OPP002 📄 Overview A patient-facing mobile application allowing individuals to track non-specific symptoms commonly associated with hypothyroidism (fatigue, weight changes, mood, cold intolerance). This data, combined with select EMR parameters (e.g., family history of autoimmune disease, existing comorbidities) and a risk algorithm, triggers a 'soft alert' to the patient to discuss their symptoms with their physician and a low-priority, contextual alert within the physician's EMR inbox, suggesting a review of the patient's reported symptoms and potentially a TSH order. Key technologies: 👤 Target users: 👍 Benefits Empower patients in their diagnostic journey • Provide more comprehensive symptom data to clinicians • Reduce patient anxiety through structured symptom tracking • Improve patient-provider communication • Facilitate earlier detection in symptomatic but undiagnosed individuals Use bullets or new lines. 👎 Challenges Ensuring patient adherence and consistent data entry • Data privacy and security for patient-generated health data (PGHD) • Integrating PGHD effectively into clinical workflow without overwhelming providers • Clinical validation of the risk algorithm • Varying digital literacy among patient populations 📋 Regulatory & Validation Patient-facing component might be lower risk (wellness) unless it directly suggests diagnosis or treatment. • EMR-linked physician alert component likely Class I or II SaMD. • Requires robust data privacy compliance (HIPAA, GDPR). • User experience testing crucial for patient engagement and data quality.