EU AI Act: Build Audit-Ready AI Competence and Clinical Surveillance Beyond Compliance

The EU AI Act’s Articles 4 and 72 require radiology to shift from legal compliance to an audit-capable AI literacy framework and a pharmacovigilance-like culture of continuous local drift detection, subgroup audits, public reporting, and shutdown criteria.

• Opinion paper outlines operational shifts for Article 4 (AI competence) and Article 72 (post-market surveillance) in radiology (no empirical data).
• Proposes radiologists be trained to detect failure modes in models deployed on their own population, not just recite known pitfalls.
• Argues the frontier of clinical AI is the distinction between documentary compliance and a genuine surveillance culture; no validation provided.

RadPigeon summaries are original and for information only. They are not clinical advice.