SaMDPlatform: 多租户 FHIR 隔离保护区、HIPAA/HITECH 与 HITRUST 高合规架构

SaMDPlatform 提供云原生医疗基础设施蓝图、多租户 HL7 FHIR 数据隔离飞地以及经过 HITRUST CSF、HIPAA/HITECH 和 ISO 27001 权威认证的预置合规护栏，赋能数字医疗创新企业在全球范围内安全快速部署 SaMD 临床级应用。

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)

云原生SaMD平台架构、多租户FHIR数据飞地、HIPAA/HITECH与HITRUST CSF认证

深入剖析 FDA 510(k)/PMA 申报、EU MDR、IEC 62304 C级软件生命周期及 IoMT 零信任互操作架构中的Cloud-Native SaMD Platform Architecture, Multi-Tenant FHIR Data Enclaves, HIPAA/HITECH & HITRUST CSF Certification关键工程实践。

Core Engineering Areas

Technical Articles