Skills › Scientific Agent Skills › clinical-decision-support › artifact_intended_use_template.json
artifact_intended_use_template.json
81 lines · skills/clinical-decision-support/assets/artifact_intended_use_template.json at 5f2bc03
1{
2 "schema_version": "1.0",
3 "artifact": {
4 "id": "REPLACE_WITH_ARTIFACT_ID",
5 "title": "Research Evaluation Artifact",
6 "type": "model_biomarker_evaluation",
7 "version": "0.1-draft",
8 "status": "draft",
9 "owner": "REPLACE_WITH_GOVERNANCE_OWNER_ROLE",
10 "date": "YYYY-MM-DD",
11 "change_summary": "Initial research-only draft."
12 },
13 "intended_use": {
14 "purpose": "Document an aggregate research evaluation and its limitations.",
15 "intended_users": [
16 "research methodologist",
17 "governance reviewer"
18 ],
19 "population_scope": "aggregate_or_synthetic_only",
20 "decision_role": "research_evaluation_governance_only",
21 "boundary_statement": "Not for patient care or live clinical use."
22 },
23 "prohibited_uses": [
24 "No patient-specific output.",
25 "No diagnosis or prognosis for a person.",
26 "No treatment recommendation, treatment selection, or care plan.",
27 "No dosing or medication instruction.",
28 "No triage or urgency assignment.",
29 "No autonomous decision.",
30 "No alarm or alert.",
31 "No bedside or point-of-care use.",
32 "No live clinical use or deployment.",
33 "No claim of regulatory compliance, authorization, or approval.",
34 "No claim of HIPAA compliance or de-identification."
35 ],
36 "data_governance": {
37 "data_level": "synthetic",
38 "phi_supplied": false,
39 "raw_rows_supplied": false,
40 "provenance": "Synthetic aggregate template; replace with approved aggregate provenance.",
41 "data_cut_date": "YYYY-MM-DD",
42 "disclosure_policy": "Organization-approved policy; minimum cell size and complementary suppression selected before release."
43 },
44 "limitations": [
45 "Aggregate summaries cannot support person-level inference.",
46 "External validity depends on the evaluated population and setting.",
47 "Passing structural checks does not establish clinical validity, utility, safety, fairness, authorization, or compliance."
48 ],
49 "human_review": {
50 "required": true,
51 "roles": [
52 "methodologist",
53 "domain expert",
54 "privacy or governance reviewer"
55 ],
56 "completed": false,
57 "approval_boundary": "Release requires documented approval by the accountable organization; no approval permits patient-care use."
58 },
59 "validation": {
60 "external_validation": "REPLACE_WITH_STATUS_AND_EVIDENCE",
61 "calibration": "REPLACE_WITH_STATUS_AND_EVIDENCE",
62 "subgroup_fairness": "REPLACE_WITH_STATUS_AND_EVIDENCE",
63 "uncertainty": "REPLACE_WITH_INTERVAL_METHOD_AND_LIMITATIONS",
64 "human_factors": "REPLACE_WITH_STATUS; live clinical evaluation is outside this skill."
65 },
66 "lifecycle": {
67 "monitoring_plan": "Define aggregate performance, calibration, subgroup, drift, incident, and review cadence.",
68 "change_control": "Record version, rationale, validation, approval, and rollback for every change.",
69 "audit_plan": "Retain sources, data/code versions, commands, reviewers, decisions, and unresolved issues without sensitive data.",
70 "retirement_criteria": "Define evidence, performance, safety, governance, or obsolescence triggers."
71 },
72 "compliance_claims": false,
73 "sources": [
74 {
75 "id": "SRC-001",
76 "citation": "REPLACE_WITH_FULL_AUTHORITATIVE_CITATION",
77 "url": "REPLACE_WITH_CANONICAL_URL",
78 "accessed": "YYYY-MM-DD"
79 }
80 ]
81}