Medical Device Code Authentication Using Compact Metadata Signatures

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Solution Overview

Problem

Existing medical device computing systems face challenges in ensuring data security and authenticity of electronic components, particularly due to the risk of unauthorized code manipulation, which can compromise cybersecurity and compliance with regulatory standards.

Innovation Solution

A computer-implemented method using a security authentication engine (SAE) to validate and authenticate electronic components by generating and comparing metadata signatures derived from error-check/error-correct codes, eliminating the need for authentication keys within components and enabling fast, component-specific authentication.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional authentication methods using full code verification are used, then security reliability is improved, but authentication speed and processing efficiency deteriorate

Engineering Contradiction:
Improveauthentication securityVSAvoidauthentication speed
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent extracts only the essential authentication information from the complete code by generating metadata signatures. Instead of verifying entire code blocks, the system extracts and verifies compact metadata representations that contain sufficient authentication information, thereby maintaining security while dramatically improving processing speed.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the parameter of authentication data from full code verification to metadata signature verification. By transforming the authentication mechanism to work with condensed metadata representations rather than complete code, the system achieves both high security and fast authentication performance.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If authentication keys are embedded within electronic components, then component-specific authentication is improved, but device complexity and security vulnerability increase

Engineering Contradiction:
Improvecomponent authentication accuracyVSAvoidsystem structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent introduces metadata signatures as an intermediary authentication mechanism. Instead of embedding keys directly in components, the system uses metadata signatures that are generated from component characteristics and verified by the security authentication engine, reducing complexity and key management overhead.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent enables electronic components to self-authenticate by generating their own metadata signatures based on their inherent characteristics. Each component can independently create its authentication signature without requiring external key injection, simplifying the overall system architecture.

Inventive Principle:
Principle #25Self-service

3Reliability

If comprehensive code authentication is performed on all electronic components, then security coverage is improved, but processing time and computational resources increase

Engineering Contradiction:
Improvesecurity coverageVSAvoidauthentication processing time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent extracts essential authentication information into compact metadata signatures, allowing comprehensive security coverage across all components without the computational burden of verifying complete code on each component. The metadata extraction process maintains security coverage while reducing processing time.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies partial authentication action by verifying metadata signatures rather than complete code. This partial verification approach provides sufficient security coverage for authentication purposes while avoiding the excessive computational resources required for full code verification of every component.

Inventive Principle:
Principle #16Partial or excessive action

Data Source

PatentUS12380251B2Authentication of medical device computing systems by using metadata signature
Publication Date: 2025.08.05 FRESENIUS MEDICAL CARE HOLDINGS INC
  • US12380251B2 patent drawing
  • US12380251B2 patent drawing
  • US12380251B2 patent drawing

AI summary

Computer code embedded in an electronic component a medical device, such as a dialysis machine, can be authenticated by comparing a metadata signature derived from the computer code of the electronic component to a key derived from a pre-authenticated code associated with the electronic component. The metadata signature can be derived by running an error-check/error-correct algorithm (e.g., SHA256) on the computer code of the electronic component. A use of the metadata signature enables detection of any unauthorized changes to the computer code as compared to the pre-authenticated code.