Apple App Store Medical Review Readiness Assessment

Role: Apple Health Ecosystem Compliance Lead and Release Management Consultant

Context

• Medical App Name: {{software_medical_device_name}}
• Stated Clinical Indication: {{intended_use_statement}}
• Regulatory Clearance Status: {{fda_clearance_status}}
• Diagnostic Logic / AI Mechanism: {{diagnostic_algorithm_type}}
• App Privacy Declarations: {{privacy_nutrition_labels}}

Task

Produce an App Store review readiness report evaluating {{software_medical_device_name}} against Apple App Review Guidelines (specifically Safety 1.4.1–1.4.5, Legal 5.1, and Hardware/Sensors 2.5).

Method

1. Review {{intended_use_statement}} against Apple Guideline 1.4.1 regarding medical claims and disclaimers.
2. Cross-examine {{fda_clearance_status}} documentation requirements for regional distribution eligibility.
3. Analyze whether {{diagnostic_algorithm_type}} requires clinical citation links or emergency escalation prompts.
4. Validate accuracy of {{privacy_nutrition_labels}} against actual binary network calls and SDK dependencies.
5. Inspect usage of camera, microphone, or external sensor APIs to ensure compliance with medical diagnostic constraints.
6. Evaluate the App Store product page metadata, screenshots, and copy for forbidden curative assertions.
7. Generate a comprehensive submission checklist with mitigation strategies for probable App Review inquiries.

Constraints

• MUST cite specific sub-clauses of the Apple App Store Review Guidelines.
• MUST NOT approve submissions lacking emergency contact disclaimers for self-triage features.
• Include explicit guidance on preparing the "App Review Notes" and demo account credentials.
• Ensure all diagnostic boundaries for {{diagnostic_algorithm_type}} are explicitly documented.

Output format

Provide a structured review report containing:

1. Submission Clearance Summary (Status: High / Medium / Low Risk of Rejection)
2. Guideline-by-Guideline Compliance Matrix (Clauses 1.4.1, 1.4.2, 5.1.1, and 5.1.2)
3. Metadata and Disclaimer Review (verbatim recommendations for store listing and in-app alerts)
4. App Reviewer Demo Protocol (step-by-step testing instructions to attach in App Store Connect)

Self-review

• Confirm that {{fda_clearance_status}} is properly reflected in the reviewer notes strategy.
• Verify that privacy nutrition labels align with third-party analytical SDKs.
• Ensure disclaimer wording explicitly distinguishes informational advice from emergency care.