Implantable Device Programming With Offline Validation and Key Revocation
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Solution Overview
Problem
Existing implantable medical devices face security risks from unauthorized access and malicious programming due to the adoption of longer range telemetry capabilities and remote care networks, which require network connectivity for validation and authorization, limiting their use in environments without consistent internet access.
Innovation Solution
Implement a multi-stage programming methodology that allows implantable medical devices to operate in offline mode with temporary validation data signed by clinician programmers, followed by subsequent network-connected validation and revocation of cryptographic keys to ensure secure therapeutic operations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If longer range telemetry capabilities and remote care networks are adopted to enable remote access and reprogramming of implantable devices, then clinical benefits to patient care are improved, but security risks from malicious parties inappropriately accessing patient data and effecting medical therapy increase
Solution Approach 1:
The system performs preliminary validation of programming data against validation data stored in the implantable device before allowing any therapeutic operations. This preliminary check ensures that even if remote access is enabled, unauthorized programming cannot take effect without proper validation, thus preventing harmful access while maintaining remote functionality.
Solution Approach 2:
Validation data acts as an intermediary between the remote programming interface and the implantable device's therapeutic operations. The validation data, which includes cryptographic signatures and programming parameters, mediates the interaction by requiring verification before any actual programming changes can be applied, thereby securing the system against malicious access while enabling legitimate remote care.
2Object-affected harmful factors
If network connectivity is required for validation and authorization of programming data, then security against unauthorized access is improved, but the system cannot operate in environments without consistent internet access
Solution Approach 1:
The system performs preliminary action by storing validation data including cryptographic signatures and programming parameters in the implantable device before network connectivity is available. This allows the device to validate programming data locally without requiring continuous network access, thus maintaining security while enabling operation in environments with inconsistent internet connectivity.
Solution Approach 2:
The implantable device performs self-validation by comparing received programming data against stored validation data locally within the device. This self-service capability eliminates the need for continuous network connectivity to verify programming authenticity, allowing the device to maintain security autonomously while operating in offline or intermittently connected environments.
3Adaptability or versatility
If temporary validation data signed by clinician programmers is used to enable offline programming, then operational flexibility in environments without network connectivity is improved, but the risk of unauthorized programming increases
Solution Approach 1:
The system uses preliminary action by pre-signing programming data with cryptographic signatures before offline use. The validation data includes these signatures and programming parameters that were established when network connectivity was available, allowing secure offline programming while maintaining accountability through the pre-established cryptographic verification mechanism.
Solution Approach 2:
The system replaces the mechanical requirement for network connectivity with a cryptographic validation mechanism. Instead of requiring continuous network access for authorization, the system uses digital signatures and validation data that can be verified offline, substituting the physical network dependency with a mathematical verification system that provides equivalent security without requiring internet access.
Data Source
AI summary
In one embodiment, a method for operating a system for management of implantable medical devices (IMDs), comprises: conducting communications sessions with a plurality of clinician programmer devices, wherein some of the communication sessions occur while the plurality of clinician programmer devices are engaged in respective programming sessions with IMDs; conducting communications sessions with a plurality of patient controller devices, wherein the communication sessions with the patient controller devices include communication of data pertaining to offline programming of IMDs; reconciling programming session data received from the plurality of clinician programmer devices with programming session data received from patient controller devices to identify instances of unauthorized IMD programming; and distributing revocation data to patient controller devices to be downloaded to corresponding IMDs, wherein the revocation data identifies cryptographic keys that are no longer trusted.