DTxSystem：閉ループ神経行動変容アルゴリズム、RCT臨床試験監査、ISO 13485完全適合

DTxSystemは、ソフトウェアコードと調剤・臨床薬学の架け橋となり、規制対象の医療アプリ向けに本人確認、医師処方箋ルーティング、クローズドループセンサフィードバック、リアルワールドエビデンス（RWE）パイプラインを提供します。

DTxSystem Prescription Delivery Architecture

EHR Prescription Routing, Activation Tokens, and Biometric Adherence

Central System: Prescription Authorization Core - EHR / Pharmacy Gateway

Clinical IoMT Nodes

  • EHR E-Prescribing Ingress (NCPDP)
  • Patient Identity & Token Vault
  • Prescription Delivery App Core
  • Wearable Sensor Adherence Loop
  • Payor Reimbursement & RWE Engine

Architectural Layers & Regulatory Standards

  • E-Prescription & Pharmacy Integration (NCPDP SCRIPT 2017071 / FHIR MedicationRequest Gateway): Ingestion of digital drug orders via NCPDP SCRIPT standards from Epic, Cerner, and national electronic health record hubs.
  • Identity Verification & Access Token Vault (OpenID Connect / NIST SP 800-63B IAL2 Identity Verification): Cryptographic patient authentication ensuring digital therapeutic software can only be activated by the prescribed individual.
  • Clinically Validated Delivery Engine (Adaptive Clinical Micro-Modules / Dynamic Gamification Enclave): Execution of cognitive behavioral therapy (CBT), motor rehabilitation protocols, or substance use disorder therapy modules.
  • Real-World Evidence & Payor Claims (ANSI 837P Healthcare Claim Generator / RWE Audit Pipeline): Continuous telemetry collection proving therapy engagement and physiological improvement to trigger insurer reimbursement claims.

Key Metrics: NCPDP (E-Prescribing Standard Adherence) | 89% (30-Day Patient Engagement Rate) | 100% (HIPAA / GDPR Data Confidentiality) | Class II (FDA Medical Device Classification)

規制対象デジタル治療の処方箋配信を標準化する

Unlike wellness apps, Prescription Digital Therapeutics require formal physician authorization, randomized controlled trial evidence, and strict pharmacy dispensing control. DTxSystem provides the full technical backbone for digital medicine delivery.

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications