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Reply to Guideline 1.4.1 - Safety - Physical Harm
Hello, we have encounter the same, every time we try to upload a new version to the App Store. The "Reviewer" if there is really one, doe not read or does not understand all the documentation we have provided as: FDA, EU (Europe) and Anvisa Clearances and Certifications. Letters from Hospital or medical institutions. Reduce the number of countries. Mentioning that the app might be used only for the Users or Patients associated with a particular Institution. Etc. Nothing is enough for Apple and its Reviewers, so we just uploaded a new bundle version with a distribution list for "0" "Zero" countries, maybe knowing that nobody will be able to download it, then Apple or its reviewers might consider it or approve it. Also, we have not found any where on any documentation that using an iPhone, watch or a MacBook, or any APple's product, the User can not make a misguided decision and have a "Physical Harm 1.4.1", ahh, but if it is made by Apple and approved by its own reviewers then is is correct. We have spent a lot of time developing these Apps and Remote Patient Monitoring Systems, but now we feel that we must move to other Platforms as the WebApps or any other distribution form without a Store, which forces developers to comply with non sense and endless requirements, and that the reviewers deny all documentations, certifications, documents, etc., provided, no end to the story, just time to move to WebApps. Good luck to all of you.
Sep ’24