Apples Requirements about medical apps

Question

Created Nov ’20

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Hi everybody,

for the publication of an app, Apple requires various documents. The app can be connected to a medical device, but does not have a medical purpose and may not be used in combination on a patient.
Apple therefore incorrectly classifies our app as a Medical App, therefore we should provide documentation of a report that shows that the app uses the medical device as described.
What are the general conditions for such a report?

Thank you for your help.

Markus

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Answer 1

corpuls_simulation OP

Nov ’20

Aditionally, Apple writes:

Regarding 1.4.1 issue, though your app is used for training purpose, your app connects to external medical hardware to provide medical services, it still need to be compliant with App Store Review Guideline 1.4.1, you must:

Demonstrate regulatory clearence for your app's use of medical hardware with documentation from the appropriate regulatory organization
Provide documentation of a report or peer-reviewd study that demonstrates your app'Äs use of medical hardware works as described

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Answer 2

michael.czyz OP

Jul ’24

Hi, I can see that your app is already on the AppStore, how did you resolve the issue?

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