JMIR Publications

ABSTRACT

Background:

Wearable biosensors, remote physiologic monitoring, and patient-generated digital data are increasingly visible in pediatric cardiology, but their clinical use remains uneven. Pediatric cardiology clinics need practical guidance on which data streams have been studied, what clinical decisions they can support, and what safety, workflow, validation, and equity barriers must be addressed before routine integration.

Objective:

To map the literature on wearable biosensors and patient-generated digital data in pediatric cardiology and congenital heart disease, with emphasis on clinical applications, implementation pathways, validation, safety, and evidence gaps.

Methods:

A scoping review protocol was developed using the Population-Concept-Context framework and PRISMA-ScR reporting principles. Publicly accessible PubMed/MEDLINE, PubMed Central, and web-indexed searches were performed on May 3, 2026, with citation chasing of key background sources. Eligible records involved children, adolescents, young adults, or congenital heart disease populations and evaluated wearable biosensors, remote monitoring, mobile health tools, patient- or family-generated health data, or clinician-facing integration of digital data into pediatric cardiology workflows.

Results:

Thirty-five unique candidate records were screened. Twenty-two primary or clinically extractable records were mapped, with 11 additional background or source-mining records. Evidence clustered into single-ventricle interstage/home monitoring; high-risk congenital heart disease mobile health programs; telemedicine-linked monitoring; digital stethoscopes; smartwatch/mobile electrocardiography; cardiac implantable electronic device remote monitoring; and advanced wearable biomarker validation. The strongest clinical integration evidence was found in interstage single-ventricle monitoring and pediatric rhythm evaluation. Across categories, studies emphasized feasibility and diagnostic or workflow utility more often than long-term outcome effects, cost-effectiveness, interoperability, privacy, or equity.

Conclusions:

Wearable biosensors and patient-generated digital data are most clinically actionable in pediatric cardiology when linked to a predefined clinical question, validated data stream, responsible reviewer, escalation threshold, and documentation pathway. Current evidence supports selective use in interstage congenital heart disease monitoring, arrhythmia capture, remote device surveillance, and telecardiology adjuncts, but routine broad deployment requires stronger pediatric validation, workflow design, safety standards, and equity-focused implementation research.