Ksb D13 K0049

• CPA-06, CPA-07

Regulatory References

• General PV competency

Instructions

When this skill is activated, Claude should:

1. Demonstrate L4 proficiency in regional ai regulatory variations
2. Apply analyze level cognitive skills to analyze the topic
3. Reference relevant regulatory guidance (general PV standards)
4. Connect to related EPAs: EPA-18, EPA-19

Key Competencies

• Comprehensive understanding of regional variations in AI regulatory requirements including FDA AI/ML guidance, EMA AI reflection paper, PMDA AI considerations, Health Canada AI approaches, and MHRA AI framework differences.

Assessment Criteria

• Can analyze core concepts independently
• Demonstrates understanding of regulatory context
• Applies knowledge appropriately to PV scenarios

Related Skills

• Other D13 skills in Regional AI Requirements
• Cross-domain integrations per DAG architecture

Generated from PV KSB Framework v1.0 | 2025-12-31