Achieving Safe DICOM Software in Medical Devices

This paper reports on an investigation on how to produce a reliable software component to extract critical information from DICOM files. The component shall manipulate safety-critical medical information, i.e. patient demographics and data specific to radiotherapy treatments including radiation target volumes and doses intensity. Handling such sensitive data can potentially lead to medical errors, and threaten the health of patients. Hence, guaranteeing reliability and safety is an essential part of the development process. Solutions for developing the component from scratch or reusing all or parts of existing systems and libraries will be evaluated and compared. The resulting component will be tested to verify that it satisfies its reliability requirements. Subsequently, the component is to be integrated within an innovating radiotherapy positioning system developed by a Swedish start-up, Micropos. While remaining objective, I will examine how the outcomes of my practical cases converge with what is discovered in the literature: a massive lack of conformance to DICOM exists…


Problem Area & Problem Statement
Delimitations & Restrictions
Document Outline
Theoretical Context
Safety-Critical Medical Devices
Risk Management
The DICOM Standard: Solutions & Issues
Research Approach
Research Process
The Cases
Selection Criteria
Evaluation Criteria
Expected Outcome
DICOM Reader Prototype
DICOM Software
Custom DICOM Reader Component
Evaluation, Test & Verification
Limitations And Future Work
Appendix A: Glossary & Definitions
Appendix B: Risk Analysis
Appendix C: Interview with a DICOM software developer
Appendix D: DICOM Software COTS
Appendix E: DICOM Files Samples Sources

Author: Debruyn, Kevin

Source: Goteborg University

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