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Authoritative Source Ledger

skills/treatment-plans/references/source_ledger.md

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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

HHS OCR — Breach Notification

FDA labeling and medication-risk programs

FDA — Human prescription-drug labeling resources

FDA — Patient labeling resources

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

Medication safety and care transitions

WHO — Transitions of Care

Joint Commission — Right Patient, Right Care / handoff process

Shared decision-making and person-centered planning

AHRQ — The SHARE Approach

AHRQ — Shared Decisionmaking strategy

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

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.