RPM-001 📄 Overview A comprehensive RPM platform integrating continuous biometric data from wearables (HRV, sleep, activity, temperature), smart home sensors (gait, falls, environmental factors), and patient-reported outcomes (ePROs) with EHR data. An advanced AI engine analyzes these multimodal inputs to predict acute exacerbations or significant health deterioration (e.g., heart failure decompensation, COPD exacerbation) up to 72 hours in advance, triggering proactive, prioritized alerts and recommended interventions for the clinical care team. Key technologies: 👤 Target users: 👍 Benefits Reduced hospital readmissions and ER visits • Improved patient quality of life and sense of security • Shift from reactive to proactive clinical intervention • Optimized clinician workload by prioritizing high-risk patients • Enhanced understanding of individual disease progression Use bullets or new lines. 👎 Challenges Managing data noise and false positive alerts to prevent clinician fatigue • Ensuring seamless integration with diverse EHR systems • Regulatory clearance for predictive diagnostic claims (SaMD Class IIb) • Patient adherence to continuous monitoring over long periods • Addressing digital literacy and access disparities for vulnerable populations 📋 Regulatory & Validation Likely SaMD Class IIb due to predictive diagnostic claims. Requires robust clinical validation, clear intended use, and demonstration of accuracy, reliability, and cybersecurity. Ethical considerations for algorithmic bias and data privacy are paramount.