Secure Medical Device Communications via Data Bearing Tag
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Solution Overview
Problem
There is a need for secure wireless communications in implantable medical devices to protect sensitive patient data and programming instructions, as existing technologies lack effective security measures to prevent interception during communication.
Innovation Solution
The implementation of a medical device system that includes a data bearing tag, such as an NFC tag or QR code, on the implantable device or its packaging unit, which provides secure communication by transmitting security data through a short-range channel to establish secure wireless communications with an external device, using electromagnetic shielding to prevent unauthorized access until the packaging is opened.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If wireless communication is implemented in implantable medical devices, then data transmission capability is improved, but security against interception is worsened
Solution Approach 1:
The communication process is segmented into two distinct phases: initial key exchange during device activation when the device is accessible, and subsequent secure communication after implantation. This segmentation allows security credentials to be established before the device is implanted, preventing interception during critical communication phases.
Solution Approach 2:
Security credentials and encryption keys are exchanged and established in advance during the device activation phase, before the implantable device is placed inside the patient. This preliminary action ensures that secure communication protocols are already in place before the device becomes inaccessible during implantation, eliminating the security vulnerability of establishing credentials after implantation.
2Reliability
If a data bearing tag is placed on the packaging unit, then secure key transmission is improved, but device complexity is worsened
Solution Approach 1:
A data bearing tag (such as an NFC tag or QR code) is introduced as an intermediary element on the packaging unit to store and transmit security credentials. This intermediary allows secure key exchange without requiring complex embedded security hardware in the implantable device itself, simplifying the overall system while maintaining security.
Solution Approach 2:
Security credentials are copied onto a data bearing tag that can be easily read by external devices during the activation process. This copying approach allows the implantable device to receive security information through a simple wireless or optical interface rather than requiring complex direct cryptographic key management hardware.
3Reliability
If electromagnetic shielding is used in the packaging unit, then prevention of unauthorized access is improved, but ease of operation is worsened
Solution Approach 1:
The packaging unit incorporates electromagnetic shielding that is dynamically configured to allow controlled communication during activation. The shielding can be temporarily bypassed or configured to permit NFC/RFID signals during the authorized activation process, then returns to its shielding state to prevent unauthorized access during storage and implantation.
Solution Approach 2:
The activation process is performed as a preliminary action before implantation, when the device is still in its accessible packaging state. This timing allows the electromagnetic shielding to be temporarily opened or configured for communication during the authorized key exchange, after which the shielding remains closed to prevent unauthorized access.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This solution ensures secure wireless communication between the implantable medical device and external devices, enhancing data protection and security by using a separate communication channel for initial key transmission, reducing the risk of interception and maintaining sterility during storage and implantation.
Implementation Method 1
the implantable medical device packaging unit can include electromagnetic shielding
Data Source
AI summary
Embodiments herein relate to medical device systems including features to enable secure wireless communications between components thereof. In an embodiment, a medical device system is included having an implantable medical device packaging unit and an implantable device. The implantable device can include a control circuit and a communications antenna. The implantable device can be configured to fit within the implantable medical device packaging unit prior to implantation in a patient. The system can also include a data bearing tag, wherein the data bearing tag is disposed on or in the implantable medical device packaging unit. In some embodiments the system can also include an external communication device. The external communication device can be configured to receive data from the data bearing tag enabling secure wireless communications between the implantable device and the external communication device. Other embodiments are also included herein.