연결형 의료기기 플릿을 위한 규제 등급 하이브리드 클라우드 인프라

SaMDInfra는 멀티 클라우드 환경에서 규제 준수를 자동화하여 환자 원격 측정 데이터가 군사 등급의 암호화로 저장되고 수학적 확실성으로 감사되도록 보장합니다.

SaMDInfra Hybrid Cloud Security Architecture

Zero-Trust Clinical Infrastructure and Cryptographic Audit Ledger

Central System: HIPAA Cloud Orchestrator - Regulatory Kubernetes Engine

Clinical IoMT Nodes

  • Dedicated HSM Vault
  • FHIR Data Lake
  • Immutable Audit Trail
  • Disaster Recovery Link
  • Zero-Trust Boundary

Architectural Layers & Regulatory Standards

  • Dedicated Cryptographic HSM Vault (PKCS#11 / FIPS 140-3 Level 3 Dedicated Hardware): FIPS 140-3 Level 3 hardware security modules managing master encryption keys and certificate authorities.
  • Zero-Trust Container Orchestration (Kubernetes / gVisor Sandboxed Runtime / Cilium eBPF): Hardened Kubernetes nodes running immutable container images with gVisor sandbox isolation.
  • FHIR Analytical Data Lake (Apache Iceberg / FHIR R4 Parquet / AES-XTS-256): Columnar Parquet and Iceberg storage for petabyte-scale longitudinal clinical analytics with automated masking.
  • Immutable 21 CFR Part 11 Audit Trail (WORM Storage / Merkle Tree Cryptographic Ledger): Append-only cryptographic hash chains ensuring every operator access and algorithm output is non-repudiable.

Key Metrics: 99.999% (Cloud Clinical Uptime SLA) | AES-256 (Data-at-Rest & In-Transit Encryption) | Zero PHI Leak (Data Loss Prevention Benchmark) | 21 CFR Part 11 (Audit Trail Compliance Standard)

미션크리티컬 텔레메트리를 위한 고가용성 클라우드 아키텍처

Deploying medical software into standard public clouds exposes developers to catastrophic regulatory penalties if unencrypted PHI leaks. SaMDInfra provides pre-qualified Kubernetes clusters with hardened cryptographic policies and continuous security compliance verification.

Core Engineering Areas

Technical Articles