AI Governance — Central Coast Perfusion LLC

Why existing HIPAA compliance infrastructure does not address AI-specific risk in cardiac surgery environments

HIPAA was written for data storage and transmission — not for algorithmic decision support at the point of care
AI tools deployed in cardiac surgery may process protected health information without triggering traditional HIPAA review pathways
Clinical AI in perfusion can alter care decisions without constituting a medical device under current FDA guidance
Hospital compliance officers typically lack the clinical context to identify AI exposure in operative environments
Institutional liability begins the moment an AI-assisted decision is made without a documented governance policy in place

A structured classification system for AI risk in cardiac surgery

Tier 1 — Informational AI: Tools that aggregate or summarize clinical data without generating actionable outputs.
Tier 2 — Decision Support AI: Tools that generate recommendations or alerts used by clinicians in real-time operative decisions.
Tier 3 — Autonomous AI: Tools with feedback loop capacity or the ability to modify parameters without direct clinician instruction. Highest risk category.
Cardiac surgery environments are disproportionately represented in Tier 2 and 3 categories
Risk classification should be conducted prior to any AI tool deployment and reviewed annually

Scalable governance solutions for hospital systems and cardiac surgery programs

Full framework licensing for health systems seeking to establish AI governance policy across cardiac surgery and perfusion departments
Customizable policy templates compatible with existing institutional compliance structures
On-site or remote consultation available for governance committee development and staff education
Volume licensing available for residency programs, ECMO centers, and multi-site hospital systems

Identify your institution's AI exposure before a compliance review does it for you.

The governance framework hospitals need before a regulator asks why they don't have one.