OPP002_CognitiveBiasCorrectionSaMD 📄 Overview A SaMD application integrated into clinical decision support systems (CDSS) that analyzes patient data (history, symptoms, lab results, imaging) and provides 'nudge' interventions or alternative diagnostic considerations to clinicians, specifically designed to mitigate common cognitive biases (e.g., anchoring bias, availability bias, confirmation bias) that can lead to diagnostic errors. Key technologies: 👤 Target users: 👍 Benefits Reduced diagnostic errors • Improved patient safety • More efficient use of diagnostic resources • Enhanced clinical reasoning and learning • Lower malpractice risks Use bullets or new lines. 👎 Challenges Gaining clinician trust and adoption • Training data bias and generalizability • Regulatory clearance for high-risk diagnostic support • Seamless integration into existing, often fragmented, CDSS workflows • Avoiding alert fatigue while being effective 📋 Regulatory & Validation Likely Class II or potentially Class III SaMD depending on the level of independent decision-making and risk. Requires rigorous clinical trials to prove efficacy in reducing diagnostic errors without unintended consequences. Must address algorithmic transparency.