Montana Code 30-23-103. Exceptions
30-23-103. Exceptions. (1) This part does not apply to:
Terms Used In Montana Code 30-23-103
- Consumer: means an individual who is a resident of this state. See Montana Code 30-23-102
- Entity: means a partnership, corporation, association, or public or private organization of any character that:
(a)offers consumer genetic testing products or services directly to a consumer; or
(b)collects, uses, or analyzes genetic data. See Montana Code 30-23-102
- Express consent: means a consumer's affirmative response to a clear, meaningful, and prominent notice regarding the collection, use, or disclosure of genetic data for a specific purpose. See Montana Code 30-23-102
- Genetic data: means any data, regardless of format, concerning a consumer's genetic characteristics. See Montana Code 30-23-102
- Governmental agency: means an executive, legislative, or judicial agency, department, board, commission, authority, institution, or instrumentality of the federal government or of a state or of a county, municipality, or other political subdivision of a state. See Montana Code 30-23-102
- Guardian: A person legally empowered and charged with the duty of taking care of and managing the property of another person who because of age, intellect, or health, is incapable of managing his (her) own affairs.
- Power of attorney: A written instrument which authorizes one person to act as another's agent or attorney. The power of attorney may be for a definite, specific act, or it may be general in nature. The terms of the written power of attorney may specify when it will expire. If not, the power of attorney usually expires when the person granting it dies. Source: OCC
- State: when applied to the different parts of the United States, includes the District of Columbia and the territories. See Montana Code 1-1-201
- United States: includes the District of Columbia and the territories. See Montana Code 1-1-201
(a)protected health information that is collected by a covered entity or business associate as those terms are defined in 45 CFR, parts 160 and 164, if separate informed consent related to the collection, use, and dissemination of genetic data is obtained from the consumer, parent, guardian, or power of attorney, and the covered entity or business associate follows the policies under 30-23-104(6)(a) through (6)(d);
(b)an entity when it is engaged only in collecting, using, or analyzing genetic data or biological samples in the context of research as defined in 45 C.F.R. § 164.501 conducted with the express consent of an individual and in accordance with:
(i)the federal policy for the protection of human research subjects under 45 CFR, part 46, the good clinical practice guideline issued by the international council for harmonisation of technical requirements for pharmaceuticals for human use; or
(ii)the United States food and drug administration policy for the protection of human subjects under 21 CFR, parts 50 and 56; or
(c)uses by a governmental agency.
(2)Beginning June 1, 2025, any collection, storage, use, or dissemination of genetic data by a governmental agency must be performed in accordance with a specific state law or executed through a search warrant.