Amended in Senate January 14, 2014

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 begin delete collecting, storing, analyzing, or disclosing genetic information end delete begin insert obtaining or analyzing a DNA sample, as defined, end insert without the written authorization of the individual to whom the begin delete information end delete begin insert DNA sample end insert pertains, and would include related findings and declarations. It also would prescribe specific circumstances under which begin delete genetic information end delete begin insert a DNA sample end insert may be begin delete collected, end delete begin insert obtained, end insert stored, begin insert or end insert analyzed, or begin insert genetic test results end insert disclosed begin insert , end insert 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 begin delete adoptions end delete begin insert adoption end insert of policies to help ensure
privacy and security, as the field of genomics advances.

(b) Various national and state policies are in place to begin delete protect
personally identifiable health information and records. end delete begin insert effectively
protect individually identifiable health information, biosamples
used in academic research end insert begin insert and records, including genetic
information. end insert

begin delete

(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)

end delete

begin insert (c) end insert  Policies should protect individual genetic information by
prohibiting the unauthorized use of surreptitious collection.

begin insert

(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.

end insert

(e) It is the intent of the Legislature to enact legislation that
would protect individuals from the unauthorized collection begin delete , storage,
and disclosure of their genetic information. end delete begin insert and analysis of their
DNA samples and genetic characteristics. end insert

begin delete

(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)

end delete

begin insert (f) end insert  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 begin insert , in accordance with Section 164.514 of Title 45 of the
Code of Federal Regulations end insert .

(2) “DNA sample” means begin delete a tissue, fluid, or other bodily sample
of an individual on which a DNA analysis can be carried out. end delete begin insert a end insert
begin insert human biological specimen that is obtained or retained for the
purpose of extracting and analyzing DNA to perform a genetic
test. end insert

(3) “Genetic characteristic” begin delete 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. end delete begin insert 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. end insert

begin delete

(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)

end delete

begin insert (4) end insert  “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.

begin delete

(7)

end delete

begin insert (5) end insert  “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 begin insert test end insert information is protected by the right
of privacy pursuant to Section 1 of Article I of the California
begin delete 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. end delete begin insert Constitution. A DNA sample shall
not be obtained or analyzed without the written authorization of
the individual to whom the DNA sample pertains. end insert

(b)  begin delete Any end delete begin insert A end insert 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
begin delete genetic information end delete begin insert DNA sample end insert pertains.

(c)  begin delete Any end delete begin insert A end insert 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 begin delete genetic
information end delete begin insert DNA sample end insert pertains.

(d)  begin delete Any end delete begin insert A end insert person who willfully or negligently violates
subdivision (a), begin delete where end delete begin insert and end insert the violation results in economic, bodily,
or emotional harm to the individual to whom the begin delete genetic
information end delete begin insert DNA sample end insert 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 begin delete genetic information end delete begin insert DNA
sampl end insert begin insert e end insert 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.

begin insert

(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.

end insert begin delete

(g) (1) Any

end delete

begin insert (h) end insert begin insert   end insert begin insert Except as provided in subdivision (i), a end insert person or entity that
wishes to obtain begin delete 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. end delete begin insert or analyze a DNA sample, shall obtain a valid
authorization from the individual to whom the DNA sample
pertains. end insert The written authorization required by this subdivision
shall do all of the following:

begin delete

(A)

end delete

begin insert (1) end insert  Be written in plain language and in a typeface no smaller
than 14-point type.

begin delete

(B)

end delete

begin insert (2) end insert  Be dated and signed by the individual or a person authorized
to act on behalf of the individual.

begin delete

(C)

end delete

begin insert (3) end insert  Specify the types of persons authorized to begin delete disclose
information end delete begin insert obtain a DNA sample and analyze and disclose the
genetic test end insert begin insert results end insert about the individual.

begin delete

(D)

end delete

begin insert (4) end insert  Specify the nature of the begin delete information authorized to be
disclosed. end delete begin insert genetic test results authorized to be obtained and
analyzed. end insert

begin delete

(E)

end delete

begin insert (5) end insert  State the name or functions of the persons or entities
authorized to receive the begin delete information. end delete begin insert genetic test results. end insert

begin delete

(F)

end delete

begin insert (6) end insert  Specify the purposes for which the begin delete information end delete begin insert DNA sample end insert
is being collected.

