Sec. 1. (a) As used in this chapter, "consumer genetic testing" means a service in which a person: (1) provides an individual with a means of submitting a sample of the individual's biological material directly to the person; (2) performs, or causes to be performed, genetic testing on the submitted biological material; and (3) returns the results of the genetic testing directly to the individual. (b) The term does not include genetic testing: (1) of biological material of a patient of a health care provider (as defined in IC 16-18-2-163 (a)), the collection and testing of which is: (A) performed at the request or direction of the health care provider for the purpose of the diagnosis, cure, mitigation, treatment, or prevention of a physical or mental illness, injury, disease, disorder, or disability; and (B) subject to the Health Insurance Portability and Accountability Act (HIPAA) (P.L. 104-191); (2) performed as required by a court order; (3) performed for purposes of a law enforcement investigation at the request or direction of a law enforcement agency; (4) performed at the request or direction of a coroner or medical examiner for purposes of investigating the cause of an individual's death; or (5) performed for purposes of research (as defined in 45 CFR 164.501) that is subject to: (A) 21 CFR 50 and 21 CFR 56; or (B) 45 CFR 46.
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