Medical Communication Abstraction Layer for Regulatory Air Interface Classification
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Solution Overview
Problem
Current air interface protocols used in medical devices do not meet the robustness, safety, and effectiveness requirements set by health regulatory authorities such as the FDA and European Commission Directorate General for Health and Consumers, despite enabling wireless transmission of medical data.
Innovation Solution
Implementing a medical communication abstraction layer that assigns classification levels to air interfaces based on health regulatory requirements, ensuring that medical data networks meet specific safety and effectiveness standards by selecting and configuring air interfaces to meet these requirements, and dynamically adjusting resources to ensure reliable data transmission.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current air interface protocols are used for wireless transmission, then data transmission capability is enabled, but robustness and safety requirements set by health regulatory authorities are not met
Solution Approach 1:
The patent segments the air interface protocol into multiple layers: a lower layer handling basic wireless communication functions and an upper medical communication abstraction layer handling medical data classification, networking, and safety requirements. This segmentation allows each layer to specialize in specific functions, improving reliability for medical applications while maintaining compatibility with existing wireless standards.
Solution Approach 2:
The patent introduces a medical communication abstraction layer as an intermediary between the standard air interface protocols and medical data transmission requirements. This intermediary layer provides classification levels, networking functions, and safety assurances without modifying the underlying air interface protocols, thus resolving the contradiction between maintaining simple protocol usage and achieving high reliability.
2Reliability
If medical data networks are established with classification levels, then safety and effectiveness standards are met, but resource allocation complexity increases
Solution Approach 1:
The patent introduces classification levels as a parameter to categorize medical data networks based on their safety and effectiveness requirements. By changing the parameter of network classification, the system can automatically apply appropriate resource allocation policies, QoS settings, and safety measures, making compliance management more systematic and less complex.
Solution Approach 2:
The patent implements dynamic resource allocation where resources are adjusted based on the classification level of active medical data networks. The system can dynamically prioritize resources for higher classification networks and adjust or terminate lower classification networks when resources are constrained, providing flexible compliance management without static complexity.
3Reliability
If existing air interface protocols are used, then wireless communication is enabled, but robustness requirements for medical devices are not ensured
Solution Approach 1:
The patent segments the communication protocol structure into existing air interface protocols for basic wireless functionality and a new medical communication abstraction layer for robustness and safety requirements. This segmentation allows the system to use proven, simple air interface protocols while adding robustness assurances through the upper layer without increasing overall complexity.
Solution Approach 2:
The medical communication abstraction layer is designed to be universal and work with multiple different air interface protocols. By creating a universal upper layer that can adapt to various lower-layer protocols, the patent ensures robustness requirements are met without being tied to protocol-specific complexity, making the solution broadly applicable.
Data Source
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AI summary
Systems, methods, and devices of the various embodiments enable classification levels (402) to be assigned to air interfaces used to transmit medical data based on health regulatory requirements. A medical communication abstraction layer executing on a computing device or node (202) may determine the requirements associated with a classification level and establish air interfaces (508) meeting those requirements with other devices (or nodes) also having medical communication abstraction layers, thereby establishing a medical data network between the devices or nodes meeting the requirements for the classification level. Medical data may also be assigned classification levels, and the assigned classification level of the medical data may be used by the medical communication abstraction layers to determine the medical data networks (404) over which the medical data may be transmitted.