NASCIS app delayed

The NASCIS app is delayed by Apple’s App Store approval process. I got this comment for which they rejected the app:

Regarding point 22.9: “Apps that calculate medicinal dosages must be submitted by the manufacturer of those medications or recognized institutions such as hospitals, insurance companies, and universities”

Below is my response, which I hope that helps to get approval for the App Store.

This app does not calculate a drug dose per se and is not referring to a specific brand of drugs. Methylprednisolone is a generic drug name and the NASCIS (National Acute Spinal Cord Injury Study) did research a specific drug dose regimen. The only thing that this drug does is help the user to calculate the drug dose as used in the NASCIS trials. The reference (also mentioned in the app description and online at the support URL) details this content.

So although I understand your concern, this app is implementing a study protocol that is used by neurosurgeons worldwide. In this case the study protocol used a drug instead of a scan or a blood test, so the app needs to mention this drug. On purpose I did not include decision making whether to use this drug, as the indication can be debated. However, once the decision is made to use it according to the NASCIS protocol, there is only one possible dose, which is the one that the app uses.

Further, being a neurosurgeon myself and already developing medical apps for five years now, I have been following all regulatory affairs with particular interest. The iRIS (interactive risk inventory system) technology which I implemented in the app (http://dign.eu/iris) is CE marked as a class 1 device according to European medical device directives, and is in line with the current (non-binding) FDA guidance on mobile medical applications according to section V. b (for which FDA intends to exercise enforcement discretion). The goal of iRIS is to offer users the advantage of a native app that is running on the device without the necessity for continuous internet access, but simultaneously offering a highly safe environment for responding to errors.

I am confident that our common interest of delivering safe apps to healthcare providers and patients is sufficiently met by this app, its scientific (peer-reviewed) knowledge base and its CE-marked risk inventory system, all tested and evaluated by a neurosurgeon who is knowledgeable about this topic. Posting some screenshots on Twitter I already got enthusiastic response from neurosurgeons on this app.

I hope you will support to improve the treatment of acute spinal cord injury by approving this interactive implementation of the NASCIS study protocol.

Yours sincerely,

Pieter Kubben, MD, PhD
neurosurgeon

Will be continued!