Executive Summary
A mid-sized organization deployed a data security platform with an AI-powered chatbot interface to manage sensitive data controls. The team relied on the chatbot to configure critical security policies. For months,
Your AI system is deployed. Or you're about to deploy it. The technical team says it works. Compliance approved the documentation. Leadership is expecting results.
And something feels off.
Maybe stakeholders
You're evaluating AI tools. The demos are impressive. The sales engineers are confident. The case studies are compelling. The pricing seems reasonable.
And you're about to buy something that
Your governance documentation looks comprehensive. You have policies, procedures, risk assessments, validation protocols. Your internal stakeholders signed off. Legal reviewed it. Compliance approved it.
And it will still fail external audit.
This isn&
When regulators first encountered biotechnology, nanomedicine, and digital health, they adapted existing frameworks. Drugs, devices, and diagnostics each had long histories of oversight, so new technologies were folded into those categories with incremental
