Existing law prohibits biomedical research, as defined, from being conducted on any prisoner in the state.

This bill would specify 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. The bill would authorize records-based biomedical research involving inmates that uses existing information, but which does not include prospective interaction with human subjects.

Existing law prohibits biomedical research, as defined, from being conducted on any prisoner in the state.

This bill would specify 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. The bill would authorize records-based biomedical research involving inmates that uses existing information, but which does not include prospective interaction with human subjects.

Existing law prohibits biomedical research, as defined, from being conducted on any prisoner in the state.

This bill would specify 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. The bill would authorize records-based biomedical research involving inmates that uses existing information, but which does not include prospective interaction with human subjects.

Existing law prohibits biomedical research, as defined, from being conducted on any prisoner in the state.

This bill would specify 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. The bill would authorize records-based biomedical research involving inmates that uses existing information, but which does not include prospective interaction with human subjects.

Date of Hearing: August 3, 2016

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Lorena Gonzalez, Chair

SBPCA Bill Id:SB 1238

Author:(Pan) – As Amended Ver:March 29, 2016

Urgency: No State Mandated Local Program: No Reimbursable: No

SUMMARY:

This bill, notwithstanding a prohibition on biomedical research on prisoners, allows records-based, statistical research involving inmates, using existing information, and specifies criteria that must be met for the use or disclosure of individually identifiable records.

FISCAL EFFECT:

Negligible state fiscal effect. There may be a slight increase in research and analytical effort based on reducing barriers to analyzing and publishing data, but any cost is anticipated to be absorbable.

COMMENTS:

Purpose. The author explains this bill is necessary in order to publish and share findings of the California Correctional Health Care Services with respect to treatment and management of health issues. The author explains the current prohibition on medical research in inmates is so broad that it creates barriers to sharing cutting-edge research and best practices, which can in turn further the practice of correctional health care. The bill is sponsored by the California Correctional Health Care Services (CCHCS; the federal receivership in charge of California's correctional health care system) and has no opposition.

Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081

Date of Hearing: June 28, 2016

Counsel: Gabriel Caswell

ASSEMBLY COMMITTEE ON PUBLIC SAFETY

Reginald Byron Jones-Sawyer, Sr., Chair

SBPCA Bill Id:SB 1238

Author:(Pan) – As Amended Ver:March 29, 2016

SUMMARY: Permits records-based, statistical research, using existing information, to be conducted on prisoners, notwithstanding a prohibition on biomedical research on prisoners. Specifically, 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:
   1. The research advisory committee, established pursuant to specified provisions of existing California regulations on research involving prisoners (currently limited to behavioral research), approves of the use or disclosure; and,
   2. 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

EXISTING LAW:

1. Defines the following terms: (Pen. Code, § 3500.)
   
   1. “Behavioral research” as studies involving, but not limited to, the investigation of human behavior, emotion, adaptation, conditioning, and response in a program designed to test certain hypotheses through the collection of objective data. 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, but not limited to, education, vocational training, productive work, counseling, recognized therapies, and programs which are not experimental in nature.
      
   2. “Biomedical research” as research relating to or involving biological, medical, or physical science.
      
   3. “Psychotropic drug” as any drug that has the capability of changing or controlling mental functioning or behavior through direct pharmacological action. Such drugs include, but are not limited to, antipsychotic, antianxiety, sedative, antidepressant, and stimulant drugs. Psychotropic drugs also include mind-altering and behavior-altering drugs which, in specified dosages, are used to alleviate certain physical disorders, and drugs which are ordinarily used to alleviate certain physical disorders but may, in specified dosages, have mind-altering or behavior-altering effects.
      
   4. “Research” as a class of activities designed to develop or contribute to generalizable knowledge such as theories, principles, or relationships, or the accumulation of data on which they may be based, that can be corroborated by accepted scientific observation and inferences.
      
   5. “Research protocol” as a formal document setting forth the explicit objectives of a research project and the procedures of investigation designed to reach those objectives.
      
   6. “Phase I drug” as any drug which is designated as a phase I drug for testing purposes under the federal Food and Drug Administration criteria in Section 312.1 of Title 21 of the Code of Federal Regulations.
      
2. Provides that the Legislature affirms the fundamental right of competent adults to make decisions about their participation in behavioral research. (Pen. Code, § 3501.)
   
3. Provides that biomedical research shall not be conducted on any prisoner in this state. (Pen. Code, § 3502.)
   
4. Provides that notwithstanding the bar of biomedical research on prisoners, any physician who provides medical care to prisoners may provide a patient who is prisoner with a drug or treatment available only through a treatment protocol or treatment IND (investigational new drug) if the physician determines that access to that drug is in the best medical interest of the patient, and the patient has given informed consent. (Pen. Code, § 3502.5.)
   
