BILL NUMBER: SB 222 AMENDED
BILL TEXT
AMENDED IN SENATE JANUARY 14, 2014
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 obtaining or analyzing a DNA sample, as
defined, without the written authorization of the
individual to whom the information DNA sample
pertains, and would include related findings and declarations.
It also would prescribe specific circumstances under which
genetic information a DNA sample may be
collected, obtained, stored, or
analyzed, or genetic test results 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 adoption 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.
effectively protect individually identifiable health
information, biosamples used in academic research and
records, including genetic information.
(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)
(c) Policies should protect individual genetic
information by prohibiting the unauthorized use of surreptitious
collection.
(d) It is the intent of the Legislature to enact legislation to
extend established protections to individually identifiable genetic
information not covered by existing national or state policies.
(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.
and analysis of their DNA samples and genetic characteristics.
(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)
(f) 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 , in accordance with Section 164.514 of Title 45 of
the Code of Federal Regulations .
(2) "DNA sample" means a tissue, fluid, or other bodily
sample of an individual on which a DNA analysis can be carried out.
a human biological specimen that is
obtained or retained for the purpose of extracting and analyzing DNA
to perform a genetic test.
(3) "Genetic characteristic" means any gene or
chromosome, or alteration thereof, 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. includes a gene,
chromosome, or alteration thereof 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.
(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" 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)
(4) "Genetic test" means a 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)
(5) "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 test 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.
Constitution. A DNA sample shall not be obtained or analyzed without
the written authorization of the individual to whom the DNA sample
pertains.
(b) Any A 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
DNA sample pertains.
(c) Any A 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 DNA sample
pertains.
(d) Any A person who willfully or
negligently violates subdivision (a), where
and the violation results in economic, bodily, or emotional
harm to the individual to whom the genetic information
DNA sample 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 DNA sampl e 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) A laboratory that performs a genetic test shall be deemed in
compliance with subdivision (a) if the laboratory believes, in good
faith and in the absence of knowledge to the contrary, that a written
consent by the individual to whom the DNA sample pertains is valid.
(g) (1) Any
(h) Except as provided in subdivision
(i), a 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. or
analyze a DNA sample, shall obtain a valid authorization from the
individual to whom the DNA sample pertains. The written
authorization required by this subdivision shall do all of the
following:
(A)
(1) Be written in plain language and in a typeface no
smaller than 14-point type.
(B)
(2) Be dated and signed by the individual or a person
authorized to act on behalf of the individual.
(C)
(3) Specify the types of persons authorized to
disclose information obtain a DNA sample and analyze
and disclose the genetic test results about the
individual.
(D)
(4) Specify the nature of the information
authorized to be disclosed. genetic test results
authorized to be obtained and analyzed.
(E)
(5) State the name or functions of the persons or
entities authorized to receive the information.
genetic test results.
(F)
(6) Specify the purposes for which the
information DNA sample is being collected.
(G)
(7) Specify the length of time the authorization shall
remain valid.
(H)
(8) Advise the person signing the authorization of his
or her right to control the use of his or her genetic
information DNA sample and test results .
(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)
(9) Advise the person signing the authorization that the
genetic information test results and
DNA sample provided must be destroyed upon achieving that
purpose.
(L)
(10) Advise the person signing the authorization of the
right to receive a copy of the authorization. Written
authorization is required for each separate disclosure of the genetic
test results.
(2)
(i) Any person who collects, stores, or
analyzes the DNA sample , or discloses the genetic
information test results, of an
individual shall comply with all of the following:
(A)
(1) The person may not collect, store, or
analyze the DNA sample , or disclose the genetic
information test results for any purpose other
than the purpose authorized by the individual to whom the
information pertains. DNA sample or genetic test
results pertain.
(B)
(2) Once the specific purpose authorized by the
individual to whom the genetic information pertains
test results pertain has been fulfilled, the
individual's genetic information test results
and DNA sample shall be destroyed.
(C)
(3) The person shall permit an individual to revoke an
authorization signed pursuant to paragraph (1)
subdivision (h) at any time.
(D)
(4) The person shall provide an individual who has
signed an authorization pursuant to paragraph (1)
subdivision (h) with a copy of that authorization upon
request.
(h)
(j) (1) Genetic information A
DNA sample may be collected obtained
, stored, or analyzed, or
and genetic test results disclosed without the authorization
required by subdivision (g) (h) , 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 A DNA
sample may be collected, obtained,
stored, or analyzed, or and
genetic test results 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 , in the
execution of his or her official duties consistent with existing law
.
(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.
(C) By a coroner or medical examiner, in the execution of his or
her official duties consistent with existing law.
(D) By a federal, state, or local governmental entity, or
contractor or designee of that governmental entity in the execution
of his or her official duties consistent with existing law.
(F)
(E) If the information is in the form of deidentified
data.
(G)
(F) 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.
(i) A person or entity covered by and required to comply with
Section 56.11 of the Confidentiality of Medical Information Act (Part
2.6 (commencing with Section 56)).
(ii) A person or entity covered by and required to comply with
Section 791.13, 10123.35, or Article 2.6 (commencing with Section
10146) of Chapter 1 of Part 2 of Division 2 of the Insurance Code.
(iii) A licensed health care professional or designee of a
licensed health care professional. "Licensed health care professional"
means any person licensed or certified pursuant to Division 2
(commencing with Section 500) of the Business and Professions Code,
the Osteopathic Initiative Act or the Chiropractic Initiative Act, or
Division 2.5 (commencing with Section 1797) of the Health and Safety
Code.
(iv) A provider of health care or a designee of a provider of
health care. "Provider of health care" means a health facility
licensed pursuant to Division 2 (commencing with Section 1200) of the
Health and Safety Code.
(v) A covered entity, business associate, or subcontractor as
those terms are defined in the federal Health Insurance Portability
and Accountability Act of 1996 (Public Law 104-191) and its
implementing regulations.
(vi) An investigator within an institution, or working in
collaboration with an institution, that holds an assurance with the
United States Department of Health and Human Services pursuant to
Part 46 (commencing with Section 46.101) of Title 45 of the Code of
Federal Regulations and who obtains informed consent or who qualifies
for an exemption from informed consent in the method and manner
required by those regulations.
(vii) A pharmaceutical company. "Pharmaceutical company" means a
company or business, or an agent or representative thereof, that
manufactures, sells, or distributes pharmaceuticals, medications, or
prescription drugs pursuant to regulations of the federal Food and
Drug Administration, and that either obtains informed consent, or
qualifies for an exemption from informed consent in the method and
manner required by those 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.