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Code Wisely: Risk assessment and mitigation for custom clinical software.

Rex A Cardan1, Elizabeth L Covington1, Richard A Popple1

  • 1Department of Radiation Oncology, University of Alabama at Birmingham, Birmingham, AL, USA.

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Summary
This summary is machine-generated.

Medical physicists need guidance for safe clinical software development. This study introduces a risk assessment model and best practices to mitigate potential issues in custom software creation.

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Area of Science:

  • Medical Physics
  • Software Engineering
  • Clinical Informatics

Background:

  • The role of medical physicists increasingly involves software development for clinical applications.
  • Many physicists lack formal training in software development best practices, leading to potential risks.
  • There is a critical need for guidance on safe and effective software coding in clinical settings.

Purpose of the Study:

  • To address the growing need for guidance in clinical software development for medical physicists.
  • To propose a novel risk assessment model for custom clinical software.
  • To outline minimum best practices for mitigating risks associated with clinical software.

Main Methods:

  • Developed a novel risk assessment model for custom clinical software, inspired by failure modes and effects analysis.
  • Integrated a literature review and institutional experience to create a practical risk mitigation guide.
  • Identified and outlined key risk mitigation techniques such as unit testing, code review, and end-user testing.

Main Results:

  • The study presents a new risk assessment model tailored for clinical software.
  • Several risk mitigation strategies, including testing and commissioning, are detailed.
  • Institutional guidelines for evaluating software risk and implementing mitigation strategies are shared.

Conclusions:

  • Limited literature currently exists for custom software development guidelines specifically for medical physicists.
  • The developed guide and institutional experience aim to support safe software development practices.
  • This work facilitates safer software creation for the evolving responsibilities of medical physicists.