BILL ANALYSIS Ó
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: SB 1238
---------------------------------------------------------------
|AUTHOR: |Pan |
|---------------+-----------------------------------------------|
|VERSION: |March 29, 2016 |
---------------------------------------------------------------
---------------------------------------------------------------
|HEARING DATE: |April 6, 2016 | | |
---------------------------------------------------------------
---------------------------------------------------------------
|CONSULTANT: |Vince Marchand |
---------------------------------------------------------------
SUBJECT : Inmates: biomedical data
SUMMARY : Permits records-based biomedical research, using existing
information, to be conducted on prisoners, notwithstanding a
prohibition on biomedical research on prisoners.
Existing 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 (CDCR) 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 (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
SB 1238 (Pan) Page 2 of ?
for a subject to give or withdraw consent freely and without
duress. Imposes penalties for violations of these
protections. For 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.
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.
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.
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.
SB 1238 (Pan) Page 3 of ?
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
statistical data in the assessment of the effectiveness of
nonexperimental public health programs or treatment programs
in which inmates routinely participate
FISCAL
EFFECT : This bill has not been heard by a fiscal committee.
COMMENTS :
1)Author's statement. According to the author, ten 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 ten 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 would authorize
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.
SB 1238 (Pan) Page 4 of ?
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)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
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.
3)Double referral. This bill is double referred. Should it pass out
of this committee, it will be referred to the Senate Public Safety
Committee.
4)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,
which is now used in making wise housing choices for inmates
statewide. Finally, CCHCS notes that the prison system just
SB 1238 (Pan) Page 5 of ?
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 would narrowly amend this prohibition to allow
CCHCS to publish findings from non-experimental public health
or treatment programs.
5)Drafting comments. The stated intent of the author is to allow
the use of statistical data from health treatment programs
within prisons in order to publish studies or reports on the
efficacy of these health treatment programs. The bill
accomplishes this in two ways. First, it excludes from the
definition of "biomedical research," and therefore exempts
from the ban on this research, the "accumulation of
statistical data" in the assessment of treatment programs in
which inmates routinely participated.
The second way this bill seeks to accomplish its objective is by
specifically authorizing biomedical research, but only when it
is records-based, using existing information, and does not
include prospective interaction with prisoners. In this
provision, the use or disclosure of individually identifiable
records is permitted, either with the written authorization of
the prisoner, or when the use or disclosure is otherwise
permitted under specified federal HIPAA regulations that
permit disclosure without written authorization under certain
circumstances. These specified HIPAA regulations, generally
speaking, permit disclosure for public health activities, such
as for controlling or preventing the outbreak of disease,
adverse event reporting, proof of immunization, etc.
While California and federal medical privacy laws generally
protect individually identifiable health information, the
author may wish to consider strengthening the privacy
protections in this bill by ensuring that the use or
SB 1238 (Pan) Page 6 of ?
disclosure of medical information is not able to be traced
back to any individual prisoner.
SUPPORT AND OPPOSITION :
Support: California Correctional Health Care Services (sponsor)
Oppose: None received
-- END --