text:
(a) Subject to subdivision (b), each clinical laboratory, as defined in Section 1206 of the Business and Professions Code, shall report all CD4+ T-Cell test results to the local health officer for the local health jurisdiction where the health care provider facility is located within seven days of the completion of the CD4+ T-Cell test.

(b) A clinical laboratory shall not be required to report a CD4+ T-Cell test result, as required by this section, if the clinical laboratory can demonstrate that the CD4+ T-Cell test result is not related to a diagnosed case of HIV infection.

(c) The clinical laboratory report with CD4+ T-Cell test results shall also include, if provided by the ordering health care provider, all of the following:

(1) The patient’s name.

(2) The patient’s date of birth.

(3) The patient’s gender.

(4) The name, telephone number, and address of the local health care provider that ordered the test.

(d) The clinical laboratory report with CD4+ T-Cell test results shall also include all of the following information:

(1) CD4+ T-Cell test results expressed as an absolute count (the number of lymphocytes containing the CD4 epitope per cubic millimeter) and, if available, the relative count (the number of lymphocytes expressing the CD4 epitope as a percentage of total lymphocytes).

(2) The type of laboratory test performed.

(3) The date the laboratory test was performed.

(4) The name, telephone number, and address of the clinical laboratory that performed the test.

(5) The laboratory CLIA number.

(6) The laboratory report number.

(e) (1) Each local health officer shall inspect each clinical laboratory CD4+ T-Cell test report to determine if the test is related to a case of HIV infection.

(2) If the clinical laboratory CD4+ T-Cell test result is related to a case of HIV infection, the local health officer shall report the case of HIV infection or AIDS, as appropriate, to the State Department of Public Health within 45 days of receipt of the laboratory report.

(3) If the clinical laboratory CD4+ T-Cell test result is not related to a case of HIV infection, the local health officer shall destroy the laboratory CD4+ T-Cell test report.

(f) Pursuant to Section 121025, CD4+ T-Cell test reports shall not be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding.

(g) CD4+ T-Cell test reports shall be considered confidential public health records as defined in Section 121035.

(h) For the purposes of this section, “CD4+ T-Cell test” means any test used to measure the number of lymphocytes containing the CD4 epitope.

history: (History: Amended by Stats. 2009, Ch. 501, Sec. 1. (AB 1045) Effective January 1, 2010.)


kind: section

code: HSC

text:
(a) Public health records relating to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS), containing personally identifying information, that were developed or acquired by a state or local public health agency, or an agent of that agency, are confidential and shall not be disclosed, except as otherwise provided by law for public health purposes or pursuant to a written authorization by the person who is the subject of the record or by the person’s guardian or conservator.

(b) A state or local public health agency, or an agent of that agency, may disclose personally identifying information in public health records, as described in subdivision (a), to other local, state, or federal public health agencies including, but not limited to, the federal Centers for Disease Control and Prevention (CDC), or to collaborating researchers, when the confidential information is necessary to carry out the duties of the agency or researcher in the investigation, control, or surveillance of disease, or the coordination of, linkage to, or reengagement in care for a person or persons, as determined by the state or local public health agency.

(c) Any disclosures authorized by subdivision (a), (b), or this subdivision shall include only the information necessary for the purpose of that disclosure and shall be made only upon the agreement that the information will be kept confidential as described in subdivision (a). Any unauthorized further disclosure shall be subject to the penalties described in subdivision (e).

(1) Notwithstanding any other law, the state or local public health agency staff may further disclose the information to a health care provider who provides care to the HIV-positive person who is the subject of the record for the purpose of assisting in compliance with subdivision (a) of Section 121022.

(2) Notwithstanding any other law, the following disclosures are authorized for the purpose of facilitating appropriate HIV/AIDS medical care and treatment:

(A) State public health agency HIV surveillance staff, HIV prevention staff, AIDS Drug Assistance Program staff, and care services staff may further disclose the information to local public health agency staff, who may further disclose the information to the HIV-positive person who is the subject of the record, or a health care provider who provides the person’s care, for the purpose of proactively offering and coordinating care and treatment services to the HIV-positive person.

(B) HIV surveillance staff, HIV prevention staff, AIDS Drug Assistance Program staff, and care services staff in the State Department of Public Health may further disclose the information directly to the HIV-positive person who is the subject of the record or the health care provider who provides their HIV care, for the purpose of proactively offering and coordinating care and treatment services to them.

(C) Local public health agency staff may further disclose acquired or developed information to the HIV-positive person who is the subject of the record or the health care provider who provides their HIV care for the purpose of proactively offering and coordinating care and treatment services to them.

(3) Notwithstanding any other law, for the purpose of facilitating appropriate case management or care coordination or delivery of medical care and treatment of persons coinfected with HIV and tuberculosis, syphilis, gonorrhea, chlamydia, hepatitis B, hepatitis C, meningococcal infection, or other reportable diseases under Section 2500 or Section 2505 of Title 17 of the California Code of Regulations, state or local public health agency staff may further disclose the information to other state or local public health agency staff, the HIV-positive person who is the subject of the record, or the HIV-positive person’s health care provider.

(4) For the purposes of paragraphs (2) and (3), “staff” does not include nongovernmental entities, but shall include state and local contracted employees who work within state and local public health departments.

(d) A confidential public health record, as defined in subdivision (c) of Section 121035, shall not be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding.

(e) (1) A person who negligently discloses the content of a confidential public health record, as defined in subdivision (c) of Section 121035, to a third party, except pursuant to a written authorization, as described in subdivision (a), or as otherwise authorized by law, shall be subject to a civil penalty in an amount not to exceed five thousand dollars ($5,000), plus court costs, as determined by the court. The penalty and costs shall be paid to the person whose record was disclosed.

(2) A person who willfully or maliciously discloses the content of any confidential public health record, as defined in subdivision (c) of Section 121035, to a third party, except pursuant to a written authorization, or as otherwise authorized by law, shall be subject to a civil penalty in an amount not less than five thousand dollars ($5,000) and not more than twenty-five thousand dollars ($25,000), plus court costs, as determined by the court. The penalty and costs shall be paid to the person whose confidential public health record was disclosed.

(3) A person who willfully, maliciously, or negligently discloses the content of a confidential public health record, as defined in subdivision (c) of Section 121035, to a third party, except pursuant to a written authorization, or as otherwise authorized by law, that results in economic, bodily, or psychological harm to the person whose confidential public health record was disclosed, is guilty of a misdemeanor, punishable by imprisonment in a county jail for a period not to exceed one year, or a fine not to exceed twenty-five thousand dollars ($25,000), or both, plus court costs, as determined by the court. The penalty and costs shall be paid to the person whose confidential public health record was disclosed.

(4) A person who commits an act described in paragraph (1), (2), or (3) is liable to the person whose confidential public health record was disclosed for all actual damages for economic, bodily, or psychological harm that is a proximate result of the act.

(5) Each violation of this section is a separate and actionable offense.

(6) This section does not limit or expand the right of an injured person whose confidential public health record was disclosed to recover damages under any other applicable law.

(f) If a confidential public health record, as defined in subdivision (c) of Section 121035, is disclosed, the information shall not be used to determine employability or insurability of a person.

history: (History: Amended by Stats. 2024, Ch. 472, Sec. 3. (SB 1333) Effective January 1, 2025.)

part: 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV)

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 8. Acquired Immune Deficiency Syndrome (AIDS) Public Health Records Confidentiality Act


text:
(a) Notwithstanding subdivision (f) of Section 120980, Section 121010, subdivision (i) of Section 121022, subdivision (f) of Section 121025, Section 121115, and Section 121280, the State Department of Public Health and qualified entities may share with each other health records involving the diagnosis, care, and treatment of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related to a beneficiary enrolled in federal Ryan White Act funded programs who may be eligible for services under the federal Patient Protection and Affordable Care Act (Public Law 111-148), as amended by the federal Health Care and Education Reconciliation Act of 2010 (Public Law 111-152). The qualified entities, who shall be covered entities under the federal Health Insurance Portability and Accountability Act (Public Law 104-191) and the final regulations issued pursuant to the act by the United States Department of Health and Human Services (45 C.F.R. Parts 160 and 164), may share records only for the purpose of enrolling the beneficiary in Medi-Cal, the bridge programs, Medicaid expansion programs, and any insurance plan certified by the California Health Benefit Exchange established pursuant to Title 22 (commencing with Section 100500) of the Government Code, or any other programs authorized under the federal Patient Protection and Affordable Care Act (Public Law 111-148), and for the purpose of continuing their access to those programs and plans without disruption.

(b) The information provided by the State Department of Public Health pursuant to this section shall be limited to only the information necessary for the purposes of this section and shall not include HIV or AIDS surveillance data. This information shall not be further disclosed by a qualified entity, except to any or all of the following as necessary for the purposes of this section:

(1) The person who is the subject of the record or to their guardian or conservator.

(2) The provider of health care for the person with HIV or AIDS to whom the information pertains.

(3) The Office of AIDS within the State Department of Public Health.

(c) For purposes of this section, the following definitions shall apply:

(1) “Contractor” means any person or entity that is a medical group, independent practice association, pharmaceutical benefits manager, or a medical service organization and is not a health care service plan or provider of health care.

