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ladill-care/docs/assessment-instrument-licensing.md
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Assessment instrument licensing review (pre-GA)

Status: Working checklist for legal/clinical review before commercial GA packaging
Date: 2026-07-16
Related: docs/layered-clinical-assessment-engine.md, content packs under database/data/assessments/

This document lists third-party and platform-authored instruments shipped as Care content packs. Shipping code and seed data does not replace a formal legal review for redistribution, branding, or clinical product claims in your jurisdiction.

Summary

Risk tier Instruments Guidance
Platform-authored universal_intake, stroke_swallow, stroke_clinical, diabetes_core, outcome_core, disease “_core” packs (HF, CKD, HTN, asthma, dementia, cancer, pregnancy, orthopaedics) Own checklist content; still not a substitute for local clinical governance
Public domain / widely free clinical tools NIHSS (NINDS/NIH origin) Confirm training/certification requirements for clinical use; attribution in pack meta.attribution
Standard scales — verify commercial rights mRS, Barthel, GCS, CAT (if used), mMRC, MMSE, MoCA, UPDRS, Hoehn & Yahr, NYHA, ECOG Legal review before selling packs as a branded clinical product; some require licenses for electronic redistribution
Names only / user-entered scores MoCA/MMSE/UPDRS fields in dementia/PD packs are score entry fields, not full electronic instruments Prefer facility-owned paper/electronic licensed tools; Care stores the numeric result

Pack-by-pack notes

Platform-authored (lower IP risk)

  • universal_intake, outcome_core, stroke_clinical, stroke_swallow, diabetes_core
  • heart_failure_core, ckd_core, hypertension_core, asthma_core, cancer_core, pregnancy_core, orthopaedics_core, dementia_core (except MMSE/MoCA entry)

Action: Clinical validation by medical lead; no third-party license expected for checklist wording authored by Ladill.

NIH Stroke Scale (nihss)

  • Origin: NIH/NINDS public clinical tool
  • Pack includes item wording adapted for electronic capture
  • Action: Confirm local training; keep attribution; do not claim NIH endorsement

Modified Rankin Scale (mrs)

  • Widely used disability scale
  • Action: Verify electronic redistribution / commercial packaging rights with counsel before GA

Barthel Index (barthel)

  • ADL scale (Mahoney & Barthel lineage)
  • Action: Licensing review for commercial electronic forms

Glasgow Coma Scale (gcs)

  • Teasdale & Jennett
  • Action: Confirm any trademark/use restrictions for branded products; clinical use is standard

COPD pack (copd_core)

  • Includes mMRC scored item and free-entry CAT total (not full CAT questionnaire)
  • Action: Full CAT electronic form may require GSK/community licensing — current pack only stores a numeric CAT score

Parkinson's (parkinsons_core)

  • Hoehn & Yahr stages; optional UPDRS total as a number (not full UPDRS form)
  • Action: Full MDS-UPDRS electronic use requires MDS permission

Dementia (dementia_core)

  • Optional MMSE / MoCA numeric fields only
  • Action: Do not embed full MMSE/MoCA item banks without licenses; MoCA especially is restricted

Heart failure (heart_failure_core)

  • NYHA class as score_item
  • Action: NYHA is a functional classification; low typical IP risk; still document clinical source

Cancer (cancer_core)

  • ECOG performance status
  • Action: Standard oncology scale; confirm branding claims

Pre-GA checklist

  1. Medical lead signs off clinical appropriateness of each pack for target markets
  2. Counsel reviews packs marked “verify commercial rights” above
  3. Attribution strings in JSON meta.attribution remain accurate
  4. Marketing copy does not claim “certified NIHSS training” or endorsement by instrument owners without agreement
  5. For MoCA/MMSE/UPDRS/CAT: either obtain licenses for full forms or keep score-entry-only fields (current design)
  6. Facility BAAs/privacy policies cover export of assessments (including FHIR export)

Export & interoperability

FHIR R4 export (FhirAssessmentExporter) emits Questionnaire + QuestionnaireResponse for interchange. It does not grant rights to redistribute third-party scale text outside Care; recipients remain responsible for their own compliance.

Contact

Escalate open license questions to product + legal before enabling assessments engine by default for all production orgs.