Clinical Decision-Support Research and Evaluation

Hard Safety Boundary

This skill produces research, evaluation, documentation, and governance artifacts only.

Never use it to:

• diagnose or classify a person;
• recommend, select, sequence, start, stop, or modify treatment;
• calculate or communicate a patient-specific dose;
• triage, prioritize, alarm, alert, or determine urgency;
• make or automate a patient-specific clinical decision;
• support bedside, point-of-care, or live clinical operation;
• replace professional judgment or a validated, authorized clinical system;
• claim FDA authorization, regulatory conformity, HIPAA compliance, or legal compliance.

If a request could affect care for a person, stop the workflow and route the matter to a licensed healthcare professional using locally validated and appropriately authorized systems. Do not redirect to another skill for patient-specific care.

In Scope

• Intended-use and limitation statements for research artifacts
• Aggregate cohort table shells with disclosure controls
• Statistical analysis plans and survival-analysis plan review
• Aggregate model or biomarker performance evaluation
• Transparent GRADE evidence-profile checklists
• Evidence-source and decision-logic traceability
• De-identification process checklists
• Fairness, subgroup, calibration, uncertainty, external-validation, monitoring, change-control, audit, and human-factors documentation

Outputs remain drafts until qualified humans approve them. Reporting guidance improves transparency; it does not establish study quality, clinical utility, safety, effectiveness, authorization, or compliance.

Data Gate

Before any script: