EMA issues initial guidance for AI Act compliance in clinical trials, highlighting data governance and model transparency.
The Story
Industry reports indicate significant unpreparedness among pharma SMEs for the August 2026 enforcement.
Why It Matters
This isn't just paperwork; it means *your* AI tools, even a Copilot plugin, must prove data security and explainability. Sending trial data to non-EU servers for AI processing is now a clear liability. Generic pharma and CROs need audited, local-first AI or risk hefty fines by August 2026. This is the new cost of doing business.
What To Do About It
I can perform a rapid compliance audit of your current AI use cases (or planned ones) against the EMA's guidance and outline a concrete, local-first implementation roadmap, leveraging your existing Microsoft 365 investment.
Sources
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