SaMDPlatform: Enclaves FHIR Multi-Tenant, HIPAA/HITECH e Arquitetura HITRUST

A SaMDPlatform fornece modelos de infraestrutura nativa da nuvem, enclaves de dados FHIR multilocatários e proteções de conformidade pré-configuradas e certificadas pelas normas HITRUST CSF, HIPAA/HITECH e ISO 27001, permitindo que empresas de saúde digital implantem aplicativos SaMD em escala global.

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)

Arquitetura de Plataforma SaMD Nativa da Nuvem, Enclaves de Dados FHIR Multi-Inquilino, Certificação HIPAA/HITECH e HITRUST CSF

Referência técnica de engenharia autoritativa para cloud-native samd platform architecture, multi-tenant fhir data enclaves, hipaa/hitech & hitrust csf certification em submissões FDA 510(k)/PMA, EU MDR, ciclo de vida IEC 62304 Classe C, ISO 13485 e interoperabilidade IoMT com segurança zero-trust.

Core Engineering Areas

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