고신뢰성 IoMT 인프라 및 자율 감시 체계로 스마트 환자 치료 안전망 구축

HealthVigilance는 침상 옆 다중 매개변수 생체 신호 수집, 마이크로 세그멘테이션 병원 보안 경계 및 정형 검증 파이프라인을 통합하여 임상 사이버 위협과 규제 미준수 위험을 원천 차단합니다.

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)

제로트러스트 생체신호 수집 및 규제 시판후 감시

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

Technical Articles

Related Cluster Architecture Specifications