Streamlining medical software development with CARE lifecycle and CARE agent: an AI-driven technology readiness level assessment tool.

Journal: BMC medical informatics and decision making
Published Date: Jul 8, 2025

Abstract

BACKGROUND: Developing medical software requires navigating complex regulatory, ethical, and operational challenges. A comprehensive framework that supports both technical maturity and clinical safety is essential for effective artificial intelligence and machine learning system deployment. This paper introduces the Clinical Artificial Intelligence Readiness Evaluator Lifecycle and the Clinical Artificial Intelligence Readiness Evaluator Agent-a framework and AI-driven tool designed to streamline technology readiness level assessments in medical software development.

Authors

  • Steven N Hart
    From the Department of Laboratory Medicine & Pathology, Mayo Clinic, Rochester, Minnesota (Flotte, Derauf, Byrd, Kroneman, Bell, Hart, Garcia).
  • Patrick L Day
    Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, United States.
  • Christopher A Garcia
    Department of Laboratory Medicine and Pathology, Mayo Clinic, 200 1st St. SW, Rochester, MN, 55901, USA.

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