BILL NUMBER: SB 222AMENDED BILL TEXT AMENDED IN SENATE MAY 7, 2013 AMENDED IN SENATE APRIL 22, 2013 AMENDED IN SENATE APRIL 1, 2013 INTRODUCED BY Senator Padilla FEBRUARY 11, 2013 An act to add Chapter 2.6 (commencing with Section 56.18) to Part 2.6 of Division 1 of the Civil Code, relating to genetic information. LEGISLATIVE COUNSEL'S DIGEST SB 222, as amended, Padilla. Genetic information: privacy. Existing law prohibits discrimination on the basis of an individual's genetic information. Existing law protects the genetic test result contained in the medical records of an applicant to, or enrollee of, a health care service plan. Existing law establishes civil and criminal penalties for the negligent or willful disclosure of a persons genetic test results, as specified. This bill would enact the Genetic Information Privacy Act, which would declare that an individual's genetic information is protected by the right of privacy. The bill would prohibit any person from collecting, storing, analyzing, or disclosing genetic information without the written authorization of the individual to whom the information pertains, and would include related findings and declarations. It also would prescribe specific circumstances under which genetic information may be collected, stored, analyzed, or disclosed without the authorization. The bill would establish civil and criminal penalties for a violation of its provisions. By creating new crimes, this bill would impose a state-mandated local program. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. The Legislature finds and declares all of the following: (a) On October 11, 2012, the Presidential Commission for the Study of Bioethical Issues (commission) released a report titled "Privacy and Progress in Whole Genome Sequencing," recommending the adoptions of policies to help ensure privacy and security, as the field of genomics advances. (b) Various national and state policies are in place to protect personally identifiable health information and records. (c) The commission urges federal and state governments to ensure a consistent floor of privacy protections covering whole genome sequencing data regardless of how they were obtained. (d) Policies should protect individual genetic information by prohibiting the unauthorized use of surreptitious collection. (e) It is the intent of the Legislature to enact legislation that would protect individuals from the unauthorized collection, storage, and disclosure of their genetic information. (f) It is the intent of the Legislature to enact legislation that would ensure that genetic information is personal information that is not collected, stored, or disclosed without the individual's authorization. (g) It is the intent of the Legislature to enact legislation that would provide protections for the collection, storage, and authorized use of genetic information. (h) It is the intent of the Legislature to enact legislation that would promote the use of genetic information for legitimate reasons, including, but not limited to, health care, research, advancement of medicine, and educational purposes, as the field of genomics advances. SEC. 2. Chapter 2.6 (commencing with Section 56.18) is added to Part 2.6 of Division 1 of the Civil Code, to read: CHAPTER 2.6. GENETIC PRIVACY 56.18. (a) This chapter shall be known, and may be cited, as the Genetic Information Privacy Act. (b) For purposes of this chapter, the following definitions apply: (1) "Deidentified data" is health information that does not identify an individual, with respect to which there is no reasonable basis to believe that the information can be used to identify an individual. (2) "DNA sample" means a tissue, fluid, or other bodily sample of an individual on which a DNA analysis can be carried out. (3) "Genetic characteristic" means anyscientifically or medically identifiablegene or chromosome, or alteration thereof,that is known to be a cause of a disease or disorder, or that is determined to be associated with a statistically increased risk of development of a disease or disorder, and that is presently not associated with any symptoms of any disease or disorder.that may be tested to determine the existence or risk of a disease, disorder, trait, propensity, or syndrome, or to identify an individual or a blood relative, or to establish or disprove paternity, or to achieve other non-health-related purposes. (4) (A) "Genetic information" means information about any of the following: (i) An individual's genetic tests. (ii) The genetic tests of that individual's family members. (iii) The manifestation of disease or disorder in family members of the individual, generally referred to as family medical history. (iv) An individual's request for, or receipt of, genetic services, or the participation in clinical research that includes genetic services by the individual or a family member of the individual. (v) The genetic information of a fetus carried by an individual or by a pregnant woman who is a family member of the individual and the genetic information of any embryo legally held by the individual or family member using an assisted reproductive technology.(B) Genetic information does not include information about the sex or age of the individual, the sex or age of family members, or information about the race or ethnicity of the individual or family members that is not derived from a genetic test.(B) "Genetic information" also includes a DNA sample. (5) "Genetic service" means a genetic test, genetic education, or genetic counseling, including obtaining, interpreting, or assessing genetic information. (6) "Genetic test" means agenetic test; genetic counseling, including obtaining, interpreting, or assessing genetic information; or genetic education.test for determining the presence or absence of genetic characteristics in the individual or in the individual's blood relatives, including tests of nucleic acids such as DNA, RNA, and mitochondrial DNA, chromosomes, or proteins, in order to diagnose or determine a genetic characteristic. (7) "Person" means a natural person, trust or estate, partnership, corporation, limited liability company, professional association or corporation, or other entity, public or private. 