面向联网医疗设备与 SaMD 集群的高合规混合云基础设施体系

SaMDInfra 实现跨多云及混合云环境的自动化医疗合规管控，确保所有患者高灵敏度生理遥测数据均采用军工级高强度加密持久化存储，并具备全流程不可篡改的数学级审计确定性。

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)

面向任务关键遥测的高可用云架构

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