# Authoritative Source Ledger

Research and access date: **2026-07-23**

Method: targeted `parallel-cli search` restricted to official domains, followed by `parallel-cli extract` for canonical pages and documents. No research output files were retained in the repository.

This ledger supports the skill's documentation and governance design. It is not a clinical evidence review and must not be used to select treatment.

## Privacy and data governance

### HHS OCR — HIPAA de-identification guidance

- URL: https://www.hhs.gov/hipaa/for-professionals/special-topics/de-identification/index.html
- Page date observed: **2026-03-20**
- Used for: the distinction between Expert Determination and Safe Harbor; required documentation for Expert Determination; Safe Harbor's actual-knowledge condition; risks in free text and clinical narratives.
- Boundary: the bundled checklist performs neither method and never claims de-identification or HIPAA compliance.

### HHS OCR — Minimum Necessary Requirement

- URL: https://www.hhs.gov/hipaa/for-professionals/privacy/guidance/minimum-necessary-requirement/index.html
- Page date observed: **2026-03-18**
- Used for: reasonable limitation of uses, disclosures, and requests; role-based policies; routine/non-routine procedures; listed exceptions including treatment-purpose disclosures and requests.
- Boundary: the skill does not decide whether an exception applies and adopts data minimization as a conservative process safeguard.

### HHS OCR — Breach Notification

- URL: https://www.hhs.gov/hipaa/for-professionals/breach-notification/index.html
- Portal: https://ocrportal.hhs.gov/ocr/breach/breach_report.jsf
- Accessed: **2026-07-23**
- Used for: identifying the official privacy-incident reporting authority and preserving a local reporting route.
- Boundary: the skill does not determine breach status, legal duty, deadline, or report content and does not submit reports.

## FDA labeling and medication-risk programs

### FDA — Human prescription-drug labeling resources

- URL: https://www.fda.gov/drugs/laws-acts-and-rules/fdas-labeling-resources-human-prescription-drugs
- Content-current date observed: **2026-03-15**
- Used for: distinguishing FDA-approved labeling in Drugs@FDA from other current/in-use labeling; identifying official labeling and safety-change databases.
- Boundary: an authorized clinician or pharmacist verifies exact product applicability. The skill never interprets labeling or derives a patient-specific action.

### FDA — Patient labeling resources

- URL: https://www.fda.gov/drugs/fdas-labeling-resources-human-prescription-drugs/patient-labeling-resources
- Content-current date observed: **2024-08-19**
- Used for: distinctions among Medication Guides, Patient Package Inserts, Instructions for Use, and non-FDA-reviewed consumer medication information.
- Boundary: the skill does not create or paraphrase product instructions.

### FDA — What's in a REMS?

- URL: https://www.fda.gov/drugs/risk-evaluation-and-mitigation-strategies-rems/whats-rems
- Content-current date shown by FDA: **2018-01-26**
- Used for: product-specific participant roles, communications, required activities, certifications, enrollment, monitoring, and safe-use conditions.
- Currency control: current programs and materials must be checked in REMS@FDA.
- Boundary: the skill does not decide applicability or whether prescribing, dispensing, or administration may proceed.

### FDA — REMS@FDA

- URL: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
- Accessed: **2026-07-23**
- Used for: authoritative current REMS program and material locators.
- Boundary: no automated lookup occurs while processing patient data.

## Medication safety and care transitions

### WHO — Transitions of Care

- URL: https://www.who.int/docs/default-source/patient-safety/9789241511599-eng.pdf?sfvrsn=a577528_2
- Publication date observed: **2016-09-19**
- Used for: process-level structure for accurate information transfer, medication reconciliation, patient/carer engagement, ownership, checklists, tracking, and local systems.
- Boundary: older global process guidance is not a current specialty treatment guideline; local institution policy and authorized clinicians control.

### Joint Commission — Right Patient, Right Care / handoff process

- URL: https://digitalassets.jointcommission.org/api/public/content/2361b813982a420cb9590bd363d9c3f1?v=994360b5
- Material reviewed: **2025 National Performance Goal content**
- Used for: high-level identification, handoff communication, critical-result communication, and continuity concepts.
- Boundary: no proprietary standard text is reproduced; the skill does not claim accreditation compliance.

## Shared decision-making and person-centered planning

### AHRQ — The SHARE Approach

- URL: https://www.ahrq.gov/health-literacy/professional-training/shared-decision/index.html
- Page review date observed: **2026**
- Used for: clinician-led dialogue about options, benefits, harms, risks, and what matters to the person.
- Boundary: the skill records a completed process; it does not conduct the conversation or generate options and risk estimates.

### AHRQ — Shared Decisionmaking strategy

- URL: https://www.ahrq.gov/cahps/quality-improvement/improvement-guide/6-strategies-for-improving/communication/strategy6i-shared-decisionmaking.html
- Accessed: **2026-07-23**
- Used for: balanced decision-aid principles and avoiding tools that steer toward one treatment.
- Boundary: no decision aid or patient-specific choice is generated.

### NICE NG197 — Shared decision making

- URL: https://www.nice.org.uk/guidance/ng197
- Published and last reviewed: **2021-06-17**
- Used for: documenting collaboration, risks, benefits, consequences, uncertainty, and organizational support.
- Boundary: NICE states the guideline excludes unexpected emergencies and does not replace professional judgment; local jurisdiction and policy control.

### CMS — Person-Centered Care

- URL: https://www.cms.gov/priorities/innovation/key-concepts/person-centered-care
- Page date observed: **2023-08-14**
- Used for: high-level goals, values, preferences, communication, coordination, and patient-reported outcomes concepts.
- Boundary: this is not treated as a universal documentation mandate. Program-specific CMS requirements are used only after applicability review.

## Reporting and safety governance

### FDA — Reporting Serious Problems to FDA / MedWatch

- URL: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
- Page date observed: **2026-06-05**
- Used for: identifying MedWatch as an official route for specified medical-product problems and distinguishing voluntary and mandatory reporting contexts.
- Boundary: local qualified personnel determine applicability and reporting obligations. The skill does not file a report.

### AHRQ PSO — Common Formats and NPSD

- URL: https://pso.ahrq.gov/common-formats
- Page last reviewed: **2026-01**
- Used for: identifying standardized patient-safety event formats and non-identifiable NPSD data within authorized PSO workflows.
- Boundary: the skill does not create a PSO submission or confer Patient Safety and Quality Improvement Act privilege/confidentiality.

## Deliberate exclusions

- No disease-specific, specialty-specific, dosing, treatment-sequencing, interaction, contraindication, tapering, prognosis, triage, or emergency-treatment source was embedded.
- No commercial point-of-care reference was treated as authoritative regulatory guidance.
- No CMS billing or care-plan rule was generalized beyond its exact program.
- No source in this ledger replaces current local institution policy or case-specific review by authorized licensed professionals.