BILL NUMBER: SB 222 AMENDED
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 any scientifically or
medically identifiable gene 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 a genetic 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.