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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
Summary
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.
- 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.
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