{ "schema_version": "1.0", "artifact": { "id": "REPLACE_WITH_ARTIFACT_ID", "title": "Research Evaluation Artifact", "type": "model_biomarker_evaluation", "version": "0.1-draft", "status": "draft", "owner": "REPLACE_WITH_GOVERNANCE_OWNER_ROLE", "date": "YYYY-MM-DD", "change_summary": "Initial research-only draft." }, "intended_use": { "purpose": "Document an aggregate research evaluation and its limitations.", "intended_users": [ "research methodologist", "governance reviewer" ], "population_scope": "aggregate_or_synthetic_only", "decision_role": "research_evaluation_governance_only", "boundary_statement": "Not for patient care or live clinical use." }, "prohibited_uses": [ "No patient-specific output.", "No diagnosis or prognosis for a person.", "No treatment recommendation, treatment selection, or care plan.", "No dosing or medication instruction.", "No triage or urgency assignment.", "No autonomous decision.", "No alarm or alert.", "No bedside or point-of-care use.", "No live clinical use or deployment.", "No claim of regulatory compliance, authorization, or approval.", "No claim of HIPAA compliance or de-identification." ], "data_governance": { "data_level": "synthetic", "phi_supplied": false, "raw_rows_supplied": false, "provenance": "Synthetic aggregate template; replace with approved aggregate provenance.", "data_cut_date": "YYYY-MM-DD", "disclosure_policy": "Organization-approved policy; minimum cell size and complementary suppression selected before release." }, "limitations": [ "Aggregate summaries cannot support person-level inference.", "External validity depends on the evaluated population and setting.", "Passing structural checks does not establish clinical validity, utility, safety, fairness, authorization, or compliance." ], "human_review": { "required": true, "roles": [ "methodologist", "domain expert", "privacy or governance reviewer" ], "completed": false, "approval_boundary": "Release requires documented approval by the accountable organization; no approval permits patient-care use." }, "validation": { "external_validation": "REPLACE_WITH_STATUS_AND_EVIDENCE", "calibration": "REPLACE_WITH_STATUS_AND_EVIDENCE", "subgroup_fairness": "REPLACE_WITH_STATUS_AND_EVIDENCE", "uncertainty": "REPLACE_WITH_INTERVAL_METHOD_AND_LIMITATIONS", "human_factors": "REPLACE_WITH_STATUS; live clinical evaluation is outside this skill." }, "lifecycle": { "monitoring_plan": "Define aggregate performance, calibration, subgroup, drift, incident, and review cadence.", "change_control": "Record version, rationale, validation, approval, and rollback for every change.", "audit_plan": "Retain sources, data/code versions, commands, reviewers, decisions, and unresolved issues without sensitive data.", "retirement_criteria": "Define evidence, performance, safety, governance, or obsolescence triggers." }, "compliance_claims": false, "sources": [ { "id": "SRC-001", "citation": "REPLACE_WITH_FULL_AUTHORITATIVE_CITATION", "url": "REPLACE_WITH_CANONICAL_URL", "accessed": "YYYY-MM-DD" } ] }