Implantable Medical Device Remote Control with Secure Authentication
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Solution Overview
Problem
Modern implantable cardioverter-defibrillators (ICDs) face challenges due to complex programmable parameters, leading to inappropriate shocks and potential device malfunctions, which can be exacerbated by inadequate programming and communication issues, necessitating remote supervision and secure access control.
Innovation Solution
The system allows for remote control of implantable medical devices like ICDs, pacemakers, and other IMDs, with communication initiated only when needed, using pre-programmed notification criteria, and incorporates secure user identification methods, including biometric features, to ensure authorized access and efficient battery management.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If remote control capability is added to IMDs, then device management and programming accuracy are improved, but device complexity and security requirements increase
Solution Approach 1:
A central station acts as an intermediary between the physician and the IMD, handling complex programming tasks remotely. The central station receives programming instructions, processes them through secure authentication, and transmits them to the device, thereby improving programming accuracy while managing complexity at the intermediary level rather than in the implantable device itself.
Solution Approach 2:
The system incorporates automatic authentication and security verification mechanisms that operate without continuous human intervention. The IMD and central station automatically verify credentials, manage session security, and handle communication protocols, reducing the burden on users while maintaining high security standards.
2Use of energy by moving object
If communication is initiated only when needed using pre-programmed criteria, then battery consumption is reduced, but response time to critical events may be delayed
Solution Approach 1:
Notification criteria are pre-programmed into the IMD before implantation or during programming sessions. The device continuously monitors physiological parameters and automatically initiates communication when pre-defined conditions are met, eliminating the need for continuous battery-powered transmission while ensuring timely response to critical events.
Solution Approach 2:
The communication system dynamically adjusts its behavior based on the patient's physiological state. During stable periods, the device remains in low-power mode with intermittent monitoring. When critical thresholds are approached or exceeded, the device automatically increases communication frequency and power output to ensure timely notification of the central station.
3Reliability
If secure access control with biometric authentication is implemented, then device security is improved, but ease of operation is reduced
Solution Approach 1:
The system automatically performs biometric authentication and credential verification without requiring user intervention. The IMD and central station automatically exchange security credentials, verify identities, and manage session security, providing high-level security while maintaining ease of operation through automation.
Solution Approach 2:
Security credentials and authentication mechanisms are pre-configured and stored in secure memory within the IMD and central station system. This preliminary setup eliminates the need for users to manually input or manage complex security information during operation, maintaining both high security and ease of use.
Data Source
AI summary
An implantable medical device (IMD) comprises a transmitting/receiving (T/R) device for transmitting medical data sensed from a patient to, and for receiving control signals from, a medical expert (a human medical professional and/or a computerized expert system) at a remote location; an electronic medical treatment device for treating the patient in response to control signals applied thereto; and a sensor circuit, having a sensor circuit output, for producing sensor circuit output signal(s) representing medical data sensed from the patient. The IMD also includes a logic device (processor) which analyzes the sensor circuit output signal(s) to detect a medical abnormality and, upon detecting an abnormality, either sends a notification signal representing a medical state of said patient to the medical expert at the remote location or sends a local treatment device control signal to the medical treatment device, or does both. The medical expert can transmit an external treatment control signal to the IMD to effect patient treatment, if treatment is warranted. To ensure that the medical expert is authorized to provide such treatment, data which identify one or more authorized medical experts is stored in an IMD memory and compared with identification data transmitted from the putative authorized medical expert along with the external treatment control signal. Only if the identification data received from the putative authorized medical expert matches the pre-stored identification data of an originally authorized medical expert does the IMD effect treatment.


