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    Federal Regulators Publish Implementation Rule for Genetic Nondiscrimination Unveiled

    Federal regulators have published a final rule for implementation of the Genetic Information Nondiscrimination Act of 2008 (Pub. L. 110-233). GINA, which was signed in May 2008 by President Bush, restricts the collection and use of genetic information in a number of ways. GINA prohibits health insurance providers and employers from requiring genetic testing. Genetic data cannot be used to determine insurance premiums, eligibility for insurance, or employment.

    GINA Title I’s health coverage provisions apply to group health plans sponsored by private employers, unions, and state and local government employers; issuers in the group and individual health insurance markets; and issuers of Medicare supplemental (Medigap) insurance. […] Title II of GINA prohibits use of genetic information in the employment context, restricts employers and other entities covered by Title II from requesting, requiring, or purchasing genetic information, and strictly limits such entities from disclosing genetic information. […]

    The Commission published a proposed rule to implement Title II of GINA on March 2, 2009, and asked for public comment on the proposed rule, the discussion in the preamble, and other Title II issues not addressed in either document. See 74 FR 9056 (March 2, 2009).

    The regulation report includes a section-by-section analysis of the rule. I suggest reading this part first and then looking more closely at the regulation itself. Here’s the analysis on “general purpose.”

    In this section, the Commission sets forth the general purposes of GINA. The language in this section of the final rule has been modified slightly in response to several comments that disagreed with the characterization of Title II as prohibiting the “deliberate acquisition” of genetic information. See Comments of the American Civil Liberties Union (ACLU), Coalition for Genetic Fairness (CGF), Genetic Alliance, and the Genetics and Public Policy Center in collaboration with Jeremy Gruber (GPPC). These organizations noted that the term “deliberate acquisition” suggested that a covered entity must have a specific intent to acquire genetic information in order to violate the law. According to these commenters, a covered entity violates GINA by engaging in acts that present a heightened risk of acquiring genetic information, even without a specific intention to do so, such as when they fail to inform an individual from whom they have requested documentation about a manifested disease or disorder not to provide genetic information or when they access sources of information (e.g., certain types of databases, Web sites, or social networking sites) that are likely to contain genetic information about individuals.

    For reasons more fully set forth in the preamble’s discussion of 1635.8(a), (b)(1) and (4), the Commission agrees that a covered entity may violate GINA without a specific intent to acquire genetic information. For that reason, the Commission has removed the reference to “deliberate acquisition” of genetic information in 1635.1. We likewise recognize that not every acquisition of genetic information violates GINA. Accordingly, the section now simply indicates that Title II of GINA restricts requesting, requiring, or purchasing genetic information. The rest of the language of 1635.1 concerning GINA’s prohibition on the use of genetic information in employment decision-making, the requirement that genetic information be kept confidential (which includes maintaining written genetic information that exists in paper or electronic form as a confidential medical record), and the limitations on disclosure of genetic information is the same as the language in the proposed rule.

    We have also modified this section to include a point made only in the preamble to the proposed rule. A new subparagraph, 1635.1(b), clarifies that the final rule does not apply to actions of a covered entity that do not pertain to an individual’s status as an employee, member of a labor organization, or participant in an apprenticeship program. The final rule offers two examples to illustrate this point. Title II of GINA would not apply to a medical examination of an individual conducted for the purpose of diagnosis and treatment unrelated to employment, which is conducted by a health care professional in the hospital or other health care facility where the individual is an employee. Similarly, Title II would not govern the actions of a covered entity carried out in its capacity as a law enforcement agency investigating criminal conduct, even where the subject of the investigation is also an employee of the covered entity.

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