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!