SaMDPlatform：マルチテナントFHIR保護区、HIPAA/HITECH＆HITRUSTアーキテクチャ

SaMDPlatformは、クラウドネイティブインフラ設計図、マルチテナントFHIRデータエンクレーブ、HITRUST CSF、HIPAA/HITECH、ISO 27001認定の事前設定済みコンプライアンスガードレールを提供し、SaMDの世界展開を支援します。

SaMDPlatform Cloud Architecture & Multi-Tenant Enclave Topology

Confidential computing enclaves, HL7 FHIR datastore, and zero-trust IAM boundaries

Central System: SaMD Cloud Platform Core - HITRUST Certified Enclave

Clinical IoMT Nodes

  • Zero-Trust Ingress
  • Multi-Tenant FHIR Core
  • Confidential Compute Node
  • Audit & Lineage Engine
  • EHR Integration Mesh

Architectural Layers & Regulatory Standards

  • Confidential Cloud Compute Layer (Hardware Memory Encryption (AMD SEV / Intel TDX)): Isolating patient health data and proprietary clinical algorithms in encrypted memory enclaves.
  • Clinical Data Storage Plane (HL7 FHIR v5.0 PostgreSQL / Encrypted S3): Managing standardized patient resources (Observation, DiagnosticReport, CarePlan) with row-level security.
  • Identity & Access Governance (OIDC / OAuth 2.0 with Fine-Grained Attribute Access (ABAC)): Enforcing role-based access control (RBAC/ABAC) ensuring clinicians access only assigned patients.
  • Security & Regulatory Compliance (HITRUST CSF v11 / HIPAA Security Rule Automation): Continuous compliance monitoring enforcing 100% encryption, key rotation, and audit retention.

Key Metrics: HITRUST CSF (Certified Security Standard) | 100% (Encrypted at Rest & in Transit) | < 25 ms (FHIR RESTful Query Latency) | HIPAA / GDPR (Dual Privacy Conformance)

クラウドネイティブSaMDプラットフォームアーキテクチャ、マルチテナントFHIRデータエンクレーブ、HIPAA/HITECHとHITRUST CSF認証

Authoritative technical engineering reference for cloud-native samd platform architecture, multi-tenant fhir data enclaves, hipaa/hitech & hitrust csf certification in FDA Premarket submissions, EU MDR, IEC 62304 Class C software lifecycle, ISO 13485 quality systems, and IoMT zero-trust interoperability.

Core Engineering Areas

Technical Articles