Protected health information (PHI) is considered de-identified by HIPAA Privacy Rule standards by:

The concept of "de-identified" protected health information (PHI) is critical under the HIPAA Privacy Rule, aimed at allowing data to be used without revealing individuals' identities. De-identification can occur in two primary ways, both of which are correctly represented in the chosen answer.

The first method is the safe harbor method, which requires the removal of 18 specified individual identifiers. These identifiers include names, dates (other than year), geographic subdivisions smaller than a state, and several other pieces of information that could be used to identify an individual. By effectively removing these identifiers, the data is classified as de-identified and no longer subject to the HIPAA Privacy Rule.

The second method involves a qualified expert making a formal determination that the risk of re-identification is very low based on the remaining information. This approach allows some flexibility, as it acknowledges that even if certain identifiers are not removed, the data can still be considered de-identified if an expert concludes that it poses no meaningful risk of identifying an individual.

Additionally, the absence of actual knowledge by the covered entity that the remaining information could identify the individual further supports the rationale for de-identification. If a covered entity is unaware that the remaining data could identify someone, this bolsters