Apple’s Move to Tighten Health App Rules Could Have Bigger Impact than FDA

A couple of months ago, the U.S. Food and Drug Administration acted to shore up criteria for digital health companies with final guidance articulating the difference between the “low-risk” digital health apps and devices for general health management and those apps and devices that needed FDA 510(k) clearance (read “FDA declines to scrutinize claims by “low risk” mhealth apps, devices. What’s the takeaway?”;


Now Apple has set down some rules for digital health companies aspiring to use the technology giant’s iOS network.


Some of the changes include:


  • Drug dosage calculating apps have to come from the drug manufacturer, a hospital, university, health insurance company, or other approved entity. This means individual developers can not make a medical app with drug dosages by themselves (Apple has actually been enforcing this for the past year already).
  • No more marijuana related apps.
  • Apps that encourage people to place their iPhones under a mattress or pillow while charging (such as those that monitor sleep) will no longer be allowed.
  • If your app has potential to cause any physical harm, Apple could reject it.
  • If your app provides inaccurate data or information that could be used to diagnose or treat patients, your app will get increased scrutiny.

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