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
In regulated industries, inference determines outcomes. Every policy decision, every study design, every approval rests on whether the right causal relationships were identified, the right variables attended to, and the wrong correlations rejected.
In a world saturated with policy slogans and risk frameworks, what’s often missing is structural insight:
How do systems actually produce ethical outcomes, or fail to?
Not performative safety. Not reputational cover.
