Guideline 1.4.1 - Safety - Physical Harm Your app connects to external medical hardware to provide medical services. However, to be compliant with App Store Review Guideline 1.4.1, you must: Provide documentation from the appropriate regulatory organization demonstrating regulatory clearance for the medical hardware used by your app Provide documentation of a report or peer-reviewed study that demonstrates your app’s use of medical hardware works as described Restrict the salable storefronts you select in App Store Connect to the regions where you have obtained regulatory clearance for the medical hardware used by your app. Otherwise, you must provide a jurisdiction statement in your app description declaring where the medical hardware has regulatory clearance to be used. I have faced same issue. your app is approved by app store team?