Medical App Rejected 1.4.1

Our app has been rejected many times from the app store because of 1.4.1 Physical Harm guideline. This app will allow users to log their health based self-assessment data like blood pressure, glucose level, temperature, body weight, BMI, temperature, etc., using of the shelf medical hardware devices, that can be found on any pharmacy, convenience store, supermarket, etc. The data will be uploaded, saved and processed in the cloud with graphics, trends, etc., so that users can visualize their vital signs, and share them with a doctor. The app doesn't make any suggestion, recommendation or diagnosis, it only gathers the data from the gadgets, produces graphics and save them in the cloud.

We have uploaded documentation showing the FDA, FCC, and other countries regulation approvals for the gadgets, but on every submission we are told to reduce the store front, so at the end there will be no country where the app will be available, or to provide documentation from the appropriate regulatory organization demonstrating regulatory clearance for the medical hardware used by your app, or provide documentation of a report or peer-reviewed study that demonstrates your app’s use of medical hardware works as described, etc.

We have done all that have been requested and the app keeps being rejected, so at this point and after reading other posts here and on the web, we are convinced that now that Apple is focused on health, there is no way to have an app like this or similar approved, no competition allowed, no other ideas accepted, nothing out of the Apple circle allowed.

So, after many months we just stop trying today to have our apps on the Apple Store, this app was meant to be free, for anybody to use, including hospitals on many places, but there are other options besides Apple to make apps available to users around the world.

And so, lets wish Apple a great show next week, showing their new devices that of course will comply with 1.4.1 Physical Harm Guideline, their new iOS16 with their new health features, and everything else to help have a better world without other's ideas.

Have a great day.

Well, finally our medical app has been approved, now we will continue to improve it and make available to any body who might need it for free. Regards.

I got the same problem as you. Please can you tell me how to pass the review? Thank you a lot.

Hi @Emmitec, we have just run into the same issue, Microlife BP device with FDA clearance. We developed our app with ACC, American College of Cardiology, but they are still rejecting our submission, and they are not giving any details on why and we don't understand what they are expecting to see.

How did you pass the review?

We have similar issue. I'm desperate.

Hello, we are experiencing the same issue with our mobile app. Could you please let me know if you have already resolved this issue and, if so, how?

We have the same issue. I'm also desperate. What did you do to pass certification? The last thing they told us is:

"Provide documentation of a report or peer-reviewed study that demonstrates the app's use of medical hardware works as described."

Do we have to hire a 3rd party consultant to make a report about the app's use of the devices we connect to? Is that what they want? "Peer-reviewed" refers to an IT professional or a medical professional?

This is not clear at all.

Medical App Rejected 1.4.1
 
 
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