Use of EHR-Based Data Network to Support Evidence Generation Across the Total Product Life Cycle (TPLC)

Overview: A collaboration between a medical device manufacturer and a large hospital health system, this project aims to develop, test, and validate the use of an electronic health record (EHR)-based data network to support evidence generation for medical devices across the total product life cycle (TPLC). A test case involves retrospectively extracting longitudinal data for all heart failure patients across the health system, some of whom will have received Chronic Resynchronization Therapy (CRT).

Impact for NESTcc: The systematic process deployed to validate and test the pathways for evidence generation is producing a scalable model to inform an industry-wide roadmap toward the use of EHR-based data networks for the responsible access and use of practice data, in both the pre-market and post-market space. While the test case is in the post-market space, the infrastructure and learnings will be used to inform future applications in the pre-market environment.

Organization(s): Medtronic, Mercy

Principal Investigator(s): Darrell Johnson, MBA (Medtronic); Joseph Drozda, MD (Mercy)