Blockchain Consent Register for Granular Data-Use Updates
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Solution Overview
Problem
Existing solutions for managing patient consent for personal health data are inadequate, particularly in electronic systems, lacking dynamic management, traceability, and granularity, and do not support patient updates or opposition, leading to underutilization of health data for research.
Innovation Solution
A method utilizing a blockchain distributed ledger to manage patient consent dynamically, allowing patients to update their consent status for specific health data items, ensuring time-stamped and inviolable traceability, and optimizing data exchanges by verifying patient identity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a touchscreen tablet interface is used to obtain patient consent, then consent can be obtained electronically, but the solution does not allow patient opposition (opt-out), remote re-information, or remote updates of consent data
Solution Approach 1:
The system implements dynamic consent management where patients can update their consent preferences at any time through a web interface. The consent status is not static but can be modified, allowing patients to opt-out, re-opt-in, or update granular consent preferences for different data types and research projects without requiring in-person visits or physical document re-signing.
Solution Approach 2:
The web interface serves multiple functions: it can present new consent requests, display current consent status, allow patients to opt-out of specific data uses, provide granular control over different types of health data, and enable remote updates. This single interface replaces multiple separate processes including initial consent, ongoing information provision, and consent withdrawal.
2Reliability
If individual patient notification is implemented to allow acceptance or refusal of consent, then patient autonomy is respected, but it becomes very difficult to manage when the number of patients is high
Solution Approach 1:
The system enables patients to self-manage their consent preferences through an autonomous web interface. Patients can view their consent status, update their preferences, opt-out of specific research projects, or modify granular consent settings without requiring manual intervention from healthcare providers or administrative staff, thereby scaling to large patient populations efficiently.
Solution Approach 2:
The system provides continuous feedback to patients about their consent status across different research projects and data types. The web interface displays current consent preferences, allows patients to see which projects have access to their data, and provides immediate confirmation when consent preferences are updated, enabling informed decision-making at scale.
3Productivity
If existing consent solutions are used, then consent requests can be sent and collected, but dynamic management of consent is not allowed and sufficient traceability of exchanges with the patient is not provided
Solution Approach 1:
The system introduces a centralized consent management platform that acts as an intermediary between patients, healthcare providers, and research projects. This platform maintains a comprehensive audit trail of all consent interactions, including when consent was obtained, what data types are covered, which projects have access, and when consent was withdrawn or modified. The audit trail is stored and can be queried to provide complete traceability while maintaining operational efficiency.
Data Source
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AI summary
The invention relates to a method for processing consent data, which method is implemented by a computer platform. Following storage of medical information on a patient in a database, the platform receives (200) an identifier of the patient and transmits (201) a consent request to the identified patient and adds (205) consent-request information to a blockchain-based distributed register. On receipt (209; 213) of consent data from the patient, the method further comprises updating (210; 214) a consent status corresponding to the consent data in the distributed register and providing notification (212; 216; 220) of the updated consent status to the database. The consent data of the patient comprise the patient's consent or refusal to consent to use of personal health data stored in the database.