Gate Control Hardware Module for Medical Device Network Security
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Solution Overview
Problem
Medical apparatuses face risks of manipulation and data breaches due to inadequate network security, with existing solutions like firewalls being vulnerable to external attacks and requiring comprehensive software verification, which can lead to hardware incompatibility issues and high maintenance costs.
Innovation Solution
Implementing a gate control hardware module that separates the communications network from the internal network, acting as a security entity to control and block external access, allowing only authorized data transfer and updates, and utilizing proprietary protocols to secure data transfer, while minimizing power consumption and allowing for easy updates without affecting medically relevant software.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a firewall is implemented to restrict network access, then network security is improved, but security holes remain and direct access to the control computer is possible if the firewall is overcome
Solution Approach 1:
The system segments the network architecture into distinct domains: an external communications network interface, a gateway control module, and an internal medical apparatus network. This segmentation isolates the control computer from direct external access, creating multiple layers that attackers must penetrate sequentially rather than providing a single point of failure.
Solution Approach 2:
A gateway control module is introduced as an intermediary between the external communications network and the internal medical apparatus network. This intermediary controls and filters all data traffic, preventing direct access to the control computer while allowing authorized communications through controlled interfaces.
2Reliability
If the operating system is updated to address security threats, then security is improved, but hardware incompatibility may occur and comprehensive reverification of software is required
Solution Approach 1:
The system separates the operating system into two distinct instances: one running on the gateway control module that interfaces with external networks, and another running on the control computer that manages medical functions. This segmentation allows independent updating of the external-facing OS without affecting the medical software stack.
Solution Approach 2:
The external network interface functionality is extracted from the control computer and placed in a separate gateway control module. This extraction allows the control computer's operating system to remain stable and certified while the gateway handles external communications and security updates independently.
3Ease of operation
If direct access to the control computer is allowed for operational flexibility, then ease of operation is improved, but manipulation and unauthorized access risks increase
Solution Approach 1:
The gateway control module serves as a mandatory intermediary for all access requests to the control computer. Even operational commands must pass through the gateway, which verifies authorization and filters traffic. This maintains operational flexibility while preventing unauthorized direct access.
Solution Approach 2:
The system performs preliminary verification of all incoming data traffic at the gateway control module before allowing access to the control computer. Authorization checks, protocol validation, and security policies are applied in advance, preventing unauthorized manipulation before it can reach the control system.
Data Source
AI summary
Computer hardware for a computer-controlled medical device, a computer-controlled medical device and a method of controlling a computer-controlled medical device. Computer hardware is configured such that there is no possibility of medically relevant software being manipulated from outside. The computer includes a control hardware module, serving an internal network of the medical device, and a gate control hardware module, serving a communication network, wherein the control hardware module and the gate control hardware module are arranged such that the communication network and the internal network are completely separated, and the gate control hardware module forms a security moderator between the communication network and the internal network. A method operates the medically relevant software in an internal network, which is completely separate from a gate control by which the medical device communicates with an external communication network and secures the medical device with regard to the external communication network.