(2) “Provider of health care” means any person licensed or certified pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code; any person licensed pursuant to the Osteopathic Initiative Act or the Chiropractic Initiative Act; any person certified pursuant to Division 2.5 (commencing with Section 1797) of the Health and Safety Code; any clinic, health dispensary, or health facility licensed pursuant to Division 2 (commencing with Section 1200) of the Health and Safety Code.

(3) “Qualified entity” means any of the following:

(A) The State Department of Health Care Services.

(B) The California Health Benefit Exchange established pursuant to Title 22 (commencing with Section 100500) of the Government Code.

(C) Medi-Cal managed care plans.

(D) Health plans participating in the Bridge Program.

(E) Health plans offered through the Exchange.

(F) County health departments delivering HIV or AIDS health care services.

(d) Notwithstanding any other law, information shared pursuant to this section shall not be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding.

(e) This section shall be implemented only to the extent permitted by federal law. All employees and contractors of a qualified entity who have access to confidential HIV-related medical records pursuant to this section shall be subject to, and all information shared pursuant to this section shall be protected in accordance with, the federal Health Insurance Portability and Accountability Act (Public Law 104-191) and the final regulations issued pursuant to that act by the United States Department of Health and Human Services (45 C.F.R. Parts 160 and 164), the Confidentiality of Medical Information Act (Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code), and the Insurance Information and Privacy Protection Act (Article 6.6 (commencing with Section 791) of Part 2 of Division 1 of the Insurance Code).

history: (History: Amended by Stats. 2025, Ch. 766, Sec. 3. (SB 504) Effective January 1, 2026.)

division: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL

chapter: 8. Acquired Immune Deficiency Syndrome (AIDS) Public Health Records Confidentiality Act


text:
(a) To the extent Chapter 7 (commencing with Section 120975) and Chapter 10 (commencing with Section 121075) apply to records or information that would be covered by this chapter, Chapters 7 and 10 shall supersede this chapter.

(b) This chapter supersedes Section 100330 to the extent it applies to records or information covered by Section 100325 or 100330.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.)


text:
For purposes of this chapter:

(a) “Disclosed” or “disclosure” or “discloses” has the same meaning as set forth in subdivision (b) of Section 121125.

(b) “State or local public health agencies” are the department, and any local entity that a health officer, as defined in Section 120100, serves.

(c) “Confidential public health record or records” means any paper or electronic record maintained by the department or a local health department or agency, or its agent, that includes data or information in a manner that identifies personal information, including, but not limited to, name, social security number, address, employer, or other information that may directly or indirectly lead to the identification of the individual who is the subject of the record.

history: (History: Amended by Stats. 2006, Ch. 20, Sec. 8. Effective April 17, 2006.)


text:
The people of the State of California find and declare that AIDS, AIDS-related conditions, and other communicable diseases pose a major threat to the public health and safety. The health and safety of the public, victims of sexual crimes, and peace officers, firefighters, and custodial personnel who may come into contact with infected persons, have not been adequately protected by law. The purpose of this chapter is to require that information that may be vital to the health and safety of the public, victims of certain crimes, certain defendants and minors, and custodial personnel, custodial medical personnel, peace officers, firefighters and emergency medical personnel put at risk in the course of their official duties, be obtained and disclosed in an appropriate manner in order that precautions can be taken to preserve their health and the health of others or that those persons can be relieved from groundless fear of infection.

It is the intent of this chapter to supersede in case of conflict existing statutes or case law on the subjects covered including but not limited to the confidentiality and consent provisions contained in Chapter 7 (commencing with Section 120975), Chapter 8 (commencing with Section 121025), and Chapter 10 (commencing with Section 121075).

history: (History: Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996. Note: Stats. 1995, Ch. 415, reenacted in this section the provisions from Section 199.95 as added on Nov. 8, 1988, by initiative Prop. 96.)

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 9. Acquired Immune Deficiency Syndrome (AIDS) Public Safety and Testing Disclosure


text:
Any defendant charged in any criminal complaint filed with a magistrate or court with any violation of Section 261, 261.5, 262, 266b, 266c, 286, 287, or 288 of, or former Section 288a of, the Penal Code, and any minor with respect to whom a petition has been filed in a juvenile court alleging violation of any of the foregoing laws, shall be subject to an order of a court having jurisdiction of the complaint or petition requiring testing as provided in this chapter.

If an alleged victim listed in the complaint or petition makes a written request for testing under this section, the prosecuting attorney, or the alleged victim may petition the court for an order authorized under this section.

The court shall promptly conduct a hearing upon any such petition. If the court finds that probable cause exists to believe that a possible transfer of blood, saliva, semen, or other bodily fluid took place between the defendant or minor and the alleged victim in an act specified in this section, the court shall order that the defendant or minor provide two specimens of blood for testing as provided in this chapter.

Copies of the test results shall be sent to the defendant or minor, each requesting victim and, if the defendant or minor is incarcerated or detained, to the officer in charge and the chief medical officer of the facility where the person is incarcerated or detained.

history: (History: Amended by Stats. 2018, Ch. 423, Sec. 37. (SB 1494) Effective January 1, 2019.)

chapter: 9. Acquired Immune Deficiency Syndrome (AIDS) Public Safety and Testing Disclosure


text:
(a) Any forensic scientist, including, but not limited to, any criminalist, toxicologist, and forensic pathologist, or any other employee required to handle or perform DNA or other forensic evidence analysis within the scope of his or her duties, who comes into contact with blood or other bodily fluids on, upon, or through the skin or membranes of his or her person while handling or performing testing on forensic evidence, may petition, ex parte, the court having jurisdiction over the laboratory in which he or she works for an order authorized under this chapter.

The employing agency, officer, or entity of the affected employee may also file an ex parte petition for an order authorized under this chapter. Before filing a petition, the requesting party shall make a reasonable effort to obtain the consent of the person whose blood or bodily fluids is to be tested.

(b) The court shall promptly consider any petition filed pursuant to this section. If the court finds that probable cause exists to believe that a possible transfer of blood, saliva, semen, or other bodily fluid took place between the forensic evidence collected and the forensic scientist, criminalist, toxicologist, forensic pathologist, or any other employee required to handle evidence or perform forensic testing thereon as specified in this section, the court shall promptly order that the existing forensic evidence be tested as provided in this chapter.

(c) (1) Except as provided in paragraph (2), copies of the test results shall be sent to each requesting employee named in the petition, and his or her employing agency, officer, or entity, to the person whose sample was tested, and to the officer in charge and the chief medical officer of the facility in which the person is incarcerated or detained.

(2) The person whose sample was tested, shall be advised that he or she will be informed of the HIV test results only if he or she wishes to be so informed. If the person declines to be informed of the HIV test results, then he or she shall sign a form documenting that refusal. The person’s refusal to sign that form shall be construed to be a request to be informed of the HIV test results.

history: (History: Added by Stats. 2001, Ch. 482, Sec. 1. Effective January 1, 2002.)


text:
(a) Any peace officer, firefighter, custodial officer, as that term is defined in subdivision (a) of Section 831 or subdivision (a) of Section 831.5 of the Penal Code, a custody assistant, as that term is defined in subdivision (a) of Section 831.7 of the Penal Code, a nonsworn uniformed employee of a law enforcement agency whose job entails the care or control of inmates in a detention facility, a nonsworn employee of a law enforcement agency whose job description entails the collection of fingerprints, or emergency medical personnel who, while acting within the scope of his or her duties, is exposed to an arrestee’s blood or bodily fluids, as defined in Section 121060.1, shall do the following:

(1) Prior to filing a petition with the court, a licensed health care provider shall notify the arrestee of the bloodborne pathogen exposure and make a good faith effort to obtain the voluntary informed consent of the arrestee or the arrestee’s authorized legal representative to perform a test for human immunodeficiency virus (HIV), hepatitis B, and hepatitis C. The voluntary informed consent shall be in writing. Once consent is given in writing, the arrestee shall provide three specimens of blood for testing as provided in this chapter.

(2) If voluntary informed consent is not given in writing, the affected individual may petition, ex parte, the court for an order requiring testing as provided in this chapter. The petition shall include a written certification by a health care professional that an exposure, including the nature and extent of the exposure, has occurred.

(b) The court shall promptly conduct a hearing upon a petition filed pursuant to paragraph (2) of subdivision (a). If the court finds that probable cause exists to believe that a possible bloodborne pathogen exposure, as defined in Section 121060.1, took place between the arrestee and the peace officer, firefighter, custodial officer, custody assistant, nonsworn uniformed employee of a law enforcement agency whose job entails the care or control of inmates in a detention facility, nonsworn employee of a law enforcement agency whose job description entails the collection of fingerprints, or emergency medical personnel, as specified in this section, the court shall order that the arrestee provide three specimens of blood for testing as provided in this chapter.

(c) (1) Except as provided in paragraph (2), copies of the test results shall be sent to the arrestee, each peace officer, firefighter, custodial officer, custody assistant, nonsworn uniformed employee of a law enforcement agency whose job entails the care or control of inmates in a detention facility, nonsworn employee of a law enforcement agency whose job description entails the collection of fingerprints, and emergency medical personnel named in the petition and his or her employing agency, officer, or entity, and if the arrestee is incarcerated or detained, to the officer in charge and the chief medical officer of the facility where the person is incarcerated or detained.

