BILL ANALYSIS Ó
Senate Appropriations Committee Fiscal Summary
Senator Kevin de León, Chair
SB 222 (Padilla) - Genetic information: privacy.
Amended: January 14, 2014 Policy Vote: Judiciary 4-3
Urgency: No Mandate: Yes
Hearing Date: January 23, 2014
Consultant: Jolie Onodera
SUSPENSE FILE.
Bill Summary: SB 222 would enact the Genetic Information Privacy
Act, which would prohibit any person, as defined, from
obtaining, analyzing, retaining, or disclosing genetic
information without the written authorization of the individual
to whom the information pertains, as specified. This bill would
specify the information that must be included in the
authorization. This bill would also establish civil and criminal
penalties for violations of the bill's provisions, as specified.
This bill would provide for the exemption of certain individuals
from the aforementioned prohibitions and penalties.
Fiscal Impact:
Increased central research and hospital administrative
costs in the range of $30 million to $40 million (General
Fund) per year to the University of California (UC) system.
Potential loss of research funding of an unknown, but
potentially significant amount in the millions of dollars
annually.
Annual costs of $350,000 to $400,000 (General Fund) to
the California Correctional Health Care Services for
increased administrative workload.
Potential annual court costs in the range of $25,000 to
$75,000 (General Fund) for every 50 limited or unlimited
civil filings per year for violations of the Act. Potential
annual court costs of $25,000 (General Fund) for every 50
new misdemeanor fillings per year for violations of the
Act.
Non-reimbursable local costs for enforcement offset to a
degree by fine revenue.
Background: Existing federal and state laws offer various
protections for genetic testing. However, in recent years,
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concerns have been raised over direct-to-consumer (DTC) genetic
testing that allows consumers to submit genetic samples in order
to test for genetic disorders, identify ancestral links, or
participate in research studies.
A 2010 report by the U.S. Government Accountability Office (GAO)
entitled "Direct-to-Consumer Genetic Tests: Misleading Test
Results are Further Complicated by Deceptive Marketing and Other
Questionable Practices," identified 10 egregious examples of
deceptive marketing, including claims made by four companies
that a consumer's DNA could be used to create personalized
supplements to cure diseases. Further, the GAO's fictitious
consumers received test results that were misleading and of
little or no practical use. For example, the GAO's donors often
received disease risk predictions that varied across the four
companies, indicating that identical DNA samples yielded
contradictory results.
Proposed Law: This bill would establish the Genetic Information
Privacy Act, as follows:
Provides that genetic information is protected by the right
of privacy pursuant to Article I of Section I of the
California Constitution.
Provides for definitions of the following terms:
deidentified data, DNA sample, genetic characteristic,
genetic information, genetic service, genetic test, and
person.
Prohibits any person from collecting, storing, analyzing, or
disclosing genetic information without the written
authorization of the individual to whom the information
pertains.
Sets forth both civil and criminal penalties, as follows:
o Any person who negligently violates these provisions
shall be assessed a civil penalty not to exceed $1,000
plus court costs, as determined by the court, to be paid
to the individual.
o Any person who willfully violates these provisions
shall be assessed a civil penalty of $1,000 to $5,000 plus
court costs, as determined by the court, to be paid to the
individual.
o Any person who willfully or negligently violates these
provisions and the violation results in economic, bodily,
or emotional harm to the individual, is guilty of a
misdemeanor punishable by a fine not to exceed $10,000.
o In addition to any assessed civil penalties, a person
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who commits a violation of these provisions shall be
liable to the person for all actual damages, including
damages for economic, bodily, or emotional harm which is
proximately caused by the act.
o Provides that each violation is a separate and
actionable offense.
Requires the written authorization, other than for
persons/entities otherwise authorized, as specified, to
satisfy all of the following requirements:
o Be written in plain language and be in a typeface no
smaller than 14-point type.
o Be dated and signed by the individual to whom the
information pertains or a person authorized to act on
behalf of the individual.
o Specify the types of persons authorized to disclose
information about the individual.
o State the name or functions of the persons or entities
authorized to receive the information.
o Specify the purposes for which the information is
being collected.
o Specify the length of time the authorization shall
remain valid.
o Advise the person signing the authorization of the
following:
§ The right to control the use, or revoke
authorization at any time, of his or her genetic
information.
§ Whether his or her information will remain
identifiable or whether measures will be taken to
make the information nonidentifiable.
§ That the genetic information and sample
provided will be destroyed upon achieving that
purpose.
§ The right to receive a copy of the
authorization.
Requires any person who collects, stores, analyzes, or
discloses the genetic information to comply with the
following:
o The person may not use the genetic information
for any purpose other than the purpose authorized by
the individual to whom the information pertains.
o Once the purpose authorized has been
fulfilled, the individual's genetic information and
DNA sample shall be destroyed.
