Blockchain EHR Sub-blocks for Secure Clinical Trial Patient Selection
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Solution Overview
Problem
Healthcare information systems face compliance challenges that limit interoperability, leading to inefficiencies in clinical trial patient selection and medical product deployment due to data silos created by regulations like HIPAA and GDPR, resulting in increased costs and risks.
Innovation Solution
A processor-implemented method that obtains health parameters and demographic information, encrypts Electronic Health Record (EHR) sub-blocks, and augments a multi-dimensional blockchain with treatment deployment information, patient profiles, and prescription data to facilitate secure clinical trial candidate selection and medical product deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If data is encrypted and stored in separate EHR sub-blocks to maintain security and compliance, then data security and regulatory compliance are improved, but interoperability and information sharing between healthcare entities are limited
Solution Approach 1:
The EHR data is divided into separate encrypted sub-blocks (demographic information sub-block, clinical information sub-block, etc.), each accessible to different entities based on their authorization. This segmentation allows security to be maintained while enabling selective interoperability - each entity can access and share only the specific sub-blocks they are authorized to handle.
Solution Approach 2:
A blockchain-based intermediary system is introduced to manage the encrypted EHR sub-blocks. The blockchain acts as a trusted mediator that stores cryptographic keys and authorization information, enabling different healthcare entities to securely access and share appropriate sub-blocks without compromising overall data security or compliance.
2Measurement precision
If manual patient screening and contact processes are used to ensure compliance and accuracy, then data accuracy and regulatory compliance are improved, but time consumption and operational efficiency are reduced
Solution Approach 1:
The system enables self-service automated patient screening by allowing patients to provide consent and demographic information through digital interfaces. The blockchain system automatically matches patients with eligible clinical trials based on predefined criteria, eliminating the need for manual screening while maintaining accuracy through automated validation rules.
Solution Approach 2:
Patient demographic information and consent preferences are collected and stored in the blockchain system in advance. When clinical trial eligibility criteria are defined, the system automatically performs preliminary matching, so that when manual review is needed, only pre-identified candidate patients require attention, significantly reducing overall processing time while maintaining selection accuracy.
3Measurement precision
If multiple manual review steps are implemented for clinical trial eligibility to ensure accuracy, then patient selection accuracy is improved, but process complexity and time requirements increase
Solution Approach 1:
The blockchain system implements automated feedback loops where eligibility criteria are continuously validated against stored patient data. The system provides automatic feedback on match quality and identifies cases requiring manual review, creating a streamlined multi-level process that maintains high accuracy while reducing unnecessary complexity in the screening workflow.
Data Source
AI summary
Embodiments facilitate interoperability and secure patient selection for clinical trials and drug/device deployments. An entity may obtain a first set of health parameters and collective demographic information associated with one or more population segments and receive Electronic Health Record (EHR) sub-blocks with patient profile information and corresponding patient medical histories for patients. The entity may determine a subset of eligible candidate patients for a treatment based on information in the EHR sub-blocks and eligibility criteria for the treatment, which may be based the first set of health parameters, and/or the collective demographic information. The entity may transmit sub-blocks comprising eligible candidate patient profiles and medical information associated with the at least one treatment, and, in response to a received transaction block with a transaction confirmation, the entity may augment a multi-dimensional blockchain by linking: the transaction block, with a drug device information block and an EHR block.