BILL ANALYSIS �
AB 1683
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Date of Hearing: April 8, 2014
ASSEMBLY COMMITTEE ON HEALTH
Richard Pan, Chair
AB 1683 (Jones) - As Amended: March 12, 2014
SUBJECT : Ken Maddy California Cancer Registry.
SUMMARY : Requires the Department of Public Health (DPH) to
inform all patients diagnosed with, or being treated for cancer
that their case has been reported to the Ken Maddy California
Cancer Registry (CCR) within six months of their case being
reported. Specifically, this bill :
1)Requires DPH to notify the patient of all of the following
information:
a) A description of the CCR;
b) An explanation of how DPH obtains all records that
identify cases of cancer and the type of information
collected by DPH;
c) The purposes for which the information obtained by DPH
is collected and intended to be used;
d) The authorization of DPH to release confidential patient
information to any person with a valid scientific interest,
other states cancer registries, federal cancer control
agencies, local health officers, or health researchers;
e) The discretion of a patient to refuse to participate in
any research study and to request that his or her contact
information be withheld; and,
f) The benefits of participating in cancer research.
2)Prohibits DPH from disclosing confidential information to any
person, other state registry, federal cancer control agency,
local health officer, or health researcher until DPH has
informed the patient their information has been reported to
the CCR.
3)Specifies that a patient may refuse to participate in any
research study and may request that his or her contact
information be withheld from those persons or health
researchers who obtain the patient's confidential information.
4)Allows the patient notifications to be sent by e-mail.
5)Requires DPH to adopt any necessary regulations to implement
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this bill.
EXISTING LAW :
1)Requires DPH to conduct a program of epidemiological
assessments of the incidence of cancer in all areas of the
state for which data is available, including the monitoring of
cancers associated with suspected carcinogens.
2)Allows DPH to enter into contracts to conduct the program and
requires the director to analyze available data, prepare
reports, and perform studies to identify cancer hazards to the
public health and their remedies.
3)Requires DPH to establish a statewide system for the
collection of information determining the incidence of cancer,
using population-based cancer registries and to create a
statewide cancer reporting system. Allows DPH to establish
regional cancer registries and to designate cancer as a
disease required to be reported in the state.
4)Requires any hospital or other facility treating cancer
patients to report each case of cancer to DPH in a format
prescribed by DPH.
5)Requires any physician, dentist, podiatrist, or other health
care practitioner diagnosing or providing treatment for cancer
to report each cancer case to DPH.
6)Requires all physicians, hospitals, outpatient clinics,
nursing homes and all other facilities, individuals, or
agencies providing diagnostic or treatment services to cancer
patients to give DPH access to all records that identify cases
of cancer, would establish characteristics of the cancer,
treatment of the cancer, or medical status of any identified
cancer patient. Provides that willful failure to do so is
punishable by a fine of up to $500 each day access is refused.
7)Requires DPH to use the information to determine the sources
of malignant cancer and evaluate measures designed to
eliminate, alleviate, or ameliorate its effect.
8)Allows DPH to grant access to the information to persons with
a valid scientific interest who are engaged in demographic,
epidemiological, or other similar studies related to health,
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who meet certain qualifications and who agree, in writing, to
maintain confidentiality.
9)Allows DPH to furnish confidential information to other
states' cancer registries, federal cancer control agencies,
local health officers, or health researchers for the purpose
of determining the sources of cancer and evaluating measures
designed to ameliorate its effect, provided the requesting
entity agrees, in writing, to maintain the confidentiality of
the information.
10)Requires out of state researchers to obtain the approval of
their committee for the protection of human subjects and
provide documentation to DPH that they have established
procedures to maintain the confidentiality of the information.
FISCAL EFFECT : This bill has not been analyzed by a fiscal
committee.
COMMENTS :
1)PURPOSE OF THIS BILL . The author states, "I know firsthand
that patients are not being informed about the CCR. As a
cancer survivor myself, I found it very invasive that the CCR
had been given my personal information, including my name,
address telephone number, and social security number, along
with my medical records, without my knowledge. Although I
have not been contacted by a researcher, I can imagine the
outrage and confusion some must feel upon learning their
personal information has been given to a government agency
without their knowledge, especially with recent privacy
concerns in the media. I encourage cancer research. I
believe that patients can be notified and have the option to
opt-out if they choose, without integrity of cancer research
being compromised. Cancer patients have the right to know who
has access to their information, and we should grant them the
right to make appropriate decisions based on this."
2)BACKGROUND . The CCR was created via legislation in 1985, and
was later named after state Senator Kenneth Maddy. The CCR is
California's statewide population-based cancer surveillance
system. The CCR collects information on almost all cancers
diagnosed in California. The information is used to develop
strategies and policies for cancer prevention, treatment, and
control. The availability of cancer data allows health
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researchers to analyze demographic and geographic factors that
affect cancer risk, early detection, and effective treatment
of cancer patients. The data also help determine where early
detection, education, and other cancer-related programs should
be directed. The CCR is recognized as one of the leading
cancer registries in the world, and has been the cornerstone
of a substantial amount of research on cancer in the
California population. To date the CCR has collected detailed
information on over 3.4 million cases of cancer among
Californians diagnosed from 1988 forward, and more than
162,000 new cases are added annually.
