Medical Device Identity Access via Cloud-Signed Authentication
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Solution Overview
Problem
Existing medical device ecosystems face challenges in ensuring secure identification, authentication, authorization, and accountability (IAAA) across diverse manufacturers, with vulnerabilities in communication stacks and Bluetooth implementations, leading to cybersecurity risks and interoperability issues.
Innovation Solution
A method and system for medical device identity and access management (MDIAMS) utilizing a cloud-based backend (MDIAMCB) to establish secure connections through zero-trust relationships, employing cryptographic key exchanges and application layer security, enabling seamless interoperability and robust cybersecurity measures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If cryptographic keys are provided to command or control a medical device together with the device (blind trust approach), then device accessibility and ease of operation are improved, but security and vulnerability to attacks worsen
Solution Approach 1:
The patent introduces an authorization service as an intermediary between the medical device and the digitally connected device. This service mediates the authentication and authorization processes, preventing direct exposure of cryptographic keys while enabling secure access. The authorization service verifies device identity and manages key distribution without requiring end-users to handle sensitive cryptographic material directly.
Solution Approach 2:
The patent extracts the cryptographic key management functions from the medical device itself and places them in a separate authorization service. This separation allows the device to maintain security while still enabling controlled access. The authorization service handles key generation, storage, and distribution, removing the security burden from the medical device and end-users.
2Reliability
If an authorization service requires online connection for key distribution, then security is improved, but device complexity and loss of time worsen
Solution Approach 1:
The patent implements preliminary action by pre-provisioning the medical device with unique identifiers and cryptographic materials during manufacturing. The device is pre-configured with certificates and keys that enable it to authenticate itself to the authorization service. This preliminary setup reduces the complexity of real-time key management while maintaining security through pre-established trust relationships.
3Adaptability or versatility
If cryptographic keys are transferred from production system to authorization service, then device functionality is improved, but vulnerability to attacks and productivity worsen
Solution Approach 1:
The authorization service acts as a secure intermediary that receives cryptographic materials from the production system and redistributes them to authorized devices. This mediation layer protects the production system from direct exposure to potential attacks while enabling flexible key management. The authorization service implements security controls and monitoring to prevent unauthorized access during key distribution.
4Reliability
If end-users must ensure cryptographic key security, then security is improved, but ease of operation worsens
Solution Approach 1:
The patent implements self-service by enabling the authorization service to automatically manage cryptographic key distribution without requiring end-user intervention. The service autonomously authenticates devices, verifies identities, and distributes appropriate cryptographic materials. This automation eliminates the burden of manual key security management from end-users while maintaining robust security through automated controls.
Data Source
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AI summary
A method for medical device identity and access management is proposed. The method comprising the following steps a) a medical device (112) to be controlled by a digitally connected device (116), transmitting, via an untrusted connection, to the digitally connected device (116) identifying information from the medical device (112), wherein the medical device (112) comprises at least one interface for communication with the digitally connected device (116) specified by the medical device manufacturer (120); b) a medical device identity and access management cloud backend (114) controlled by the medical device manufacturer (120), receiving an application programming interface, API, request from the digitally connected device (116), wherein the API request comprises a request for authentication information generated by the digitally connected device (116), wherein the request for authentication information comprises identifying information about the digitally connected device (116), generating, upon verifying and validating the API request and the request for authentication information, the authentication information comprising a certificate or a signature, wherein the authentication information depends on the identifying information of the digitally connected device (116) as pre-specified by the medical device manufacturer (120), signing the authentication information by using a private key of the medical device identity and access management cloud backend (114), and transmitting an API response comprising the signed authentication information to the digitally connected device (116); c) receiving via the untrusted connection at the medical device (112) from the digitally connected device (116) the signed authentication information, wherein, upon verifying and validating the authentication information at the medical device (112), an application layer security is established between the medical device (112) and the digitally connected device (116) using at least one cryptographic key exchange procedure.