Apple's new digital health rules may have more sway than FDA's
Following the US FDA's recent fine-tuning of criteria for digital health apps, Apple has issued some rules for digital health companies wanting to use its iOS network. The changes include; requiring drug dosage calculating apps to come from approved sources; apps that encourage people to place their iPhones under their pillows or mattresses will be disallowed, and apps that give inaccurate information that could be used for diagnosis will face increased scrutiny. iMedicalApps believes that Apple's rules could have more impact than the FDA's because they represent a change to the screening process for apps.

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.

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

MedPage Today’s online publication iMedicalApps highlighted some of the changes including:

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.

As iMedicalApps points out, the changes by Apple could have a more tangible impact than those made by the FDA, and it raises the stakes for developers.

There is no way the FDA can regulate the hundreds of thousands of health and medical apps and the updates made to them. The screening process is what has to change — and it seems like Apple is finally stepping up to the plate to do this.

Apple did not immediately respond to a request for comment.

Different groups, both public and private have sought to establish a regulatory framework to reign in the mobile health app “Wild West.” Earlier this year, the Federal Trade Commission offered some guidance for digital health developers.

Happtique tried and failed utterly. Social Wellth took up the cause, in a collaboration with HITLab called Xcertia. Social Wellth also works with payers, such as Cigna, to provided a set of curated apps for Cigna customers.

In an effort to lead by example after having dismissed unproven digital health apps as this century’s digital snake oil, the American Medical Association is working with Health2047 to validate such tools.

Other healthcare companies have cultivated app/API marketplaces for their customers such as electronic health record providers and health systems so they can screen these tools themselves.

With this latest effort from Apple, the private sector appears to be well positioned to have a bigger impact on digital health as gatekeepers.

Photo: Apple HealthkKit