56.18.1. (a) Genetic information is protected by the right of privacy pursuant to Section 1 of Article I of the California Constitution and, notwithstanding subdivision (c) of Section 56.10, or any other law, shall not be collected, stored, analyzed, or disclosed without the written authorization of the individual to whom the information pertains. (b) Any person who negligently violates subdivision (a) shall be assessed a civil penalty in an amount not to exceed one thousand dollars ($1,000) plus court costs, as determined by the court, which penalty and costs shall be paid to the individual to whom the genetic information pertains. (c) Any person who willfully violates subdivision (a) shall be assessed a civil penalty in an amount not less than one thousand dollars ($1,000) and not more than five thousand dollars ($5,000) plus court costs, as determined by the court, which penalty and costs shall be paid to the individual to whom the genetic information pertains. (d) Any person who willfully or negligently violates subdivision (a), where the violation results in economic, bodily, or emotional harm to the individual to whom the genetic information pertains, is guilty of a misdemeanor punishable by a fine not to exceed ten thousand dollars ($10,000). (e) In addition to the penalties listed in subdivisions (b) and (c), a person who commits an act described in subdivision (b) or (c) shall be liable to the person to whom the genetic information pertains for all actual damages, including damages for economic, bodily, and emotional harm that is proximately caused by that act. (f) Each violation of this section is a separate and actionable offense. (g) (1) Any person or entity that wishes to obtain genetic information, other than a person or entity authorized to receive genetic information pursuant to subdivision (h), shall obtain a valid authorization for the release of that information. The written authorization required by this subdivision shall do all of the following:(1)(A) Be written in plain language and in a typeface no smaller than 14-point type.(2)(B) Be dated and signed by the individual or a person authorized to act on behalf of the individual.(3)(C) Specify the types of persons authorized to disclose information about the individual.(4)(D) Specify the nature of the information authorized to be disclosed.(5)(E) State the name or functions of the persons or entities authorized to receive the information.(6)(F) Specify the purposes for which the information is being collected.(7)(G) Specify the length of time the authorization shall remain valid. (H) Advise the person signing the authorization of his or her right to control the use of his or her genetic information. (I) Advise the person signing the authorization of his or her right to revoke authorization at any time. (J) Advise the person signing the authorization as to whether his or her information will remain identifiable or whether measures will be taken to make the information nonidentifiable. (K) Advise the person signing the authorization that the genetic information and sample provided must be destroyed upon achieving that purpose.(8)(L) Advise the person signing the authorization of the right to receive a copy of the authorization. (2) Any person who collects, stores, analyzes, or discloses the genetic information of an individual shall comply with all of the following: (A) The person may not collect, store, analyze, or disclose the genetic information for any purpose other than the purpose authorized by the individual to whom the information pertains. (B) Once the specific purpose authorized by the individual to whom the genetic information pertains has been fulfilled, the individual' s genetic information and DNA sample shall be destroyed. (C) The person shall permit an individual to revoke an authorization signed pursuant to paragraph (1) at any time. (D) The person shall provide an individual who has signed an authorization pursuant to paragraph (1) with a copy of that authorization upon request. (h) (1) Genetic information may be collected, stored, analyzed, or disclosed without the authorization required by subdivision (g), in accordance with paragraph (2), provided that the entity may collect, store, analyze, or disclose the information only for the purposes specified. Use for any other purpose is subject to the authorization required by subdivision (a). (2) Genetic information may be collected, stored, analyzed, or disclosed under this subdivision, as follows: (A) By a law enforcement official or correctional officer in the execution of his or her official duties consistent with existing law. (B) By a hospital, laboratory, or physician carrying out court-ordered tests for genetic information. (C) By a licensed health care professional, as defined in Section 56.05, in a medical emergency. (D) By a coroner or medical examiner, in the execution of his or her official duties consistent with existing law. (E) For purposes of any screening of a newborn infant required by state or federal law. (F) If the information is in the form of deidentified data. (G) By any person or entity covered by and required to comply with any of the following: (i) The Health Insurance Portability and Accountability Act of 1996 (Public Law 104-191). (ii) Section 56.11 of the Confidentiality of Medical Information Act (Part 2.6 (commencing with Section 56)). (iii) Section 791.13, 10123.35 or Article 2.6 (commencing with Section 10146) of Chapter 1 or Part 2 of Division 2 of the Insurance Code. (iv) Section 50.25 of Title 21 of the Code of Federal Regulations. (v) Section 46.116 of Title 28 of the Code of Federal Regulations. SEC. 3. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.