Defendiendo la Atención Conectada al Paciente con IoMT de Alta Seguridad y Vigilancia Autónoma

HealthVigilance integra ingesta multiparamétrica de bioseñales a la cabecera del paciente, perímetros hospitalarios microsegmentados y flujos de verificación formal para eliminar ciberamenazas clínicas y discrepancias regulatorias.

HealthVigilance Clinical IoMT Architecture

End-to-End Biosignal Ingestion, SaMD Logic, and Regulatory Surveillance

Central System: Clinical Vigilance Core - IEC 62304 / Zero-Trust Engine

Clinical IoMT Nodes

Multi-Lead Biosensors
FHIR R4 Gateway
SaMD Inference Core
Adverse Event Engine
EHR Interconnect

Architectural Layers & Regulatory Standards

Physical Biosignal Acquisition (IEEE 11073-10406 / BLE 5.3 Medical Coded PHY): Continuous telemetry from multi-lead ECG, PPG, and SpO2 sensors with hardware root-of-trust authentication.
Transport & Cryptographic Boundary (HL7 FHIR Release 4 / mTLS RFC 8446 / DICOMweb): Mutual TLS microsegmentation and FHIR REST JSON-LD data streaming across hospital boundaries.
SaMD Algorithmic Execution (IEC 62304 Class C / ISO 14971 Risk Engine): Deterministic bedside inference, arrhythmia detection, and hemodynamics modeling verified under IEC 62304 Class C.
Continuous Post-Market Vigilance (FDA 21 CFR Part 803 / EU MDR Article 87 EUDAMED): Automated anomaly ingestion, drift detection, and electronic FDA 21 CFR 803 / EU MDR adverse event dispatch.

Key Metrics: < 5 ms (Bedside Telemetry Jitter) | 99.999% (High-Assurance Uptime) | Class C (IEC 62304 Software Safety Level) | Zero-Trust (Hospital Boundary Security Model)

Ingesta de Bioseñales Zero-Trust y Vigilancia Regulatoria Postcomercialización

Modern healthcare infrastructure is vulnerable to ransomware and unvalidated SaMD logic. HealthVigilance establishes cryptographic integrity across the entire patient data continuum, pairing IEEE 11073 device profiles with automated FDA 21 CFR 803 incident reporting.

Core Engineering Areas

Clinical Risk Management (ISO 14971) — Systematic methodologies for identifying biological, software, and cybersecurity hazards in connected healthcare systems.
Zero-Trust IoMT Perimeter Security — Isolating life-critical infusion pumps, telemetry patches, and patient monitors behind identity-aware zero-trust proxies.
Post-Market Device Vigilance (FDA MDR) — Real-time algorithmic ingestion of device malfunction telemetries to dispatch compliant MedWatch and EUDAMED regulatory submissions.

Technical Articles

Related Cluster Architecture Specifications

AgenticSaMD — Autonomous Agentic Software as a Medical Device, Multi-Agent Clinical Decision Support & FDA GMLP Guardrails
AITelemonitoring — Autonomous AI Telemonitoring, Virtual Nursing Assistants & Predictive Clinical Deterioration Scoring
BCI2IoMT — Brain-Computer Interface IoMT Gateways, Neural Decoding & Electrophysiological Streaming
BCIIoMT — Implantable Brain-Computer Interfaces, Inductive Telemetry & Chronic Neuromodulation Safety