No misleading health or medical claims — diagnostic or treatment claims require regulatory proof
Why it matters
Apple guideline 5.1.3 and Google Play's Health Apps policy, reinforced by FTC health claims regulations, prohibit unsubstantiated diagnostic and treatment claims — 'clinically proven to reduce anxiety' or 'detects your condition' require verifiable regulatory clearance (FDA 510(k), CE mark) that the vast majority of wellness apps do not have. Beyond rejection, the FTC actively pursues health claim enforcement actions against app developers, with civil penalties in the millions. A missing disclaimer on a health screen also creates tort liability if a user delays seeking medical care based on the app's output.
Severity rationale
High because unsubstantiated health claims trigger Apple rejection plus FTC enforcement exposure, and the absence of a medical disclaimer creates independent tort liability if users rely on the app's output for clinical decisions.
Remediation
Replace all diagnostic and treatment language with informational framing, and add a disclaimer to every screen that presents health content:
// src/components/HealthDisclaimer.tsx
export function HealthDisclaimer() {
return (
<Text style={styles.disclaimer}>
This app provides general wellness information only and is not a
substitute for professional medical advice, diagnosis, or treatment.
</Text>
);
}
Search and replace specific language: "you may have" → "you may want to discuss with your doctor", "clinically proven" → remove unless a specific FDA clearance number is cited inline. If the app makes a clinical claim, engage a regulatory attorney before resubmitting — there is no copy-edit workaround for claims that require a regulatory clearance.
DetectionPro
The detection method for this pattern is part of AuditBuffet Pro.
The full method (what to look for, pass and fail conditions, and how results get reported) ships inside the App Store Policy & Content Compliance Audit. The pattern definition, severity rationale, and remediation remain openly licensed under CC-BY-4.0.
External references
- external · apple-guideline-5.1.3 — App Store Review Guidelines 5.1.3 — Health and Fitness
- external · google-play-health-apps — Google Play Health Apps Policy
- external · ftc-health-claims — FTC Guidance on Health and Wellness Claims
Taxons
History
- 2026-04-18·v1.0.0·Initial import from app-store-policy-compliance·automated