Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment

Area of Science:

• Health Informatics
• Blockchain Technology
• Regulatory Science

Background:

• Novel data-sharing methods are needed to securely transmit clinical information from electronic health records (EHRs) to regulatory bodies like the Food and Drug Administration (FDA).
• Blockchain technology offers a potential solution for secure and auditable data exchange.

Purpose of the Study:

• To assess the technical and legal readiness of healthcare institutions for sharing EHR data via a secure data broker (SDB) to the FDA's blockchain.
• To identify challenges and requirements for implementing such a system.

Main Methods:

• The study involved an institutional EHR readiness assessment, legal consultation, and institutional review board (IRB) application submission.
• A test of healthcare data transmission over a blockchain infrastructure was conducted, including data extraction from EHRs and transmission via an SDB.

Main Results:

• Participating institutions could electronically extract data from EHRs for research purposes.
• Data transmission to the FDA blockchain via an SDB met success criteria, demonstrating connectivity from within institutional firewalls.
• Formal legal agreements were not required for the initial test but will be necessary for future real patient data exchange.

Conclusions:

• Healthcare institutions possess advanced analytic capabilities but show inconsistent utilization of Fast Healthcare Interoperability Resources (FHIR) format, despite 21st Century Cures Act requirements.
• Further testing and annual exercises are recommended to determine the feasibility of blockchain-based data exchange for public health emergencies and multisite data extraction.
• The FDA's RAPID program identified key technical and legal challenges for rapid data exchange to a government entity using blockchain infrastructure.