00 SENATE BILL NO. 217 01 "An Act relating to genetic privacy; and amending Rule 82, Alaska Rules of Civil 02 Procedure, and Rule 508, Alaska Rules of Appellate Procedure." 03 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 04 * Section 1. AS 18 is amended by adding a new chapter to read: 05 Chapter 13. Genetic Privacy. 06 Sec. 18.13.010. Legislative findings; purposes. (a) The legislature finds that 07 (1) the DNA molecule contains information about the probable 08 medical future of an individual and the individual's blood relatives; this information is 09 written in a code that is rapidly being deciphered; 10 (2) genetic information is uniquely private and personal information 11 that generally should not be collected, retained, or disclosed without the individual's 12 authorization; 13 (3) the improper collection, retention, or disclosure of genetic 14 information can lead to significant harm to an individual and the individual's blood 01 relatives, including stigmatization and discrimination in areas such as employment, 02 education, health care, and insurance; 03 (4) an analysis of an individual's DNA provides information not only 04 about the individual, but also about blood relatives of the individual, with the potential 05 for affecting family privacy, including reproductive decisions; 06 (5) current legal protections for medical information, tissue samples, 07 and DNA samples are inadequate to protect genetic privacy; and 08 (6) laws for the collection, storage, and use of identifiable DNA 09 samples and private genetic information obtained from those samples are needed both 10 to protect individual and family privacy and to permit and encourage legitimate 11 scientific and medical research. 12 (b) The purposes of this chapter are as follows: 13 (1) to define the rights of individuals whose genetic information is 14 collected, retained, or disclosed and the rights of the individuals' blood relatives; 15 (2) to define the circumstances under which an individual may be 16 subjected to genetic testing; 17 (3) to define the circumstances under which an individual's genetic 18 information may be collected, retained, or disclosed; 19 (4) to protect against discrimination by an insurer or employer based 20 upon an individual's genetic characteristics; and 21 (5) to define the circumstances under which a DNA sample or genetic 22 information may be used for research. 23 Sec. 18.13.020. Informed consent for obtaining genetic information. (a) A 24 person may not obtain genetic information from an individual or from an individual's 25 DNA sample without first obtaining informed consent of the individual or the 26 individual's representative, except 27 (1) as authorized by AS 44.41.035 or comparable provisions of another 28 jurisdiction relating to the identification of persons, or for the purpose of establishing 29 the identity of a person in the course of an investigation conducted by a law 30 enforcement agency, the Department of Law, or a medical examiner; 31 (2) for anonymous research conducted after notification as provided in 01 AS 18.13.030(b); 02 (3) as permitted by regulations of the Department of Health and Social 03 Services for identification of, or testing to benefit blood relatives of, deceased 04 individuals; 05 (4) as permitted by regulations of the Department of Health and Social 06 Services for newborn screening procedures; or 07 (5) as authorized by statute for the purpose of establishing paternity. 08 (b) Except as provided in (c) of this section, a physician licensed under 09 AS 08.64 shall seek the informed consent of the individual or the individual's 10 representative for the purposes of (a) of this section in the manner the physician 11 obtains informed consent for medical procedures. Except as provided in (c) of this 12 section, any other licensed health care provider or facility must seek the informed 13 consent of the individual or the individual's representative for the purposes of (a) of 14 this section in a manner substantially similar to the manner physicians obtain informed 15 consent for medical procedures. 16 (c) A person conducting research shall seek the informed consent of the 17 individual or the individual's representative for the purposes of (a)(2) of this section in 18 the manner provided by AS 18.13.030. 19 (d) Except as provided in AS 44.41.035, any person not described in (b) or (c) 20 of this section must seek the informed consent of the individual or the individual's 21 representative for the purposes of (a)(3) - (5) of this section in the manner provided by 22 regulations adopted by the Department of Health and Social Services. 23 (e) The Department of Health and Social Services may not adopt regulations 24 under (a)(4) of this section that would require the providing of a DNA sample for the 25 purpose of obtaining complete genetic information used to screen all newborns. 26 Sec. 18.13.030. Individual's rights in genetic information; retention of 27 information; destruction of information. (a) Subject to the other provisions of this 28 chapter, an individual's genetic information and DNA sample are private and must be 29 protected, and an individual has a right to the protection of that privacy. Any person 30 authorized by law or by an individual or an individual's representative to obtain, 31 retain, or use an individual's genetic information or any DNA sample shall maintain 01 the confidentiality of the information or sample and protect the information or sample 02 from unauthorized disclosure or misuse. 