BILL ANALYSIS �
AB 1683
Page 1
Date of Hearing: April 30, 2014
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Mike Gatto, Chair
AB 1683 (Jones) - As Amended: April 10, 2014
Policy Committee: HealthVote:19-0
Urgency: No State Mandated Local Program:
No Reimbursable: No
SUMMARY
This bill requires the Department of Public Health (DPH) to
notify a patient diagnosed with cancer, or provided treatment for
cancer, of the requirement that their data be reported to the
California Cancer Registry (Registry). Additionally, this bill:
1)Relieves physicians of a similar notification requirement.
2)Requires DPH to inform a patient of how and for what purpose
their information will be used, how the cancer registry works,
the availability of their data to public health agencies and
cancer researchers, the discretion of patients to decline
participation in research studies and to request their contact
information be withheld, and the benefits to participating in
cancer research.
3)Requires the notifications to be distributed in a
cost-effective manner, including, but not limited to, by
e-mail.
4)Requires DPH to adopt regulations it deems necessary for
implementation.
FISCAL EFFECT
1)Increased costs to DPH to operate the Registry of approximately
$400,000 annually to notify each person diagnosed with cancer
and respond to inquiries.
2)Minor one-time costs to DPH to update the Registry IT system to
generate notification.
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COMMENTS
1)Purpose . This bill is intended to ensure cancer patients are
informed their data is being shared with the Registry. The
author indicates firsthand experience that patients are not
being informed about the Registry as required by current DPH
regulations. The author suggests patients may find it invasive
to be contacted by a researcher with whom their personal health
data was shared without their knowledge.
2)Background . Current law establishes the California Cancer
Registry for collection of data about cancer cases for public
health purposes. Current law also requires both facilities and
individual providers treating cancer patients to report cases
to DPH. Because of its public health importance, reporting of
cancer data to registries is excluded from HIPAA rules
(regulations that govern confidential patient data pursuant to
the federal Health Insurance Portability and Accountability
Act). Thus, the law does not require written or verbal patient
consent to report cancers to the Registry. However, this
exemption may not be well-known among patients, resulting in
confusion or anger about why and how personal health
information was shared with a public health agency, or with
researchers who are able to directly contact patients in
certain cases. Cancer registries indicate even many providers
are unfamiliar with the HIPAA exemption for public health
purposes.
3)Current Patient Notification and Protections . Current DPH
regulations require physicians to notify patients their data is
being transmitted to the Registry. DPH has developed a "Patient
Information Sheet" for this purpose which describes the
Registry, data confidentiality and applicable laws, and
Registry research, including a notification that they may be
contacted by researchers and their ability to opt out of
research.
In addition, all research involving human subjects requires
approval by an appropriate Institutional Review Board (IRB).
The IRB responsible for reviewing all research-related requests
for state personally identifiable information from DPH and
other health-related departments is the California Committee
for the Protection of Human Subjects. Finally, a DPH manual
related to registry operations outlines a number of guidelines
to be followed by researchers requesting to contact
individuals, including appropriate sensitivity to the timing of
AB 1683
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an individual's diagnosis, rules for providing information and
context about the research, and requirements that any hostile
refusals be reported and placed on a "Do Not Contact" list.
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 would be
heeded any better than when information is provided by the
physician. They further argue that/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)Staff Comments: Who Should Be Notified, and Who Should Notify ?
This bill requires DPH to notify all patients diagnosed with
cancer, or provided treatment for cancer. However, staff notes
DPH would not know about a patient's diagnosis in absence of
their data being reported to the registry, so they would not be
able to notify anyone whose cancer was not reported.
Staff notes the notification requirement does not distinguish
between patients whose data is reported to the registry, and
the smaller subset of patients proposed for direct contact by
researchers. If the concern is related to individuals being
contacted by researchers, a narrower requirement would suffice.
Finally, staff notes it is far from obvious that notification
from DPH, rather than from a patient's own physician, would be
preferable from a patient perspective. Additionally, the
prospect of email notification raises concerns about the
security of this health information, and whether it is
effectively transmitted to the patient, as compared to current
law. Email addresses are also currently not collected by the
Registry.
Analysis Prepared by : Lisa Murawski / APPR. / (916) 319-2081