Skip to main content
U.S. flag

An official website of the United States government

Return to Search

FAQ 314 When is a researcher considered to be a covered health care provider under HIPAA?

This is guidance for when a researcher is a covered health care provider under HIPAA

Final

Issued by: Office for Civil Rights (OCR)

When is a researcher considered to be a covered health care provider under HIPAA?

Answer:

A researcher is a covered health care provider if he or she furnishes health care services to individuals, including the subjects of research, and transmits any health information in electronic form in connection with a transaction covered by the Transactions Rule. See 45 CFR 160.102, 160.103.

For example, a researcher who conducts a clinical trial that involves the delivery of routine health care, such as an MRI or liver function test, and transmits health information in electronic form to a third party payer for payment, would be a covered health care provider under the Privacy Rule. Researchers who provide health care to the subjects of research or other individuals would be covered health care providers even if they do not themselves electronically transmit information in connection with a HIPAA transaction, but have other entities, such as a hospital or billing service, conduct such electronic transactions on their behalf. For further assistance in determining covered entity status, see the CMS decision tool.

 

 

Date Created: 12/20/2002
Last Updated: 11/27/2006

HHS is committed to making its websites and documents accessible to the widest possible audience, including individuals with disabilities. We are in the process of retroactively making some documents accessible. If you need assistance accessing an accessible version of this document, please reach out to the guidance@hhs.gov.

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.