Digital Biomarker Integration Platform for Clinical Data Harmonization
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Solution Overview
Problem
Current systems lack the ability to effectively harness and analyze clinically relevant patient-specific data at a population level, particularly for cancer patients, limiting early warning of treatment failure or disease recurrence and progression, and hindering clinical decision support and patient adherence to medical recommendations.
Innovation Solution
A scalable and flexible software platform that integrates and analyzes digital biomarker data from various medical and wearable devices, enabling real-time monitoring, prediction of outcomes, and automated treatment recommendations, while ensuring regulatory compliance and patient engagement features.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If digital biomarker data is collected from diverse medical devices and wearable devices, then the quantity and granularity of patient data is improved, but the complexity of data integration and analysis increases
Solution Approach 1:
The patent creates a universal data integration platform that can collect and process digital biomarker data from multiple diverse sources including medical devices, wearable devices, and clinical systems. The platform uses standardized data models and protocols to handle different device types uniformly, enabling one system to serve multiple data collection functions without proportionally increasing complexity
Solution Approach 2:
The patent introduces intermediary components including data standardization layers, protocol translators, and centralized processing servers that mediate between diverse data sources and the analysis system. These intermediaries normalize data formats and protocols, reducing the integration complexity that would otherwise arise from directly connecting numerous heterogeneous devices
2Reliability
If real-time analysis of patient data is performed, then early warning of treatment failure or disease progression is improved, but the computational resources and processing time required increases
Solution Approach 1:
The patent implements preliminary data processing and filtering steps that prepare and pre-process patient data before full analysis. By performing initial data validation, normalization, and anomaly detection in advance, the system reduces the computational burden during real-time critical analysis, enabling early warning capabilities with optimized resource usage
Solution Approach 2:
The patent applies different levels of analysis processing to different data streams based on their criticality and characteristics. High-priority data streams requiring immediate attention receive intensive real-time processing, while less critical data undergoes batch processing or lighter analysis, optimizing the distribution of computational resources across multiple data sources
3Loss of information
If comprehensive clinical study patient information is collected and shared, then the ability to answer clinically relevant questions and improve clinical decision support is improved, but data privacy and regulatory compliance challenges increase
Solution Approach 1:
The patent segments patient data into different categories and applies appropriate privacy protection measures to each segment. Sensitive personally identifiable information is separated from clinical data, with different access controls and protection levels applied to each segment, allowing comprehensive information sharing while maintaining privacy compliance
Solution Approach 2:
The patent introduces intermediary processing layers including de-identification systems, encryption protocols, and compliance validation services that mediate between data collection and sharing requirements. These intermediaries ensure data is processed and shared in compliance with HIPAA and other regulations while still enabling comprehensive clinical analysis
4Adaptability or versatility
If multiple wearable device platforms are incorporated to collect patient-generated data, then the versatility and scope of data collection is improved, but the difficulty of data harmonization and standardization increases
Solution Approach 1:
The patent develops a universal data acceptance layer that can receive data from multiple wearable device platforms including Apple Watch, Fitbit, and other commercial devices. This layer implements standardized data models and protocols that translate diverse device formats into a common structure, enabling versatile multi-platform data collection without proportionally increasing harmonization complexity
Data Source
AI summary
The instant system and method will be a scalable and flexible software platform to agnostically capture wearable, implantable, or external device data and create a digital biomarker for various disease conditions, care and analysis. The system and method also provides an informatics tool for automated data aggregation, integration, and machine learning algorithms to uniformly compare/contrast/couple data streams as a function of patient and context over time. The focus is on user engagement and usability, accessibility and reporting to the clinical care team, and usability by researchers interested in analyzing data and outcomes.