(2) The person whose sample was tested, shall be advised that he or she will be informed of the hepatitis B, hepatitis C, and HIV test results only if he or she wishes to be so informed. If the person consents to be informed of the hepatitis B, hepatitis C, and HIV test results, then he or she shall sign a form documenting that consent. The person’s refusal to sign that form shall be construed to be a refusal to be informed of the hepatitis B, hepatitis C, and HIV test results.

(3) Except as otherwise provided under this section, all confidentiality requirements regarding medical records shall apply to the test results obtained.

history: (History: Amended by Stats. 2010, Ch. 688, Sec. 1. (AB 2635) Effective January 1, 2011. Note: Stats. 1995, Ch. 415, reenacted in this section the provisions from Section 199.97 as added on Nov. 8, 1988, by initiative Prop. 96.)


text:
(a) For purposes of Section 121060, “bloodborne pathogen exposure” means a percutaneous injury, including, but not limited to, a needle stick or cut with a sharp object, or the contact of nonintact skin or mucous membranes with any of the bodily fluids identified in subdivision (b), in accordance with the most current bloodborne pathogen exposure definition established by the federal Centers for Disease Control and Prevention.

(b) “Bodily fluids” means any of the following:

(1) Blood.

(2) Tissue.

(3) Mucous containing visible blood.

(4) Semen.

(5) Vaginal secretions.

history: (History: Added by Stats. 2008, Ch. 554, Sec. 2. Effective January 1, 2009.)


text:
(a) The withdrawal of blood shall be performed in a medically approved manner. Only a physician, registered nurse, licensed vocational nurse, licensed medical technician, or licensed phlebotomist may withdraw blood specimens for the purposes of this chapter.

(b) The court shall order that the blood specimens be transmitted to a licensed medical laboratory and that tests be conducted thereon for medically accepted indications of exposure to or infection by HIV, hepatitis B, and hepatitis C.

(c) (1) The test results shall be sent to the designated recipients with the following disclaimer:

“The tests were conducted in a medically approved manner. Persons receiving this test result should continue to monitor their own health and should consult a physician as appropriate. Recipients of these test results are subject to existing confidentiality protections for any identifying information about HIV, hepatitis B, or hepatitis C test results. Medical information regarding the HIV, hepatitis B, or hepatitis C status of the source patient shall be kept confidential and may not be further disclosed, except as otherwise authorized by law.”

(2) The exposed individual shall also be informed of the penalties for disclosure for which he or she would be personally liable pursuant to Section 120980.

If the person subject to the test is a minor, copies of the test result shall also be sent to the minor’s parents or guardian.

(d) The court shall order all persons, other than the test subject, who receive test results pursuant to Sections 121055, 121056, or 121060, to maintain the confidentiality of personal identifying data relating to the test results except for disclosure that may be necessary to obtain medical or psychological care or advice.

(e) The specimens and the results of tests ordered pursuant to Sections 121055, 121056, and 121060 shall not be admissible evidence in any criminal or juvenile proceeding.

(f) Any person performing testing, transmitting test results, or disclosing information pursuant to the provisions of this chapter shall be immune from civil liability for any action undertaken in accordance with the provisions of this chapter.

history: (History: Amended by Stats. 2008, Ch. 554, Sec. 3. Effective January 1, 2009. Note: Stats. 1995, Ch. 415, reenacted in this section the provisions from Section 199.98 as added on Nov. 8, 1988, by initiative Prop. 96.)


text:
(a) Any medical personnel employed by, under contract to, or receiving payment from the State of California, any agency thereof, or any county, city, or city and county to provide service at any state prison, the Medical Facility, any Youth Authority institution, any county jail, city jail, hospital jail ward, juvenile hall, juvenile detention facility, or any other facility where adults are held in custody or minors are detained, or any medical personnel employed, under contract, or receiving payment to provide services to persons in custody or detained at any of the foregoing facilities, who receives information as specified herein that an inmate or minor at the facility has been exposed to or infected by the AIDS virus or has an AIDS-related condition or any communicable disease, shall communicate the information to the officer in charge of the facility where the inmate or minor is in custody or detained.

(b) Information subject to disclosure under subdivision (a) shall include the following: any laboratory test that indicates exposure to or infection by the AIDS virus, AIDS-related condition, or other communicable diseases; any statement by the inmate or minor to medical personnel that he or she has AIDS or an AIDS-related condition, has been exposed to the AIDS virus, or has any communicable disease; the results of any medical examination or test that indicates that the inmate or minor has tested positive for antibodies to the AIDS virus, has been exposed to the AIDS virus, has an AIDS-related condition, or is infected with AIDS or any communicable disease; provided, that information subject to disclosure shall not include information communicated to or obtained by a scientific research study pursuant to prior written approval expressly waiving disclosure under this section by the officer in charge of the facility.

(c) The officer in charge of the facility shall notify all employees, medical personnel, contract personnel, and volunteers providing services at the facility who have or may have direct contact with the inmate or minor in question, or with bodily fluids from the inmate or minor, of the substance of the information received under subdivisions (a) and (b) so that those persons can take appropriate action to provide for the care of the inmate or minor, the safety of other inmates or minors, and their own safety.

(d) The officer in charge and all persons to whom information is disclosed pursuant to this section shall maintain the confidentiality of personal identifying data regarding the information, except for disclosure authorized hereunder or as may be necessary to obtain medical or psychological care or advice.

(e) Any person who wilfully discloses personal identifying data regarding information obtained under this section to any person who is not a peace officer or an employee of a federal, state, or local public health agency, except as authorized hereunder, by court order, with the written consent of the patient or as otherwise authorized by law, is guilty of a misdemeanor.

history: (History: Amended by Stats. 2003, Ch. 468, Sec. 6. Effective January 1, 2004. Note: Stats. 1995, Ch. 415, reenacted in this section the provisions from Section 199.99 as added on Nov. 8, 1988, by initiative Prop. 96.)


text: Research records, in a personally identifying form, developed or acquired by any person in the course of conducting research or a research study relating to HIV or AIDS shall be confidential, and these confidential research records shall not be disclosed by any person in possession of the research record, nor shall these confidential research records be discoverable, nor shall any person be compelled to produce any confidential research record, except as provided by this chapter.

history: (History: Amended by Stats. 2006, Ch. 20, Sec. 9. Effective April 17, 2006.)

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 10. Acquired Immune Deficiency Syndrome (AIDS) Research Confidentiality Act


text:
Confidential research records may be disclosed in accordance with the prior written consent of the research subject with respect to whom the research record is maintained, but only to the extent, under the circumstances, to the persons, and for the purposes the written consent authorizes. Any disclosure authorized by a research subject shall be accompanied by a written statement containing substantially the same language as follows:

“This information has been disclosed to you from a confidential research record the confidentiality of which is protected by state law and any further disclosure of it without specific prior written consent of the person to whom it pertains is prohibited. Violation of these confidentiality guarantees may subject you to civil or criminal liabilities.”

chapter: 10. Acquired Immune Deficiency Syndrome (AIDS) Research Confidentiality Act


text:
(a) Confidential research records shall be protected in the course of conducting financial audits or program evaluations, and audit personnel shall not directly or indirectly identify any individual research subject in any report of a financial audit or program evaluation. To the extent it is necessary for audit personnel to know the identity of individual research subjects, authorized disclosure of confidential research records shall be made on a case-by-case basis, and every prudent effort shall be exercised to safeguard the confidentiality of these research records in accordance with this chapter. Information disclosed for audit or evaluation purposes should be used only for audit and evaluation purposes and may not be redisclosed or used in any other way.

(b) Nothing in this section imposes liability or criminal sanction for disclosure of confidential research records in accordance with any reporting requirement for a case of HIV, including AIDS, by the department or the Centers for Disease Control and Prevention under the United States Public Health Services.

history: (History: Amended by Stats. 2006, Ch. 20, Sec. 10. Effective April 17, 2006.)


text:
Notwithstanding Section 121080, whether or not the research subject, with respect to whom any confidential research record is maintained, gives prior written consent, the content of the confidential research record may be disclosed in any of the following situations:

(a) To medical personnel to the extent it is necessary to meet a bona fide medical emergency of a research subject.

(b) To the department to the extent necessary for the conduct of a special investigation pursuant to Section 100325, in which case the confidentiality provisions of Chapter 8 (commencing with Section 121025) shall apply.


text: The content of any confidential research record shall be disclosed to the research subject, the legal representative of the research subject if the research subject is a minor, or the personal representative of a deceased research subject to whom the record pertains, thirty (30) days after written request therefor by the research subject, the legal representative or the personal representative.


text:
(a) No confidential research record may be compelled to be produced in any state, county, city or other proceeding in order to initiate or substantiate any criminal charge or charges against a research subject, or to conduct an investigation of a research subject, unless a court finds there is reasonable likelihood that the records in question will disclose material information or evidence of substantial value in connection with the criminal charge or charges or investigation, and there is no other practicable way of obtaining the information or evidence.

In addition, no confidential research record shall be disclosed, discoverable, or compelled to be produced in order to initiate or substantiate any criminal charge or charges against a research subject until after a showing of good cause. In assessing good cause, the court shall weigh the public interest and need for disclosure against the injury to the research subject and the harm to the research being undertaken. Upon the granting of an order to produce, the court, in determining the extent to which disclosure of all or any part of a confidential research record is necessary, shall impose appropriate safeguards against unauthorized disclosure, that shall include, but not necessarily be limited to, the individuals or bodies that may have access to the data, the purposes for which the data shall be used, prohibitions on further disclosure and protection of the identities of other research subjects.

