§ 202.224. Human `omic data.
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/us/cfr/t28/s§ 202.224·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)The term human`omic data means:
(1)Human genomic data. Data representing the nucleic acid sequences that constitute the entire set or a subset of the genetic instructions found in a human cell, including the result or results of an individual's "genetic test" (as defined in 42 U.S.C. 300gg-91(d)(17)) and any related human genetic sequencing data.
(2)Human epigenomic data. Data derived from a systems-level analysis of human epigenetic modifications, which are changes in gene expression that do not involve alterations to the DNA sequence itself. These epigenetic modifications include modifications such as DNA methylation, histone modifications, and non-coding RNA regulation. Routine clinical measurements of epigenetic modifications for individualized patient care purposes would not be considered epigenomic data under this rule because such measurements would not entail a systems-level analysis of the epigenetic modifications in a sample.
(3)Human proteomic data. Data derived from a systems-level analysis of proteins expressed by a human genome, cell, tissue, or organism. Routine clinical measurements of proteins for individualized patient care purposes would not be considered proteomic data under this rule because such measurements would not entail a systems-level analysis of the proteins found in such a sample.
(4)Human transcriptomic data. Data derived from a systems-level analysis of RNA transcripts produced by the human genome under specific conditions or in a specific cell type. Routine clinical measurements of RNA transcripts for individualized patient care purposes would not be considered transcriptomic data under this rule because such measurements would not entail a systems-level analysis of the RNA transcripts in a sample.
(b)The term human `omic data excludes pathogen-specific data embedded in human`omic data sets.
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§ 202.224
Human `omic data.
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