Creation of clinical research databases in the 21st century: a practical algorithm for HIPAA Compliance

Surgical Infections
Scott R Schell

Abstract

Enforcement of the Health Insurance Portability and Accountability Act (HIPAA) began in April, 2003. Designed as a law mandating health insurance availability when coverage was lost, HIPAA imposed sweeping and broad-reaching protections of patient privacy. These changes dramatically altered clinical research by placing sizeable regulatory burdens upon investigators with threat of severe and costly federal and civil penalties. This report describes development of an algorithmic approach to clinical research database design based upon a central key-shared data (CK-SD) model allowing researchers to easily analyze, distribute, and publish clinical research without disclosure of HIPAA Protected Health Information (PHI). Three clinical database formats (small clinical trial, operating room performance, and genetic microchip array datasets) were modeled using standard structured query language (SQL)-compliant databases. The CK database was created to contain PHI data, whereas a shareable SD database was generated in real-time containing relevant clinical outcome information while protecting PHI items. Small (< 100 records), medium (< 50,000 records), and large (> 10(8) records) model databases were created, and the resultant data mode...Continue Reading

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Citations

Jun 3, 2010·Journal of Digital Imaging·Alicia Baltasar Sánchez, Angel González-Sistal
Jan 16, 2008·Clinics in Laboratory Medicine·Jason A LymanJames H Harrison
Oct 23, 2015·British Journal of Cancer·Aisyah Mohd NoorAnita Grigoriadis
Feb 26, 2010·Biodemography and Social Biology·Henry T Greely

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