(b) No confidential research record may be compelled to be produced in any state, county, city or other civil proceeding, except as expressly provided in this chapter.


text:
Prior to participation of an individual in a research study relating to HIV or AIDS, both of the following requirements shall be met:

(a) The informed consent of each research subject shall be obtained in the method and manner required by Section 46.116, (a) and (b), of Part 46 of Title 45 of the Code of Federal Regulations and be documented in accordance with Section 46.117 of that part.

(b) Each research subject shall be provided with an explanation in writing, in language understandable to the research subject, of the rights and responsibilities of researchers and research subjects under this chapter.

history: (History: Amended by Stats. 2006, Ch. 20, Sec. 11. Effective April 17, 2006.)


text:
(a) Any person who negligently discloses the content of any confidential research record, as defined in subdivision (c) of Section 121125, to any third party, except pursuant to this chapter, shall be assessed a civil penalty in an amount not to exceed two thousand five hundred dollars ($2,500), plus court costs, as determined by the court, which penalty and costs shall be paid to the subject of the test.

(b) Any person who willfully or maliciously discloses the content of any confidential research record, as defined in subdivision (c) of Section 121125, to any third party, except pursuant to this chapter, shall be assessed a civil penalty in an amount not less than five thousand dollars ($5,000) and not more than ten thousand dollars ($10,000), plus court costs, as determined by the court, which penalty and costs shall be paid to the subject of the test.

(c) Any person who willfully, maliciously, or negligently discloses the content of any confidential research record, as defined in subdivision (c) of Section 121125, to a third party, except pursuant to this chapter, that results in economic, bodily, or psychological harm to the research subject, is guilty of a misdemeanor, punishable by imprisonment in the county jail for a period not to exceed one year, or a fine of not to exceed twenty-five thousand dollars ($25,000), or both.

(d) Any person who commits any act described in subdivision (a) or (b) shall be liable to the subject for all actual damages for economic, bodily, or psychological harm that is a proximate result of the act.

(e) Any person who negligently or willfully violates Section 121105 is guilty of an infraction punishable by a fine of twenty-five dollars ($25).

(f) Each violation of this chapter is a separate and actionable offense.

(g) Nothing in this section limits or expands the right of an injured research subject to recover damages under any other applicable law.

history: (History: Amended by Stats. 2006, Ch. 20, Sec. 12. Effective April 17, 2006.)


text: In the event that the participation of an individual in a research study is disclosed, the information shall not be used to determine the employability or insurability of the research subject.


text: Nothing in this chapter shall preclude disclosure of information in order to further research efforts, including, but not limited to, the publication, dissemination, or sharing of raw data, statistics, or case studies, so long as no confidential research records concerning any research subject are disclosed.


text:
For purposes of this chapter:

(a) “AIDS” means acquired immunodeficiency syndrome.

(b) “Disclosed” means to disclose, release, transfer, disseminate, or otherwise communicate all or any part of any confidential research record orally, in writing, or by electronic means to any person or entity, or to provide the means for obtaining the records.

(c) “Confidential research record or records” means any data or information in a personally identifying form, including name, social security number, address, employer, or other information that could, directly or indirectly, in part or in sum, lead to the identification of the individual research subject, developed or acquired by any person in the course of conducting research or a research study relating to HIV or AIDS.

(d) “HIV” means human immunodeficiency virus.

history: (History: Amended by Stats. 2006, Ch. 20, Sec. 13. Effective April 17, 2006.)


text: The Legislature hereby finds and declares that the department, working with the California AIDS Leadership Committee, has developed a draft state AIDS plan for comprehensive, coordinated government action against AIDS and HIV infection. It is the intention of the Legislature to implement those recommendations pertaining to infectious-disease screening of blood and other body parts and fluids, and to notifying donors of the results of those screening tests.

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 11. Acquired Immune Deficiency Syndrome (AIDS) Research and Workshop Grants


text:
(a) There is hereby created in the state department an AIDS Advisory Committee. The membership of the committee shall be composed of eight members who have knowledge or expertise in the area of public health or AIDS research, or have been educated in the areas for which the grants are to be directed by the committee. These members shall be appointed by the following:

(1) Two by the Speaker of the Assembly.

(2) Two by the Senate Rules Committee.

(3) Four by the Governor.

(b) In addition to the membership prescribed by subdivision (a), the following persons shall be ex officio members:

(1) The Director of Health Services or a designee shall be a voting member.

(2) The Director of Mental Health, or a designee, a designee, requested to be appointed by the President of the University of California, with knowledge, experience, and responsibility for the university-wide allocation of AIDS research grants, shall be nonvoting members.

(c) The committee shall be abolished effective July 1, 1990, unless extended by subsequent legislative action.

chapter: 11. Acquired Immune Deficiency Syndrome (AIDS) Research and Workshop Grants


text:
The members of the AIDS Advisory Committee shall serve at the pleasure of the appointing powers. The members shall serve without compensation, but shall be reimbursed for necessary and travel expenses incurred in the performance of the duties of the committee.

The committee shall advise and assist the state in addressing the public health issues associated with Acquired Immune Deficiency Syndrome, and shall work with the department in statewide efforts to promote primary prevention, public education, and the advancement of knowledge regarding Acquired Immune Deficiency Syndrome.


text: The committee may establish rules or criteria for grants under this chapter as it deems necessary. Pursuant to the rules or criteria, the committee may review and recommend approval by the director of grant applications and monitor programs receiving grants under this chapter.


text:
The director may award grants from any funds that may be made available for the purposes of this chapter to individuals, organizations, or facilities for activities that may include, but need not be limited to, any of the following:

(a) Education regarding primary prevention for high risk groups.

(b) Public education to reduce panic and lessen unnecessary anxiety about AIDS among California residents.

(c) Interdisciplinary or educational workshops to facilitate the interchange of knowledge among investigators regarding AIDS and related disorders.

(d) Research grants that would assist the state with the educational efforts outlined in subdivisions (a) and (b).

(e) Grants to provide seed money for larger grants funded by the federal government or other sources.


text:
The department may do all of the following:

(a) Accept any federal funds provided for any of the purposes of this chapter.

(b) Accept any gift, donation, bequest, or grant of funds from a private or public agency for any of the purposes of this chapter.


text: Not more than 10 percent of any money appropriated for purposes of this chapter shall be utilized for the administration of this chapter.


text:
The Legislature finds and declares all of the following:

(a) Over the past five years AIDS has reached an epidemic stage and is estimated to affect 30,000 Californians by 1990.

(b) The estimated cost of medical care alone for the 4,000 AIDS cases that have occurred to date in California totals approximately two hundred fifty million dollars ($250,000,000). By the end of 1990, medical care is projected to approach three billion five hundred million dollars ($3,500,000,000) and the total public health and medical care expenditures are expected to exceed five billion dollars ($5,000,000,000).

(c) There is no cure for the AIDS virus. The long-term solution to the elimination of AIDS lies in conducting vaccine research.

(d) Much research has already been completed by the private sector and should be utilized to the maximum extent possible, including supplementing with public funds.

(e) Profitmaking corporations are (1) not eligible for most of the existing public funding sources as are institutions of higher learning and nonprofit corporations; (2) when eligible, the public funding amounts are not adequate to conduct research; and (3) private grants are only available to nonprofit corporations.

(f) Moreover, private research companies, already having established vaccine development and manufacturing capabilities, are uniquely situated to maximize available resources and to utilize both management and research staff, equipment, and technical innovations to their greatest efficiency towards the specific goal of developing and manufacturing an AIDS vaccine at the earliest possible time.

(g) Exclusion of private corporations from public funding to develop an approved vaccine will likely result in (1) a delay in the development of a vaccine to prevent AIDS; (2) continued spread of AIDS to the general population; and (3) continued increases in private and public funds to provide care to AIDS victims.

(h) It is appropriate to mandate that a grant made to a private entity to develop an AIDS vaccine, once the vaccine has been approved by the FDA for use by the general population, should be reimbursed to the state from the sale of the vaccine.

history: (History: Amended by Stats. 1997, Ch. 294, Sec. 18. Effective August 18, 1997.)

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 12. Acquired Immune Deficiency Syndrome (AIDS) Vaccine Research and Development Grant Program


text:
If a California manufacturer that is a grant recipient sells, delivers, or distributes an AIDS vaccine that has received FDA approval for use by the general population and that was developed in whole or in part using a grant awarded pursuant to this chapter, the State of California shall be reimbursed for the grant as provided in this section.

Until the total amount of the grant is repaid, repayments in the amount of one dollar ($1) per dose from the sale of the AIDS vaccine shall be deposited by the grant recipient into the General Fund. Upon payment in full of the grant amount into the General Fund, a royalty on the sale of the vaccine from the grant recipient shall be deposited into the General Fund. The percentage amount of the royalty shall be negotiated at the time of the grant award.

chapter: 12. Acquired Immune Deficiency Syndrome (AIDS) Vaccine Research and Development Grant Program


text:
The Legislature finds and declares all of the following:

(a) The rapidly spreading AIDS epidemic poses an unprecedented major public health crisis in California, and threatens, in one way or another, the life and health of every Californian.

