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Safety design guidelines for clinician-AI interaction in computer-aided diagnosis systems using system-theoretic
Yuki Hagiwara1, Katherine Fitch2, Mario Trapp2,3
1Fraunhofer Institute for Cognitive Systems IKS, Garching bei München, Germany. yuki.hagiwara@iks.fraunhofer.de.
Scientific Reports
|July 29, 2026
Summary
This study introduces a human-centered framework to enhance the safety of Artificial Intelligence (AI) in Computer-Aided Diagnosis (CADx). It addresses AI-clinician interaction hazards to improve diagnostic accuracy and patient care.
Area of Science:
- Medical Informatics
- Human-Computer Interaction
- Artificial Intelligence Safety
Background:
- Patient safety is paramount in AI-enabled Computer-Aided Diagnosis (CADx).
- Current safety frameworks inadequately address human-AI interaction complexities in clinical settings.
- Underexplored human-centered safety challenges in AI diagnostic tools pose risks.
Purpose of the Study:
- To develop a systematic, human-centered approach for safety guidelines in clinician-AI interaction for CADx systems.
- To identify and mitigate hazards associated with AI collaboration in diagnostic decision-making.
- To enhance the reliability and safety of AI-driven diagnostic tools.
Main Methods:
- System-Theoretic Process Analysis (STPA) was employed to identify critical hazards in clinician-AI collaboration.
- Safety design guidelines were formulated based on identified unsafe control actions.
- A CADx interaction framework with a safety-oriented GUI and multiple explanation methods was developed.
- A safety-oriented evaluation approach using explanation consistency was introduced.
Main Results:
- Critical hazards like automation bias and misinterpretation of AI explanations were identified.
- Actionable safety design guidelines promoting transparency, coherent explanations, and calibrated trust were formulated.
- A novel interaction framework operationalized guidelines, enhancing clinician engagement.
- An evaluation method using explanation consistency was proposed to detect unreliable AI explanations.
Conclusions:
- The proposed unified framework effectively links safety analysis, interaction design, and explainability evaluation for AI in CADx.
- This approach provides a reusable method for improving the safety and reliability of AI-driven diagnostic systems.
- Prioritizing human-centered design and robust evaluation is crucial for safe AI implementation in healthcare.
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