Mobile Device Medical Controller Secure Configuration via Segmentation
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Solution Overview
Problem
Mobile devices, when used as external controllers for implantable medical devices, pose security risks due to their multifunctional nature and configuration with various communication protocols, potentially leading to mis-programming and non-compliance with FDA regulations.
Innovation Solution
A Medical Device Application (MDA) is developed to initialize mobile devices into a secure configuration for use as medical controllers, by disabling or reconfiguring hardware modules and terminating software tasks that could interfere with medical device operation, and providing a graphical user interface for communication with implantable medical devices, ensuring compliance with FDA standards.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If mobile devices are used as external controllers for implantable medical devices, then ease of operation and accessibility are improved, but security risks and compliance with FDA regulations deteriorate due to multifunctional nature and various communication protocols
Solution Approach 1:
The mobile device is segmented into two distinct operational modes: a consumer mode for general mobile functions and a medical device mode for implantable medical device control. The application creates isolated communication channels and separate configuration spaces, ensuring that medical device operations are independent from other mobile device functions, thereby maintaining security while preserving ease of operation.
Solution Approach 2:
The patent introduces an intermediary layer in the form of a dedicated application that acts as a mediator between the mobile device's general functions and the implantable medical device. This intermediary manages communication protocols, filters and validates data transmissions, and enforces security policies, allowing the mobile device to safely control medical devices without exposing vulnerabilities from its multifunctional nature.
2Adaptability or versatility
If mobile devices are configured with multiple communication protocols and functions, then adaptability and versatility are improved, but the risk of mis-programming and interference with medical device operation increases
Solution Approach 1:
The patent extracts and isolates the medical device control functionality from the mobile device's general operating system and application ecosystem. By creating a dedicated, sandboxed environment with controlled access to communication protocols and device settings, the system maintains adaptability for different medical devices while preventing harmful interference from other mobile device functions or unauthorized applications.
3Ease of operation
If mobile devices are used without configuration restrictions, then ease of operation is improved, but compliance with FDA regulations and patient safety deteriorate
Solution Approach 1:
The application implements dynamic configuration that adapts based on the operational context. When the mobile device is used for medical device control, the application automatically applies appropriate security policies, communication protocols, and operational constraints. This dynamic adjustment maintains ease of operation for authorized medical functions while enforcing necessary restrictions to ensure patient safety and FDA compliance.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution renders mobile devices safer and compliant with FDA regulations, reducing the risk of mis-programming and ensuring secure communication with implantable medical devices, thereby enhancing patient safety.
Implementation Method 1
Wireless data transfer between the IPG and the external controller typically takes place via magnetic inductive coupling between coils 24 and 56
Data Source
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Figure 3A~3B
AI summary
A Medical Device Application (MDA) operates on the mobile device to temporarily configure it into a known secure configuration for use as an external controller, and to prevent operation of the mobile device inconsistent with this function. In particular, the MDA operates to (1) disable or reconfigure hardware modules, and/or (2) terminate or suspend software tasks, that might corrupt operation of the mobile device as an external controller. The MDA can comprise an application ("app") that the patient can download onto his mobile device and run to initialize the mobile device into the known secure configuration. The MDA also preferably provides a graphical user interface to allow a user to communicate with the implantable medical device using the now-secure mobile device. After using the mobile device to communicate with the implantable medical device, the MDA can be exited and the mobile device returned to its original configuration.