Get the weekly research letter
Companies change their terms quietly. We read every version and catch what actually changed. One email a week on the changes that matter and what they mean. No account.
Medical apps making accuracy claims for health measurements must disclose their data and methodology to support those claims; apps claiming to perform clinical measurements using only device sensors without validated methodology are not permitted, and apps with regulatory clearance must submit that documentation during review.
This analysis describes what Apple's agreement states, permits, or reserves. It does not constitute a legal determination about enforceability. Regulatory applicability and practical outcomes may vary by jurisdiction, enforcement context, and individual circumstances. Read our methodology
This provision establishes specific accuracy disclosure and methodology validation requirements for medical apps, and requires submission of FDA or equivalent international regulatory clearance documentation, creating a direct interaction between App Review and medical device regulatory status.
The updated guidelines state that developers must ensure kids receive age-appropriate experiences within their apps and must remove user-generated content that violates the guidelines, terms of service, or community standards. Under the revised policy, if Apple identifies policy-violating content, the developer will be asked to remove it and provide a compliance improvement plan. Based on the developer's response, the app may be removed from the App Store until compliance is demonstrated. This establishes a formal escalation pathway where developer inaction or inadequate remediation can result in app suspension or removal.
View change record →Under this provision, medical apps available on the App Store are required to support their health measurement accuracy claims with disclosed methodology, and apps claiming clinical measurement capabilities without validated methodology will not be distributed, which affects the types of health-related functionality consumers may encounter in App Store apps.
Cross-platform context
See how other platforms handle Medical App Accuracy and Regulatory Clearance Requirements and similar clauses.
Compare across platforms →Monitoring
Apple has changed this document before.
Receive same-day alerts, structured change summaries, and monitoring for up to 20 platforms.
"Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny. Apps must clearly disclose data and methodology to support accuracy claims relating to health measurements, and if the level of accuracy or methodology cannot be validated, we will reject your app. For example, apps that claim to take x-rays, measure blood pressure, body temperature, blood glucose levels, or blood oxygen levels using only the sensors on the device are not permitted. Apps should remind users to check with a doctor in addition to using the app and before making medical decisions. If your medical app has received regulatory clearance, please submit a link to that documentation with your app.Excerpt from Apple's App Store Review Guidelines
1) REGULATORY LANDSCAPE: This provision directly interacts with FDA oversight of software as a medical device (SaMD) under the Federal Food, Drug, and Cosmetic Act and FDA's Digital Health Center of Excellence guidance. International counterparts including the EU Medical Device Regulation, Health Canada, and the TGA in Australia regulate equivalent categories. The requirement to submit regulatory clearance documentation links App Store approval to regulatory status, though App Store approval does not constitute or substitute for FDA clearance. HHS OCR is not directly engaged unless health data handling under HIPAA is involved. 2) GOVERNANCE EXPOSURE: High for developers in the medical and health measurement category. The provision restricts specific sensor-based health measurement claims, creates a methodology disclosure obligation, and requires regulatory clearance documentation for cleared devices. Non-compliance results in app rejection. Developers marketing health measurement features that approach the line between wellness and medical device functionality face heightened scrutiny. 3) JURISDICTION FLAGS: FDA jurisdiction applies to US-distributed medical apps. EU MDR applies to EU-distributed apps meeting the medical device definition. Developers distributing in multiple markets must assess regulatory clearance requirements in each jurisdiction and ensure that the documentation submitted to Apple covers the relevant regulatory territories. Australia TGA and Health Canada requirements create additional compliance layers for those markets. 4) CONTRACT AND VENDOR IMPLICATIONS: Developers using third-party health measurement SDKs or algorithms should obtain representations from those vendors regarding regulatory clearance status and methodology documentation. If a third-party SDK's accuracy claims are unsupported, the developer bears the App Review rejection risk. Regulatory counsel should be engaged for apps that measure physiological parameters using device sensors. 5) COMPLIANCE CONSIDERATIONS: Legal and compliance teams should assess whether health measurement features in their app meet the threshold for SaMD classification under FDA guidance, and if so, ensure appropriate 510(k) clearance or De Novo authorization is obtained and documented. Apps reminding users to consult a doctor should include this disclosure in a prominent, user-facing location within the app flow. Methodology disclosure requirements should be addressed in app metadata and in-app disclosures rather than solely in App Review notes.
Regulatory citations, enforcement risk, and due diligence action items.
Provision-level monitoring, governance timelines, and regulatory mapping built from archived source documents and historical version tracking.
This provision establishes specific accuracy disclosure and methodology validation requirements for medical apps, and requires submission of FDA or equivalent international regulatory clearance documentation, creating a direct interaction between App Review and medical device regulatory status.
Under this provision, medical apps available on the App Store are required to support their health measurement accuracy claims with disclosed methodology, and apps claiming clinical measurement capabilities without validated methodology will not be distributed, which affects the types of health-related functionality consumers may encounter in App Store apps.
No. ConductAtlas is an independent monitoring service. We are not affiliated with, endorsed by, or sponsored by Apple.