Enhancing Patient Privacy and Compliance in Clinical Trials: The Importance of Data Separation
The separation of patient profile data from clinical trial data in clinical data management systems (CDMS) is essential for maintaining data privacy, regulatory compliance, and facilitating independent analysis of patient information. This approach aligns with the Health Insurance Portability and Accountability Act (HIPAA) principles, particularly the “minimum necessary” access to protected health information (PHI). Vital…