scope:

This recommended practice specifies recommendations for the use of consumer mobile devices (CMDs) in the control of diabetes-related medical devices. While these recommendations may be applied to other medical use cases, they are targeted specifically for diabetes related control use cases. The following two use cases are covered by this recommended practice: open loop remote control and automated insulin dosing (AID) systems. In general, the recommendations within this recommended practice apply to both use cases unless explicitly indicated otherwise.

Open loop use case

One or more mobile applications (apps) running on a CMD are used to perform some command operation, upon request by the CMD user, on a wirelessly connected diabetes device. For example, a diabetes control app may provide a user interface that enables the user to specify the amount of insulin to be dosed by a wirelessly connected insulin pump. The CMD and its diabetes-related apps replace the traditional remote-control medical device manufactured by a medical device supplier.

Automated insulin dosing (AIM) control use case

The CMD is used to host software that performs some portion of a AID control system. For example, a continuous glucose monitoring system transmits (via wireless network) sensor readings to a CMD app; the CMD app executes an algorithm to compute treatments of insulin; the CMD autonomously transmits (via wireless network) treatment commands to an insulin pump. The CMD and its diabetes-related apps are executing a continuously repeating algorithm for which each algorithm computation results in a treatment to the patient that should be delivered within some developer-specified time frame in order to maintain use.

Explicitly not in scope

This document does not cover standards or guidance already covered in other, pre-existing medical standards and guidance. For example, for the remote-control use case, this guidance does not explain how a developer of a remote-control solution, which happens to use a CMD and CMD software, follows existing FDA recommended development standards or other regulatory body standards and obtains regulatory approvals to develop and deploy that remote-control solution. Rather, this guidance discusses the additional considerations related to the use of CMDs in the context of existing standards and approvals.

Purpose

This recommended practice defines recommendations for the use of mobile devices in diabetes contexts, as deemed necessary and sufficient by an appropriate set of stakeholders. These recommendations are intended to be used within a security evaluation program, as defined in other components of this multi-part standard.