Assess whether the system is high-risk under the EU AI Act (4ec401)

SITUATION Privacy counsel supporting AI inventory is responsible for the system is high-risk in a pharma company using LLMs on trial documents, using EU AI Act high-risk classification worksheet as the only working extract. A business unit that already went live without a risk tier is what reset the timeline for this AI Governance Policy and Oversight file.

DECISION Privacy counsel supporting AI inventory in a pharma company using LLMs on trial documents must choose Policy or governance breach / Model defect / Dual failure / Hold for the missing fact using EU AI Act high-risk classification worksheet after a business unit that already went live without a risk tier.

HYPOTHESES TO TEST 1. Privacy counsel supporting AI inventory can defend Policy or governance breach from EU AI Act high-risk classification worksheet after a business unit that already went live without a risk tier in a AI Governance challenge. 2. Privacy counsel supporting AI inventory cannot defend Policy or governance breach from EU AI Act high-risk classification worksheet; Model defect is what the extract actually supports after a business unit that already went live without a risk tier. 3. A business unit that already went live without a risk tier never reached the population in EU AI Act high-risk classification worksheet — reopen intake, do not close the system is high-risk. 4. Two facts in EU AI Act high-risk classification worksheet after a business unit that already went live without a risk tier conflict for privacy counsel supporting AI inventory; hold this Policy and Oversight file.

ANALYSIS REQUIRED 1. Check intended purpose and inventory status against EU AI Act / exam-readiness language after a business unit that already went live without a risk tier. 2. Map the approved-use case to the system the system is high-risk would bind. 3. Check intended purpose and inventory status against EU AI Act / exam-readiness language after a business unit that already went live without a risk tier. 4. For this AI Governance Policy and Oversight file, read EU AI Act high-risk classification worksheet against a business unit that already went live without a risk tier and write the one fact that would move the system is high-risk for privacy counsel supporting AI inventory.

RECOMMENDATION Choose Policy or governance breach / Model defect / Dual failure / Hold for the missing fact on this AI Governance / Policy and Oversight packet (EU AI Act high-risk classification worksheet after a business unit that already went live without a risk tier). The follow-on Policy and Oversight action is what privacy counsel supporting AI inventory does next: implement the option, assign an owner, and log the missing fact.