03 (b) A person may use an individual's DNA sample or genetic information for 04 anonymous research only if the individual was notified the sample or genetic 05 information may be used for anonymous research and the individual did not, at the 06 time of notification, request that the sample not be used for anonymous research. The 07 Department of Health and Social Services shall adopt regulations to implement this 08 subsection after considering similar federal regulations. 09 (c) A person may not retain another individual's genetic information or DNA 10 sample without first obtaining authorization from the individual or the individual's 11 representative, unless retention is 12 (1) authorized by AS 44.41.035 or comparable provisions of another 13 jurisdiction relating to identification of persons, or is necessary for the purpose of a 14 criminal or death investigation, a criminal or juvenile proceeding, an inquest, or a 15 child fatality review by a multidisciplinary child protection team; 16 (2) authorized by specific court order under rules adopted by the 17 Alaska Supreme Court for civil actions; 18 (3) permitted by regulations of the Department of Health and Social 19 Services for identification of, or testing to benefit blood relatives of, deceased 20 individuals; 21 (4) permitted by regulations of the Department of Health and Social 22 Services for newborn screening procedures; or 23 (5) for anonymous research conducted after notification under (b) of 24 this section. 25 (d) The DNA sample of an individual from which genetic information has 26 been obtained shall be destroyed promptly upon the specific request of that individual 27 or the individual's representative, unless retention is 28 (1) authorized by AS 44.41.035 or comparable provisions of another 29 jurisdiction relating to identification of persons, or is necessary for the purpose of a 30 criminal or death investigation, a criminal or juvenile proceeding, an inquest, or a 31 child fatality review by a multidisciplinary child protection team; 01 (2) authorized by specific court order under rules adopted by the 02 Alaska Supreme Court for civil actions; or 03 (3) for anonymous research conducted after notification under (b) of 04 this section. 05 (e) A DNA sample from an individual that is the subject of a research project, 06 other than an anonymous research project, shall be destroyed promptly upon 07 completion of the project or withdrawal of the individual from the project, whichever 08 occurs first, unless the individual or the individual's representative directs otherwise 09 by informed consent. 10 (f) A DNA sample from an individual for insurance or employment purposes 11 shall be destroyed promptly after the purpose for which the sample was obtained has 12 been accomplished unless retention is authorized by specific court order under rules 13 adopted by the Alaska Supreme Court. 14 (g) An individual or an individual's representative, promptly upon request, 15 may inspect, request correction of, and obtain genetic information from the records of 16 the individual, unless the genetic information has been made anonymous by 17 destruction of all information that could allow disclosure of the identity of the 18 individual who provided the sample or the identity of the individual's blood relatives. 19 (h) Subject to the other provisions of this chapter, and to policies adopted by 20 the person in possession of a DNA sample, an individual or the individual's 21 representative may request that the individual's DNA sample be made available for 22 additional genetic testing for medical diagnostic purposes. If the individual is deceased 23 and has not designated a representative to act on behalf of the individual after death, a 24 request under this subsection may be made by the closest surviving blood relative of 25 the decedent or, if there is more than one surviving blood relative of the same degree 26 of relationship to the decedent, by the majority of the surviving closest blood relatives 27 of the decedent. 28 (i) The Department of Health and Social Services shall coordinate the 29 implementation of this section. 30 (j) This section applies only to genetic information that can be identified as 31 belonging to an individual or the individual's blood relative. This section does not 01 apply to a law, contract, or other arrangement that determines a person's rights to 02 compensation relating to substances or information derived from an individual's DNA 03 sample. 04 Sec. 18.13.040. Disclosure of genetic information; exceptions. (a) 05 Regardless of the manner of receipt or the source of genetic information, including 06 information received from an individual or a blood relative of the individual, a person 07 may not disclose or be compelled, by subpoena or any other means, to disclose the 08 identity of an individual upon whom a genetic test has been performed or the identity 09 of a blood relative of the individual, or to disclose genetic information about the 10 individual or a blood relative of the individual in a manner that permits identification 11 of the individual or a blood relative of the individual, unless disclosure is 12 (1) authorized by AS 44.41.035 or comparable provisions of another 13 jurisdiction relating to identification of persons, or is necessary for the purpose of a 14 criminal or death investigation, a criminal or juvenile proceeding, an inquest, or a 15 child fatality review by a multidisciplinary child protection team; 16 (2) required by specific court order entered under rules adopted by the 17 Alaska Supreme Court for civil actions; 18 (3) authorized by statute for the purpose of establishing paternity; 19 (4) specifically authorized by the tested individual or the tested 20 individual's representative by signing a consent form prescribed by regulations of the 21 Department of Health and Social Services; or 22 (5) for identification of, or testing to benefit blood relatives of, 23 deceased individuals. 