OPP003 📄 Overview A highly specialized SaMD solution that integrates multi-modal patient data (continuous physiological data from wearables, medication adherence, recent lab results, patient-reported symptoms like severe tremor or confusion, and even relevant environmental factors like heatwaves) to calculate a dynamic, real-time risk score for thyroid storm. The platform provides immediate, personalized alerts to high-risk patients and their designated clinicians, coupled with an in-app, clinician-approved emergency action plan, including contact information for emergency services and clear steps to take. Key technologies: 👤 Target users: 👍 Benefits Potentially life-saving by enabling extremely early intervention for thyroid storm • Significant reduction in thyroid storm-related hospitalizations and mortality • Enhanced patient and family preparedness for medical emergencies • Improved safety and confidence for high-risk patients • Optimized resource allocation in healthcare systems by preventing severe events Use bullets or new lines. 👎 Challenges Extremely high regulatory bar due to the life-critical nature (likely Class III SaMD) • Achieving exceptionally high predictive accuracy to minimize false positives/negatives • Ethical considerations around alerting patients to life-threatening risks • Seamless and reliable integration with emergency services and clinical communication channels • Maintaining data integrity and system availability under all conditions 📋 Regulatory & Validation Almost certainly Class III SaMD due to the high consequence of inaccurate information. • Requires extensive, prospective clinical trials demonstrating impact on mortality/morbidity. • Robust cybersecurity, fault tolerance, and redundancy are absolutely critical. • Clear liability frameworks and clinician oversight protocols are essential.