(b) The best hope of stemming the spread of the AIDS virus among the general public is the development of an AIDS vaccine to develop an immunity to exposure.

(c) No vaccine has yet been fully developed, tested, or approved for AIDS. An effective vaccine, especially when directed at high-risk groups of unexposed persons, will virtually eliminate the risk of contracting AIDS, just as the risk of contracting polio and smallpox have been virtually eliminated by earlier vaccine development, production, and use among the general public.

(d) Private industry today has the capability of conducting the vaccine research, biological research, immunology, and genetic engineering of appropriate viral components needed to formulate, develop, produce, and test an AIDS vaccine. Whenever these and other appropriate expertise cannot be found within a single company, the formation of multiinstitutional research groups should be encouraged and prioritized, as it is in the public interest to encourage efforts toward vaccine production.

(e) It is of the highest importance and in the public interest to maximize public protection by developing an AIDS vaccine and by establishing high levels of immunization, initially among high-risk populations.

(f) The continuous spread of AIDS and especially the threat of infection spreading among population groups previously considered low-risk demands that the highest of priorities be given to the development of a universal immunoprophylaxis.

(g) The use of vaccines to control the spread of infectious pathogens is recognized as one of the genuinely decisive technologies of modern medicine. Recent advances in pharmaceutical technology combined with better understanding of the immune process offer the hope of an AIDS vaccine that is effective, safe, relatively inexpensive, and relatively easy to administer.

(h) Utilization of this new science may be forestalled, however, by problems that have recently deterred the development of vaccines by traditional means. These problems must be resolved before the full public health benefits of new approaches to vaccine development can be fully and expeditiously realized.

(i) The marketplace conditions facing vaccine manufacturers and developers today have changed considerably over the past 30 years. Private manufacturers and developers of vaccines cannot be forced to produce vaccines, and may choose, under the free enterprise system, not to produce them if marketplace conditions are unfavorable.

(j) Certain market conditions are slowing and threatening to halt the development of an AIDS vaccine. Any delay in the discovery, testing, approval, and production of the vaccine because of these secondary considerations may cost tens of thousands of human lives annually, unnecessary pain and suffering for hundreds of thousands of infected Americans, and billions of dollars in medical costs and in lost productivity.

(k) Resource constraints in the public and private sectors and the time required to bring vaccines to market presently limit investments in vaccines research and development. Although universities constitute a significant resource in AIDS research in particular and vaccines research in general, university funding limitations and conflicting research priorities make reliance on the resources and expertise of the private pharmaceutical industry a necessary supplement to public funding of AIDS research.

( l) There has been a decrease in the willingness of pharmaceutical companies to become involved in vaccine research, development, and manufacturing because of uncertain profitability and perceived and actual marketplace risks and disincentives.

(m) It is clearly in the public interest to provide appropriate and necessary incentives toward the timely development and production of an effective and safe AIDS vaccine.

(n) The development of an AIDS vaccine provides an exceptionally important benefit, making its availability highly desirable. However, certain conditions may preclude that development, including the following:

(1) There is a high cost for capital expenditures for vaccine development (estimated to be from ten million dollars ($10,000,000) to thirty million dollars ($30,000,000)). Testing costs of clinical trials (twenty million dollars ($20,000,000) per vaccine, by some estimates) are particularly burdensome, especially for smaller firms.

(2) There is an uncertain market demand for a vaccine once development costs have been invested and FDA marketing approval has been secured.

(o) Without state intervention to assure minimal profitability of an AIDS vaccine, inadequate incentives may exist for the private sector to commit resources and expertise to the accelerated development of an AIDS vaccine.

(p) In light of the dangers inherent in the AIDS epidemic to the general public of California, it is crucial that to the extent possible any serious obstacles to the development of a vaccine be removed.

(q) Because an AIDS vaccine provides an exceptionally important public benefit, it is in the public interest to take uncommon action to facilitate the development and production of a vaccine.

(r) It is as well in the public interest to assure fair compensation, if necessary at public expense, to any innocent victim who may be injured by an AIDS vaccine, as a part of implementing the socially beneficial policy of establishing high levels of AIDS immunization.

(s) In light of the high incidence of AIDS amongst Californians, the California Legislature must lead our country into the 20th century in this effort.

(t) It is therefore fitting and proper that the State of California enact uncommon and exceptional legislation in order to prevent the further spread of the AIDS epidemic.

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 13. Acquired Immune Deficiency Syndrome (AIDS) Immunization


text:
The Legislature further finds and declares all of the following:

(a) Acquired immune deficiency syndrome (AIDS) is caused by the virus human T-cell lymphotropic virus, type III (HTLV-3) that initially cripples the body’s immune system and eventually leaves the body open to an array of lethal opportunistic infections.

(b) So far, there is no known cure for AIDS and once a person is AIDS infected, the virus remains throughout the rest of his or her life.

(c) The AIDS virus has a three-to-seven year incubation period, making it one of the most difficult diseases to combat and trace.

(d) An easily administered blood test can determine whether a person has been exposed to the AIDS virus.

(e) In 1979, when AIDS was first diagnosed in the United States, the number of newly diagnosed victims was doubling every six to nine months; today the number of people diagnosed with AIDS doubles each year.

(f) Nationally, between 500,000 and 2,000,000 Americans are estimated to have been exposed to the AIDS virus. Of those exposed, between 25,000 and 500,000 persons (5 percent–25 percent) may be expected to die of AIDS.

(1) Another 25,000 to 500,000 persons may be expected to develop AIDS Related Complex (ARC). The range of illnesses these individuals will suffer from may range from minor ailments to brain damage.

(2) The remaining majority of those exposed may never suffer its consequences, but may carry and transmit the disease unknowingly.

(3) Some experts estimate as many as 1,000 additional people are exposed daily.

(g) The department, in its report to the Legislature (March 1986) estimated conservatively that over 30,000 Californians shall have contracted AIDS by 1990, about 50 percent having succumbed. The disease is believed to be fatal within 18 months of diagnosis. To date, more than half the 16,000 people with AIDS in the United States have died.

(h) The AIDS virus is transmitted primarily through sexual contact, and also through the sharing of hypodermic needles, contaminated blood transfusions, and during pregnancy to the fetus.

(i) While the earliest spread of the AIDS virus was primarily among homosexuals, the virus is now found and spreading among heterosexuals as well.

(j) Additionally, drug abusers are highly susceptible to the AIDS virus since the drugs diminish the ability of the body’s immune system to function. Intravenous drug abusers traditionally come into contact with the virus from sharing hypodermic needles.

(k) Persons sexually active in the heterosexual community are also at risk. Until a vaccine is developed, the AIDS virus will cross over from the high-risk groups to the lower risk groups. At this time, it is not known how fast the AIDS virus will penetrate other population groups, but it is not expected to be nearly as rapid. To date, partners of high-risk groups (bisexual men and intravenous drug users) are considered the main means of transmitting the AIDS virus to the heterosexual population. Other means include pregnant women who pass the infection on to the child and prostitutes who pass on the infection to their clients.

( l) Of the first 9,000 AIDS cases diagnosed in the United States, almost 1,000 were women. Fourteen percent of these women developed AIDS through sexual contact. Recent studies have demonstrated that the virus can be transmitted by women to their male sexual partners. Sexual contact with an infected partner may transmit the virus and fatally infect the partner.

chapter: 13. Acquired Immune Deficiency Syndrome (AIDS) Immunization


text:
The Legislature further finds and declares all of the following:

(a) The average cost per patient in the treatment of AIDS until death is now one hundred fifty thousand dollars ($150,000). It is estimated that total costs including health care of the first 10,000 AIDS cases in the United States totaled more than six billion three hundred million dollars ($6,300,000,000). By 1990, according to the department, Californians will spend almost five billion dollars ($5,000,000,000) in medical costs alone in care and treatment of 30,000 AIDS patients, with no realistic hope for their remission or cure. This cost does not include money spent on education, research, and lost income.

(b) To date, the costs of caring for people with AIDS related complex (ARC) has not been officially calculated. However, it is safe to assume the costs are substantial over time. Experts fear that the illnesses of ARC patients, although they may not be fatal, are severe. For example, the virus invades the brain rendering the patients incapable of caring for themselves. It is, therefore, plausible that a percentage of ARC patients will need to be institutionalized.

(c) The Legislature intends by this chapter to take uncommon action to remove the impediments to the expeditious development of an AIDS vaccine.

(d) It is further the intent of the Legislature to provide to any person, whose injury is proximately caused by the use of the vaccine, except to the extent the injuries are attributable to the comparative negligence of the claimant in the use of the vaccine, all of the following:

(1) Compensation for related medical costs associated with the care and treatment of the injury.

(2) Compensation for the loss of any and all earnings caused by the injury.

(3) Compensation for pain and suffering caused by the injury, except that in no action shall the amount of damages for noneconomic losses exceed five hundred fifty thousand dollars ($550,000).

(e) It is further the intent of the Legislature to establish the AIDS Clinical Trials Testing Fund that will be available to not more than three California manufacturers of an AIDS vaccine approved by the federal Food and Drug Administration (FDA) or the department pursuant to Part 5 (commencing with Section 109875) of Division 104 for clinical trials with humans.

