Safety and Scope

Intended Use

Use this skill only to create or check research, evaluation, documentation, and governance artifacts from synthetic or aggregate data.

Acceptable examples:

• an intended-use statement for a retrospective model evaluation;
• an aggregate subgroup performance report;
• a statistical analysis plan;
• a GRADE evidence-profile shell for a human panel;
• a release-gate traceability matrix;
• a de-identification process checklist.

Prohibited Use

Do not:

• accept or produce a record about a person;
• infer a diagnosis, prognosis, phenotype, biomarker class, or eligibility for a person;
• recommend or compare care options for a person;
• provide medication, dose, schedule, monitoring, or contraindication instructions;
• triage, assign urgency, create an alarm, or suggest escalation;
• deploy logic in an EHR, bedside tool, portal, order set, or alerting workflow;
• represent output as clinical advice, a validated medical device, or an authorized clinical system;
• claim legal, regulatory, quality-system, or HIPAA compliance.

No disclaimer makes an otherwise prohibited workflow acceptable.

Stop Conditions

Stop and do not process the input when any of the following is present:

• names, record numbers, contact details, precise locations, or person-linked dates;
• row-level records, timelines, notes, images, signals, or sequences;
• a request about “this patient,” “this result,” or an individual case;
• instructions to choose a therapy, test, dose, disposition, or urgency;
• instructions to push output to a live clinical system;
• an assertion that passing a checklist proves authorization or compliance.

Explain the boundary briefly. For care, direct the requester to a licensed healthcare professional and locally validated, appropriately authorized systems. For privacy, regulatory, or legal determinations, direct them to qualified organizational reviewers.

Required Intended-Use Elements

An artifact is incomplete unless it states:

1. Purpose — the specific research or governance question.
2. Users — named roles, not “clinicians” broadly.
3. Population scope — aggregate cohort or synthetic data only.
4. Decision role — descriptive, evaluative, or governance support.
5. Excluded uses — every prohibited use above.
6. Data level — aggregate or synthetic, with no PHI/raw rows supplied.
7. Limitations — known gaps, assumptions, transportability, and failure modes.
8. Human review — required roles and approval status.
9. Versioning — owner, version, release date, changes, and retirement criteria.
10. Monitoring — drift, calibration, subgroup performance, incidents, and review cadence when applicable.

Human Review Matrix

Artifact	Minimum review roles
Evidence profile	systematic-review methodologist; domain experts; panel chair
Cohort report	statistician/epidemiologist; data steward; domain expert
Survival plan	statistician with time-to-event expertise; domain expert
Model/biomarker evaluation	prediction-model methodologist; assay/domain expert; fairness reviewer
Privacy checklist	privacy official or qualified de-identification expert
Logic traceability	system owner; independent validator; governance approver
Regulatory context	qualified legal/regulatory counsel

Review completion must be recorded by the responsible organization. The scripts do not authenticate reviewers or approvals.

Safe Language

Prefer:

• “The aggregate evaluation estimated…”
• “Performance differed across evaluated subgroups; causes and practical importance require review.”
• “The evidence panel judged certainty as…; rationale and sources are recorded.”
• “This checklist is complete; it is not a compliance determination.”
• “External validation has not been performed.”

Avoid:

• “The model is safe/fair/clinically valid.”
• “This biomarker means the patient should…”
• “The tool is FDA compliant/approved.”
• “The dataset is HIPAA compliant.”
• “The recommendation is Grade 1A” without the framework, panel process, outcome-specific judgments, and source trail.

Audit Trail

Record:

• immutable artifact ID and version;
• source versions and access dates;
• data provenance and cut date;
• code version and command;
• declared thresholds before analysis;
• reviewer roles, dates, decisions, and unresolved objections;
• change reason, validation evidence, rollback plan, and retirement decision.

Do not put secrets, credentials, or patient information in audit logs.