Medical Device Interoperability via Authorization-Service Key Verification
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Solution Overview
Problem
Existing automated insulin delivery (AID) systems face challenges in ensuring secure interoperability between components from different manufacturers, leading to potential security breaches and unauthorized disclosure of patient data or incorrect insulin dosages.
Innovation Solution
A method for secure medical device interoperability involving user authentication, establishment of an untrusted connection, exchange of cryptographic keys, and verification of a control application and user authorization to establish a trusted connection using public and private key pairs and authorization services.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If strict limits are imposed on the types of devices that can operate within an AID system to ensure security, then security is improved, but device compatibility and user choice are reduced
Solution Approach 1:
An authorization service acts as an intermediary between the control device and the medical device. The control device requests authorization to control the medical device, and the authorization service verifies the control device's credentials and establishes a trusted relationship. This mediator enables secure interoperability between devices from different manufacturers without requiring strict limits on device types.
2Adaptability or versatility
If interoperability is enabled between components from different manufacturers, then device compatibility is improved, but security risks increase
Solution Approach 1:
The system performs preliminary authorization verification before establishing control relationships. The control device must present valid credentials and receive authorization from the authorization service before it can control the medical device. This preliminary security check enables interoperability while maintaining security by verifying device legitimacy in advance.
3Reliability
If cryptographic verification and authorization processes are implemented, then security is improved, but system complexity increases
Solution Approach 1:
The complex cryptographic verification and authorization logic is extracted from the control device and medical device themselves, and concentrated in a separate authorization service. The medical device contains only the cryptographic verification functionality, while the authorization service handles the complex credential verification and authorization decision-making. This extraction reduces the complexity burden on individual devices.
4Ease of operation
If an untrusted connection is initially established for key exchange, then ease of connection is improved, but security exposure increases
Solution Approach 1:
The system rapidly exchanges cryptographic keys and establishes trust relationships over the untrusted connection before any sensitive operations occur. The authorization service and control device complete the cryptographic verification and key exchange in a quick sequence, minimizing the time window during which the untrusted connection could be exploited. This rushing through the vulnerable phase reduces security exposure while maintaining ease of connection establishment.
Data Source
AI summary
A method for secure interoperability between an electronic device and a medical device has been developed. The method includes executing a control application configured to provide communication between the electronic device and medical device, receiving user authentication data from an authentication service, receiving a key identifier from the medical device via an untrusted connection, and transmitting a message with an identifier of the user, the user authentication data, the key identifier, an identifier of the control application, and a cryptographic signature to an authorization service. The method further includes receiving a medical device cryptographic key from the authorization service only in response to successful verification of the message to enable at least one of control communication and data communication between the control application and the medical device.