Health Information Management

HIPAA Q&A: You’ve got questions. We’ve got answers!

HIM-HIPAA Insider, November 24, 2014

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Submit your HIPAA questions to Editor Jaclyn Fitzgerald at jfitzgerald@hcpro.com and we will work with our experts to provide you with the information you need.

 
Q: The hospital where I am employed conducts research. The research coordinators are hospital employees, and the screening is to find candidates who meet the study criteria, so no information is shared with the research sponsors unless the patient is enrolled and signs an informed consent for the study. The consent explains in detail what information will be collected and with whom it is shared. We always include an institutional review board (IRB) waiver of authorization for our studies. Is the work done by research coordinators to find suitable candidates for a research study reasonably considered part of operations under HIPAA?
 
A: Research is not part of healthcare operations, but it is permitted. The preparatory research provision [45 CFR 164.512(i)(1)(ii)] permits covered entities (CE) to use or disclose PHI for purposes preparatory to research, such as to aid study recruitment. However, the researcher is not permitted to remove PHI from the CE's site.
 
A researcher who is an employee or a member of the CE's workforce may use PHI to contact prospective research subjects. In that instance, an IRB waiver of authorization is not required.
 
Researchers who are not part of the CE need a partial waiver of individual authorization by an IRB or privacy board to obtain contact information.
 
The OCR website provides answers to many practice questions, including those involving research. Go to the website and type a keyword into the search bar or select a category (e.g., research) from the dropdown menu.
 
Editor’s note: Mary D. Brandt, MBA, RHIA, CHE, CHPS, vice president of health information at Baylor Scott & White Health in Temple, Texas, answered this question for HCPro’'s Briefings on HIPAA newsletter.

 

 



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