AgenticSaMD：確定論的ガードレール、有界エージェント推論、Class C最高安全基準医療ソフトウェア

AgenticSaMDは、自律エージェント型医療機器ソフトウェア（SaMD）向けのエンジニアリングアーキテクチャと規制ガードレールを策定し、マルチエージェント臨床推論、適正機械学習プラクティス（GMLP）、FDA市販前申請およびEU MDR準拠の決定論的臨床安全インターロックを統合します。

AgenticSaMD Multi-Agent Orchestration & Clinical Guardrail Architecture

Clinical reasoning supervisor, deterministic safety interlock, and automated EHR decision loop

Central System: Clinical Agent Supervisor - GMLP Safety Interlock Core

Clinical IoMT Nodes

  • Diagnostic Reasoning Agent
  • Contraindication Validator
  • Clinical Guideline Arbiter
  • Human-in-the-Loop Gate
  • Audit Trail Notarizer

Architectural Layers & Regulatory Standards

  • Multi-Agent Clinical Reasoning Plane (CoT Agentic Swarms / Specialized Diagnostic Sub-Agents): Distributing clinical analysis across specialized sub-agents: radiology, pathology, pharmacology, and patient history.
  • Deterministic Clinical Guardrails (Rule-Based Deterministic Safety Interlocks): Vetoing agent recommendations that violate established clinical dosage, contraindication, or allergy boundaries.
  • Physician-in-the-Loop Attestation (Clinician Attestation & Structured Override UI): Requiring board-certified physician sign-off before committing high-stakes diagnostic or therapeutic recommendations.
  • Continuous Real-World Vigilance (Automated Drift Telemetry & Adverse Event Tracing): Monitoring agent diagnostic concordance and logging reasoning steps for post-market surveillance.

Key Metrics: Class C (IEC 62304 Safety Tier) | 100% (Deterministic Guardrail Veto) | < 450 ms (Multi-Agent Consensus Time) | Zero Hallucination (Clinical Grounding Margin)

自律型エージェンティックソフトウェア医療機器、マルチエージェント臨床意思決定支援とFDA GMLPガードレール

Authoritative technical engineering reference for autonomous agentic software as a medical device, multi-agent clinical decision support & fda gmlp guardrails 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

Related Cluster Architecture Specifications