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FMRP-LEAN: A HIPAA-Compliant AI-Augmented LIMS Architecture for End-to-End Clinical Assay Workflow Optimization

Building a secure lab system that tracks patient samples and speeds up test results

Researchers created FMRP-LEAN, a laboratory management system that replaces spreadsheets and manual tracking with automated workflows that keep patient data private under HIPAA rules. The system cuts down delays in quality checks and gives lab staff, researchers, and clinicians a real-time view of where each patient sample is in the testing process.

Clinical labs running complex multi-day tests like the FMRP assay currently lose time and risk errors by juggling spreadsheets and disconnected systems. FMRP-LEAN solves this by automating the entire sample lifecycle while keeping all patient information locked within hospital infrastructure—meaning faster, more reliable test results without compromising privacy or regulatory compliance.