Supporting Patients in Managing Electronic Health Records and Biospecimens Consent for Research: Insights from a Mixed-Methods Usability Evaluation of the iAGREE Portal
🤖 AI Summary
In the AI era, re-identification risks associated with electronic health records (EHRs) and biospecimen research have intensified, while traditional informed consent management remains impractical and lacks transparency. To address this, we designed and implemented iAGREE—a patient-centered digital consent portal supporting fine-grained authorization, dynamic preference configuration, and privacy-enhancing mechanisms to strengthen patient autonomy and data control. We employed a mixed-methods usability evaluation framework involving 40 real users, integrating interaction log analysis and qualitative feedback to iteratively refine the interface and workflow. Empirical results demonstrate high system usability and yield actionable improvements and novel feature requirements. This work advances a trustworthy, scalable, patient-empowering digital consent paradigm, offering both theoretical grounding and practical implementation pathways for ethical health data governance.
Application Category
📝 Abstract
De-identified health data are frequently used in research. As AI advances heighten the risk of re-identification, it is important to respond to concerns about transparency, data privacy, and patient preferences. However, few practical and user-friendly solutions exist. We developed iAGREE, a patient-centered electronic consent management portal that allows patients to set granular preferences for sharing electronic health records and biospecimens with researchers. To refine the iAGREE portal, we conducted a mixed-methods usability evaluation with 40 participants from three U.S. health systems. Our results show that the portal received highly positive usability feedback. Moreover, participants identified areas for improvement, suggested actionable enhancements, and proposed additional features to better support informed granular consent while reducing patient burden. Insights from this study may inform further improvements to iAGREE and provide practical guidance for designing patient-centered consent management tools.
Problem
Research questions and friction points this paper is trying to address.
Managing granular consent for health data sharing
Addressing transparency and privacy concerns in research
Developing patient-centered electronic consent management tools
Innovation
Methods, ideas, or system contributions that make the work stand out.
Developed patient-centered electronic consent management portal
Allows granular preferences for health data sharing
Conducted mixed-methods usability evaluation for refinement
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