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 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.

GINA requires covered entities to provide clear notice to consumers about the collection, use and disclosure of their genetic information through their privacy policy and to obtain “express consent” from the consumer for the collection, use, and disclosure of the genetic data. Separate informed consent is required for the disclosure of genetic data to a third party.

The new law codifies basic notice and consent ideals for the collection of sensitive data from consumers that consumers may mistakenly believe HIPAA applies to genetic information. (See previous Privacy Tip on disclosure of genetic information). This emphasizes how important reading an entity’s website privacy policy is before you send a swab to a genetic testing company. GINA gives the Montana Attorney General jurisdiction to enforce violations of the law, including actual damages to a consumer, attorney’s fees, and costs and up to $2500 per violation.