begin delete

(G)

end delete

begin insert (7) end insert  Specify the length of time the authorization shall remain
valid.

begin delete

(H)

end delete

begin insert (8) end insert  Advise the person signing the authorization of his or her
right to control the use of his or her begin delete genetic information end delete begin insert DNA
sample and test results end insert .

begin delete

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

end delete begin delete

(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 delete begin delete

(K)

end delete

begin insert (9) end insert  Advise the person signing the authorization that the genetic
begin delete information end delete begin insert test results end insert and begin insert DNA end insert sample provided must be
destroyed upon achieving that purpose.

begin delete

(L)

end delete

begin insert (10) end insert  Advise the person signing the authorization of the right to
receive a copy of the authorization. begin insert Written authorization is
required for each separate disclosure of the genetic test results. end insert

begin delete

(2)

end delete

begin insert (i) end insert  Any person who collects, stores, begin insert or end insert analyzes begin insert the DNA sample end insert ,
or discloses the genetic begin delete information end delete begin insert test results, end insert of an individual
shall comply with all of the following:

begin delete

(A)

end delete

begin insert (1) end insert  The person may not collect, store, begin insert or end insert analyze begin insert the DNA
sample end insert , or disclose the genetic begin delete information end delete begin insert test results end insert for any
purpose other than the purpose authorized by the individual to
whom the begin delete information pertains. end delete begin insert DNA sample or genetic test results
pertain. end insert

begin delete

(B)

end delete

begin insert (2) end insert  Once the specific purpose authorized by the individual to
whom the genetic begin delete information pertains end delete begin insert test results pertain end insert has been
fulfilled, the individual’s genetic begin delete information end delete begin insert test results end insert and DNA
sample shall be destroyed.

begin delete

(C)

end delete

begin insert (3) end insert  The person shall permit an individual to revoke an
authorization signed pursuant to begin delete paragraph (1) end delete begin insert subdivision (h) end insert at
any time.

begin delete

(D)

end delete

begin insert (4) end insert  The person shall provide an individual who has signed an
authorization pursuant to begin delete paragraph (1) end delete begin insert subdivision (h) end insert with a copy
of that authorization upon request.

begin delete

(h)

end delete

begin insert (j) end insert  (1)  begin delete Genetic information end delete begin insert A DNA sample end insert may be begin delete collected end delete
begin insert obtained end insert , stored, begin insert or end insert analyzed, begin delete or end delete begin insert and genetic test results end insert disclosed
without the authorization required by subdivision begin delete (g) end delete begin insert (h) end insert , in
accordance with paragraph (2), begin delete provided that the entity may collect,
store, analyze, or disclose the information end delete only for the purposes
specified. Use for any other purpose is subject to the authorization
required by subdivision (a).

(2)  begin delete Genetic information end delete begin insert A DNA sample end insert may be begin delete collected, end delete
begin insert obtained, end insert stored, begin insert or end insert analyzed, begin delete or end delete begin insert and genetic test results end insert disclosed begin insert , end insert
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 begin insert , in the execution of his
or her official duties consistent with existing law end insert .

begin delete

(C) By a licensed health care professional, as defined in Section
56.05, in a medical emergency.

end delete begin delete

(D) By a coroner or medical examiner, in the execution of his
or her official duties consistent with existing law.

end delete begin delete

(E) For purposes of any screening of a newborn infant required
by state or federal law.

end delete begin insert

(C) By a coroner or medical examiner, in the execution of his
or her official duties consistent with existing law.

end insert begin insert

(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.

end insert begin delete

(F)

end delete

begin insert (E) end insert  If the information is in the form of deidentified data.

begin delete

(G)

end delete

begin insert (F) end insert  By begin delete any person or entity covered by and required to comply
with end delete any of the following:

begin delete

(i) The Health Insurance Portability and Accountability Act of
1996 (Public Law 104-191).

end delete begin delete

(ii) Section 56.11 of the Confidentiality of Medical Information
Act (Part 2.6 (commencing with Section 56)).

end delete begin delete

(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.

end delete begin delete

(iv) Section 50.25 of Title 21 of the Code of Federal
Regulations.

end delete begin delete

(v) Section 46.116 of Title 28 of the Code of Federal
Regulations.

end delete begin insert

(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)).

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert begin insert

(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.

end insert

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.