Tenn. Code Ann. § 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.

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;

'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.

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;

(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

(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;

(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;

(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

e United States Food and Drug Administration Policy for the Protection of Human Subjects under 21 CFR Parts 50 and 56;

(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

(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;

(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;

(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;

(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;

n 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;

(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

(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.