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Onset Scope Split: Wellness vs FDA-Gated

Purpose

Define a controlled product boundary between: - a wellness-only App Store release profile, and - an FDA-gated adaptive profile that remains disabled until clearance.

Wellness-Only (Current App Store Profile)

These features are enabled and supported as general wellness software: - Routine timeline organization by time block - Daily Journal logging (self-reported values) - Intake completion tracking and streaks - Trends charts (raw data and averages only) - Supplement reference information - Inventory reminders and low-stock notifications - Optional Apple Health read-only trend display

Required flag state in Onset/Core/FeatureFlags.swift: - adaptiveProtocol = false - aiInsights = false - advisoryCopy = false - checkInFeedback = false - labInterpretation = false - protocolScoring = false - lifeEventModifiers = false

FDA-Gated Adaptive Profile (Future, Not for Store Submission)

These capabilities are preserved in code but disabled for current release: - Adaptive routine mutation based on Daily Journal and context - AI-generated personalized guidance surfaces - Lab interpretation and lab-driven routine adjustments - Advisory interaction copy and contextual coaching - Protocol scoring and life-event-driven adaptation

Technical Control Strategy

  1. Compile-time constants as release guardrail
  2. FDA-gated flags are hard-coded to false in repository default.
  3. UI and engine dual-gating
  4. Logic blocks and UI surfaces both require the same flag.
  5. Reviewer reproducibility
  6. App Review notes include explicit flag matrix and click paths.
  7. Change control
  8. Any flag change requires regulatory sign-off and documented validation run.

Verification Checklist

  • xcodebuild release/simulator build passes with all FDA-gated flags OFF.
  • Interaction/advisory cards do not render when advisoryCopy is false.
  • Daily Journal submit flow saves entry only and does not claim adaptation.
  • Trends screen contains charts/averages only, with no interpretive recommendations.

Ownership

  • Product/Regulatory: defines intended-use boundary and claims.
  • Engineering: enforces technical gates and evidence of disabled adaptive behavior.
  • QA: executes release gate checklist before each submission.