Last reviewed: 2026-07-23
Sources support provenance; they do not authorize the agent to make a clinical decision. A current source may still be inapplicable to a specific person, setting, product, formulation, route, indication, jurisdiction, or institution.
Only an authorized licensed professional may:
The package stores the professional's verified decision and source locator. It does not reproduce a recommendation from the source.
FDA's human prescription-drug labeling resources distinguish FDA-approved labeling from other "current" or "in use" labeling. FDA states that Drugs@FDA contains the most recent CDER-approved Prescribing Information and patient labeling for covered products, while other databases may include company-submitted changes under review.
For an already selected medication, the authorized clinician or pharmacist must verify, as applicable:
This skill records fact IDs and verification. It must not search for a product while processing real-patient content, interpret sections, compare alternatives, or decide dosing, contraindications, interactions, monitoring, or eligibility.
FDA-approved patient labeling includes Medication Guides, Patient Package Inserts, and Instructions for Use. FDA notes that not every prescription drug has FDA-approved patient labeling and that consumer medication information developed outside the applicant is not reviewed or approved by FDA.
Do not:
Record only which current material the authorized clinician or pharmacist verified and where it is held in the local system.
REMS are product-specific safety programs. FDA explains that participant roles, communications, required activities, certifications, enrollment, monitoring, and safe-use conditions vary by medication. Current requirements and materials are maintained in REMS@FDA.
The package may document:
The skill must not decide whether a REMS applies, enroll anyone, certify a prescriber or site, interpret a safe-use condition, or determine whether prescribing or dispensing may proceed.
WHO transition guidance supports process concepts such as:
Joint Commission materials similarly emphasize reliable identification, handoff communication, and continuity. Use these sources only to structure documentation and local governance.
Do not copy proprietary standards, claim accreditation compliance, or convert process guidance into patient-specific content. The current institution policy controls.
CMS publishes person-centered care concepts and program-specific documentation requirements. Requirements vary by program, provider type, setting, state, contract, and date.
Do not treat a CMS innovation concept, job aid, measure, billing rule, or conditions-of-participation excerpt as a universal treatment-plan requirement.
Before recording a CMS requirement, the authorized compliance owner must identify:
The skill does not support coding, billing-level selection, medical-necessity decisions, or reimbursement claims.
The responsible clinician must use:
This repository intentionally contains no disease-specific treatment recommendations or specialty schedules. Do not add them to templates, tests, examples, or references.
The package records local routes; it does not submit reports.
Potential routes may include:
Never decide reportability, causality, seriousness, legal duty, deadline, recipient, or content. Never transmit patient data from a bundled script.
At each authorized revision:
The dated ledger in source_ledger.md documents the process sources used to design this skill. It is not a substitute for current case-specific review.