24 (b) The prohibitions of this section apply to redisclosure by a person after 25 another person has disclosed genetic information or the identity of an individual upon 26 whom a genetic test has been performed, or has disclosed genetic information or the 27 identity of a blood relative of the individual. 28 (c) A release or publication is not a disclosure if 29 (1) it involves a good faith belief by the person who caused the release 30 or publication that the person was not in violation of this section; 31 (2) it is not due to intentional conduct or gross negligence; 01 (3) it is corrected in the manner described in AS 18.13.050(c); 02 (4) the correction with respect to genetic information is completed 03 before the information is read or heard by a third party; and 04 (5) the correction with respect to DNA samples is completed before 05 the sample is retained or genetically tested by a third party. 06 Sec. 18.13.050. Private right of action; remedies; affirmative defense; 07 attorney fees. (a) An individual or an individual's blood relative, representative, or 08 estate may bring a civil action against a person who violates a provision of this 09 chapter. 10 (b) For a violation of this chapter, the court shall award the greater of actual 11 damages or 12 (1) $1,000 for an inadvertent violation that does not arise out of the 13 negligence of the defendant; 14 (2) $5,000 for a negligent violation; 15 (3) $100,000 for a knowing or reckless violation; 16 (4) $150,000 for a knowing violation based on a fraudulent 17 misrepresentation; or 18 (5) $250,000 for a knowing violation committed with intent to sell, 19 transfer, or use for commercial advantage, personal gain, or malicious harm. 20 (c) It is an affirmative defense to an action described in (b)(1) or (2) of this 21 section that the defendant corrected the violation through destruction of illegally 22 retained or obtained samples or information, or took other action to correct the 23 violation, if the correction was completed within 120 days after the defendant knew or 24 should have known that the violation occurred. 25 (d) The court may provide the equitable relief it considers necessary or proper. 26 (e) The court may award attorney fees to a defendant only if the court finds 27 that the plaintiff did not have an objectively reasonable basis for asserting a claim or 28 for appealing an adverse decision of the trial court. 29 (f) An action authorized by (a) of this section must be commenced within 30 three years after the date the plaintiff knew or should have known of the violation, but 31 in no instance more than 10 years after the date of the violation. 01 (g) A plaintiff may recover damages provided by this section for each 02 violation by a defendant. 03 Sec. 18.13.060. Criminal penalty. (a) A person commits the crime of 04 unlawfully obtaining, retaining, or disclosing genetic information if the person, with 05 criminal negligence, obtains, retains, or discloses genetic information in violation of 06 this chapter. 07 (b) In this section, "criminal negligence" has the meaning given in 08 AS 11.81.900. 09 (c) Unlawfully obtaining, retaining, or disclosing genetic information is a 10 Class A misdemeanor. 11 Sec. 18.13.070. Enforcement; Department of Law; intervention. (a) The 12 attorney general may bring an action against a person who violates this chapter. In 13 addition to remedies otherwise available or provided in this chapter, the court shall 14 award to the attorney general the costs of this investigation. 15 (b) The attorney general may intervene in a civil action brought under this 16 chapter if the attorney general certifies that, in the opinion of the attorney general, the 17 action is of general public importance. In the action, the attorney general shall be 18 entitled to the same relief as if the attorney general had instituted the action under this 19 section. 20 Sec. 18.13.080. Department of Health and Social Services regulations; 21 procedures. (a) The Department of Health and Social Services shall adopt regulations 22 for conducting research using DNA samples, genetic testing, and genetic information. 23 Regulations establishing minimum research standards must conform to the Federal 24 Policy for the Protection of Human Subjects, 45 C.F.R. 46, that is current at the time 25 the rules are adopted. The regulations may be changed from time to time as may be 26 necessary. 27 (b) The regulations adopted by the Department of Health and Social Services 28 must address the operation and appointment of institutional review boards. The 29 regulations must conform to the compositional and operational standards for 30 institutional review boards contained in the Federal Policy for the Protection of 31 Human Subjects that is current at the time the regulations are adopted. The 01 regulations must require that research conducted under (a) of this section be conducted 02 with the approval of an institutional review board. 