Providing Restricted Access to an Electronic Medical Record for Research Monitoring

Area of Science:

• Health Informatics
• Clinical Research Management
• Data Privacy

Background:

• Healthcare institutions increasingly utilize electronic medical records (EMRs).
• EMRs store sensitive protected health information (PHI).
• Clinical research relies on source data verification, often requiring access to patient records.

Purpose of the Study:

• To identify the challenges posed by EMR adoption in clinical research.
• To highlight the risks to non-study participant PHI during research monitoring.
• To underscore the need for solutions balancing research access and data privacy.

Main Methods:

• Analysis of EMR system functionalities in relation to clinical research protocols.
• Review of data access controls and potential breaches during source verification.
• Examination of privacy regulations and their implications for EMR use in research.

Main Results:

• Direct access for research monitors to EMRs can inadvertently expose PHI of individuals not enrolled in studies.
• Existing EMR access protocols may not adequately differentiate between research-related data needs and general patient information.
• The integration of EMRs presents a significant hurdle for maintaining participant confidentiality in clinical trials.

Conclusions:

• The widespread adoption of EMRs necessitates a re-evaluation of data access policies for clinical research.
• Implementing robust data anonymization or de-identification techniques is crucial.
• Developing secure, role-based access systems for research monitoring is essential to protect PHI.