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    HIPAA Regulations: General Provisions: Definitions - Genetic Services - § 160.103

    As Contained in the HHS HIPAA Rules

     

    HHS Regulations as Added by the January 2013 Amendments
    General Provisions: Definitions - Genetic Services - § 160.103

     

    Genetic services means:

    (1) A genetic test;

    (2) Genetic counseling (including obtaining, interpreting, or assessing genetic information); or

    (3) Genetic education.

     

    HHS Description and Commentary From the January 2013 Amendments
    General Provisions: Definitions - Genetic Services

     

    Proposed Rule

    GINA provides that the term “genetic information” includes, with respect to any individual, any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by such individual or any family member of such individual. Section 102(a)(4) of GINA defines “genetic services” to mean: (1) a genetic test; (2) genetic counseling (including obtaining, interpreting, or assessing genetic information); or (3) genetic education. Thus, the fact that an individual or a family member of the individual requested or received a genetic test, counseling, or education is information protected under GINA. Genetic counseling and education are means by which individuals can obtain information and support about potential risks for genetic diseases and disorders. The Department proposed to add the statutory definition of “genetic services” to the Privacy Rule.

    Overview of Public Comments

    The Department received one comment requesting that the Department add language to the definition to make clear that the genetic tests, genetic counseling, or genetic education of a family member of an individual are specifically covered by the term.

    Final Rule

    The final rule adopts without modification the definition of “genetic services” proposed in the NPRM. This definition is consistent with the definition found in the implementing regulations for sections 101-103 of GINA and with which compliance is already required by most health plans. The Department does not believe it necessary to add the term “family member” to the definition of “genetic services” because the definition of “genetic information” makes clear that information about any request for, or receipt of, genetic services by a family member of an individual is protected information.