Implantable Medical Device Programming Validation via Segmented Sessions
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Solution Overview
Problem
The risk of malicious access to patient data and unauthorized programming of implantable medical devices exists due to the potential for malicious parties to exploit longer range telemetry capabilities and remote care networks, compromising patient safety and therapy efficacy.
Innovation Solution
Implementing a multi-stage programming methodology that allows implantable medical devices to verify programming data using validation keys, enabling offline programming with temporary keys and subsequent validation through a remote server, and utilizing revocation data to manage cryptographic keys and prevent unauthorized access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If longer range telemetry capabilities and remote care networks are adopted, then patient care benefits are improved, but security risk increases due to potential malicious access
Solution Approach 1:
The system segments the programming process into multiple stages: initial programming without network connection, followed by separate validation and revocation data distribution phases. This segmentation allows the device to gain remote capabilities while limiting the attack window for each individual data set, thereby reducing overall security risk.
Solution Approach 2:
The device performs preliminary programming actions offline before connecting to the network for validation. By pre-programming with temporary restrictions and then validating afterward, the system enables remote care functionality while maintaining security controls throughout the process.
2Ease of operation
If offline programming is enabled, then ease of operation is improved, but security vulnerability increases due to lack of immediate validation
Solution Approach 1:
The system performs preliminary programming offline to improve ease of operation, then subsequently validates the programming data when network connection becomes available. This two-phase approach maintains operational flexibility while ensuring security validation occurs.
Solution Approach 2:
The system implements feedback mechanisms where programming data is validated against cryptographic keys and revocation data after offline programming. This feedback loop ensures that even though programming occurs offline, security verification happens through network connection, maintaining reliability.
3Adaptability or versatility
If multiple programming sessions are conducted, then adaptability is improved, but risk of unauthorized programming increases
Solution Approach 1:
Each programming session is segmented with its own validation and revocation data distribution phase. The system tracks and validates programming data from multiple sessions separately, ensuring that each session's data is independently verified against cryptographic keys, thereby maintaining security despite multiple programming operations.
Solution Approach 2:
The system performs periodic validation of programming data against revocation data and cryptographic keys after programming sessions occur. This periodic security check ensures that even with multiple programming sessions, unauthorized changes can be detected and prevented.
Data Source
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AI summary
In one embodiment, a method for operating a system for management of implantable medical devices (IMDs), comprises: conducting communication sessions with a plurality of clinician programmer devices while the clinician programmer devices are engaged in respective programming sessions with IMDs; receiving and storing second programming data from a plurality of clinician programmer devices, wherein the second programming data was created during programming sessions with IMDs without network communication to the system for management of IMDs for validation data; reconciling programming of the plurality of IMDs that were programmed with the second programming data with data stored by the system for management of IMDs; and communicating second signed validation data to cause IMDs to conduct therapeutic operations according to programming data validated by respective instances of second validation data.