(f) The AIDS Vaccine Research and Development Advisory Committee shall review requests from California manufacturers for funds from the AIDS Clinical Trials Testing Fund and shall make recommendations to the department regarding the award of funds, including the appropriate amount of funding. The department, taking into consideration the committee’s recommendations, may allocate the funds to the manufacturers specified in the protocol approved by the FDA or the department pursuant to Part 5 (commencing with Section 109875) of Division 104 for administering the clinical trials.

(g) A California manufacturer seeking the approval of the FDA, rather than the department, for administering clinical trials of an AIDS vaccine may apply while FDA approval is pending to the AIDS Vaccine Research and Development Advisory Committee for the committee’s recommendation that the manufacturer receive funds from the AIDS Clinical Trials Testing Fund upon FDA approval.

history: (History: Amended by Stats. 1997, Ch. 294, Sec. 22. Effective August 18, 1997.)


text: “State,” as used in this chapter, has the same meaning as set forth in Section 900.6 of the Government Code.


text:
(a) There is hereby created the AIDS Vaccine Victims Compensation Fund.

(b) For the purposes of this section, the following definitions apply:

(1) “AIDS vaccine” means a vaccine that (A) has been developed by any manufacturer and (B) is approved by the FDA or the department pursuant to Part 5 (commencing with Section 109875) of Division 104 as a safe and efficacious vaccine for the purpose of immunizing against AIDS.

(2) “Damages for personal injuries” means the direct medical costs for the care and treatment of injuries to any person, including a person entitled to recover damages under Section 377 of the Code of Civil Procedure, proximately caused by an AIDS vaccine, the loss of earnings caused by the injuries, and the amount necessary, but not to exceed five hundred fifty thousand dollars ($550,000), to compensate for noneconomic losses, including pain and suffering caused by the injuries.

(3) “Fund” means the AIDS Vaccine Victims Compensation Fund.

(c) The Department of General Services shall pay from the fund, contingent entirely upon the availability of moneys as provided in subdivision (o), damages for personal injuries caused by an AIDS vaccine that is sold in or delivered in California, and administered or dispersed in California to the injured person except that no payment shall be made for any of the following:

(1) Damages for personal injuries caused by the vaccine to the extent that they are attributable to the comparative negligence of the person making the claim.

(2) Damages for personal injuries in any instance when the manufacturer has been found to be liable for the injuries in a court of law.

(3) Damages for personal injuries due to a vaccination administered during a clinical trial.

(d) An application for payment of damages for personal injuries shall be made on a form prescribed by the Department of General Services within one year of the date that the injury and its cause are discovered. This application may be required to be verified. Upon receipt, the Department of General Services may require the submission of additional information necessary to evaluate the claim.

(e) (1) Within 45 days of the receipt of the application and the submission of any additional information, the Department of General Services shall do either of the following:

(A) Allow the claim in whole or part.

(B) Disallow the claim.

(2) In those instances of unusual hardship to the victim, the board may grant an emergency award to the injured person to cover immediate needs upon agreement by the injured person to repay in the event of a final determination denying the claim.

(3) If the claim is denied in whole or part, the victim may apply within 60 days of denial for a hearing. The hearing shall be held within 60 days of the request for a hearing unless the injured person requests a later hearing.

(f) At the hearing, the injured person may be represented by counsel and may present relevant evidence as defined in subdivision (c) of Section 11513 of the Government Code. The Department of General Services may consider additional evidence presented by its staff. If the injured person declines to appear at the hearing, the Department of General Services may act solely upon the application, the staff report, and other evidence that appears on the record.

(g) The Department of General Services may delegate the hearing of applications to hearing examiners.

(h) The decision of the Department of General Services shall be in writing and shall be delivered or mailed to the injured person within 30 days of the hearing. Upon the request by the applicant within 30 days of delivery or mailing, the Department of General Services may reconsider its decision.

(i) Judicial review of a decision shall be under Section 1094.5 of the Code of Civil Procedure, and the court shall exercise its independent judgment. A petition for review shall be filed as follows:

(1) If no request for reconsideration is made, within 30 days of personal delivery or mailing of the Department of General Services’ decision on the application.

(2) If a timely request for reconsideration is filed and rejected by the Department of General Services, within 30 days of personal delivery or mailing of the notice of rejection.

(3) If a timely request for reconsideration is filed and granted by the Department of General Services, or reconsideration is ordered by the Department of General Services, within 30 days of personal delivery or mailing of the final decision on the reconsidered application.

(j) The Department of General Services shall adopt regulations to implement this section, including those governing discovery.

(k) The fund is subrogated to any right or claim that any injured person may have who receives compensation pursuant to this section, or any right or claim that the person’s personal representative, legal guardian, estate, or survivor may have, against any third party who is liable for the personal injuries caused by the AIDS vaccine, and the fund shall be entitled to indemnity from that third party. The fund shall also be entitled to a lien on the judgment, award, or settlement in the amount of any payments made to the injured person.

(l) In the event that the injured person, or his or her guardian, personal representative, estate, or survivors, or any of them, bring an action for damages against the person or persons liable for the injury or death giving rise to an award by the Department of General Services under this section, notice of institution of legal proceedings and notice of any settlement shall be given to the Department of General Services in Sacramento except in cases where the Department of General Services specifies that notice shall be given to the Attorney General. All notices shall be given by the attorney employed to bring the action for damages or by the injured person, or his or her guardian, personal representative, estate, or survivors, if no attorney is employed.

(m) This section is not intended to affect the right of any individual to pursue claims against the fund and lawsuits against manufacturers concurrently, except that the fund shall be entitled to a lien on the judgment, award, or settlement in the amount of any payments made to the injured party by the fund.

(n) There is hereby created the AIDS Vaccine Injury Compensation Policy Review Task Force consisting of 14 members. The task force shall be composed of 10 members appointed by the Governor, of which two shall be from a list provided by the California Trial Lawyers Association, one from the department, the Director of Finance, one unspecified member, and one attorney with experience and expertise in products liability and negligence defense work, two representing recognized groups that represent victims of vaccine induced injuries or AIDS victims, or both, and two representing manufacturers actively engaged in developing an AIDS vaccine. In addition four Members of the Legislature or their designees shall be appointed to the task force, two of which shall be appointed by the Speaker of the Assembly and two of which shall be appointed by the Senate Committee on Rules. The chairperson of the task force shall be appointed by the Governor from the membership of the task force. The task force shall study and make recommendations on the legislative implementation of the fund created by subdivision (a). These recommendations shall at least address the following issues:

(1) The process by which victims are to be compensated through the fund.

(2) The procedures by which the fund will operate and the governance of the fund.

(3) The method by which manufacturers are to pay into the fund and the amount of that payment.

(4) The procedural relationship between a potential victim’s claim through the fund and a court claim made against the manufacturer.

(5) Other issues deemed appropriate by the task force.

The task force shall make its recommendations to the Legislature on or before June 30, 1987.

(o) The fund shall be funded wholly by a surcharge on the sale of an AIDS vaccine, that has been approved by the FDA, or by the department pursuant to Part 5 (commencing with Section 109875) of Division 104, in California in an amount to be determined by the department. The surcharge shall be levied on the sale of each unit of the vaccine sold or delivered, administered, or dispensed in California. The appropriate amount of the surcharge shall be studied by the AIDS Vaccine Injury Compensation Policy Review Task Force, which shall recommend the appropriate amount as part of its report, with the amount of the surcharge not to exceed ten dollars ($10) per unit of vaccine. Expenditures of the task force shall be made at the discretion of the Director of Finance or the director’s designee.

(p) For purposes of this section, claims against the fund are contingent upon the existing resources of the fund as provided in subdivision (o), and in no case shall the state be liable for any claims in excess of the resources in the fund.

history: (History: Amended by Stats. 2016, Ch. 31, Sec. 175. (SB 836) Effective June 27, 2016.)


text:
(a) Because the development of a vaccine now costs somewhere between twenty million dollars ($20,000,000) and forty million dollars ($40,000,000), and because the last vaccine produced and marketed did not sell well, vaccine manufacturers are hesitant to proceed to invest their resources in a risky venture. It is, therefore, in the public health interest of California to assure that manufacturers proceed to develop this vaccine and protect Californians against this dread disease and protect the State of California against the enormous fiscal costs of treatment for persons getting AIDS. It is a sound and worthwhile investment to provide a guarantee of a market to lessen the risk of loss and assure the development of an AIDS vaccine.

It is anticipated that this AIDS vaccine will consist of a three-unit series. The State of California is willing to guarantee that at least 175,000 persons will be vaccinated, and to guarantee the purchase, within three years after the FDA or the department pursuant to Part 5 (commencing with Section 109875) of Division 104 approves marketing of an AIDS vaccine, of at least 500,000 units, at a cost of no more than twenty dollars ($20) per dosage, by all companies, anywhere in the United States.

Therefore, the State of California, by moneys to be appropriated later through the Budget Act, commits itself to purchasing, at the end of three years after the FDA or the department pursuant to Part 5 (commencing with Section 109875) of Division 104 has approved the marketing on a competitive basis, at not more than twenty dollars ($20) per dosage, the difference between 500,000 units and the actual amount sold, delivered, administered, or dispensed by all companies throughout the United States, including units sold to or reimbursed by Medi-Cal, Medicare, or other public programs, providing that fewer than 500,000 units are sold, delivered, administered, or dispensed.

