(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.
As added by P.L.233-2025, SEC.2.