BILL ANALYSIS Ó
AB 2325
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CONCURRENCE IN SENATE AMENDMENTS
AB
2325 (Bonilla)
As Amended August 10, 2016
Majority vote
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|ASSEMBLY: | 79-0 |(May 5, 2016) |SENATE: | 39-0 |(August 17, |
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Original Committee Reference: HEALTH
SUMMARY: Requires, on or after January 1, 2019, a pathologist
diagnosing cancer to report cancer diagnoses to the Department
of Public Health (DPH) by electronic means in a format
prescribed by DPH and establishes a pilot project to enable DPH
and authorized users to conduct electronic specific data element
searches of the information collected by the Ken Maddy
California Cancer Registry (CCR).
The Senate amendments clarify that the College of American
Pathologists cancer protocols may be used to report cancer
diagnoses to DPH in addition to any other standardized format
approved by DHCS, specify that a pathologist who submits an
electronic report does not need to submit the same report more
than once, delete provisions establishing a pilot project within
DPH to enable users to conduct electronic specific data element
searches of the information collected by the CCR, and make other
technical changes.
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EXISTING LAW:
1)Requires DPH to conduct a program of epidemiological
assessments of the incidence of cancer. Requires the program
to encompass all areas of the state for which cancer incidence
data are available, and to include monitoring of cancers
associated with suspected carcinogens encountered by the
general public both in occupational locations and in the
environment.
2)Allows DPH to contract with an agency, including, but not
limited to a health systems agency, single or multiple county
health departments, or nonprofit professional associations,
representing a designated cancer reporting region for the
purposes of collecting and collating cancer incidence data.
3)Requires the Director of DPH (Director) to establish the CCR,
a statewide system to collect information on the incidence of
cancer using population-based cancer registries. Requires
these registries to be implemented or initiated by July 1,
1988, and requires that the statewide cancer reporting system
be fully operational by July 1, 1990.
4)Requires specified health care providers diagnosing or
providing treatment for cancer patients to report all cancers
to DPH or an authorized representative, with specified
exemptions, and allows DPH access to those records.
5)Permits persons with a valid scientific interest who are
engaged in demographic, epidemiological, or other similar
studies related to health who meet certain qualifications as
determined by DPH, and who agree, in writing, to maintain
confidentiality, to access confidential information.
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6)Requires, prior to confidential information being disclosed to
designated entities, those designated entities to agree in
writing to maintain the confidentiality of the information,
and requires researchers to do both of the following:
a) Obtain approval of their committee for the protection of
human subjects in accordance with federal regulations; and,
b) Provide documentation to DPH that demonstrates that the
entity has established appropriate procedures and its
ability to maintain the confidentiality of the information.
7)Specifies that any disclosure of information include only the
information necessary for the stated purpose of the requested
disclosure, used for the approved purpose, and not be further
disclosed.
8)Requires DPH to maintain an accurate record of all persons who
are given access to confidential information in the CCR
including:
a) The name of the person authorizing access;
b) Name, title, address, and organizational affiliation of
persons given access;
c) Dates of access; and,
d) The specific purpose for which information is to be
used.
9)Requires records of those who access the CCR, pursuant to 8)
above, to be open to public inspection.
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10)Requires the individual to whom the information pertains to
have access to his or her own information made available in
the CCR.
FISCAL EFFECT: According to Senate Appropriations Committee,
pursuant to Senate Rule 28.8, this bill has negligible state
fiscal effect.
COMMENTS: According to the author, this bill creates an
innovative, new tool which will allow researchers working on
clinical trials to reach out to patients to provide them the
opportunity to participate in cutting edge treatments. This
bill removes the burden of searching for a cancer clinical trial
from patients who are battling cancer and places it on the
clinician. The author states that roadblocks to innovative uses
of the CCR data stem from long delays in cancer reporting. At
best, cancer diagnosis information is reported to the CCR within
six to nine months after diagnosis. In reality, it could take
one to two years before information is fully reported.
Modernization of the CCR, through electronic pathology
reporting, will significantly increase the speed at which
diagnosis reports are deposited within the CCR. Because of the
real-time reporting, researchers will be able to request
diagnosis information to identify matches to ongoing cancer
clinical trials. As a result, trial participants will be
identified much faster with no burden on cancer patients. Due
to the rapid matching of patients to trials and increased
participation, cancer therapies will be developed and improved
much faster than currently possible because patients will be
connected to potentially lifesaving treatments.
According to the DPH and the American Cancer Society 2015 report
of California Cancer Facts and Figures, figures show that cancer
incidence rates have dropped 13% and death rates have declined
26% in California since 1988. Additionally, the overall
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incidence rate remains lower than the rest of the nation. Even
with those declines, an estimated 172, 090 Californians will be
diagnosed with cancer and 58,180 will die of the disease in
2015. The most commonly diagnosed cancers in men will be
prostate, lung and colorectal cancers and breast, lung and
colorectal cancers will be the most frequently diagnosed among
women.
The University of Southern California (USC), a cosponsor of the
bill, states that although the CCR is a powerful tool, currently
available technologies would allow it to do so faster and more
efficiently. Roadblocks to innovative uses of the CCR data stem
from long delays in cancer reporting due to reliance on 30 year
old methods. At best, cancer diagnosis information is reported
to the CCR within six to nine months after diagnosis. In
reality, it can take one to two years before that information is
fully reported. The long reporting times occur because of
inefficient data collection methods. USC argues that this
measure will ensure that rapid, real-time electronic cancer
diagnosis reporting becomes standard in California, providing
higher quality data and allowing new uses of the CCR. For
nearly all new cancer diagnoses, the pathology report is the
first available record and virtually all are prepared
electronically. Yet, pathology reports are not prepared, stored
or accessed in a consistent method.
USC states that modernization of the CCR, through electronic
pathology reporting, will significantly increase the speed at
which diagnosis reports are available within the CCR. Public
health officials, researchers and medical providers will be able
to monitor cancer occurrence months to years earlier than
currently possible and the public will be reassured that the
identification of possible new risks will occur as early as
possible. USC concludes that this measure will significantly
enhance cancer research and monitoring in California through
modernization of the CCR.
Analysis Prepared by:
Paula Villescaz / HEALTH / (916) 319-2097 FN:
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