OPP002 📄 Overview An intelligent SaMD platform that utilizes continuous passive sensing (e.g., smartphone usage patterns, voice analysis, activity data from wearables) combined with self-reported mood/symptom data to dynamically adapt and deliver personalized therapeutic interventions. This could include AI-driven CBT exercises, mindfulness sessions, coaching messages, or medication adherence reminders, all optimized in real-time based on the user's current state and progress. The platform would be clinically validated for specific indications (e.g., anxiety, depression, diabetes management). Key technologies: 👤 Target users: 👍 Benefits Scalable, evidence-based mental health support • Improved adherence to treatment regimens for chronic conditions • Reduced burden on traditional healthcare systems • Personalized and adaptive intervention delivery Use bullets or new lines. 👎 Challenges Clinical validation and efficacy across diverse patient populations • Ethical use of passive sensing data and privacy concerns • Integration into existing clinical workflows and referral pathways • Sustaining user engagement over long periods • Reimbursement models that recognize adaptive, continuous care 📋 Regulatory & Validation Class II or III SaMD depending on claims (e.g., 'treats' vs. 'manages') • Clear guidelines for algorithm updates and post-market surveillance • Data security and ethical AI guidelines for passive data collection