5. States that any physical or mental injury of a prisoner resulting from the participation in behavioral research, irrespective of causation of such injury, shall be treated promptly and on a continuing basis until the injury is cured. (Pen. Code, § 3504.)
   
6. Requires that behavioral research be limited 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. Informed consent shall not be required for participation in behavioral research when the department determines that it would be unnecessary or significantly inhibit the conduct of such research. In the absence of such determination, informed consent shall be required for participation in behavioral research. (Pen. Code, § 3505.)
   
7. Requires that behavioral-modification techniques shall be used only if such techniques are medically and socially acceptable means by which to modify behavior and if such techniques do not inflict permanent physical or psychological injury. (Pen. Code, § 3508.)
   

FISCAL EFFECT:

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 and Latino. SB 1238 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.

"In August of 2015, microscopic bacteria contaminated the water supply of San Quentin State Prison (SQ). A physician working in the prison noticed an unusual number of inmate-patients with pneumonia. Two hours into a collaborative email chain, the healthcare providers of SQ identified the cause of the pneumonia increase: Legionnaires’ disease. Data sharing among the heath care staff enabled the California Correctional Health Care Services (CCHCS) and the California Department of Corrections and Rehabilitation to respond to the potential health crisis immediately. The quick identification and effective treatment of the disease prevented the crisis from turning fatal. Data sharing enabled this life-saving response. The ability to publish some of this data would allow other health care agencies to learn to better manage similar health crises. Nonexperimental medical data can be used to save lives while completely avoiding the ethical dilemmas of allowing experimental biomedical research in prisons.

"California’s prison system has been on the cutting edge of providing health care to prison inmates, but current law prevents the publishing of non-experimental medical data that could be used to improve health care in correctional facilities and potentially save lives. Prisons face unique health care challenges, and SB 1238 would allow health care providers to share and learn from non-experimental data in order to provide higher quality health care."

1. California Department of Corrections Healthcare: Federal Receivership: CCHCS (federal receivership) was established as a result of a class action lawsuit (Plata v. Brown) brought against the State of California over the quality of medical care in the state’s 34 adult prisons. In its ruling, the federal court found that the care was in violation of the Eighth Amendment of the U.S. Constitution which prohibits cruel and unusual punishment. The state settled the lawsuit and entered into a stipulated settlement in 2002, agreeing to a range of remedies that would bring prison medical care in line with constitutional standards. The state failed to comply with the stipulated settlement and on February 14, 2006, the federal court appointed a receiver to manage medical care operations in the prison system. The current receiver was appointed in January of 2008. The receivership continues to be unprecedented in size and scope nationwide.

CCHCS is the sponsor of this legislation and states in support:

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. 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, for the past several years, the prison system has undertaken a massive program for identifying and treating Valley Fever in our central valley prisons: 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, just recently the prison system had an outbreak of Legionnaires Disease at San Quentin (SQ) State Prison where, due to quick identification and effective treatment, doctors were able to successfully treat inmates at SQ without the loss of life.

California Correctional Health Care Services, which oversees prison medical care, would like to publish our findings in medical journals that would be of benefit to other correctional and community entities. However, under current law (added in the 1970s) there currently is a prohibition in the California Penal Code for performing or undertaking biomedical research on prisoners Unfortunately, the broad nature of the current statute 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 described above.

This bill would narrowly amend the Penal Code to allow CCHCS to publish findings from non-experimental public health or treatment programs.

1. Effect of This Legislation: This bill provides for 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. Specifically, this bill 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. This bill, additionally, authorizes 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 privacy regulations that permit disclosure without written authorization under certain circumstances.

REGISTERED SUPPORT / OPPOSITION:

Support

California Correctional Health Care Services (CCHCS)

Opposition

None

Analysis Prepared by: Gabriel Caswell / PUB. S. / (916) 319-3744

Date of Hearing: June 21, 2016

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SB 1238

Author:(Pan) – As Amended Ver: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:
   1. The research advisory committee established to oversee research activities within the California Department of Corrections and Rehabilitation (CDCR) approves the use or disclosure; and,
   2. 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 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 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.
   1. 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 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.
      
   2. 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.
      
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

Opposition

None on file.

Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097

 THIRD READING  

Bill No: SB 1238

Author:

:

Vote:

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:

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.
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 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:
   1. 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,
   2. 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

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 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.: Yes Local: No

SUPPORT: (Verified 5/18/16)

California Correctional Health Care Services

OPPOSITION: (Verified 5/18/16)

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, 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

**** END ****

SENATE COMMITTEE ON PUBLIC SAFETY

Senator Loni Hancock, Chair

2015 - 2016 Regular

Bill No: SB 1238 Hearing Date: April 19, 2016

Subject: Inmates: Biomedical Data

HISTORY

Source: California Correctional Healthcare Services

Prior Legislation: None known

Support: Unknown

Opposition: None known

PURPOSE

The purpose of this bill is to permit records-based biomedical research, using existing information, to be conducted on prisoners, notwithstanding a prohibition on biomedical research on prisoners.

Existing law defines:

• “Behavioral research” as studies involving, but not limited to, the investigation of human behavior, emotion, adaptation, conditioning, and response in a program designed to test certain hypotheses through the collection of objective data. 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, but not limited to, education, vocational training, productive work, counseling, recognized therapies, and programs which are not experimental in nature.
• “Biomedical research” as research relating to or involving biological, medical, or physical science.
• “Psychotropic drug” as any drug that has the capability of changing or controlling mental functioning or behavior through direct pharmacological action. Such drugs include, but are not limited to, antipsychotic, antianxiety, sedative, antidepressant, and stimulant drugs. Psychotropic drugs also include mind-altering and behavior-altering drugs which, in specified dosages, are used to alleviate certain physical disorders, and drugs which are ordinarily used to alleviate certain physical disorders but may, in specified dosages, have mind-altering or behavior-altering effects.
• “Research” as a class of activities designed to develop or contribute to generalizable knowledge such as theories, principles, or relationships, or the accumulation of data on which they may be based, that can be corroborated by accepted scientific observation and inferences.
• “Research protocol” as a formal document setting forth the explicit objectives of a research project and the procedures of investigation designed to reach those objectives.
• “Phase I drug” as any drug which is designated as a phase I drug for testing purposes under the federal Food and Drug Administration criteria in Section 312.1 of Title 21 of the Code of Federal Regulations.

(Penal Code § 3500.)

Existing law provides that the Legislature affirms the fundamental right of competent adults to make decisions about their participation in behavioral research. (Penal Code § 3501.)

Existing law provides that biomedical research shall not be conducted on any prisoner in this state. (Penal Code § 3502.)

Existing law provides that notwithstanding Section 3502, any physician who provides medical care to prisoners may provide a patient who is prisoner with a drug or treatment available only through a treatment protocol or treatment IND (investigational new drug) if the physician determines that access to that drug is in the best medical interest of the patient, and the patient has given informed consent. And, notwithstanding any other provision of law, neither a public

entity nor a public employee shall be liable for any injury caused by the administration of a drug pursuant, where the administration is made as specified. (Penal Code § 3502.5.)

Existing law states that any physical or mental injury of a prisoner resulting from the participation in behavioral research, irrespective of causation of such injury, shall be treated promptly and on a continuing basis until the injury is cured. (Penal Code § 3504.)

Existing law requires that behavioral research be limited 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. Informed consent shall not be required for participation in behavioral research when the department determines that it would be unnecessary or significantly inhibit the conduct of such research. In the absence of such determination, informed consent shall be required for participation in behavioral research. (Penal Code § 3505.)

Existing law requires that behavioral modification techniques shall be used only if such techniques are medically and socially acceptable means by which to modify behavior and if such techniques do not inflict permanent physical or psychological injury. (Penal Code § 3508.)

This bill 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.

This bill 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:

• 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,
• The prisoner provides written authorization for the use or disclosure, or the use or disclosure is permitted by specified provisions of federal HIPAA regulations.

This bill 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

RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION

For the past several years this Committee has scrutinized legislation referred to its jurisdiction for any potential impact on prison overcrowding. Mindful of the United States Supreme Court ruling and federal court orders relating to the state’s ability to provide a constitutional level of health care to its inmate population and the related issue of prison overcrowding, this Committee has applied its “ROCA” policy as a content-neutral, provisional measure necessary to ensure that the Legislature does not erode progress in reducing prison overcrowding.

On February 10, 2014, the federal court ordered California to reduce its in-state adult institution population to 137.5% of design capacity by February 28, 2016, as follows:

• 143% of design bed capacity by June 30, 2014;
• 141.5% of design bed capacity by February 28, 2015; and,
• 137.5% of design bed capacity by February 28, 2016.

