OPP002 📄 Overview An integrated SaMD system that combines continuous physiological monitoring (e.g., advanced wearables, smart home sensors, ambient monitoring) with contextual and behavioral data. It uses AI to detect subtle changes, predict exacerbations, and deliver adaptive, personalized digital interventions (e.g., CBT modules for mental health, medication reminders, activity prompts, nutritional guidance) to manage chronic conditions or support recovery. Key technologies: 👤 Target users: 👍 Benefits Reduced hospitalizations and emergency visits • Improved self-management and adherence to care plans • Enhanced quality of life and functional independence • Real-time clinical decision support and timely interventions • Expansion of care access to remote or underserved populations Use bullets or new lines. 👎 Challenges Sensor accuracy, reliability, and battery life for continuous use • User adherence and engagement with devices and interventions over time • Mitigating alert fatigue for both patients and clinicians • Seamless integration with existing EHRs and clinical workflows • Ensuring cybersecurity and data privacy across multiple devices and platforms 📋 Regulatory & Validation SaMD classification for monitoring and potentially for active treatment • Specific requirements for data security and device interoperability • Usability validation (e.g., IEC 62366) to ensure safe and effective use • Clinical validation of intervention efficacy and safety outcomes