BILL ANALYSIS Ó
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|SENATE RULES COMMITTEE | SB 1238|
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THIRD READING
Bill No: SB 1238
Author: Pan (D)
Amended: 3/29/16
Vote: 21
SENATE HEALTH COMMITTEE: 9-0, 4/6/16
AYES: Hernandez, Nguyen, Hall, Mitchell, Monning, Nielsen,
Pan, Roth, Wolk
SENATE PUBLIC SAFETY COMMITTEE: 7-0, 4/19/16
AYES: Hancock, Anderson, Glazer, Leno, Liu, Monning, Stone
SENATE APPROPRIATIONS COMMITTEE: Senate Rule 28.8
SUBJECT: Inmates: biomedical data
SOURCE: Author
DIGEST: This bill permits records-based biomedical research,
using existing information, to be conducted on prisoners,
notwithstanding a prohibition on biomedical research on
prisoners.
ANALYSIS:
Existing federal law:
1)Establishes various procedures and protections relating to the
use of human subjects in medical research, including a
requirement that an investigator obtain the legally effective
informed consent of the subject or the subject's legally
authorized representative prior to involving a human being as
a subject in research.
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2)Establishes the Health Information Portability and
Accountability Act of 1996 (HIPAA). HIPAA established federal
protections for patient's health information held by "covered
entities" and any "business associates" that a covered entity
engages to help it carry out its health care activities. A
covered entity can be a provider, a health plan, or a health
care clearinghouse that processes health information it
receives from another entity. While HIPAA establishes a
federal floor for minimum privacy protections of individually
identifiable health information, states are permitted to enact
laws that provide greater privacy protections or rights.
Existing state law:
1)Prohibits biomedical research, as defined, from being
conducted on any prisoner in California, with the exception of
permitting a physician to provide a patient who is a prisoner
with a drug or treatment that is part of a new drug trial, and
the patient has given informed consent.
2)Defines "biomedical research," for purposes of the above
prohibition, as research relating to or involving biological,
medical, or physical science.
3)Limits behavioral research, as defined, to studies of the
possible causes, effects and processes of incarceration and
studies of prisons as institutional structures or of prisoners
as incarcerated persons which present minimal or no risk and
no more than mere inconvenience to the subjects of the
research. Specifies that informed consent is not required for
participation in behavioral research when the California
Department of Corrections and Rehabilitation determines that
it would be unnecessary or significantly inhibit the conduct
of such research.
4)Establishes, under the Protection of Human Subjects in the
Medical Experimentation Act, various protections for subjects
of medical experimentation relating to a bill of rights;
informed consent procedures and documentation; and, the
provision of specified disclosures, including the right for a
subject to give or withdraw consent freely and without duress.
Imposes penalties for violations of these protections. For
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purposes of these provisions of law, "medical experiment" is
defined as penetrating or damaging tissues, or the use of a
drug or device, in the practice or research of medicine in a
manner not reasonably related to maintaining or improving the
health of the subject, or the investigational use of a drug or
device, or withholding medical treatment.
5)Establishes the California Medical Information Act, which
prohibits a health care provider, health care service plan, or
contractor from disclosing medical information regarding a
patient without first obtaining authorization. Defines
"medical information" as any individually identifiable
information, in electronic or physical form, in possession of,
or derived from, a health care provider, health plan,
pharmaceutical company, or contractor regarding a patient's
medical history, mental or physical condition, or treatment.
This bill:
1)Permits records-based biomedical research using existing
information, without prospective interaction with human
subjects, to be conducted on prisoners, notwithstanding a
prohibition on biomedical research on prisoners.
2)Restricts the use or disclosure of individually identifiable
records pursuant to the above provision permitting
records-based biomedical research to only occurring after both
of the following requirements have been met:
a) The research advisory committee, established pursuant to
specified provisions of existing California regulations
pertaining to research involving prisoners (currently
limited to behavioral research), approves of the use or
disclosure; and,
b) The prisoner provides written authorization for the use
or disclosure, or the use or disclosure is permitted by
specified provisions of federal HIPAA regulations.
