Privacy Considerations
Section 1
Introduction
Embedded pragmatic clinical trials (ePCTs) integrate research into routine clinical care. Therefore, data are typically collected from the electronic health record (EHR), through claims data sources, and via patient-reported outcomes. Because these data are often collected for the primary purpose of patient care and billing, there can be privacy considerations for studies that use these data.
In this chapter, we will examine the privacy considerations in ePCTs by reviewing the current regulatory frameworks and discussing studies that use real-word data for research. We will explore privacy considerations from patient, clinician, and healthcare system perspectives.
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