                                 CODE OF VIRGINIA

DEFINITIONS (§ 59.1-593)

As used in this chapter, unless the context requires a different meaning:
		&#8220;Affirmative authorization&#8221; means an action that demonstrates an
intentional decision by a consumer.
		&#8220;Biological sample&#8221; 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).
		&#8220;Consumer&#8221; means a natural person who is a resident of the
Commonwealth.
		&#8220;Deidentified data&#8221; 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.
		&#8220;Direct-to-consumer genetic testing company&#8221; 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. &#8220;Direct-to-consumer genetic testing
company&#8221; 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.
		&#8220;Express consent&#8221; means a consumer&#8217;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.
		&#8220;Genetic data&#8221; 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).
&#8220;Genetic data&#8221; includes uninterpreted data that results from the
analysis of the biological sample and any information extrapolated, derived, or
inferred therefrom. &#8220;Genetic data&#8221; 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.
		&#8220;Genetic testing&#8221; 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.
		&#8220;Service provider&#8221; 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&#8217;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.

HISTORY: 2023, c. 526.