The missing layer: decision integrity as a verifiable assurance layer in interpretive clinical artificial intelligence.

OBJECTIVE

Interpretive clinical artificial intelligence (AI), in which a clinician interprets an image or signal and an AI system offers a competing or confirming read, is increasingly routine in radiology, pathology, dermatology, and endoscopy. Oversight of these systems assumes that independent human judgment occurred before AI influence entered the decision. The informatics infrastructure, meaning the electronic health record, its audit logs, and the reporting systems built on them, does not verify this.

DISCUSSION: We name the missing assurance layer decision integrity, situate it between cybersecurity verification and clinical quality review, and argue it is a measurement construct distinct from diagnostic accuracy. Drawing on the logic of preregistration, we propose a candidate architecture, a minimal six-event record under sequential disclosure, preserving tamper-evident evidence of pre-AI judgment, post-AI revision, and rationale.

CONCLUSION

The architecture is a candidate for evaluation, not a validated standard; its purpose is to make clinician independence auditable rather than assumed.