De-identified information means that direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s) and the remaining information cannot reasonably be used by anyone to identify the source(s).  

For purposes of Human Research Protection Program policy, health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule). Other demographic information, such as gender, race, ethnicity and marital status are not included in the list of identifiers that must be removed.