2023 Tennessee Code › Title 47 - COMMERCIAL INSTRUMENTS AND TRANSACTIONS (§§ 47-1-101 — 47-50-121) › Chapter 18 - CONSUMER PROTECTION (§§ 47-18-101 — 47-18-5706) › Part 49 - GENETIC INFORMATION PRIVACY ACT (§§ 47-18-4901 — 47-18-4906) › Section 47-18-4902 - Part definitions

As used in this part:
(1)
"Biological sample" means a human material known to contain DNA, including tissue, blood, urine, or saliva;
(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 CFR 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.
Added by 2023 Tenn. Acts, ch. 324, s 1, eff. 7/1/2023.