ClinicalSoftwareAI: Конформная оценка неопределенности, контрфактический аудит и одобренный FDA вывод

ClinicalSoftwareAI предоставляет инженерную инфраструктуру для создания, клинической сертификации и непрерывной актуализации алгоритмов машинного обучения в соответствии со стандартами FDA GMLP, Законом ЕС об ИИ и IEC 62304.

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)

Раскрытие потенциала адаптивного клинического ИИ без постоянных повторных подач

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