Montana Governor Greg Gianforte has signed SB 351, the Genetic Information Privacy Act (GINA), which “requires an entity to provide consumer information regarding the collection, use, and disclosure of genetic data; providing for limitations and exclusions; providing for enforcement authority; and providing definitions.”
GINA requires entities that collect genetic data, defined as:
any data, regardless of format, concerning a consumer’s genetic characteristics, which includes but is not limited to:
(i) raw sequence data that result from sequencing all or a portion of a consumer’s extracted DNA;
(ii) genotypic and phenotypic information obtained from analyzing a consumer’s raw sequence data; and
(iii) self-reported health information regarding a consumer’s health conditions that the consumer provides to an entity that the entity:
(A) uses for scientific research or product development; and
(B) analyzes in connection with the consumer’s raw sequence data.
GINA applies to any entity that offers consumer genetic testing products or services (like 23andMe and Ancestry.com) directly to a consumer, or collects, uses, or analyzes genetic data. It does not apply to genetic testing that is covered by HIPAA, which would include genetic testing done through a physician or hospital.