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.