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o The person shall permit an individual to
revoke an authorization signed at any time.
o The person shall provide an individual who has
signed an authorization with a copy of that
authorization upon request.
Provides that genetic information may be collected, stored,
analyzed, or disclosed without authorization for the following
cases, provided the information is only for the specified
purposes indicated, and any other use would be subject to the
authorization:
A law enforcement official or correctional officer in
the execution of his or her official duties consistent with
existing law.
A hospital, laboratory, or physician carrying out
court-ordered tests for genetic information.
A licensed health care professional, as defined, in a
medical emergency.
A coroner or medical examiner in the execution of his or
her official duties consistent with existing law.
Any screening of newborn infants required by state or
federal law.
If the information is in the form of deidentified data,
as defined.
By any person covered by and required to comply with
HIPAA, CMIA, Insurance Code, and federal regulations.
Related Legislation: SB 1267 (Padilla) 2012 was similar to this
measure but included fewer exceptions to the release of genetic
information as well as different definitions for various terms.
This bill was held on the Suspense file of this committee.
SB 559 (Padilla) Chapter 261/2011 prohibits discrimination under
the Unruh Civil Rights Act and Fair Employment and Housing Act
on the basis of genetic information.
SB 482 (Padilla) 2009 would have specifically provided that
companies providing direct-to-consumer genetic testing are not
clinical laboratories and are therefore not subject to
requirements for those entities. This bill was referred but not
heard in the Senate Committee on Judiciary.
Staff Comments: The University of California (UC) estimates the
provisions of this bill could increase central research and
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hospital administrative costs in the range of $40 million
(General Fund) per year. These costs would result from the
increased workload associated with obtaining authorizations for
research not covered by the exceptions enumerated in this bill.
To the extent researchers/doctors would be required to obtain
additional authorization for biosamples and data from research
studies that under federal regulations would be determined to be
exempt or not human subject research, significant costs could be
incurred.
In addition, to the extent the use of existing biobanks could
require re-consent from thousands of individuals to use the
samples for another analysis or purpose could potentially cost
in the millions of dollars. According to the University of
California, San Francisco (UCSF) Participant Recruitment and
Study Management Service, the calculated per patient cost to
re-consent is $216. The UCSF Helen Diller Family Comprehensive
Cancer Center biorepository contains over 250,000 individual
specimens from approximately 14,000 individuals patients
covering various disease areas. Re-consent for the individuals
at this center alone would cost in excess of $3 million. Given
the UC operates five comprehensive cancer centers, costs
associated with re-consenting materials system-wide would likely
be much greater. The UC indicates there would also be additional
costs to obtain consent when disclosing genetic information to
state entities not covered by an exception listed in the
provisions of this bill.
Representatives from UC also indicated concern that the
provisions of this bill could place UC at a competitive
disadvantage for public and private research grants. UC received
$2.8 billion in federal research funding alone in Fiscal Year
2011-12. To the extent research involving biosamples and data
could become more difficult to conduct, sponsors could be
compelled to look to other states to conduct research. To the
extent the provisions of this bill result in even a small
percentage reduction in these awards, a loss of millions of
dollars in research funding brought into the state could result.
The California Correctional Health Care Services (CCHCS) has
also indicated the provisions of this bill will result in
increased administrative workload costs of $350,000 to $400,000
(General Fund) associated with reviewing inmate medical records
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prior to disclosure to entities other than those exempted in the
bill.
This bill establishes both civil and criminal penalties for
violations of the written authorization requirements of the
bill. To the extent the provisions of this bill result in
additional actions brought for violations of the Act, additional
costs to the courts could result. Based on information from the
GAO report, genetic tests range from $299 to $999 per test. As a
result, it is assumed that most filings would be limited civil
filings (claims under $25,000), however, to the extent the bill
provides for the payment of damages for economic, bodily, or
emotional harm, in addition to the fine, the number of unlimited
civil filings could also increase. The cost for 50 new limited
or unlimited civil filings would increase costs to the courts in
the range of $25,000 to $75,000 (General Fund) per year.
Assuming 50 new misdemeanor filings per year (which equates to
less than one filing per county per year), would increase court
costs by approximately $25,000 (General Fund) per year.
Recent author amendments:
Revise the definition of "DNA sample" and "genetic
characteristic" and delete the definitions for "genetic
information" and "genetic service."
Replace references to "genetic information" throughout
the bill with "DNA sample."
Specify that a laboratory that performs a genetic test
shall be deemed to be in compliance with constitutional
rights to privacy 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.
Inadvertently delete the consumer protection provisions
that require the written authorization to advise the person
signing the authorization of his or her right to revoke
authorization at any time, and as to whether his or her
information will remain identifiable or whether measures
will be taken to make the information non-identifiable.
Add additional exemptions to the requirement for a
written authorization to include a pharmaceutical company,
a licensed health care professional, a provider of health
care, and an investigator within an institution, as
specified.
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