(1) 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.
(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
(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;
(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.