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IEC 62304 Draft: Software Requirements Specification

Document Control

  • Product: Onset iOS
  • Version baseline: 1.2.6 (build 1)
  • Status: Draft for FDA workstream kickoff

1. System Context

Onset provides wellness routine organization and tracking. Adaptive/AI behavior exists behind feature flags and is disabled in the current App Store release profile.

2. Safety/Regulatory Boundary Requirements

  • SR-001 The app shall expose a wellness-only operating profile when all FDA-gated flags are OFF.
  • SR-002 The app shall not present adaptive guidance copy when advisoryCopy is OFF.
  • SR-003 The app shall not alter generated daily routine from Daily Journal input when adaptiveProtocol is OFF.
  • SR-004 The app shall not present lab interpretation when labInterpretation is OFF.
  • SR-005 The app shall provide explicit user-facing medical disclaimer content.

3. Functional Requirements (Wellness Profile)

  • FR-101 Users shall log Daily Journal values (sleep, energy, mood, soreness, optional sex-specific fields).
  • FR-102 Users shall save and update Daily Journal entries without adaptive recommendation output.
  • FR-103 Users shall view Trends as raw charts and averages for journal/adherence/health series.
  • FR-104 Users shall manage routine items and completion state by time block.
  • FR-105 Users shall receive neutral routine reminders and inventory-low notifications.

4. Functional Requirements (FDA-Gated Adaptive Profile)

  • FR-201 Adaptive routine mutation shall execute only when adaptiveProtocol is true.
  • FR-202 AI summary/generator surfaces shall execute only when aiInsights is true and user cloud consent is active.
  • FR-203 Advisory interaction surfaces shall execute only when advisoryCopy is true.
  • FR-204 Lab interpretation logic shall execute only when labInterpretation is true.

5. Non-Functional Requirements

  • NFR-301 Build shall pass with all FDA-gated flags OFF.
  • NFR-302 No known flagged language remains in Swift user-facing copy for release branch.
  • NFR-303 Version/build numbers shall remain synchronized across app and extensions.
  • NFR-304 Core data operations (journal save, completion save, notifications) shall remain functional with adaptive profile disabled.

6. Risk Control Requirements

  • RC-401 Feature flags must be documented in reviewer notes for each submission.
  • RC-402 Any change to FDA-gated defaults requires approval from regulatory owner.
  • RC-403 Release checklist shall include grep and UI review for prohibited adaptive phrasing.

7. Traceability Seeds

This SRS maps to initial verification items in: - docs/fda/IEC_62304_VERIFICATION_TRACEABILITY.md