All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). For purposes of the HRPP 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 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule)