Implantable Medical Device Remote Programming Security

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Solution Overview

Problem

Existing methods for secure remote programming of implantable medical devices (IMDs) require additional hardware and software, which increases cost, occupies space, and drains battery power, necessitating a more efficient and secure communication method.

Innovation Solution

The IMDs utilize a cryptographic hash verification system to authenticate and validate programming updates, ensuring the integrity and authenticity of configuration change requests by decrypting a signature with a unique key, comparing hashes, and verifying transaction credentials before executing updates.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If proximity detection or network connectivity is added to authenticate programming communications, then security is improved, but device complexity, cost, and power consumption increase

Engineering Contradiction:
ImprovesecurityVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The IMD uses its existing wireless communication transceiver to perform authentication functions. The device serves itself by utilizing its already-present hardware components (transceiver and processor) to detect proximity and validate programming requests, eliminating the need for separate authentication hardware.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The existing transceiver component is made multi-functional by using it not only for its primary wireless communication purpose but also for proximity detection and authentication of programming requests. This universal use of the transceiver avoids adding dedicated hardware for security functions.

Inventive Principle:
Principle #6Universality (Multi-functionality)

2Reliability

If proximity sensor or network connectivity hardware is added for authentication, then security is improved, but the housing space is reduced

Engineering Contradiction:
ImprovesecurityVSAvoidhousing space
Core Design Contradiction:
ReliabilityVSVolume of moving object

Solution Approach 1:

The transceiver performs multiple functions including wireless communication, proximity detection, and authentication. By making this single component universal, no additional space-consuming hardware is required in the IMD housing.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The authentication functionality is merged with the existing transceiver and processor components. The proximity detection and authentication logic are combined in the same hardware that already handles wireless communication, consolidating functions rather than adding separate components.

Inventive Principle:
Principle #5Merging (Combining)

3Reliability

If additional hardware and software for authentication is added, then security is improved, but power consumption increases

Engineering Contradiction:
ImprovesecurityVSAvoidpower consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The IMD uses its existing transceiver and processor to handle authentication without adding dedicated power-consuming authentication hardware. The device leverages its already-powered components to perform security functions, avoiding additional battery drain.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The authentication functionality is extracted from separate dedicated hardware and integrated into the existing transceiver and processor. This extraction eliminates the need for additional power-consuming components while maintaining security functions.

Inventive Principle:
Principle #2Taking out (Extraction)

Data Source

PatentEP4140534B1System and method for implantable medical device remote programming
Publication Date: 2025.06.25 PACESETTER INC
  • EP4140534B1 patent drawingFigure 1
  • EP4140534B1 patent drawingFigure 2
  • EP4140534B1 patent drawingFigure 3

AI summary

Computer-implemented methods and systems (10, 100) are provided that receive, at an implantable medical device (IMD) (12, 102), a programming package (!08) comprising a collection (112) of configuration change requests (114), transaction credentials (130), and a signature (132) indicative of a source of the programming package (108). The transaction credentials (130) include a first hash of the collection (112) of configuration change requests (114). The IMD (12, 102) validates an external device (14, 104, 106) as the source by decrypting the signature (132) using a key that is uniquely associated with the external device (14, 104, 106). The IMD (12, 102) verifies the transaction credentials (130) and the configuration change requests (114) of the programming package (108), and generates a second hash of the collection (112) of configuration change requests (114). Responsive to both (i) the second hash matching the first hash and (ii) the transaction credentials (130) and the configuration change (114) requests being verified, the IMD (12, 102) executes the collection (112) of configuration change requests (114) to update an operating configuration of the IMD (12, 102).