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Healthcare AI

The IRB Exemption Pressure-Test: 3 Questions for AI Governance Teams

A Mayo Clinic whistleblower suit alleges an AI study bypassed IRB review — but the real story is structural: who holds exemption authority, and what happens when staff disagree. Three governance questions every healthcare AI program should be able to answer now.

Prior authorization accountability gap: complete teal wireframe column beside an unresolved grey structure on deep navy.

Healthcare compliance

H.R. 9396 Prior Authorization Accountability Act: Disclosure Without Accuracy Verification

H.R. 9396 would require health plans to publish PA denial rates, appeal outcomes, and AI decision metrics starting 2027 — but contains no attestation, audit, or accuracy framework. Here's what compliance teams need to watch before rulemaking closes.

AI synthesizing healthcare data into decision pathways within regulatory boundaries, shown as abstract signal flows and governance grids on a dark intelligence backdrop.

Healthcare AI

Healthcare AI Is Entering a Regulatory Gray Zone Without Formal Reclassification

Healthcare AI platforms are increasingly synthesizing and interpreting patient data over time while remaining outside formal clinical regulation, creating a gray zone where evidentiary and governance expectations are still undefined.