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This mixed-methods study evaluated the performance of consumer-grade versus clinical-grade IoMT devices for chronic disease management in 50 patients within Costa Rica's public healthcare system. Consumer wearables showed significantly lower sensitivity (43%) for cardiac event detection compared to clinical-grade devices (92%) and poorer integration with electronic health records. The study also identified cost implications associated with false positives from consumer devices and patient overestimation of their diagnostic capabilities.
Consumer-grade IoMT devices demonstrate significantly lower diagnostic accuracy and interoperability compared to clinical-grade devices in a LMIC public healthcare system, challenging assumptions about their universal applicability.
The Internet of Medical Things (IoMT) holds promise for chronic disease management, yet evidence from low- and middle-income countries (LMICs) remains scarce, limiting equitable digital health policy development. No previous studies have clinically validated IoMT device performance against electronic health records (EHRs) within Central American public healthcare systems, leaving assumptions about consumer device adequacy untested in resource-constrained settings. This mixed-methods study evaluated IoMT implementation in Costa Rica's Caja Costarricense de Seguro Social (CCSS) system, examining (1) diagnostic accuracy stratification between consumer and clinical-grade devices, (2) healthcare system interoperability challenges, and (3) cost implications of false alerts. Among 50 chronic disease patients, consumer wearables demonstrated 43% sensitivity for cardiac event detection versus 92% for clinical-grade devices (p<0.001). Only 25% of consumer devices integrated with CCSS EHRs versus 100% of clinical-grade devices, requiring 22 minutes of manual data entry per encounter. False positives occurred in 12% of consumer-device alerts, costing an average of $35 per event. Qualitative analysis revealed that 45% of participants overestimated consumer-device diagnostic capabilities. These findings challenge assumptions about universal consumer-technology applicability in LMICs and support tiered implementation frameworks. As Costa Rica prepares for its Digital Health Act 2025, evidence-based device categorization, interoperability investments, and patient education are essential for equitable IoMT integration.
