Secured Electronic Key for Medical Device Data Transfer
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Solution Overview
Problem
Networked medical devices are vulnerable to malware and cyber threats, and regulatory requirements demand additional testing and threat analysis, while non-networked devices are less prone to obsolescence but lack data transfer capabilities.
Innovation Solution
Implementing a system that uses a secured electronic key with encrypted memory to control medical device usage, allowing secure data transfer and authorization through a cloud-based interface, with a public and private key pair for secure communication, and a treatment counter to limit device usage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a medical device is connected to a computer network to enable data transfer and communication capabilities, then data transfer capability is improved, but vulnerability to malware and cyber threats increases
Solution Approach 1:
The system divides the medical device into networked and non-networked segments. The main device controller remains isolated from direct network access, while a separate communication module handles data transfer through secure interfaces. This segmentation allows data transfer capability while protecting the core medical functions from network vulnerabilities.
Solution Approach 2:
A secure communication interface acts as an intermediary between the medical device and external networks. This intermediary layer filters and validates all data transfers, blocking malicious content while allowing legitimate medical data exchange. The interface includes encryption and authentication mechanisms to prevent unauthorized access.
2Reliability
If a medical device is designed as non-networked to simplify the system and reduce obsolescence risk, then device complexity is reduced and reliability is improved, but data transfer capability is lost
Solution Approach 1:
The system performs preliminary data processing and validation at the device level before transfer. Critical medical data is prepared and encrypted locally, then transferred through secure channels when needed. This preliminary action ensures data integrity and reduces the need for continuous network connectivity, maintaining reliability while enabling periodic data exchange.
3Object-affected harmful factors
If authentication and encryption hardware is added to protect against unauthorized access, then security is improved, but device complexity increases
Solution Approach 1:
The authentication and encryption functions are merged into the existing device controller rather than adding separate hardware modules. The controller integrates security protocols directly into its firmware, combining data processing and security functions in a single unified system. This reduces overall device complexity while maintaining strong security protections.
Data Source
AI summary
Various embodiments provide systems and methods for securely transferring data from a secured site to a medical device. Some embodiments provide systems and methods for securely uploading data from a medical device to a secured site. In some embodiments described herein, data can be downloaded from a secured site to a key and after severing communication with the secured site, key can be coupled to a device and download the data to the device, in some embodiments, a public and private key pair may be used to securely download data to a device.