Empowering Patients for Disease Diagnosis and Clinical Treatment: A Smart Contract-Enabled Informed Consent Strategy

TL;DR

This paper addresses the privacy and accountability challenges of digitized health data by introducing a blockchain-based framework for informed consent in disease diagnosis and clinical treatment. It formalizes the Patient-Provider Agreement ($PPA$) and the Informed Consent ($IC$) structures, and implements a Smart Contract Generation mechanism that stores active consents in a repository and historical ones in an archive, ensuring immutable provenance. An Authorization Module enforces PHI access decisions using ABAC, while a graph-database provenance service provides transparent, real-time reports on given and executed consents. Experimental evaluation on public test networks demonstrates feasibility and reveals network-dependent costs and performance trade-offs, supporting integration with existing healthcare systems and outlining directions for policy-compliance frameworks and future improvements such as a blockchain-based provenance and $PoC$-driven compliance verification.

Abstract

Digital healthcare systems have revolutionized medical services, facilitating provider collaboration, enhancing diagnosis, and optimizing and improving treatments. They deliver superior quality, faster, reliable, and cost-effective services. Researchers are addressing pressing health challenges by integrating information technology, computing resources, and digital health records. However, digitizing healthcare introduces significant risks to patient data privacy and security, with the potential for unauthorized access to protected health information. Although patients can authorize data access through consent, there is a pressing need for mechanisms to ensure such given consent is informed and executed properly and timely. Patients deserve transparency and accountability regarding the access to their data: who access it, when, and under what circumstances. Current healthcare systems, often centralized, leave much to be desired in managing these concerns, leading to numerous security incidents. To address these issues, we propose a system based on blockchain and smart contracts for managing informed consent for accessing health records by the treatment team members, incorporating safeguards to verify that consent processes are correctly executed. Blockchain's inherent immutability ensures the integrity of consent. Smart contracts automatically execute agreements, enhancing accountability. They provide a robust framework for protecting patient privacy in the digital age. Experimental evaluations show that the proposed approach can be integrated easily with the existing healthcare systems without incurring financial and technological challenges.

Figures (13)

• Figure 1: Smart Contract-Based Informed Consent Management Framework al2023informed.
• Figure 2: Informed Consent Components al2023informed.
• Figure 3: Informed Consent Enforcement Process for PHI Access Authorization.
• Figure 4: Proposed Graph Database Based Consent Service Providing Mechanism.
• Figure 5: User-Oriented Given Consents al2023informed.