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C-Scrum: Agile and Automated Software Development for Digital Health.

Marius Gerdes1, Florian Mazura1, Rick Petzold1

  • 1Karlsruhe Institute of Technology, Karlsruhe, Germany.

Studies in Health Technology and Informatics
|May 17, 2025
PubMed
Summary
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Digital health software can now be both compliant and agile using C-Scrum (Compliant-Scrum). This hybrid model integrates risk analysis and automated tracking to meet stringent certification demands while retaining Scrum

Area of Science:

  • Digital Health
  • Software Engineering
  • Regulatory Compliance

Background:

  • Digital health software necessitates rigorous certification processes.
  • Traditional plan-driven development often conflicts with agile methodologies like Scrum.
  • Bridging the gap between compliance and agility is crucial for digital health innovation.

Purpose of the Study:

  • To introduce C-Scrum (Compliant-Scrum), a novel hybrid model.
  • To reconcile the demands of stringent certification with Scrum's agile principles.
  • To enhance the development process for compliant digital health software.

Main Methods:

  • Developed C-Scrum, a hybrid agile framework.
  • Incorporated feature-based risk analysis into the development lifecycle.
Keywords:
IEC 62304SaMDdigital healthmedical software development

Related Experiment Videos

  • Integrated automated compliance tracking mechanisms.
  • Leveraged Continuous Integration and Continuous Deployment (CI/CD) pipelines.

    • Main Results:

    • C-Scrum effectively bridges the gap between compliance and agility.
    • The model demonstrated intuitive design and practical viability.
    • Expert evaluation validated the framework's ability to maintain both regulatory adherence and development flexibility.
    • Successful integration of risk analysis, automated tracking, and CI/CD.

    Conclusions:

    • C-Scrum offers a viable solution for developing compliant digital health software.
    • The hybrid model supports both stringent certification requirements and agile adaptability.
    • C-Scrum facilitates efficient and compliant software development in the digital health sector.