AgenticSaMD: 确定性形式化安全护栏、有界智能体临床推理与 C 级最高风险医疗软件认证

AgenticSaMD 确立自主代理型医疗器械软件 (Agentic SaMD) 的系统工程架构与法规遵从安全护栏，深度融合多智能体临床医学推理、良好机器学习规范 (GMLP) 及美国 FDA 上市前审查与欧盟 MDR 框架下的确定性临床安全联锁机制。

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)

自主智能体软件作为医疗器械、多智能体临床决策支持与FDA GMLP护栏机制

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Autonomous Agentic Software as a Medical Device, Multi-Agent Clinical Decision Support & FDA GMLP Guardrails关键工程实践。

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications