<?xml version="1.0"?>
<law><site_title>Virginia Decoded</site_title><site_url>https://vacode.org</site_url><law_id>63239</law_id><section_number>59.1-593</section_number><catch_line>Definitions</catch_line><edition url="https://vacode.org/2025/" slug="2025" current="TRUE" last_updated="">2025</edition><structure><unit label="title" level="1" order_by="1" identifier="59.1">Trade and Commerce</unit><unit label="chapter" level="2" order_by="1" identifier="56">Genetic Data Privacy</unit></structure><text>
						<section><p>As used in this chapter, unless the context requires a different meaning:
		&#x201C;<span class="dictionary">Affirmative authorization</span>&#x201D; means an action that demonstrates an intentional decision by a <span class="dictionary">consumer</span>.
		&#x201C;<span class="dictionary">Biological sample</span>&#x201D; means any <span class="dictionary">material</span> part of the human, discharge therefrom, or derivative thereof, such as tissue, blood, urine, or saliva, known to contain deoxyribonucleic acid (DNA).
		&#x201C;<span class="dictionary">Consumer</span>&#x201D; means a natural person who is a resident of the Commonwealth.
		&#x201C;<span class="dictionary">Deidentified data</span>&#x201D; means data that cannot be used to infer information about, or otherwise be linked to, a particular individual, provided that the <span class="dictionary">direct-to-<span class="dictionary">consumer</span> genetic testing company</span> (i) takes reasonable measures to ensure that such information cannot be associated with a <span class="dictionary">consumer</span> 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 <span class="dictionary">direct-to-<span class="dictionary">consumer</span> genetic testing company</span> 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 <span class="dictionary">direct-to-<span class="dictionary">consumer</span> genetic testing company</span> 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 <span class="dictionary">consumer</span> or household and to commit to maintaining and using the information only in deidentified form and not to reidentify the information.
		&#x201C;<span class="dictionary">Direct-to-<span class="dictionary">consumer</span> genetic testing company</span>&#x201D; means an entity that (i) offers <span class="dictionary">consumer</span>-initiated genetic testing products or services directly to a <span class="dictionary">consumer</span> or (ii) collects, uses, or analyzes <span class="dictionary">genetic data</span> that is collected or derived from a direct-to-<span class="dictionary">consumer</span> genetic testing product or service and is directly provided by a <span class="dictionary">consumer</span>. &#x201C;<span class="dictionary">Direct-to-<span class="dictionary">consumer</span> genetic testing company</span>&#x201D; does not include an entity when such entity is only engaged in collecting, using, or analyzing <span class="dictionary">genetic data</span> or <span class="dictionary">biological samples</span> 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.
		&#x201C;<span class="dictionary">Express consent</span>&#x201D; means a <span class="dictionary">consumer</span>&#x2019;s <span class="dictionary">affirmative authorization</span> to grant permission in response to a clear, meaningful, and prominent notice regarding the collection, use, maintenance, or disclosure of <span class="dictionary">genetic data</span> for a specific purpose.
		&#x201C;<span class="dictionary">Genetic data</span>&#x201D; means any data, regardless of its format, that results from the analysis of a <span class="dictionary">biological sample</span> from a <span class="dictionary">consumer</span>, or from another element enabling equivalent information to be obtained, and concerns genetic <span class="dictionary">material</span>. Genetic <span class="dictionary">material</span> includes deoxyribonucleic acids (DNA), ribonucleic acids (RNA), genes, chromosomes, alleles, genomes, alterations, or modifications to DNA or RNA, and single nucleotide polymorphisms (SNPs). &#x201C;<span class="dictionary">Genetic data</span>&#x201D; includes uninterpreted data that results from the analysis of the <span class="dictionary">biological sample</span> and any information extrapolated, derived, or inferred therefrom. &#x201C;<span class="dictionary">Genetic data</span>&#x201D; does not include (i) <span class="dictionary">deidentified data</span> or (ii) data or a <span class="dictionary">biological sample</span> to the extent that data or a <span class="dictionary">biological sample</span> 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 <span class="dictionary">laws</span> 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. &#xA7;&#xA0;1232g.
		&#x201C;Genetic testing&#x201D; means any laboratory test of a <span class="dictionary">biological sample</span> from a <span class="dictionary">consumer</span> for the purpose of determining information concerning genetic <span class="dictionary">material</span> contained within the <span class="dictionary">biological sample</span>, or any information extrapolated, derived, or inferred therefrom.
		&#x201C;<span class="dictionary">Service provider</span>&#x201D; 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 <span class="dictionary">consumer</span>&#x2019;s <span class="dictionary">biological sample</span> or extracted genetic <span class="dictionary">material</span> (a) on behalf of the <span class="dictionary">direct-to-<span class="dictionary">consumer</span> genetic testing company</span> or (b) on behalf of any other company that collects, uses, maintains, or discloses <span class="dictionary">genetic data</span> collected or derived from a direct-to-<span class="dictionary">consumer</span> genetic testing product or service or directly provided by a <span class="dictionary">consumer</span> or (ii) the delivery of the results of the analysis of the <span class="dictionary">biological sample</span> or genetic <span class="dictionary">material</span>.</p></section></text><history>2023, c. 526.</history><metadata></metadata></law>
