OPP003 📄 Overview An intelligent SaMD platform designed to significantly improve medication adherence and promote sustainable healthy lifestyle changes. It leverages smart IoT devices (e.g., smart pill bottles, smart inhalers, ingestible sensors for medication confirmation), biometric wearables, and an AI-driven mobile application. The system provides personalized, gamified challenges and rewards, adaptive nudges based on real-time behavioral and physiological data, and proactive alerts for missed doses or deviations from lifestyle plans. It provides data insights to patients and their care teams. Key technologies: 👤 Target users: 👍 Benefits Significantly improved medication adherence rates • Better treatment outcomes and reduced disease progression • Decreased healthcare costs associated with non-adherence • Enhanced patient self-efficacy and engagement in their health journey Use bullets or new lines. 👎 Challenges Integration with existing EHRs and pharmacy systems • Ensuring accuracy and reliability of sensor data (e.g., ingestible sensors) • Preventing user fatigue and maintaining long-term engagement • Cost of hardware and accessibility for diverse populations 📋 Regulatory & Validation Likely Class I or II SaMD depending on the claims made (e.g., purely adherence tracking vs. dose adjustment recommendations). • Data privacy and security for highly sensitive adherence data are critical. • Usability and human factors engineering are important for ensuring safe and effective use.