Infusion Pump Role-Based Authorization for Flexible Secure Access
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Solution Overview
Problem
Current medical devices lack flexibility in granting access authorization, as the number of possible manipulations is fixed by hard-coded codes, restricting or preventing adaptation and expansion of code-specific manipulations, and different user groups have different access levels.
Innovation Solution
A database system is implemented to store multiple operator types or groups with assigned authorization levels, and medications/therapies with corresponding manipulations, allowing flexible authorization based on identity verification using identification documents or codes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a hard-coded code lock is used to protect critical medications and therapies, then security and reliability are improved, but adaptability and ease of operation deteriorate because the number of possible manipulations is fixed
Solution Approach 1:
The authorization system is segmented into multiple hierarchy levels (e.g., level 1 for nurses, level 2 for physicians, level 3 for pharmacists) with each level having specific authorization rights. This allows the system to maintain security through structured access control while enabling adaptability by assigning different authorization levels to different user groups based on their roles and responsibilities.
Solution Approach 2:
The system transitions from a static hard-coded authorization model to a dynamic database-driven model where authorization levels and user assignments can be modified without changing the underlying software code. Administrators can add, remove, or modify authorization levels and user assignments in the database, allowing the system to adapt to changing organizational needs while maintaining security through consistent authorization checks.
2Reliability
If a hard-coded code lock is used to protect critical medications and therapies, then security and reliability are improved, but ease of operation worsens because code entry is required for manipulations
Solution Approach 1:
The system implements self-service authorization where users automatically receive appropriate access rights based on their assigned authorization level and the specific medication or therapy being accessed. The system automatically determines what manipulations are permitted based on the user's role and the drug's properties, eliminating the need for manual code entry while maintaining security through automated authorization checks.
Solution Approach 2:
The system changes the authorization parameter from a universal code entry requirement to role-based automatic authorization. Instead of requiring all users to enter a code, the system checks the user's authorization level parameter and automatically grants or denies access based on pre-defined rules, significantly improving ease of operation while maintaining security through consistent parameter validation.
3Reliability
If different user groups have different access levels with code protection, then security is improved, but device complexity increases due to multiple authorization levels and code management
Solution Approach 1:
The database-driven authorization system serves multiple functions: it stores user information, defines authorization levels, manages user-group assignments, and controls access to different medications and therapies. This universal approach consolidates what would otherwise require multiple separate code management systems into a single flexible platform, reducing overall system complexity while maintaining comprehensive security.
Solution Approach 2:
The system introduces an intermediary authorization level between the user and the critical functions. Instead of directly managing multiple codes for different functions, the system uses authorization levels as an intermediary layer that mediates access requests. This intermediary approach simplifies the system architecture by providing a single point of control for all authorization decisions, reducing complexity while maintaining security.
Data Source
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AI summary
The present disclosure relates to a security system (1) of or for a medical device (2) for granting identity-specific selectable authorization releases to operators for performing authorization-dependent manipulations on the medical device (2), comprising a data storage device (4) containing data identifying a number of authenticatable operators to whom individual authorization levels are assigned or assignable, an authentication device (6) designed and configured to establish the identity of a current operator, and an authentication device (8) designed and configured to confirm the identity of the authenticated operator based on the data stored in the data storage device (4), wherein an authorization release selection device (10) designed and configured toUpon successful authentication, a predetermined authorization release is selected and granted depending on the authorization level of the authenticated operator. Furthermore, the present disclosure relates to a method for granting identity-specific authorization releases to operators for performing authorization-dependent manipulations on a medical device (2).