3)Excludes from the definition of "biomedical research," for
purposes of provisions of law governing biomedical and
behavioral research of prisoners, the accumulation of
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statistical data in the assessment of the effectiveness of
nonexperimental public health programs or treatment programs
in which inmates routinely participate
Comments
1)Author's statement. According to the author, 10 years ago,
federal court placed the state's prison health care system
under a receivership after determining that an average of one
inmate per week died as a result of medical malpractice or
neglect. The receivership has improved healthcare in prisons
over the last 10 years, but the inability to share data-backed
best practices contributes to the challenge of providing
quality health care to 127,000 inmates, who are
disproportionately black or Latino. This bill authorizes the
publication of statistical data in the assessment of the
effectiveness of nonexperimental public health programs or
treatment programs in which inmates routinely participate.
This would enable health care providers in prisons and jails
to learn from the best practices used at state correctional
facilities, and utilize these life-saving techniques.
California's prison system has been on the cutting edge of
providing health care to inmates, but current law prevents the
publishing of even non-experimental medical data that could be
used to improve health care and potentially save lives.
Prisons face unique health care challenges, and this bill
allows health care providers in correctional facilities to
publish and learn from non-experimental data in order to
provide higher quality health care.
2)Federal receivership for prison health care. In 2005, a
federal judge, acting on a class-action lawsuit alleging poor
medical care in California state prisons violated the
constitutional protection against cruel and unusual
punishment, ordered that the California prison health care
system be placed under federal control. California officially
ceded control in 2006 to a court-appointed receiver, formally
called California Correctional Health Care Services. Under the
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court's order, the receiver is to bring the level of medical
care in California prisons to a standard that no longer
violates the Constitution, and then return control of prison
medical care to the state. In July of last year, Folsom State
Prison became the first of the state's correctional facilities
to have health care returned to state control, marking what is
hoped to be the beginning of the end of the federal
receivership.
FISCAL EFFECT: Appropriation: No Fiscal
Com.:YesLocal: No
SUPPORT: (Verified5/18/16)
California Correctional Health Care Services
OPPOSITION: (Verified5/18/16)
None received
ARGUMENTS IN SUPPORT: This bill is supported by California
Correctional Health Care Services (CCHCS, the federal receiver
for prison health care), which states that over the last several
years, the prison system has been the site of extremely
newsworthy medical developments, and has been on the cutting
edge of providing treatment to prison inmates that would be
beneficial to share with the medical community at large.
According to CCHCS, between 2012 and 2014, the prison system
experienced hunger strikes that lasted for a significant period
of time. As a result, prison doctors developed an effective
monitoring system that provided appropriate treatment as needed
during the strikes. Additionally, CCHCS states that for the past
several years, the prison system has undertaken a massive
program for identifying and treating Valley Fever in central
valley prisons. According to CCHCS, California was the first
health care system in the nation to use a newly developed skin
test that identifies exposure/non-exposure to Valley Fever,
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which is now used in making wise housing choices for inmates
statewide. Finally, CCHCS notes that the prison system just
recently had an outbreak of Legionnaires Disease at San Quentin
State Prison, where, due to quick identification and effective
treatment, doctors were able to successfully treat inmates
without the loss of life. CCHCS states that it would like to
publish its findings in medical journals that would be of
benefit to other correctional and community entities, but under
current law that dates to the 1970s, there is a prohibition for
undertaking biomedical research on prisoners. CCHCS states that
the broad nature of this prohibition would even prohibit CCHCS
from publishing an accumulation of statistical data that
provided an assessment of the effectiveness of any
non-experimental public health or treatment program such as
those described above. CCHCS states that this bill narrowly
amends this prohibition to allow CCHCS to publish findings from
non-experimental public health or treatment programs.
Prepared by:Vince Marchand / HEALTH /
5/18/16 16:28:00
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