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.
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.
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.
ID: app-store-policy-compliance.content-restrictions.health-claims
Severity: high
What to look for: Count all relevant instances and enumerate each. Search all UI copy, screen strings, marketing metadata, and AI-generated response templates for health and medical claims. Specifically look for: (1) Diagnostic language — strings containing "diagnose", "diagnosis", "detects [disease]", "identifies [condition]", "you have", "you may have", "test for [condition]" in non-informational contexts; (2) Treatment claims — "treats", "cures", "heals", "eliminates [symptom]", "proven to reduce", "clinically proven", "FDA approved" without citing a specific, verifiable approval; (3) Wellness over-claims — "improves mental health", "reduces anxiety", "boosts immunity" used as definitive statements rather than informational goals; (4) Medical advice substitution — screens that present personalized health recommendations as medical advice rather than general information. Also check whether the app's App Store category or description uses medical terminology that implies regulatory clearance the app does not have. Apple guideline 5.1.3 (Health and Fitness) and Google Play Health apps policy require that medical claims be substantiated.
Pass criteria: Health content is framed as general wellness information, not medical advice. At least 1 implementation must be verified. Diagnostic or treatment claims are either absent or accompanied by a verifiable regulatory clearance citation (FDA 510(k) number, CE mark). Disclaimers are present ("This app is not a substitute for professional medical advice").
Fail criteria: App makes diagnostic claims without regulatory clearance; treatment claims are unsubstantiated; "clinically proven" or "FDA approved" language used without a cited, verifiable approval; no disclaimer present despite health-oriented content.
Skip (N/A) when: App has no health or medical content whatsoever — it is not a wellness, fitness, nutrition, mental health, or medical app, and contains no health-related copy.
Detail on fail: "src/screens/SymptomChecker.tsx displays 'Based on your symptoms, you may have [condition]' — this is a diagnostic claim without regulatory clearance" or "App description claims 'clinically proven to reduce stress' with no cited study or FDA clearance"
Remediation: Unsubstantiated health claims are a top reason Apple rejects health and wellness apps.
Review the configuration in src/ or app/ directory for implementation patterns.