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

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).

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.