When is a "disclosure accounting" required under HIPAA?

A "disclosure accounting" is required under HIPAA specifically for situations where protected health information (PHI) is used without proper authorization, with the exception being limited data sets. This requirement is in place to ensure that individuals are informed about how their health information has been disclosed for purposes beyond treatment, payment, or healthcare operations.

When research involves the use of PHI without authorization, individuals have the right to know to whom their information has been disclosed, what information was shared, and for what purpose. However, limited data sets, which are subsets of PHI that exclude certain direct identifiers, do not trigger the same disclosure accounting requirements. This distinction is crucial because it allows researchers to use health data for specific purposes without imposing a significant burden to track every individual disclosure, as long as they handle the data appropriately.

In contrast, the other options either overstate the circumstances under which a disclosure accounting is necessary or introduce requirements that are not stipulated by HIPAA. For instance, not all human subjects research requires disclosure accounting, particularly when proper authorization is in place. Also, the discretion of the principal investigator is not a relevant factor in the legal requirements set by HIPAA regarding disclosure accounting. Lastly, the crossing of state lines is not a specific criterion that