Reimagining Patient Data Access for Researchers.

Area of Science:

• Health Economics and Outcomes Research (HEOR)
• Health Data Management
• Patient Privacy

Background:

• The widespread adoption of electronic health records (EHRs) presents an opportunity to leverage comprehensive patient data beyond traditional claims data for HEOR studies.
• Existing data infrastructure and intellectual property frameworks may not be optimized for maximizing researcher access to EHR data while ensuring robust patient privacy protections.

Purpose of the Study:

• To explore organizational structures and intellectual property rights that facilitate greater researcher access to full EHR data for HEOR.
• To identify strategies for protecting patient privacy rights within expanded EHR data utilization for research.
• To analyze data protection requirements and financial incentives at patient, aggregator, and system levels.

Main Methods:

• Comparative analysis of existing and proposed organizational structures and intellectual property rights for EHR data aggregation.
• Evaluation of data protection requirements and financial incentives for patient participation and data aggregation.
• Assessment of the role of trusted third parties (TTPs) and secondary data aggregators in creating usable HEOR databases.

Main Results:

• New HEOR data systems necessitate novel organizational models and funding mechanisms, alongside stringent patient data privacy measures.
• The Cures Act facilitates a market for TTPs to aggregate patient data, with secondary aggregators combining individual EHRs into valuable HEOR databases.
• Full health insurance coverage for data transmission costs is essential for maximizing patient participation.

Conclusions:

• Significant advancements are still needed to achieve maximal availability of HEOR data while upholding patient privacy.
• HEOR data is a public good, indicating that private incentives alone are insufficient for system creation and operation.
• Public and private investment is vital to scale the system and enhance its impact on public health.