(b) The AIDS Vaccine Guaranteed Purchase Fund is hereby established and shall be administered by the department, which may develop necessary regulations to carry out the purpose of this section.

(c) The department may carry out this section, when those funds are appropriated through the State Budget. In determining which vaccine shall be purchased by the state from among those manufacturers selling or distributing in California, an AIDS vaccine approved by the FDA or the department pursuant to Part 5 (commencing with Section 109875) of Division 104, the department shall take into consideration at least all of the following factors:

(1) The length of time each AIDS vaccine has been in the marketplace in California.

(2) Each AIDS vaccine’s history of efficacy since approval by the FDA or the department.

(3) Each AIDS vaccine’s history of side effects experienced by previous recipients of the vaccine.

(4) The relative cost of each competing manufacturer’s AIDS vaccine.

history: (History: Amended by Stats. 2006, Ch. 538, Sec. 443. Effective January 1, 2007.)


text:
(a) In enacting this section the Legislature finds and declares:

(1) It is in the interest of the people of California to develop a vaccine that will prevent the infection of HIV, the agent that causes AIDS.

(2) In order to develop that vaccine, a prototype vaccine must be first given to HIV-negative people to determine the following:

(A) The vaccine’s toxicity.

(B) The vaccine’s efficacy.

(C) The human immune response to the vaccine.

(3) These studies are currently impossible because vaccine manufacturers fear that, by inoculating HIV-negative individuals with an experimental vaccine, they will elicit a positive immune response as measured by an enzyme linked immunosorbent assay (ELISA), western blot or other federal Food and Drug Administration approved in vitro diagnostic test, thereby placing vaccine volunteers at risk for denial of health or life insurance by insurance carriers as a consequence of their participation.

(4) Insurers need a reliable mechanism by which they can verify the insurability of a vaccine trial participant.

(b) No health care service plan, disability insurer, nonprofit hospital service plan, self-insured employee welfare benefit plan, or life insurer may withhold any settlement or coverage of an individual solely because of his or her participation in an AIDS/HIV vaccine clinical trial studied under an investigational new drug application effective pursuant to Section 312 of Title 21 of the Code of Federal Regulations, or Section 111595.

(c) The sponsor of any such trial shall make a confidential certificate with all the necessary particulars, which shall be determined by the department, for each enrollee and then submit it to the department, which shall endorse it and return it to the vaccine recipient. A copy of this confidential certificate shall be kept on file indefinitely by both the study sponsor and the department.

(d) Release of a confidential certificate shall be by written authorization of the enrollee named in the certificate. If the enrollee is unable to provide the written authorization, a person designated in the certificate by the enrollee may provide the written authorization. The written authorization shall include the name of the person or entity to whom the disclosure would be made.

Disclosure as used in this section means to release, transfer, disseminate or otherwise communicate all or part of any confidential certificate orally, in writing, or by electronic means to any person or entity.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 7. Effective January 1, 1996.)


text:
In order to assist pharmacists and pharmacy personnel in the education of consumers who are at risk of bloodborne infections regarding methods and opportunities for improving and protecting their health, and thereby protect the public health, the Office of AIDS shall develop and maintain all of the following information, on its Internet Web site, and the California State Board of Pharmacy shall also post, or maintain a link to, the information on its Internet Web site:

(a) How consumers can access testing and treatment for HIV and viral hepatitis.

(b) How consumers can safely dispose of syringes and hypodermic needles or other sharps waste.

(c) How consumers can access drug treatment.

history: (History: Added by Stats. 2011, Ch. 738, Sec. 12. (SB 41) Effective January 1, 2012.)


text:
(a) There are hereby established public health demonstration projects to allow for innovative, evidence-based approaches to provide outreach, HIV and hepatitis C screenings, and linkage to, and retention in, quality health care for the most vulnerable and underserved individuals with a high risk for HIV infection.

(b) The demonstration projects may operate for a period of up to two years. The department shall implement up to four demonstration projects. The demonstration projects shall be designed to be capable of replication and expansion on a statewide basis.

(c) After conclusion of the demonstration projects, the department shall review the effectiveness of each demonstration project and make a determination of whether the demonstration project model can be implemented on a statewide basis.

history: (History: Added by Stats. 2014, Ch. 40, Sec. 2. (SB 870) Effective June 20, 2014.)

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 13.6. Public Health Demonstration Projects


text:
Upon an appropriation for this purpose in the annual Budget Act, the department shall award funding, on a competitive basis, to a community-based organization or local health jurisdiction to operate a demonstration project pursuant to this chapter. The department shall determine the funding levels of each demonstration project based on scope and geographic area. An applicant shall demonstrate each of the following qualifications:

(a) Leadership on access to HIV care and testing issues and experience addressing the needs of highly marginalized populations in accessing medical and HIV care and support.

(b) Experience with the target population or relationships with community-based organizations or nongovernmental organizations, or both, that demonstrate expertise, history, and credibility working successfully in engaging the target population.

(c) Experience working with nontraditional collaborators who work within and beyond the field of HIV/AIDS education and outreach, including areas of reproductive health, housing, immigration, and mental health.

(d) Strong relationships with community-based HIV health care providers that have the trust of the targeted populations.

(e) Strong relationships with the state and local health departments.

(f) Capacity to coordinate a communitywide planning phase involving multiple community collaborators.

(g) Experience implementing evidence-based programs or generating innovative strategies, or both, with at least preliminary evidence of program effectiveness.

(h) Administrative systems and accountability mechanisms for grant management.

(i) Capacity to participate in evaluation activities.

(j) Strong communication systems that are in place to participate in public relations activities.

chapter: 13.6. Public Health Demonstration Projects


text: Each demonstration project shall prepare and disseminate information regarding best practices for, and the lessons learned regarding, providing outreach and education to the most vulnerable and underserved individuals with a high risk for HIV infection for use by providers, the Office of AIDS, State Department of Public Health, federal departments and agencies, including the Department of Health and Human Services, and other national HIV/AIDS groups.


text:
(a) There is hereby established the Statewide African-American Initiative to address the disproportionate impact of HIV/AIDS on the health of African-Americans by coordinating prevention and service networks around the state and increasing the capacity of core service providers. For purposes of this chapter, “initiative” means the Statewide African-American Initiative.

(b) The initiative shall have an executive director who shall coordinate the initiative and report to the Office of AIDS through the Statewide African-American HIV/AIDS Steering Committee formally established pursuant to Section 121290.8.

(c) The initiative shall be implemented in the following five designated regions:

(1) Alameda/San Francisco.

(2) Los Angeles.

(3) Sacramento/Central Valley.

(4) San Bernardino/Riverside.

(5) San Diego.

(d) (1) The Office of AIDS shall provide initial administrative support for the core functions of the initiative.

(2) Until January 1, 2008, the initiative shall be housed at the Office of AIDS. By January 1, 2008, the initiative shall establish itself as an independent nonprofit organization for purposes of Section 501(c)(3) of the Internal Revenue Code.

history: (History: Added by Stats. 2005, Ch. 403, Sec. 1. Effective January 1, 2006.)

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 13.7. Statewide African-American Initiative


text:
The initiative shall sponsor and conduct an annual Summit on African-Americans and HIV. The summit shall be funded solely by private funds. The summit shall do all of the following:

(a) Provide a report on the progress of the initiative.

(b) Offer technical assistance workshops.

(c) Provide an overview of local, regional, and national efforts concerning health disparities relating to African-Americans and HIV.

chapter: 13.7. Statewide African-American Initiative


text:
The initiative shall have all of the following responsibilities:

(a) To design and conduct a series of complementary projects to implement policy and planning to address the disproportionate impact of HIV/AIDS on the African-American community, focusing on all of the following categories:

(1) Research.

(2) Policy and advocacy.

(3) Workforce development.

(4) Organizational capacity.

(5) Prevention and treatment information and resources.

(b) To provide integrated leadership in developing, implementing, evaluating, and sustaining HIV-related services and programmatic partnerships between research institutions, community-based organizations, the business community, and public sector agencies.

(c) To improve the efficacy of local service providers through the central coordination of service availability, data, and funding sources through the development of a central coordinating body.


text:
The initiative shall employ all of the following strategies to achieve its objectives:

(a) Serve as a community resource for technical assistance and training in the communication and dissemination of information, and for the synthesis, interpretation, and dissemination of HIV/AIDS data and public health information.

(b) Assemble a network of health experts, HIV/AIDS service providers, community-based organizations, and relevant public and private sector stakeholders who will be accessible through the regional centers, to support the capacity building of community-based programs to eliminate HIV-related health disparities for African-Americans.

(c) Establish the administrative, educational, and communication infrastructure, including personnel, facilities, and technology, to support the activities of the initiative’s provider network.

(d) Assess the availability and allocation of scientific, governmental, and private sector resources to reduce the impact of HIV/AIDS on African-Americans.

(e) Evaluate community-focused interventions and demonstration projects to eliminate disparities in the evaluation and treatment of HIV/AIDS, based on information from the work of the initiative and local and regional resources.

(f) Coordinate and disseminate data, including epidemiology, outcome assessment, and informatics, to provider networks addressing health disparities regarding HIV/AIDS.

(g) Facilitate the development of lasting academic and community partnerships that promote healthy lifestyles, prevent disease, and reduce risk factors for HIV/AIDS.

