EU AI Act Readiness for Clinical AI
3
AI Systems Governed
4 months
Compliance Timeline
2
New Partnerships
47
Risk Categories Mapped
THE CHALLENGE
A mid-size pharmaceutical company had deployed AI-assisted clinical decision support across three therapeutic areas. With the EU AI Act classifying healthcare AI as high-risk and penalties reaching €35 million or 7% of annual turnover, they faced a compliance cliff with no governance framework in place. Two prospective hospital partnerships were contingent on demonstrable AI governance.
OUR APPROACH
CENDRYON deployed the AI Governance Vault methodology. We inventoried all AI systems and classified them against the EU AI Act's four-tier risk framework. For each high-risk system, we designed human oversight protocols for clinical recommendations, established data provenance chains from training data to patient-facing outputs, conducted bias audits across all 47 risk categories, and built continuous monitoring for model drift.
THE OUTCOME
All three AI systems achieved EU AI Act compliance two months before the audit deadline. The governance framework — covering fairness, transparency, accountability, privacy, and security — became a competitive differentiator, accelerating partnerships with two major hospital networks that required vendor compliance certification.
Similar challenge?
Book a free consultation to discuss how we can help.