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SOFTWARE ENGINEERING

Healthcare AI Regulatory Submission Artifact and Audit Trail ER Diagram

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UPDATED 2026-09-20
TYPEErd
USE-CASEAi Sdlc Artifact Tracking
EXAMPLEHealthcare AI Regulatory Submission Artifact and Audit Trail ER Diagram
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CASE ANALYSIS

Scenario

A healthcare AI team needs to model how SDLC artifacts (model cards, data cards, evaluation reports) are tracked, linked to compliance requirements, audited, and included in regulatory submissions.

Key decisions

  • Introduced a SubmissionArtifact join table to support many-to-many between RegulatorySubmission and Artifact.
  • Separated AuditEvent and ComplianceCheck to distinguish continuous audit logging from one-time compliance verification.
  • Linked Artifact to Project, ArtifactType, and User to capture ownership, categorization, and creation context.

When to reuse this

Use this schema when building a regulated AI SDLC system that must maintain artifact provenance, demonstrate compliance, and produce regulatory submission records.

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