Supervising Entity for Medical App Safety
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Solution Overview
Problem
Small medical devices like insulin pumps, which are not developed according to medical safety guidelines, pose safety risks when controlled by consumer devices like smartphones, as they may perform life-critical actions without adequate supervision, especially when multiple processes interact and communication between modules is limited.
Innovation Solution
A supervising entity or safety module is introduced to monitor and control the execution of medical apps on mobile devices, ensuring that safety-critical processes are only executed if all requirements are met, by measuring patient laboratory values, comparing them to predefined ranges, and generating monitoring signals to trigger appropriate actions or alerts.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a consumer device like a smartphone is used to control a medical device, then ease of operation is improved, but reliability deteriorates because the consumer device is not developed according to medical safety guidelines
Solution Approach 1:
A supervising entity is introduced as an intermediary between the consumer device (smartphone) and the medical device (infusion pump). The supervising entity runs safety-critical processes that verify the correctness of control commands before they reach the medical device, thus maintaining ease of operation while ensuring reliability through an additional safety layer.
2Adaptability or versatility
If multiple processes are executed in a medical app to perform life-critical actions, then functionality is improved, but reliability deteriorates due to limited communication between modules and inability to verify correct execution order
Solution Approach 1:
The supervising entity implements feedback mechanisms where each process in the sequence reports its execution status and results to the supervising entity. The supervising entity then verifies whether the output of each process matches expected safety criteria before allowing the next process to execute, ensuring correct execution order and maintaining reliability across multiple functional processes.
Data Source
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AI summary
The present invention relates to method for generating a monitoring signal by monitoring laboratory values of a patient using a medical app (122). The medical app (122) is executed on a mobile device (102) of the patient, wherein the execution of the medical app (122) on the mobile device (102) of the patient is supervised by a supervising entity or safety module (106, 128), the supervising entity or safety module (106, 128) comprising at least executable program instructions (130). The medical app (122) comprises executable instructions for executing at least one sequence of processes for generating the monitoring signal. The processes comprise safety critical processes. The sequence of processes is triggered by the measurement of the blood glucose level of the patient. The method comprises executing a first process of the sequence of processes, wherein the execution results in the generation of an information, forwarding the information of the executed process to the supervising entity or safety module (106, 128), evaluating the received information by the supervising entity or safety module (106, 128) and executing a second process of the sequence of processes depending on the result of the evaluation.