コネクテッド医療機器フリートのための規制適合ハイブリッドクラウド基盤

SaMDInfraは、マルチクラウド環境における規制コンプライアンスを自動化し、患者のテレメトリデータが軍用グレードの暗号化で保存され、数学的確実性をもって監査されることを保証します。

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)

ミッションクリティカルなテレメトリのための高可用性クラウドアーキテクチャ

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