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HIPAA Frequently Asked Questions


General Information about HIPAA

What is the HIPAA Privacy Rule?

What type of research does HIPAA affect?

Information about PHI

What is PHI?

When is research using personal identifying information not PHI?

Do all human research studies use PHI?

What is meant by use of PHI?

What is meant by disclosure of PHI?

What is meant by creation of PHI?

What do I need to do to use or disclose PHI in my research?

How do I obtain subjects authorization to use or disclose PHI as part of my research?

Protecting PHI

How do I protect the PHI in my research study?

What is a breach of security? What should I do if PHI may have been disclosed to unauthorized individuals?

HIPAA Waiver of Authorization

What is a waiver of authorization?

How do I request a waiver of HIPAA authorization for my study?

Identified Data

What is de-identified data?

What specific identifiers must be removed to create de-identified data?

Data Use Agreement

What is a limited data set with a Data Use Agreement?

Where can I find a Data Use Agreement template and who can I contact with questions?

I am a UCLA investigator and will be receiving a limited data set from my research collaborator at another UC. Do I need to sign a Data Use Agreement?

HIPAA and International Studies

Does HIPAA apply to my international study?

Database and Registries

Can databases or registries be created under HIPAA? Can I create a research database without obtaining an authorization from every single research subject?

Decedent Research

Is IRB approval required for decedent research at UCLA?

Information about the HIPAA Research Authorization Form

The sample consent form supplied by my clinical trial sponsor includes HIPAA language. Do I still need to use the HIPAA authorization form?

Do I need to submit the "University of California Permission to Use Personal Health Information for Research" form as part of my application to the IRB?

Is the "University of California Permission to Use Personal Health Information for Research" form available in languages other than English?

Sponsors and Medical Records

Can a sponsor audit the source documents contained in the official medical record to verify the accuracy of research reports?

Can a sponsor of an FDA-regulated trial continue to monitor or audit source documents generated during the trial after the expiration date?

HIPAA and a Business Associate Agreement

Do I need a Business Associate Agreement (BAA) for my research?

HIPAA Training

Do I need to take the HIPAA Research Training Certification Course?



Page Last Updated: June 26, 2017