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

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.