Amended in Senate May 7, 2013

Amended in Senate April 22, 2013

Amended in Senate April 1, 2013

Senate Bill No. 222

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 begin delete scientifically or
medically identifiable end delete gene or chromosome, or alteration thereof,
begin delete 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. end delete begin insert 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. end insert

(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.

begin delete

(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.

end delete begin insert

(B) “Genetic information” also includes a DNA sample.

end insert

(5) “Genetic service” means a genetic test, genetic education,
or genetic counseling, including obtaining, interpreting, or
assessing genetic information.

(6) “Genetic test” means a begin delete genetic test; genetic counseling,
including obtaining, interpreting, or assessing genetic information;
or genetic education. end delete begin insert 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. end insert

(7) “Person” means a natural person, trust or estate, partnership,
corporation, begin insert limited liability company, end insert 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)  begin insert (1) end insert begin insert   end insert 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:

begin delete

(1)

end delete

begin insert (A) end insert  Be written in plain language and in a typeface no smaller
than 14-point type.

begin delete

(2)

end delete

begin insert (B) end insert  Be dated and signed by the individual or a person authorized
to act on behalf of the individual.

begin delete

(3)

end delete

begin insert (C) end insert  Specify the types of persons authorized to disclose
information about the individual.

begin delete

(4)

end delete

begin insert (D) end insert  Specify the nature of the information authorized to be
disclosed.

begin delete

(5)

end delete

begin insert (E) end insert  State the name or functions of the persons or entities
authorized to receive the information.

begin delete

(6)

end delete

begin insert (F) end insert  Specify the purposes for which the information is being
collected.

begin delete

(7)

end delete

begin insert (G) end insert  Specify the length of time the authorization shall remain
valid.

begin insert

(H) Advise the person signing the authorization of his or her
right to control the use of his or her genetic information.

end insert begin insert

(I) Advise the person signing the authorization of his or her
right to revoke authorization at any time.

end insert begin insert

(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.

end insert begin insert

(K) Advise the person signing the authorization that the genetic
information and sample provided must be destroyed upon achieving
that purpose.

end insert begin delete

(8)

end delete

begin insert (L) end insert  Advise the person signing the authorization of the right to
receive a copy of the authorization.

begin insert

(2) Any person who collects, stores, analyzes, or discloses the
genetic information of an individual shall comply with all of the
following:

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(C) The person shall permit an individual to revoke an
authorization signed pursuant to paragraph (1) at any time.

end insert begin insert

(D) The person shall provide an individual who has signed an
authorization pursuant to paragraph (1) with a copy of that
authorization upon request.

end insert

(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.