As used in this chapter, unless the context requires a different meaning:
"Affirmative authorization" means an action that demonstrates an intentional decision by a consumer.
"Biological sample" means any material part of the human, discharge therefrom, or derivative thereof, such as tissue, blood, urine, or saliva, known to contain deoxyribonucleic acid (DNA).
"Consumer" means a natural person who is a resident of the Commonwealth.
"Deidentified data" means data that cannot be used to infer information about, or otherwise be linked to, a particular individual, provided that the direct-to-consumer genetic testing company (i) takes reasonable measures to ensure that such information cannot be associated with a consumer or household;
(ii)publicly commits to maintain and use such informa
Free access — add to your briefcase to read the full text and ask questions with AI
As used in this chapter, unless the context requires a different meaning:
"Affirmative authorization" means an action that demonstrates an intentional decision by a consumer.
"Biological sample" means any material part of the human, discharge therefrom, or derivative thereof, such as tissue, blood, urine, or saliva, known to contain deoxyribonucleic acid (DNA).
"Consumer" means a natural person who is a resident of the Commonwealth.
"Deidentified data" means data that cannot be used to infer information about, or otherwise be linked to, a particular individual, provided that the direct-to-consumer genetic testing company (i) takes reasonable measures to ensure that such information cannot be associated with a consumer or household; (ii) publicly commits to maintain and use such information only in deidentified form and not to attempt to reidentify the information, except that the direct-to-consumer genetic testing company may attempt to reidentify the information solely for the purpose of determining whether its deidentification processes satisfy the requirements of this clause, provided that the direct-to-consumer genetic testing company does not use or disclose any information reidentified in this process and destroys the reidentified information upon completion of that assessment; and (iii) contractually obligates any recipients of the information to take reasonable measures to ensure that the information cannot be associated with a consumer or household and to commit to maintaining and using the information only in deidentified form and not to reidentify the information.
"Direct-to-consumer genetic testing company" means an entity that (i) offers consumer-initiated genetic testing products or services directly to a consumer or (ii) collects, uses, or analyzes genetic data that is collected or derived from a direct-to-consumer genetic testing product or service and is directly provided by a consumer. "Direct-to-consumer genetic testing company" does not include an entity when such entity is only engaged in collecting, using, or analyzing genetic data or biological samples in the context of research conducted in accordance with the (a) federal Common Rule, 45 C.F.R. Part 46; (b) International Conference on Harmonization Good Clinical Practice Guideline; or (c) U.S. Food and Drug Administration Policy for the Protection of Human Subjects, 21 C.F.R. Parts 50 and 56.
"Express consent" means a consumer's affirmative authorization to grant permission in response to a clear, meaningful, and prominent notice regarding the collection, use, maintenance, or disclosure of genetic data for a specific purpose.
"Genetic data" means any data, regardless of its format, that results from the analysis of a biological sample from a consumer, or from another element enabling equivalent information to be obtained, and concerns genetic material. Genetic material includes deoxyribonucleic acids (DNA), ribonucleic acids (RNA), genes, chromosomes, alleles, genomes, alterations, or modifications to DNA or RNA, and single nucleotide polymorphisms (SNPs). "Genetic data" includes uninterpreted data that results from the analysis of the biological sample and any information extrapolated, derived, or inferred therefrom. "Genetic data" does not include (i) deidentified data or (ii) data or a biological sample to the extent that data or a biological sample is collected, used, maintained, and disclosed exclusively for scientific research conducted by an investigator with an institution that holds an assurance with the U.S. Department of Health and Human Services pursuant to 45 C.F.R. Part 46, in compliance with all applicable federal and state laws and regulations for the protection of human subjects in research, including the Common Rule pursuant to 45 C.F.R. Part 46, U.S. Food and Drug Administration regulations pursuant to 21 C.F.R. Parts 50 and 56, and the federal Family Educational Rights and Privacy Act, 20 U.S.C. § 1232g.
"Genetic testing" means any laboratory test of a biological sample from a consumer for the purpose of determining information concerning genetic material contained within the biological sample, or any information extrapolated, derived, or inferred therefrom.
"Service provider" means a sole proprietorship, partnership, limited liability company, corporation, association, or other legal entity that is organized or operated for the profit or financial benefit of its shareholders or other owners that is involved in (i) the collection, transportation, and analysis of the consumer's biological sample or extracted genetic material (a) on behalf of the direct-to-consumer genetic testing company or (b) on behalf of any other company that collects, uses, maintains, or discloses genetic data collected or derived from a direct-to-consumer genetic testing product or service or directly provided by a consumer or (ii) the delivery of the results of the analysis of the biological sample or genetic material.