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).

    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.

  • Impact for NESTcc

    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.

  • Organizations

    Medtronic, Mercy

  • Principal Investigators

    Darrell Johnson, MBA, Medtronic and Joseph Drozda, MD, Mercy

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NESTcc's Test-Case study protocol on synthetic mid-urethral slings for stress urinary incontinence in women is open for public comment through June 12. More: 1 day ago

NESTcc is requesting public comments on the study protocol of our Test-Case focused on synthetic mid-urethral slings for stress urinary incontinence in women. The comment period is open until June 12. More: 1 week ago

National Evaluation System for health Technology Coordinating Center (NESTcc)
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