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Lacuna Health

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Healthcare & Health Services Data, Analytics & Artificial Intelligence

About

Lacuna Health is a Franklin, TN diagnostic-safety company. Its Diagnostic Intelligence engine flags clinically significant absent actions — information already present in the patient record that generated no documented clinical response — and surfaces them for clinician review after the encounter closes, with the full basis attached. Every existing tool in the clinical stack fires on something present: a result, an alert, a finding. Lacuna fires on what's absent — the action that should have followed and didn't — across the entire care team, not just the physician.


The problem is large and structurally unmeasured: diagnostic error kills or permanently disables 795,000 Americans every year (BMJ Quality & Safety, 2024), and that number is the floor. Three separate ICU analyses spanning tens of thousands of critical-care records, all under peer review, found the absence signal associated with more than double the odds of the adverse outcomes studied.


The business model is licensing — the Dolby model. Lacuna doesn't sell software; it licenses the patent-pending capability to health-IT platforms that embed it in tools providers already run, to risk-bearing organizations deploying it across the populations they manage, and to payers and medical-malpractice carriers as a de-identified risk signal. Designed and operated as non-device clinical decision support under the 21st Century Cures Act and FDA's 2026 CDS guidance. 

Additional Info

  • Lacuna Health is a healthcare diagnostic safety company

  • Patent pending — non-provisional under USPTO expedited examination

  • Three separate ICU studies spanning tens of thousands of critical-care records, all under peer review — absence signal associated with more than double the odds of the adverse outcomes studied

  • 795,000 Americans killed or permanently disabled annually by diagnostic error (BMJ Quality & Safety, 2024) — the floor, not the ceiling

  • Non-device clinical decision support under the 21st Century Cures Act and FDA's 2026 CDS guidance
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