BILL ANALYSIS                                                                                                                                                                                                    Ó



          SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:                    SB 1238             
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          |AUTHOR:        |Pan                                            |
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          |VERSION:       |March 29, 2016                                 |
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          |HEARING DATE:  |April 6, 2016  |               |               |
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          |CONSULTANT:    |Vince Marchand                                 |
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           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  







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            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.









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          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.  








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            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  








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            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  








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            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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