[Regulatory/Claims] Maintain the general-purpose non-medical product scope

[KeyffMS]

Decision

SightAdapt is permanently maintained as general-purpose accessibility and display-personalization software, not software intended for a medical purpose. No external medical-device classification audit is required or planned because medical positioning, clinical claims and regulated workflows are excluded from the project scope.

This is an internal product and claims decision. It does not claim regulatory approval or professional classification.

Acceptance criteria

• Define intended users, environment, function and exclusions.
• Record the general-purpose, non-medical product position.
• Review repository, About, release, website/store and support wording against that position.
• Prohibit diagnosis, treatment, therapy, prevention, monitoring and clinical-effectiveness claims.
• Define approved non-medical wording.
• Control terminology such as correction, assistive, compensation, patient, therapy and named conditions.
• Apply the same rule to screenshots, testimonials, categories and metadata.
• Define out-of-scope medical features and claims that must not be merged or marketed.
• Require a maintainer claims review when external content or product behavior changes.
• Remove external classification-audit requirements from the project plan.

Maintained boundary

Medical targeting, clinical workflows, patient-specific analysis, health measurements, treatment recommendations, medical-device integrations and clinical-effectiveness claims are outside SightAdapt's current scope.

Re-review triggers

Reopen this decision only if maintainers explicitly propose replacing the general-purpose scope with a separate regulated-product plan.

Implementation

• PR Define intended purpose and control medical claims #132 established the intended-purpose and claims policy.
• PR Replace external audit gates with maintainer risk decisions #139 made the non-medical scope permanent and removed the external-audit dependency.

[KeyffMS]

Wynik audytu uzupełniającego — 2026-07-30

Ocena: polityka repozytorium jest kompletna dla obecnego non-medical alpha, ale kontrola rzeczywistych powierzchni zewnętrznych jest niepełna; ponownie otwarte.

Repozytorium zawiera poprawne intended purpose, zakazane claims i triggery ponownego przeglądu. Brakuje trwałego dowodu, że finalna strona internetowa, listing store/directory, screenshoty, metadata, testimonials i materiały wsparcia zostały sprawdzone w dokładnie opublikowanej wersji.

Pozostałe prace

• wprowadzić wersjonowany rejestr przeglądu zewnętrznych powierzchni zawierający URL, datę, wersję treści, screenshoty/checksumy i osobę zatwierdzającą;
• powiązać publikację strony/store description z zatwierdzonym intended-purpose record;
• blokować lub oznaczać do ponownego przeglądu zmianę kategorii, metadata lub treści tworzącą potencjalny medical purpose;
• uzyskać profesjonalną ocenę przed jakimkolwiek targetowaniem rozpoznanych schorzeń lub claims medycznymi.

Issue może zostać zamknięte po udokumentowaniu kontroli faktycznie publikowanych materiałów, nie tylko zasad repozytorium.

[KeyffMS]

Triage priority — P2

Reason: the repository intended-purpose policy is coherent for the current general-purpose alpha, but the actual website, store listing, screenshots, metadata and external support copy are not preserved as versioned reviewed evidence.

Close only when:

• every published external surface is inventoried and versioned;
• rendered text, categories, metadata and screenshots are reviewed against the approved intended purpose;
• the review record identifies date, product version, materials and reviewer;
• the professional-assessment trigger remains enforceable for medical targeting or claims.

Escalation: immediately move to P0 before using a named condition, patient/clinical workflow, medical category or clinical-effectiveness claim.