When does a covered entity have discretion to determine whether a research component of the entity is part of their covered functions, and therefore, subject to the HIPAA Privacy Rule?

Answer:

A covered entity that qualifies as a hybrid entity, meaning that the entity is a single legal entity that performs both covered and non-covered functions, may choose whether it wants to be a hybrid entity. If such a covered entity decides not to be a hybrid entity then it, and all of its components, are subject to the Privacy Rule in its entirety. Therefore, if a researcher is an employee or workforce member of a covered entity that has decided not to be a hybrid entity, the researcher is part of the covered entity and is, therefore, subject to the Privacy Rule.

If a covered entity decides to be a hybrid entity, it must define and designate its health care component(s). Research components of a hybrid entity that function as health care providers and engage in standard electronic transactions must be included in the hybrid entity's health care component(s), and be subject to the Privacy Rule.

However, research components that function as health care providers, but do not engage in standard electronic transactions may, but are not required to, be included in the health care component(s) of the hybrid entity. For example, a hybrid entity, such as a university, has the option to include or exclude a research laboratory, that functions as a health care provider but does not engage in electronic transactions, as part of the hybrid entity’s health care component. If such a research laboratory is included in the hybrid entity’s health care component, then the employees or workforce members of the laboratory must comply with the Privacy Rule. But if the research laboratory is excluded from the hybrid entity’s health care component, the employees or workforce members of the laboratory are not subject to the Privacy Rule.

Date Created: 12/20/2002
Last Updated: 03/14/2006