Remote Key Authority for Implantable Medical Device Authorization
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Solution Overview
Problem
There is a need to control and restrict non-routine programming tasks for implantable medical devices to prevent accidental execution and ensure patient safety, while allowing necessary updates or system resets when required.
Innovation Solution
A medical system and method that uses an external programmer device to communicate with an implantable medical device, requesting permission from a remote key authority for restricted instructions through a digital key, ensuring authorization and limiting the duration of access to prevent unauthorized changes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If programming instructions are freely delivered to the implantable medical device, then ease of operation is improved, but patient safety deteriorates due to risk of accidental execution
Solution Approach 1:
A remote key authority server acts as an intermediary between the programmer device and the implantable medical device. When restricted programming instructions are attempted to be delivered, the system automatically communicates with the remote key authority server to obtain authorization. This intermediary layer prevents direct unauthorized modifications while maintaining ease of operation for legitimate programming tasks.
2Reliability
If authorization requirements are implemented for restricted instructions, then patient safety is improved, but device complexity increases
Solution Approach 1:
The programming instructions are segmented into restricted and non-restricted categories. The implantable medical device includes a restricted instruction module that specifically handles restricted instructions by intercepting them and requiring authorization before execution. This segmentation allows the majority of non-restricted programming tasks to proceed without additional complexity, while only restricted functions trigger the authorization workflow.
3Productivity
If automatic authorization is implemented, then productivity is improved, but reliability deteriorates due to potential unauthorized changes
Solution Approach 1:
The system implements automatic feedback loops where the implantable medical device monitors for restricted programming instructions and automatically initiates communication with the remote key authority server. The server responds with authorization decisions based on pre-configured policies, patient information, and instruction characteristics. This automated feedback mechanism maintains high productivity by eliminating manual authorization steps while preserving reliability through systematic security checks.
Data Source
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AI summary
Embodiments of the invention are related to medical systems and methods for controlling authorization of restricted functionality, amongst other things. In an embodiment, the invention includes a medical system including an external medical device programmer comprising control circuitry and a wireless communications module for sending instructions selected from a set of instructions wirelessly to a specific implanted medical device. In an embodiment, the external medical device programmer can be configured to initiate a transfer of verifying data to a remote key authority requesting permission if the user input directs delivery of restricted instructions to the specific implanted medical device, the verifying data including information regarding the specific implanted medical device. Other embodiments are also included herein.