87-902. Terms, defined.
452 words·~2 min read·
/ne/chapter-87/87-902A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
For purposes of the Genetic Information Privacy Act:
(1)Biological sample means any material part of a human being, discharge therefrom, or derivative thereof, such as tissue, blood, urine, or saliva, known to contain DNA;
(2)Consumer means an individual who is a resident of Nebraska;
(3)Direct-to-consumer genetic testing company or company means an entity that
(a)offers consumer genetic testing products or services directly to a consumer, or
(b)collects, uses, or analyzes genetic data that resulted from a direct-to-consumer genetic testing product or service and was provided to the company by a consumer. Direct-to-consumer genetic testing company does not include any entity that is solely engaged in collecting, using, or analyzing genetic data or biological samples in the context of research, as defined in 45 C.F.R. 164.501, conducted in accordance with the Federal Policy for the Protection of Human Subjects, 45 C.F.R. part 46, the Good Clinical Practice Guideline issued by the International Council for Harmonisation, or the United States Food and Drug Administration Policy for the Protection of Human Subjects under 21 C.F.R. parts 50 and 56;
(4)DNA means deoxyribonucleic acid;
(5)Express consent means a consumer's affirmative response to a clear, meaningful, and prominent notice regarding the collection, use, or disclosure of genetic data for a specific purpose;
(6)(a) Genetic data means any data, regardless of its format, that concerns a consumer's genetic characteristics. Genetic data includes, but is not limited to:
(i)Raw sequence data that results from sequencing of a consumer's complete extracted DNA or a portion of the extracted DNA;
(ii)genotypic and phenotypic information that results from analyzing the raw sequence data; and
(iii)self-reported health information that a consumer submits to a company regarding the consumer's health conditions and that is used for scientific research or product development and analyzed in connection with the consumer's raw sequence data.
(b)Genetic data does not include de-identified data. For purposes of this subdivision, de-identified data means data that cannot reasonably be used to infer information about, or otherwise be linked to, an identifiable consumer, and that is subject to:
(i)Administrative and technical measures to ensure that the data cannot be associated with an identifiable consumer;
(ii)public commitment by the company to maintain and use data in de-identified form and not attempt to reidentify data; and
(iii)legally enforceable contractual obligations that prohibit any recipients of the data from attempting to reidentify the data;
(7)Genetic testing means any laboratory test of a consumer's complete DNA, regions of DNA, chromosomes, genes, or gene products to determine the presence of genetic characteristics of a consumer; and
(8)Person means an individual, partnership, corporation, association, business, business trust, or legal representative of an organization.