FMRP-LEAN

FMRP-LEAN: HIPAA-compliant AI-augmented LIMS architecture for clinical assay workflow management

A preprint from arXiv introduces FMRP-LEAN, a Laboratory Information Management System (LIMS) architecture designed for HIPAA-compliant clinical biomarker workflows in translational research. The system combines a self-hosted Supabase/PostgreSQL stack, finite-state workflow modeling, REDCap synchronization, and a governance-constrained AI operations module that operates only on aggregate projections with deterministic fallback guarantees. The architecture targets multi-day assays like Luminex-based FMRP quantification, demonstrating improved workflow observability and reduced QC latency. It represents a deployment case study of constrained AI integration in regulated healthcare infrastructure.