ClinicalSoftwareAI: 컨포멀 불확실성 추정, 반사실적 설명 감사 및 미국 FDA 인허가 기준 충족 임상 추론

ClinicalSoftwareAI는 FDA GMLP, EU AI 법 및 IEC 62304 표준을 준수하여 임상 머신러닝 알고리즘을 구축, 승인 획득 및 지속적으로 업데이트하는 데 필요한 엔지니어링 인프라를 제공합니다.

Clinical AI Governance Architecture

Continuous Drift Detection, PCCP Validation, and Explainability Gateway

Central System: Clinical AI Governance Core - FDA GMLP & Drift Engine

Clinical IoMT Nodes

  • Clinical Data Lineage Tracker
  • Distribution Drift Monitor
  • PCCP Performance Bounds Enforcer
  • Explainable Saliency Engine
  • EHR Clinical Decision Interface

Architectural Layers & Regulatory Standards

  • Clinical Data Provenance & Lineage (DVC (Data Version Control) / Merkle Provenance Hashes): Immutable tracking of clinical training datasets, demographic distributions, and data harmonization pipelines.
  • Real-Time Distribution Drift Detection (Kolmogorov-Smirnov Drift Test / Maximum Mean Discrepancy (MMD)): Continuous statistical evaluation of inbound hospital telemetry against training baselines detecting covariate and concept shift.
  • Predetermined Change Control Enforcer (PCCP Boundary Validator / Automated Regression Test Matrix): Automated verification that continuous weight updates stay within the pre-cleared sensitivity, specificity, and demographic parity boundaries.
  • Explainability & Human-in-the-Loop Gateway (Integrated Gradients / Grad-CAM++ / Expected Calibration Error (ECE)): Synthesizing pixel attribution maps, confidence calibration scores, and contraindication warnings for clinician review.

Key Metrics: 10 Principles (FDA/Health Canada GMLP Adherence) | < 1 Sec (Real-Time Drift Detection Window) | 100% (Traceable Training Data Lineage) | High Risk (EU AI Act Classification Readiness)

지속적인 재제출 없이 적응형 임상 AI 구현하기

Traditional medical software clearance freezes machine learning weights at regulatory submission. ClinicalSoftwareAI implements FDA Predetermined Change Control Plans (PCCP), enabling continuous retraining on real-world clinical datasets within strictly validated performance envelopes.

Core Engineering Areas

Technical Articles

Related Cluster Architecture Specifications