Reporting. Medical treatment facilities collect and report
cancer data from their medical records. Physicians report
information on cancer patients who are not referred to a
medical treatment facility. A network of 10 reporting regions
receives the data and checks for accuracy, performs analyses,
and conducts studies specific to the local area. The central
registry in Sacramento collates the data, performs additional
quality control, and analyzes the data on a statewide basis.
All information collected by the CCR is considered
confidential. Researchers with a valid scientific interest who
are engaged in demographic, epidemiological, or other similar
health studies must meet qualifications established by DPH and
agree, in writing, to maintain confidentiality. DPH may then
allow access to confidential information for research.
Contacting patients. According to the CCR manual, "Policies
and Procedures for Access to and Disclosure of Confidential
Data from the CCR," researchers conducting projects that
involve patient contact need to be sensitive to the physical
and emotional difficulties which patients may be experiencing.
In addition to confidentiality agreements, researchers
requesting disclosure of CCR data and who want to contact
patients must comply with the following requirements:
a) Multiple researchers should not contact cancer patients
within a short time of each other, especially during the
first year after diagnosis while undergoing therapy.
However, the CCR can only limit multiple patient contacts
by researchers using CCR data. Patients may also have been
approached by researchers who received contact information
from another source;
b) No patient contact is allowed for six weeks after
diagnosis to give the appropriate attending physician time
to inform the patient of their diagnosis and possible
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treatment;
c) The first contact with a patient must be in writing.
Specifically, the investigator must send a contact letter
to the patient that explains how the patient's name was
obtained and why the CCR was created. A copy of the CCR
brochure, Cancer Research in California should also be
included; and,
d) During the patient recruitment phase of a study, any
problems that arise with individual patients, for example
hostile refusals, must be promptly reported to DPH or the
regional registry. Any patient who states that he/she does
not wish to be contacted again by any researcher must be
reported to DPH or the regional registry promptly in
writing. This is then recorded in the regional and
statewide databases with a Do Not Contact flag.
3)SUPPORT . The American Federation of State, County and
Municipal Employees, AFL-CIO supports this bill because it
would require DPH to better inform those receiving treatment
for cancer, DPH's authorization to release a patient's private
health care information to health researchers. Though cancer
research is incredibly important, DPH should not have the
ability to overlook a patient's right to privacy without
adequately informing the patient and allowing him or her to
decide whether they mind having their private health care
information released to another party.
4)OPPOSITION . The American Cancer Society Cancer Action Network
opposes this bill, writing that it is not an effective
solution for the concern about current notification practices
and that there is no evidence that a communication from
DPH/CCR would be heeded any better than when information is
provided by the physician. They further argue that, in fact,
patient/physician contact provides greater opportunity for
communication in a culturally appropriate manner that accounts
for language barriers and is likely trusted more than contact
from a government agency would be.
5)PREVIOUS LEGISLATION . AB 48 (Cedillo), Chapter 368, Statutes
of 2000, renames the CCR the Ken Maddy CCR, after the late
state Senator Kenneth Maddy, former Minority Leader of the
State Senate. AB 136 (Connelly), Chapter 841, Statutes of
1985, established the CCR.
6)SUGGESTED AMENDMENTS . Regulations promulgated by DPH require
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physicians to notify patients that their diagnosis is being
reported to the CCR. Should this bill pass this Committee,
staff suggests amending the bill to require DPH to update
those regulations to delete that requirement because it will
duplicate what DPH will be required to do.
As currently drafted the bill prohibits DPH/CCR from sharing
confidential information with any other state's cancer
registries, federal cancer control agencies, local health
officers, or health researchers until the department informs
the patient their information has been reported to the CCR.
Given that the bill has no mechanism to ensure that a patient
has received the notification from CCR, committee staff
suggests deleting this requirement.
As currently drafted the bill allows a patient to refuse to
participate in any research study and to request that his or
her contact information be withheld from those persons or
health researchers who obtain the patient's confidential
information. As noted in existing law above, there are
protocols in place to ensure that cancer patients are
contacted by researchers in a respectful manner, that all
information is held in strict confidentiality, and to allow
patients to refuse to participate in a study. Given that one
of the primary goals of the CCR is to support research to find
the causes and cures of cancer, the Committee may want to
consider whether or not they want to allow patients to
prohibit their contact information from being shared with
researchers. Committee staff suggests deleting this
requirement.
REGISTERED SUPPORT / OPPOSITION :
Support
American Federation of State, County and Municipal Employees,
AFL-CIO
Opposition
American Cancer Society Cancer Action Network
Analysis Prepared by : Lara Flynn / HEALTH / (916) 319-2097
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