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Deploy Ladill Care / deploy (push) Successful in 1m26s
Add a template-driven assessment system with universal intake, clinical pathways, disease instruments (stroke MVP + extended, diabetes, and ten specialty packs), scoring, patient outcome trends, REST/API + FHIR export, and Enterprise org-level assessment analytics. Seed packs and design/licensing docs ship for deploy and pre-GA review.
89 lines
4.5 KiB
Markdown
89 lines
4.5 KiB
Markdown
# Assessment instrument licensing review (pre-GA)
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**Status:** Working checklist for legal/clinical review before commercial GA packaging
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**Date:** 2026-07-16
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**Related:** `docs/layered-clinical-assessment-engine.md`, content packs under `database/data/assessments/`
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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.
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## Summary
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| Risk tier | Instruments | Guidance |
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|-----------|-------------|----------|
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| **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 |
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| **Public domain / widely free clinical tools** | NIHSS (NINDS/NIH origin) | Confirm training/certification requirements for clinical use; attribution in pack `meta.attribution` |
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| **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 |
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| **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 |
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## Pack-by-pack notes
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### Platform-authored (lower IP risk)
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- `universal_intake`, `outcome_core`, `stroke_clinical`, `stroke_swallow`, `diabetes_core`
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- `heart_failure_core`, `ckd_core`, `hypertension_core`, `asthma_core`, `cancer_core`, `pregnancy_core`, `orthopaedics_core`, `dementia_core` (except MMSE/MoCA entry)
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**Action:** Clinical validation by medical lead; no third-party license expected for checklist wording authored by Ladill.
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### NIH Stroke Scale (`nihss`)
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- Origin: NIH/NINDS public clinical tool
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- Pack includes item wording adapted for electronic capture
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- **Action:** Confirm local training; keep attribution; do not claim NIH endorsement
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### Modified Rankin Scale (`mrs`)
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- Widely used disability scale
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- **Action:** Verify electronic redistribution / commercial packaging rights with counsel before GA
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### Barthel Index (`barthel`)
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- ADL scale (Mahoney & Barthel lineage)
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- **Action:** Licensing review for commercial electronic forms
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### Glasgow Coma Scale (`gcs`)
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- Teasdale & Jennett
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- **Action:** Confirm any trademark/use restrictions for branded products; clinical use is standard
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### COPD pack (`copd_core`)
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- Includes **mMRC** scored item and free-entry **CAT** total (not full CAT questionnaire)
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- **Action:** Full CAT electronic form may require GSK/community licensing — current pack only stores a numeric CAT score
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### Parkinson's (`parkinsons_core`)
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- Hoehn & Yahr stages; optional **UPDRS total** as a number (not full UPDRS form)
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- **Action:** Full MDS-UPDRS electronic use requires MDS permission
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### Dementia (`dementia_core`)
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- Optional **MMSE** / **MoCA** numeric fields only
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- **Action:** Do not embed full MMSE/MoCA item banks without licenses; MoCA especially is restricted
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### Heart failure (`heart_failure_core`)
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- **NYHA** class as score_item
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- **Action:** NYHA is a functional classification; low typical IP risk; still document clinical source
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### Cancer (`cancer_core`)
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- **ECOG** performance status
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- **Action:** Standard oncology scale; confirm branding claims
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## Pre-GA checklist
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1. [ ] Medical lead signs off clinical appropriateness of each pack for target markets
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2. [ ] Counsel reviews packs marked “verify commercial rights” above
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3. [ ] Attribution strings in JSON `meta.attribution` remain accurate
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4. [ ] Marketing copy does **not** claim “certified NIHSS training” or endorsement by instrument owners without agreement
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5. [ ] For MoCA/MMSE/UPDRS/CAT: either obtain licenses for full forms or keep score-entry-only fields (current design)
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6. [ ] Facility BAAs/privacy policies cover export of assessments (including FHIR export)
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## Export & interoperability
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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.
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## Contact
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Escalate open license questions to product + legal before enabling assessments engine by default for all production orgs.
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