In December of 2015 the administration reported that as “of December 9, 2015, 112,510 inmates were housed in the State’s 34 adult institutions, which amounts to 136.0% of design bed capacity, and 5,264 inmates were housed in out-of-state facilities. The current population is 1,212 inmates below the final court-ordered population benchmark of 137.5% of design bed capacity, and has been under that benchmark since February 2015.” (Defendants’ December 2015 Status Report in Response to February 10, 2014 Order, 2:90-cv-00520 KJM DAD PC, 3-Judge Court, Coleman v. Brown, Plata v. Brown (fn. omitted).) One year ago, 115,826 inmates were housed in the State’s 34 adult institutions, which amounted to 140.0% of design bed capacity, and 8,864 inmates were housed in out-of-state facilities. (Defendants’ December 2014 Status Report in Response to February 10, 2014 Order, 2:90-cv-00520 KJM DAD PC, 3-Judge Court, Coleman v. Brown, Plata v. Brown (fn. omitted).)

While significant gains have been made in reducing the prison population, the state must stabilize these advances and demonstrate to the federal court that California has in place the “durable solution” to prison overcrowding “consistently demanded” by the court. (Opinion Re: Order Granting in Part and Denying in Part Defendants’ Request For Extension of December 31, 2013 Deadline, NO. 2:90-cv-0520 LKK DAD (PC), 3-Judge Court, Coleman v. Brown, Plata v. Brown (2-10-14). The Committee’s consideration of bills that may impact the prison population therefore will be informed by the following questions:

• Whether a proposal erodes a measure which has contributed to reducing the prison population;
• Whether a proposal addresses a major area of public safety or criminal activity for which there is no other reasonable, appropriate remedy;
• Whether a proposal addresses a crime which is directly dangerous to the physical safety of others for which there is no other reasonably appropriate sanction;
• Whether a proposal corrects a constitutional problem or legislative drafting error; and
• Whether a proposal proposes penalties which are proportionate, and cannot be achieved through any other reasonably appropriate remedy.

COMMENTS

1. Need for This Bill

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 and Latino. SB 1238 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.

In August of 2015, microscopic bacteria contaminated the water supply of San Quentin State Prison (SQ). A physician working in the prison noticed an unusual number of inmate-patients with pneumonia. Two hours into a collaborative email chain, the healthcare providers of SQ identified the cause of the pneumonia increase: Legionnaires’ disease. Data sharing among the heath care staff enabled the California Correctional Health Care Services (CCHCS) and the California Department of Corrections and Rehabilitation to respond to the potential health crisis immediately. The quick identification and effective treatment of the disease prevented the crisis from turning fatal. Data sharing enabled this life-saving response. The ability to publish some of this data would allow other health care agencies to learn to better manage similar health crises. Nonexperimental medical data can be used to save lives while completely avoiding the ethical dilemmas of allowing experimental biomedical research in prisons.

California’s prison system has been on the cutting edge of providing health care to prison inmates, but current law prevents the publishing of non-experimental medical data that could be used to improve health care in correctional facilities and potentially save lives. Prisons face unique health care challenges, and SB 1238 would allow health care providers to share and learn from non-experimental data in order to provide higher quality health care.

2. California Department of Corrections Healthcare: Federal Receivership

CCHCS (federal receivership) was established as a result of a class action lawsuit (Plata v. Brown) brought against the State of California over the quality of medical care in the state’s 34 adult prisons. In its ruling, the federal court found that the care was in violation of the Eighth Amendment of the U.S. Constitution which prohibits cruel and unusual punishment. The state settled the lawsuit and entered into a stipulated settlement in 2002, agreeing to a range of remedies that would bring prison medical care in line with constitutional standards. The state failed to comply with the stipulated settlement and on February 14, 2006, the federal court appointed a receiver to manage medical care operations in the prison system. The current receiver was appointed in January of 2008. The receivership continues to be unprecedented in size and scope nationwide.

CCHCS is the sponsor of this legislation and states in support:

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. 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, for the past several years, the prison system has undertaken a massive program for identifying and treating Valley Fever in our central valley prisons: 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, just recently the prison system had an outbreak of Legionnaires Disease at San Quentin (SQ) State Prison where, due to quick identification and effective treatment, doctors were able to successfully treat inmates at SQ without the loss of life.

California Correctional Health Care Services, which oversees prison medical care, would like to publish our findings in medical journals that would be of benefit to other correctional and community entities. However, under current law (added in the 1970s) there currently is a prohibition in the California Penal Code for performing or undertaking biomedical research on prisoners Unfortunately, the broad nature of the current statute 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 described above.

This bill would narrowly amend the Penal Code to allow CCHCS to publish findings from non-experimental public health or treatment programs.

3. Effect of This Legislation

This bill provides for 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. Specifically, this bill 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. This bill, additionally, authorizes 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 privacy regulations that permit disclosure without written authorization under certain circumstances.

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SENATE COMMITTEE ON HEALTH

Senator Ed Hernandez, O.D., Chair

BILL NO: SB 1238

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 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.
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:
   1. 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,
   2. 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. 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 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 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

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