{"data":{"id":"us-tn/tenn.-code-ann.-47-18-4902","jurisdiction":"us-tn","citation":"Tenn. Code Ann. § 47-18-4902","heading":"Part definitions","body":"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.\nAs used in this part:\n(1) \"Biological sample\" means a human material known to contain DNA, including tissue, blood, urine, or saliva;\n(2) \"Consumer\" means an individual who is a resident of the state;\n'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.\nAs used in this part:\n(1) \"Biological sample\" means a human material known to contain DNA, including tissue, blood, urine, or saliva;\n(2) \"Consumer\" means an individual who is a resident of the state;\n(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;\n(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\n(i) Cannot reasonably be linked to an identifiable individual; or\n(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\n(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;\n(i) Takes administrative and technical measures to ensure that the data cannot be associated with a particular consumer;\n(ii) Makes a public commitment to maintain and use data in deidentified form and not attempt to reidentify data; and\n(iii) Enters into a legally enforceable contractual obligation that prohibits a recipient of the data from attempting to reidentify the data;\n(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;\n(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\ne United States Food and Drug Administration Policy for the Protection of Human Subjects under 21 CFR Parts 50 and 56;\n(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\n(i) Offers consumer genetic testing products or services directly to a consumer; or\n(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\n(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;\n(i) A law enforcement agency; or\n(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;\n(a) The Federal Policy for the Protection of Human Subjects, as described in 45 CFR Part 46;\n(b) The Good Clinical Practice Guideline issued by the International Council for Harmonization; or\n(c) The United States Food and Drug Administration Policy for the Protection of Human Subjects under 21 CFR Parts 50 and 56;\n(5) \"DNA\" means deoxyribonucleic acid;\n(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;\n(7) \"First-party relationship\" means the relationship between a company and a consumer from which the company has collected genetic data;\n(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;\n(A) Raw sequence data that results from sequencing all or a portion of a consumer's extracted DNA;\n(B) Genotypic and phenotypic information obtained from analyzing a consumer's raw sequence data; or\n(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;\nn of a consumer's extracted DNA;\n(B) Genotypic and phenotypic information obtained from analyzing a consumer's raw sequence data; or\n(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(i) Uses for scientific research or product development; and\n(ii) Analyzes in connection with the consumer's raw sequence data;\n(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\n(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\n(B) An interpretation of a consumer's genetic data; and\n(10) \"Person\" means an individual, corporation, business, partnership, limited liability company, or other business entity.","path":["TN Code","Title 47","Chapter 18"],"source_url":"https://oss-data-us.vaquill.ai/v2026.08/us_tn_statutes.parquet","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:26Z","sha256":"5da39de0190b3b5b78e9210d4c13e03fcf815cbb837f4cfab3ef9db7ba7b8241","source_id":"us-tn","stale":false,"prev":"us-tn/tenn.-code-ann.-47-18-4901","next":"us-tn/tenn.-code-ann.-47-18-4903"},"notice":"GroundRules: Original legal text. Not legal advice."}