(h) Increase ongoing access to culturally appropriate health care for African-Americans living with HIV/AIDS.


text:
(a) The initiative shall establish a central coordinating body to provide administrative, technical, educational, and health information dissemination services to the initiative’s network of community-based organizations.

(b) The duties of the central coordinating body shall include, but not be limited to, all of the following:

(1) Helping to provide program administration services, project management, fiscal support, resource allocation, and program evaluation to the initiative.

(2) Assisting in the collection, management, and analysis of primary and secondary data, and providing technical support and training.

(3) Aiding in the synthesis, interpretation, and dissemination of information on HIV and African-Americans.

(c) The objectives of the central coordinating body shall include, but not be limited to, both of the following:

(1) To achieve economies of scale in effort, expertise, and equipment, and thereby build the capacity of the provider network and the Office of AIDS to develop, implement, and evaluate community programs to address HIV/AIDS among African-Americans.

(2) To pool services, expertise, equipment, and facilities to support several interrelated projects and collaborating organizations, thereby leveraging greater resources than those that would be provided separately to each project and without formal interactions among the Office of AIDS, community-based organizations, and public sector agencies.


text: The Office of AIDS shall appoint an internal advisory committee composed of the office’s African-American HIV specialist, a section head from the office, and a designee to supervise the day-to-day activities of the initiative.


text: There is hereby established the Statewide African-American HIV/AIDS Steering Committee. The committee shall be appointed by the Office of AIDS and shall initially consist of the current membership of the informally established Statewide African-American HIV/AIDS Steering Committee, which consists of leadership from service providers, researchers, educators, community-based organizations, and public sector agencies.


text: The requirements of this chapter shall be implemented only after the Department of Finance makes a determination that nonstate funds in an amount sufficient to fully support the activities of the initiative have been deposited with the state. Thereafter, the requirements of this chapter shall be implemented only to the extent that nonstate funds are received for the purposes of this chapter.


text:
(a) The State Department of Public Health, in consultation with the California Department of Aging, shall establish a program for demonstration projects to allow for innovative, evidence-informed approaches to improve the health and well-being of older people living with HIV.

(b) The demonstration projects shall address the multidisciplinary clinical and nonclinical needs of older people living with HIV.

(c) The demonstration projects shall be responsive to the unique needs of older people living with HIV in the specific geographic area.

(d) The demonstration projects shall operate for a period of up to three years. The department shall implement up to five demonstration projects.

(e) The demonstration projects shall include an evaluation component and a plan for disseminating lessons learned in order to develop new programs and strengthen existing programs.

(f) (1) The department shall establish a process to request applications, and award funding on a competitive basis, for an eligible entity to operate a demonstration project pursuant to this chapter.

(2) An application to operate a demonstration project under this chapter shall be evaluated based on need in the geographic area, populations served, competency of the entity applying, and program design.

(g) The department shall determine the funding levels of each demonstration project based on the scope of the project and need in the specific geographic area.

(h) Any entity in any county shall be eligible to operate a demonstration project pursuant to this chapter if it meets both of the following requirements:

(1) Demonstrates experience and expertise in providing culturally appropriate services to the most vulnerable and underserved older people living with HIV, including, but not limited to, older people living with HIV who are Black, Indigenous, and people of color.

(2) Demonstrates the capacity to ensure that the multidisciplinary clinical and nonclinical needs of older people living with HIV are assessed and addressed. Services may be colocated or coordinated across different locations, including through referrals or partnerships with other entities.

history: (History: Added by Stats. 2021, Ch. 143, Sec. 25. (AB 133) Effective July 27, 2021.)

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 13.8. HIV and Aging Demonstration Projects


text:
The Legislature finds and declares all of the following:

(a) Nearly 90 percent of the cases of pediatric AIDS in the United States occur as a result of maternal infant transmission.

(b) It is estimated that from 13 to 45 percent of infants born to HIV-infected mothers will acquire HIV either in utero, during delivery, or postpartum.

(c) In 1990, the number of cases of AIDS in women in the United States increased by 34 percent compared to an increase of 18 percent in men. As a consequence of this increased dissemination of HIV in women, there has been a concomitant increase in the number of HIV infected infants.

(d) Approximately 6,000 children were born to HIV-infected women in the United States in 1990. This resulted in 1,500 to 2,000 newly infected infants. Internationally, it is estimated that one million children acquired HIV through maternal transmission in 1990.

(e) HIV infection that is transmitted maternally progresses more rapidly than HIV infection in adults, with most infants developing advanced symptoms of infection within 18 months. Costs for care of infants infected with HIV have been estimated to be comparable or higher than the cost of treating HIV-related illness in adults. Currently, limited data exists for the costs of treating HIV-infected children. A recent estimate for those costs is as follows:

(1) For the mean lifetime hospital costs per child: ninety thousand dollars ($90,000).

(2) For the mean annual cost per child hospitalized all year: two hundred nineteen thousand dollars ($219,000). A significant portion of pediatric hospital costs may be due to a prolonged hospitalization because of the lack of foster homes for children.

(3) For the estimated annual medicaid cost: eighteen thousand dollars ($18,000) to forty-two thousand dollars ($42,000).

(4) In comparison, recent estimates of the national cost of treating an adult with HIV and without AIDS is five thousand dollars ($5,000) per year and the average cost of treating an adult person with AIDS is thirty-two thousand dollars ($32,000) per year of that twenty-four thousand dollars ($24,000) is inpatient costs and eight thousand dollars ($8,000) for other services.

(f) AIDS vaccines are now available for testing in FDA-approved clinical trials in HIV-infected pregnant women for the purpose of protecting against HIV transmission from mother to child.

(g) Manufacturers are hesitant to conduct these trials because of the combined threat of liability and the limited market to reimburse the research and clinical trial investment.

(h) The California Legislature wishes to encourage FDA-approved AIDS vaccine clinical trials to protect against maternal HIV transmission from mother to child, that may also provide a therapeutic effect in the HIV-infected mother. It is appropriate to mandate that grants be made to encourage qualified manufacturers to conduct these trials for the benefit of California citizens.

path: 105. COMMUNICABLE DISEASE PREVENTION AND CONTROL > 4. HUMAN IMMUNODEFICIENCY VIRUS (HIV) > 14. Acquired Immune Deficiency Syndrome (AIDS) Clinical Trial Grant Award for the Prevention of Maternal Transmission of Human Immunodeficiency Virus (HIV) Infection


text:
For the purposes of this chapter, the following definitions apply:

(a) “AIDS” means acquired immune deficiency syndrome.

(b) “An HIV-positive individual” means an individual who is infected with the AIDS virus.

(c) “Committee” means the AIDS Vaccine Research and Development Advisory Committee.

(d) “Grant award” means an AIDS Vaccine Clinical Trial Grant Award for the Prevention of Maternal Transmission of HIV Infection.

(e) “AIDS vaccine,” for the purposes of this chapter, means a vaccine that has been developed by a manufacturer and is being tested and administered for the purposes of determining whether immunization of HIV-infected pregnant women will protect against maternal transmission of the AIDS virus. Clinical trials must be conducted under an investigational new drug (IND) application on file with the federal Food and Drug Administration (FDA).

(f) “Research subject” means a person who is administered an AIDS vaccine, or a fetus of a woman administered an AIDS vaccine, or a child born to a woman administered an AIDS vaccine during pregnancy.

(g) “Researcher” means a person employed by or affiliated with a manufacturer or a research institution, who participates in the development or testing or administration of an AIDS vaccine, or who is involved in the diagnosis and treatment of a research subject.

history: (History: Amended by Stats. 1997, Ch. 294, Sec. 23. Effective August 18, 1997.)

chapter: 14. Acquired Immune Deficiency Syndrome (AIDS) Clinical Trial Grant Award for the Prevention of Maternal Transmission of Human Immunodeficiency Virus (HIV) Infection


text:
A manufacturer, research institution, or researcher shall, prior to the administration of an AIDS vaccine to a research subject, obtain that woman’s informed consent, that shall comply with all applicable statutes and regulations.

(a) The informed consent shall contain a statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject.

(b) A copy of the informed consent shall be maintained with the woman’s medical records.


text:
(a) A manufacturer, research institution, or researcher shall not be strictly liable for personal injury or wrongful death resulting from the administration of any AIDS vaccine to a research subject participating in the clinical trials described in this chapter.

(b) It is the intent of the Legislature in enacting this section to confer upon manufacturers, research institutions, and researchers participating in the clinical trials described in this chapter an immunity from liability to the same extent as conferred upon specified pharmaceutical manufacturers under Brown v. Superior Court, 44 Cal. 3d 1049.

(c) No immunity shall be conferred to the extent that the injury or death was caused by the negligence, gross negligence, or reckless, willful, or wanton misconduct of the manufacturer, research institution, or researcher or the manufacturer, research institution, or the researcher has failed to comply with Section 121310.

(d) The immunity provided by this section shall not apply to a manufacturer, research institution, or researcher who intentionally provided false information to the FDA in connection with an IND application.

(e) Notwithstanding the immunity provided by this section, nothing in this section shall be construed to affect the inapplicability or applicability of the holding in Brown v. Superior Court, 44 Cal. 3d 1049 to other situations involving the same or similar conduct.


text: No person shall be denied the opportunity to be a research subject because of the inability to pay for medical treatment.