03 (c) Persons proposing to conduct anonymous research or genetic research that 04 is otherwise thought to be exempt from review shall, before conducting the research, 05 obtain a determination from an institutional review board that the proposed research is 06 exempt from review. 07 (d) A person proposing to conduct research under this section, including 08 anonymous research, shall disclose to an institutional review board the proposed use 09 of DNA samples, genetic testing, or genetic information. 10 (e) The Department of Health and Social Services shall adopt regulations 11 requiring that all institutional review boards operating under (b) of this section register 12 with the department. 13 (f) Research conducted in accordance with this section is rebuttably presumed 14 to comply with this chapter. 15 (g) In cases in which informed consent is required by this chapter or the 16 Federal Policy for the Protection of Human Subjects, samples collected before the 17 effective date of this Act with blanket informed consent for research may be used for 18 genetic research without specific informed consent, but samples obtained after the 19 effective date of this Act must have specific informed consent from the individual for 20 genetic research. 21 (h) Except as otherwise allowed by regulation of the Department of Health 22 and Social Services, if DNA samples or genetic information obtained for either 23 clinical or research purposes is used in research, a person may not recontact the 24 individual or the individual's physician by using research information with personal 25 identifiers. The Department of Health and Social Services shall adopt by regulation 26 criteria for recontacting an individual or an individual's physician. In adopting the 27 criteria, the department shall consider the recommendations of national organizations 28 such as those created by executive order by the President of the United States. 29 Sec. 18.13.100. Definitions. In this chapter, 30 (1) "anonymous research" means scientific or medical research 31 conducted in such a manner that the identity of an individual who has provided a 01 sample, or the identity of an individual from whom genetic information has been 02 obtained or the identity of the individual's blood relatives, cannot be determined; 03 (2) "blanket informed consent" means that the individual has 04 consented to the use of the individual's DNA sample or health information for any 05 future research, but has not been provided with a description of or consented to the use 06 of the sample in genetic research or any specific genetic research project; 07 (3) "blood relative" means a person who is 08 (A) related by blood to an individual; and 09 (B) a parent, sibling, son, daughter, grandparent, grandchild, 10 aunt, uncle, first cousin, niece, or nephew of the individual; 11 (4) "clinical" means relating to or obtained through the actual 12 observation, diagnosis, or treatment of patients and not through research; 13 (5) "disclose" means to release, publish, or otherwise make known to a 14 third party a DNA sample or genetic information; 15 (6) "DNA" means deoxyribonucleic acid; 16 (7) "DNA sample" means any human biological specimen that is 17 obtained or retained for the purpose of extracting and analyzing DNA to perform a 18 genetic test; "DNA sample" includes DNA extracted from the specimen; 19 (8) "genetic characteristic" includes a gene, chromosome, or alteration 20 of a gene or chromosome that may be tested to determine the existence or risk of a 21 disease, disorder, trait, propensity, or syndrome, or to identify an individual or a blood 22 relative; "genetic characteristic" does not include family history or a genetically 23 transmitted characteristic whose existence or identity is determined other than through 24 a genetic test; 25 (9) "genetic information" means information about an individual or the 26 individual's blood relatives obtained from a genetic test; 27 (10) "genetic research" means research using DNA samples, genetic 28 testing, or genetic information; 29 (11) "genetic test" means a test for determining the presence or 30 absence of genetic characteristics in an individual or the individual's blood relatives, 31 including tests of nucleic acids such as DNA, RNA, mitochondrial DNA, 01 chromosomes, or proteins in order to diagnose or determine a genetic characteristic; 02 (12) "obtain genetic information" means performing or getting the 03 results of a genetic test; 04 (14) "research" means a systematic investigation, including research 05 development, testing, and evaluation, designed to develop or contribute to generalized 06 knowledge; 07 (15) "retain," 08 (A) when used with regard to a DNA sample, means the act of 09 storing the DNA sample; 10 (B) when used with regard to genetic information, means 11 making a record of the genetic information. 12 * Sec. 2. The uncodified law of the State of Alaska is amended by adding a new section to 13 read: 14 INDIRECT COURT AMENDMENTS. AS 18.13.050(e), added by sec. 1 of this Act, 15 has the effect of amending Rule 82, Alaska Rules of Civil Procedure, and Rule 508, Alaska 16 Rules of Appellate Procedure, relating to the awarding of attorney fees.