Hardware Key Interface for Medical Device Data Security
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Solution Overview
Problem
Medical devices, such as blood glucose meters, face challenges in securing software, firmware, and data from unauthorized access, especially when connected to external systems for updates or modifications, as existing digital security techniques can be vulnerable to tampering.
Innovation Solution
A hardware key is physically coupled to the medical device via a separate communication path, requiring validation of a key code before data can be accessed or modified, ensuring that only authorized changes can be made, whether during manufacturing, maintenance, or in the field, thus enhancing data security.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If digital security techniques are used to protect software and data on medical devices, then data security is improved, but vulnerability to tampering and unauthorized access increases
Solution Approach 1:
A hardware key serves as an intermediary physical object that mediates access to the medical device. The key contains a key code that must be physically present and validated by the device before allowing software access or data modification. This physical intermediary layer prevents direct digital attacks on the system's software security.
Solution Approach 2:
The patent replaces purely digital security mechanisms with a physical hardware key system. Instead of relying solely on software-based authentication and encryption, the system requires a physical key with conducting lines that establish electrical contact with the device, substituting mechanical/physical security for digital security vulnerabilities.
2Reliability
If a hardware key interface is added to the medical device, then data security against unauthorized access is improved, but device complexity increases
Solution Approach 1:
The hardware key interface is designed to be multi-functional. The same physical interface and communication path can accommodate both the hardware key for security authentication and potentially other diagnostic or configuration tools. The key code validation process can serve multiple security-related functions including software protection, data access control, and system configuration authorization.
Data Source
AI summary
A medical device includes at least one memory device storing data; a communication interface defining a first communication path to allow communications between the medical device and an external device or network; and a hardware key interface defining a second communication path that is separate from the first communication path. A hardware key is configured to be coupled to the meter via the second communication path defined by the hardware key interface. The data on the at least one memory device cannot be modified unless the hardware key interface is physically coupled to the hardware key. The hardware key may include a key code component and conducting lines, where the hardware key interface receives the key code via the conducting lines and the data on the at least one memory device cannot be modified unless the key code provided by the hardware key is validated.