App Rejected for Diabetes Risk Assessment – Asked for Regulatory Approval in Every Country

Hi everyone,

I’m looking for guidance from developers who have dealt with App Review for health-related apps.

I have an app that presents users with a questionnaire using images and multiple-choice answers. Based on the responses, the app categorizes the user into a general diabetes risk category.

A few important points about the app:

  • The app does NOT provide a diagnosis.
  • The app clearly states that it is informational/advisory only.
  • We added disclaimers throughout the app.
  • We included references to published research papers the methodology is based on.
  • The app does not connect to medical devices or Apple Health.
  • No treatment or medication recommendations are provided.

However, the app keeps getting rejected during App Review. Apple is asking us to provide documentation/approval from health regulatory authorities for every country where the app will be distributed.

This is where I’m confused:

  • Is this actually required for apps like this?
  • Are reviewers classifying this as a regulated medical device?
  • How are similar diabetes risk / health risk apps on the App Store handling this?
  • Is there a recommended way to position the app as wellness/educational instead of diagnostic?

We’ve already tried:

  • strengthening disclaimers,
  • clarifying that it is not a diagnosis,
  • removing strong medical claims,
  • submitting from both personal and organization accounts.

Still receiving the same type of rejection.

Would really appreciate advice from anyone who has successfully navigated this type of review process.

Thanks!

App Rejected for Diabetes Risk Assessment – Asked for Regulatory Approval in Every Country
 
 
Q