February 15, 2013. Today, we present several new definitions relating to the Genetic Information Nondiscrimination Act (GINA), which addressed the application of the HIPAA Privacy Rule to genetic information. The definitions are in the Final Rule: Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act [HITECH Act] and the Genetic Information Nondiscrimination Act; Other Modifications of the HIPAA Rules, which was published in the Federal Register on January 25, 2013. The effective date of the Final Rule is March 26, 2013, and covered entities and business associates must comply by September 23, 2013.
The Final Rule states: “The Genetic Information Nondiscrimination Act of 2008, Public Law 110-233, 122 STAT. 881, prohibits discrimination based on an individual’s genetic information in both the health coverage and employment contexts. With respect to health coverage, Title I of GINA generally prohibits discrimination in premiums or contributions for group coverage based on genetic information, proscribes the use of genetic information as a basis for determining eligibility or setting premiums in the individual and Medicare supplemental (Medigap) insurance markets, and limits the ability of group health plans, health insurance issuers, and Medigap issuers to collect genetic information or to request or require that individuals undergo genetic testing. Title II of GINA generally 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…
“In addition to these nondiscrimination provisions, section 105 of Title I of GINA contains new privacy protections for genetic information, which require the Secretary of HHS to revise the Privacy Rule to clarify that genetic information is health information and to prohibit group health plans, health insurance issuers (including HMOs), and issuers of Medicare supplemental policies from using or disclosing genetic information for underwriting purposes.” 78 Federal Register 5658-5659
Below are new GINA-related definitions for the discussion in this series on the January 25, 2013, Final Rule Modifications as they relate to HIPAA Privacy Rule provisions. 45 CFR 160.103, at 78 Federal Register 5688-5689
Family member means, with respect to an individual:
(1) A dependent (as such term is defined in 45 CFR 144.103), of the individual; or
(2) Any other person who is a first-degree, second-degree, third-degree, or fourth-degree relative of the individual or of a dependent of the individual. Relatives by affinity (such as by marriage or adoption) are treated the same as relatives by consanguinity (that is, relatives who share a common biological ancestor). In determining the degree of the relationship, relatives by less than full consanguinity (such as half-siblings, who share only one parent) are treated the same as relatives by full consanguinity (such as siblings who share both parents).
(i) First-degree relatives include parents, spouses, siblings, and children.
(ii) Second-degree relatives include grandparents, grandchildren, aunts, uncles, nephews, and nieces.
(iii) Third-degree relatives include great-grandparents, great-grandchildren, great aunts, great uncles, and first cousins.
(iv) Fourth-degree relatives include great-great grandparents, great-great grandchildren, and children of first cousins.
Genetic information means:
(1) Subject to paragraphs (2) and (3) of this definition, with respect to an individual, information about:
(i) The individual’s genetic tests;
(ii) The genetic tests of family members of the individual;
(iii) The manifestation of a disease or disorder in family members of such individual; or
(iv) Any request for, or receipt of, genetic services, or participation in clinical research which includes genetic services, by the individual or any family member of the individual.
(2) Any reference in this subchapter to genetic information concerning an individual or family member of an individual shall include the genetic information of:
(i) A fetus carried by the individual or family member who is a pregnant woman; and
(ii) Any embryo legally held by an individual or family member utilizing an assisted reproductive technology.
(3) Genetic information excludes information about the sex or age of any individual.
Genetic services means:
(1) A genetic test;
(2) Genetic counseling (including obtaining, interpreting, or assessing genetic information); or
(3) Genetic education.
Genetic test means an analysis of human DNA, RNA, chromosomes, proteins, or metabolites, if the analysis detects genotypes, mutations, or chromosomal changes. Genetic test does not include an analysis of proteins or metabolites that is directly related to a manifested disease, disorder, or pathological condition.
Manifestation or manifested means, with respect to a disease, disorder, or pathological condition, that an individual has been or could reasonably be diagnosed with the disease, disorder, or pathological condition by a health care professional with appropriate training and expertise in the field of medicine involved. For purposes of this subchapter, a disease, disorder, or pathological condition is not manifested if the diagnosis is based principally on genetic information.
In addition to the new GINA-related definitions above, the definition of Health information below was revised “to make clear that the term includes ‘genetic information’.
Health information means any information, including genetic information, whether oral or recorded in any form or medium, that:
(1) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and
(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual.
Next week, on Monday and Tuesday, we look at how GINA modified the HIPAA Privacy Rule, Wednesday and Thursday, we look at how the Final Rule modified the Enforcement Rule, and Friday look at how FERPA and HIPAA interact with respect to school immunization records.