This section defines terms used in the chapter, including biological sample, consumer, contractor, deidentified data, DNA, express consent, genetic data, genetic testing, genetic testing company, and health care provider.
For purposes of this chapter, the following words have the following meanings: (1) BIOLOGICAL SAMPLE. Any human material known to contain DNA, including, but not limited to, tissue, saliva, blood, or urine. (2) CONSUMER. Any individual who is an Alabama resident. (3) CONTRACTOR. A person that contracts with a genetic testing company to provide a service necessary to the genetic testing company’s consumer products or services which requires possession of a consumer’s biological sample or genetic data, including laboratory facilities for genetic testing. (4) DEIDENTIFIED DATA. Genetic data possessed by a genetic testing company which cannot be used to infer information about, or otherwise be linked to, an identifiable consumer and which either meets the requirements for deidentification of genetic data set forth in 45 C.F.R. § 164.514 or is subject to the following: a. Administrative and technical measures put in place by the genetic testing company to ensure that the data cannot be associated with an identified consumer. b. A public commitment by the genetic testing company to undertake all of the following: 1. Maintain and use the data only in a deidentified form. 2. Prohibit any attempts to reidentify the data. 3. Take legal action to enforce contractual obligations that prohibit any recipient of the data from attempting to reidentify the data. (5) DNA. Deoxyribonucleic acid. (6) EXPRESS CONSENT. A consumer’s acknowledgment or permission, in writing or captured electronically, to a clear, meaningful, and prominent written notice regarding the collection, use, retention, or disclosure of the consumer’s biological sample or genetic data for a specific purpose. (7) GENETIC DATA. a. Any data derived from analysis of a biological sample which concerns a consumer’s genetic characteristics and which may include, but is not limited to, any of the following formats or sources: 1. Raw data that results from sequencing all or a portion of a consumer’s extracted DNA. 2. Genotypic and phenotypic information obtained from analyzing a consumer’s raw sequence data. 3. Health information self-reported by the consumer to a genetic testing company to be used by the company in connection with analyzing the consumer’s raw sequence data or for product development or scientific research. b. Genetic data does not include deidentified data. (8) GENETIC TESTING. Laboratory testing of a consumer’s biological sample to analyze DNA, including, but not limited to, chromosomes and single nucleotide polymorphisms in order to derive and interpret genetic data. (9) GENETIC TESTING COMPANY or COMPANY. Any person, other than a health care provider, who directly solicits a biological sample from a consumer for analysis in order to provide products or services to the consumer which include disclosure of information that may include, but is not limited to, the following: a. The genetic link of the consumer to certain population groups based on ethnicity, geography, or anthropology. b. The probable relationship of the consumer to other individuals based on matching DNA for purposes that include genealogical research. c. Recommendations to the consumer for managing wellness which are based on physical or metabolic traits, lifestyle tendencies, or disease predispositions that are associated with genetic markers present in the consumer’s DNA. (10) HEALTH CARE PROVIDER. Any hospital, as defined in Section 22-21-20, licensed by the Alabama Department of Public Health, and any physician, nurse, or other licensed medical practitioner, whether in individual, group, professional corporation, or professional association practice, which provides diagnostic services or treatment for a patient of the hospital, physician, nurse, or other licensed medical practitioner.