributed research network that leverages electronic health records and administrative claims for patient-centered observational and comparative effectiveness research, as well as implications for the use of EHR data more broadly to support regulatory decision-making.
- Medical informaticists, medical product safety and real world evidence researchers and regulators
View a recording of the webinar here.
Keith Marsolo, PhD