Medical Device Hardware Identity Authentication
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Solution Overview
Problem
Current medical devices, such as ultrasound devices, lack effective protection against unauthorized hardware replacement, which can compromise device reliability and safety.
Innovation Solution
A hardware identity authentication method that binds all hardware components of a medical device together for authentication, using unique identifiers and cryptographic keys to verify the identity of the hardware and prevent unauthorized replacement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a simple hardware protection mechanism is used, then the device structure remains simple and easy to maintain, but the core components cannot be covered and unauthorized hardware replacement can easily occur
Solution Approach 1:
The patent implements a nested authentication structure where OTP-ROM modules are embedded within hardware components, and each component contains nested authentication elements (unique identifiers, cryptographic keys). This nested design allows comprehensive security coverage without proportionally increasing overall system complexity, as the authentication functionality is integrated into existing hardware structures.
Solution Approach 2:
The authentication system is segmented into independent OTP-ROM modules, each associated with specific hardware components. This segmentation allows the security system to be broken down into manageable units that can be independently implemented, tested, and maintained, reducing the perceived complexity while achieving comprehensive protection.
2Ease of repair
If hardware components are made replaceable for ease of maintenance, then the ease of repair improves, but unauthorized replacement and quality reliability deteriorate
Solution Approach 1:
The system dynamically adjusts the authentication process based on whether components are original or replaced. Authorized maintenance is enabled through dynamic key verification and authentication protocols that allow legitimate replacements while blocking unauthorized ones. The system transitions between locked and unlocked states based on authentication results, maintaining security while permitting legitimate repairs.
3Reliability
If all hardware components are bound together for authentication, then unauthorized replacement is prevented, but the device complexity increases
Solution Approach 1:
The OTP-ROM modules serve multiple functions: they store unique identifiers for component identification, contain cryptographic keys for authentication, and provide binding information for system-wide verification. This multi-functionality reduces the need for separate authentication components, thereby limiting the increase in overall system complexity while achieving comprehensive security.
Data Source
AI summary
The hardware identity authentication method for a medical device includes, after all hardware to be authenticated of the medical device is started, acquiring unique identifiers of all the hardware to be authenticated; calculating a first key according to the unique identifiers of all the hardware to be authenticated; and matching the first key with a pre-stored second key, and determining whether the identity authentication is passed according to a matching result. All the hardware to be authenticated is bound together for authentication, which can effectively prevent replacement of an entire module, so that hardware maintenance of the medical device may be performed only in an authorized state, thereby improving the reliability of a system and the quality of hardware maintenance.