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 --