As used in this part:

(1) “Biological sample” means a human material known to contain DNA, including tissue, blood, urine, or saliva;
contract signature

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Terms Used In Tennessee Code 47-18-4902

  • Consumer: means an individual who is a resident of the state. See Tennessee Code 47-18-4902
  • Corporation: A legal entity owned by the holders of shares of stock that have been issued, and that can own, receive, and transfer property, and carry on business in its own name.
  • Deidentified data: means data that:
    (A)
    (i) Cannot reasonably be linked to an identifiable individual. See Tennessee Code 47-18-4902
  • DNA: means deoxyribonucleic acid. See Tennessee Code 47-18-4902
  • Genetic data: means data, excluding deidentified data, regardless of format, concerning a consumer's genetic characteristics, including:
    (A) Raw sequence data that results from sequencing all or a portion of a consumer's extracted DNA. See Tennessee Code 47-18-4902
  • Genetic testing: means :
    (A) A laboratory test of a consumer's complete DNA, regions of DNA, chromosomes, genes, or gene products to determine the presence of genetic characteristics of the consumer. See Tennessee Code 47-18-4902
  • Obligation: An order placed, contract awarded, service received, or similar transaction during a given period that will require payments during the same or a future period.
  • Partnership: A voluntary contract between two or more persons to pool some or all of their assets into a business, with the agreement that there will be a proportional sharing of profits and losses.
  • State: when applied to the different parts of the United States, includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
  • United States: includes the District of Columbia and the several territories of the United States. See Tennessee Code 1-3-105
(2) “Consumer” means an individual who is a resident of the state;
(3) “Deidentified data” means data that:

(A)

(i) Cannot reasonably be linked to an identifiable individual; or
(ii) Meets the standard for deidentification under the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) (42 U.S.C. § 1320d et seq.) and rules promulgated pursuant to that act; and
(B) Is possessed by a company that:

(i) Takes administrative and technical measures to ensure that the data cannot be associated with a particular consumer;
(ii) Makes a public commitment to maintain and use data in deidentified form and not attempt to reidentify data; and
(iii) Enters into a legally enforceable contractual obligation that prohibits a recipient of the data from attempting to reidentify the data;
(4) “Direct-to-consumer genetic testing company” or “company”:

(A) Means an entity that:

(i) Offers consumer genetic testing products or services directly to a consumer; or
(ii) 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; and
(B) Does not include:

(i) A law enforcement agency; or
(ii) An entity that is, and only while, engaged in collecting, using, or analyzing genetic data or biological samples in the context of research, as defined in 45 CFR § 164.501, that is conducted in accordance with:

(a) The Federal Policy for the Protection of Human Subjects, as described in 45 C.F.R. part 46;
(b) The Good Clinical Practice Guideline issued by the International Council for Harmonization; or
(c) The United States Food and Drug Administration Policy for the Protection of Human Subjects under 21 CFR Parts 50 and 56;
(5) “DNA” means deoxyribonucleic acid;
(6) “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;
(7) “First-party relationship” means the relationship between a company and a consumer from which the company has collected genetic data;
(8) “Genetic data” means data, excluding deidentified data, regardless of format, concerning a consumer’s genetic characteristics, including:

(A) Raw sequence data that results from sequencing all or a portion of a consumer’s extracted DNA;
(B) Genotypic and phenotypic information obtained from analyzing a consumer’s raw sequence data; or
(C) Self-reported health information regarding a consumer’s health conditions that the consumer provides to a company and that the company:

(i) Uses for scientific research or product development; and
(ii) Analyzes in connection with the consumer’s raw sequence data;
(9) “Genetic testing” means:

(A) A laboratory test of a consumer’s complete DNA, regions of DNA, chromosomes, genes, or gene products to determine the presence of genetic characteristics of the consumer; or
(B) An interpretation of a consumer’s genetic data; and
(10) “Person” means an individual, corporation, business, partnership, limited liability company, or other business entity.
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