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
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.
