Table 1. Modes of DEDUCE access.
Mode of access | Description |
---|---|
Quality and safety operations | Investigators can analyze and integrate EDW data to support research for the purpose of internal quality investigation. Users have full access to PHI. Requires approval of medical director/department chair |
Review preparatory to research | Investigators can define a cohort based on parameters such as lab values, diagnoses, or demographics. This enables researchers to characterize patient volumes across Duke Medicine and facilitates statistical power calculations. Extracts are limited datasets with no directly identifiable patient information. Requires IRB notification |
IRB-exempt protocols | Researchers may view and extract de-identified data [11] (which may include dates) to support research. Requires IRB approval |
IRB-approved protocol with waiver/alteration of consent and HIPAA authorization | Investigators may view and extract PHI data elements for research purposes. Electronic chart review is available in this mode & access to clinical data with PHI is permitted within context of approved protocol. Requires IRB approval |
Educational purposes | Educators may define a cohort based on specific clinical parameters such as lab values, diagnoses, and demographics and export limited datasets (no direct patient identifiers) to prepare teaching materials. Requires departmental approval |
Abbreviations: DEDUCE, Duke Enterprise Data Unified Content Explorer; EDW, electronic data warehouse; HIPAA, Health Insurance Portability and Accountability Act; IRB, institutional review board; PHI, protected health information.