# 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.
