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.
4.5 KiB
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_coreheart_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
- Medical lead signs off clinical appropriateness of each pack for target markets
- Counsel reviews packs marked “verify commercial rights” above
- Attribution strings in JSON
meta.attributionremain accurate - Marketing copy does not claim “certified NIHSS training” or endorsement by instrument owners without agreement
- For MoCA/MMSE/UPDRS/CAT: either obtain licenses for full forms or keep score-entry-only fields (current design)
- 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.