BILL ANALYSIS Ó
SB 1238
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Date of Hearing: June 21, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
SB
1238 (Pan) - As Amended March 29, 2016
SENATE VOTE: 39-0
SUBJECT: Inmates: biomedical data.
SUMMARY: Grants an exception to the existing prohibition on
biomedical research on prisoners, therefore permitting
records-based biomedical research, using existing information.
Specifically, this bill:
1)Clarifies that biomedical research does not include the
accumulation of statistical data in the assessment of the
effectiveness of nonexperimental public health programs or
treatment programs in which inmates routinely participate.
2)Specifies that the use or disclosure of individually
identifiable records for records-based biomedical research
will only occur if both of the following requirements have
been met:
a) The research advisory committee established to oversee
research activities within the California Department of
Corrections and Rehabilitation (CDCR) approves the use or
disclosure; and,
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b) The inmate provides written authorization for the use or
disclosure, or the use or disclosure is permitted by
specified provisions of federal Health Information
Portability and Accountability Act of 1996 (HIPAA)
regulations.
EXISTING STATE LAW:
1)Prohibits conducting biomedical research on any prisoner in
the state.
2)Defines biomedical research as research relating to or
involving biological, medical, or physical science.
3)Defines behavioral research as studies involving the
investigation of human behavior, emotion, adaptation,
conditioning, and response in a program designed to test
certain hypotheses through the collection of objective data.
Specifies that behavioral research does not include the
accumulation of statistical data in the assessment of the
effectiveness of programs to which inmates are routinely
assigned, such as education, vocational training, productive
work, counseling, recognized therapies, and programs which are
not experimental in nature.
4)Establishes, under the Protection of Human Subjects in the
Medical Experimentation Act, various protections for subjects
of medical experimentation including 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.
Defines, for purposes of these provisions, "medical
experiment" as penetrating or damaging tissues, or the use of
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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.
EXISTING FEDERAL LAW enacts HIPAA which provides protections for
individually identifiable health information held by covered
entities and their business associates and gives patients an
array of rights with respect to that information. Permits,
under HIPAA, the disclosure of certain health information as
needed for patient care and certain other purposes, including:
public health activities; research; prevention of a serious
threat to health or safety; law enforcement purposes; and,
judicial and administrative proceedings. Covered entities under
the HIPAA Privacy Rule are health care providers, health plans,
and health care clearinghouses.
FISCAL EFFECT: According to the Senate Appropriations
Committee, pursuant to Senate Rule 28.8, negligible state costs.
COMMENTS:
1)PURPOSE OF THIS BILL. According to the author, 10 years ago,
a federal court placed the state's prison health care system
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under a receivership after determining that an average of one
inmate per week died as a result of medical malpractice or
neglect. The author states that 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 and Latino, and this
bill would authorize the publication of statistical data in
the assessment of the effectiveness of non-experimental public
health programs or treatment programs in which inmates
routinely participate. The author notes this bill 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. The author contends
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. The
author concludes that prisons face unique health care
challenges, and this bill would allow health care providers in
correctional facilities to publish and learn from
non-experimental data in order to provide higher quality
health care.
2)BACKGROUND.
a) Federal receivership for prison health care. In 2001, a
federal class-action lawsuit alleged that the dire state of
medical care in California state prisons violated the
Eighth Amendment of the U.S. Constitution, which prohibits
cruel and unusual punishment. In 2002, the state settled
the lawsuit by agreeing to reform the system. In 2005,
after several years of little progress, the court removed
control of prison medical care from CDCR and appointed a
federal Receiver to oversee the reform process. The
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receiver's job is to bring the level of medical care in
California prisons to a standard which no longer violates
the U.S. Constitution. Once that goal is accomplished and
sustainability is ensured, the court will return control of
prison medical care to the state and the Receivership will
end. The Receiver is responsible for providing health care
to 135,913 inmates (93% male, 7% female); delivering health
care at 34 adult institutions in California; and,
overseeing more than 7,000 California prison health care
positions, including doctors, nurses, pharmacists, and
administrative staff. To date, the federal receiver has
only returned oversight of the Folsom State Prison to the
state.
b) Recent experiences in prison health care. According to
California Correctional Health Care Services (CCHCS) the
prison system has been on the cutting edge of providing
treatment to prison inmates. Between 2012 and 2014 the
prison system experienced hunger strikes that lasted a
significant period of time, and as a result, prison doctors
developed an effective monitoring system that provided
appropriate treatment as needed during the strikes.
Additionally, for the past several years, the prison system
has undertaken a program for identifying and treating
Valley Fever in the central valley prisons: California was
the first prison health care system in the nation to use a
newly developed skin test that identifies
exposure/non-exposure to Valley Fever, which is now used in
making housing choices for inmates statewide. Most
recently the prison system had an outbreak of Legionnaires
Disease at San Quentin State Prison where, due to quick
identification and treatment, doctors were able to avoid
the loss of life. CCHCS would like to publish findings
regarding these recent experiences in medical journals that
would be of benefit to other correctional and community
entities, however the current ban on biomedical research
(added to law in the 1970s) prohibits CCHCS from publishing
an accumulation of statistical data that provided an
assessment of the effectiveness of non-experimental public
health or treatment programs such as described above.
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3)SUPPORT. CCHCS is the sponsor of this bill and notes that
CDCR and CCHCS currently have responsibility for insuring that
over 127,000 inmates receive appropriate medical, mental
health, and dental care. CCHCS states that over the last
several years, the prison system has been the site of
extremely newsworthy medical developments, providing certain
treatments to prison inmates that would be beneficial to share
with the medical community at large. CCHCS notes this bill
would narrowly amend the Penal Code to allow CCHCS to publish
findings from non-experimental public health or treatment
programs.
4)RELATED LEGISLATION. SB 1443 (Galgiani) permits the sharing
of medical, mental health and dental information between
correctional facilities, as specified. SB 1443 was held in
the Senate Appropriations Committee.
5)DOUBLE REFERRAL. This bill is double referred; upon passage
in this Committee, this bill will be referred to the Assembly
Public Safety Committee.
REGISTERED SUPPORT / OPPOSITION:
Support
California Correctional Health Care Services
Health Officers Association of California
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Opposition
None on file.
Analysis Prepared by:Lara Flynn / HEALTH / (916)
319-2097