text:
(a) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For purposes of this chapter, this information shall be referred to as “confidential information.” Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.

(b) The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.

(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Satisfaction of the terms of the director’s rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department that the entity has established the procedures and ability to maintain the confidentiality of the information.

(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.

(e) The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.

(f) Whenever program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.

(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall prohibit the publishing by the department of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.

(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department or any person.

(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.

history: (History: Amended by Stats. 2001, Ch. 444, Sec. 1. Effective October 3, 2001.)


kind: section

code: HSC

text: The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 4. Effective January 1, 1996.)

chapter: 1. Birth Defects Monitoring Program

path: 102. VITAL RECORDS AND HEALTH STATISTICS > 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE > 1. Birth Defects Monitoring Program


text:
(a) The department shall conduct a program of epidemiological assessments of the incidence of Parkinson’s disease. The program shall encompass all areas of the state for which Parkinson’s disease incidence data are available. The program shall include the monitoring of Parkinson’s disease associated with suspected chemical agents encountered by the general public both in occupational locations and in the environment generally.

(b) The program shall be under the direction of the director, who may enter into contracts as are necessary for the conduct of the program and may accept, on behalf of the state, grants of public or private funds for the program. The director shall analyze available incidence data and prepare reports as necessary to identify Parkinson’s disease hazards to the public health and their remedies.

(c) This chapter shall be implemented only to the extent funds from federal or private sources are made available for this purpose. When the department determines that sufficient private or federal funds have been received for the implementation of this chapter, the department shall provide notification of the receipt of the funds on its Internet Web site and shall also provide that information to associations representing physicians and pharmacists, and directly to the California State Board of Pharmacy and the Medical Board of California within 90 days.

(d) The department is encouraged to convene a task force comprised of researchers with expertise in Parkinson’s disease, advocates for patients with Parkinson’s disease, and other individuals with relevant expertise to provide support and advice for the implementation and funding of the California Parkinson’s Disease Registry.

history: (History: Added by Stats. 2004, Ch. 945, Sec. 1. Effective January 1, 2005.)

chapter: 1.5. Parkinson’s Disease Registry

path: 102. VITAL RECORDS AND HEALTH STATISTICS > 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE > 1.5. Parkinson’s Disease Registry


text:
(a) The director shall establish a statewide system for the collection of information determining the incidence of Parkinson’s disease. Commencing January 1, 2005, the director shall begin phasing in the statewide Parkinson’s disease reporting regions. By July 1, 2006, all county or regional registries shall be implemented or initiated. By July 1, 2007, the statewide Parkinson’s disease reporting system shall be fully operational. On or before June 1, 2005, the director shall submit an implementation and funding schedule to the Legislature.

(b) The department may designate any demographic parts of the state as regional Parkinson’s disease incidence reporting areas and may establish regional Parkinson’s disease registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide to the department, on a timely basis, Parkinson’s disease incidence data as designated by the department. The department may contract with an agency, including, but not limited to, a health systems agency, single-county health department, multicounty health department grouping, or nonprofit professional association, representing a designated Parkinson’s disease reporting region for the purposes of collecting and collating Parkinson’s disease incidence data.

(c) The director shall designate Parkinson’s disease as a disease required to be reported in the state or any demographic parts of the state in which Parkinson’s disease information is collected under this section. All cases of Parkinson’s disease diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the Parkinson’s disease data, or any individual, agency, or organization designated to cooperate with that representative.

(d) (1) Any hospital or other facility providing therapy to Parkinson’s disease patients within an area designated as a Parkinson’s disease reporting area shall report each case of Parkinson’s disease to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the department’s authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other facility shall reimburse the department or the authorized representative for its costs to access and report the information.

(2) Any physician and surgeon, pharmacist, or other health care practitioner diagnosing or providing treatment for Parkinson’s disease patients shall report each Parkinson’s disease case to the department or the authorized representative of the department except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnosis or treatment of that instance of Parkinson’s disease.

(e) All physicians, hospitals, outpatient clinics, and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with Parkinson’s disease shall grant to the department or the authorized representative access to all records that would identify cases of Parkinson’s disease or would establish characteristics of Parkinson’s disease, treatment of Parkinson’s disease, or medical status of any identified Parkinson’s disease patient. Willful failure to grant access to those records shall be punishable by a civil penalty of up to five hundred dollars ($500) each day access is refused. Any civil penalties collected pursuant to this subdivision shall be deposited by the department in the General Fund.

(f) (1) Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as “confidential information.”

(2) The department and any regional Parkinson’s disease registry designated by the department shall use the information to determine the sources of Parkinson’s disease.

(3) Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.

(4) The department and any regional Parkinson’s disease registry designated by the department may enter into agreements to furnish confidential information to other states’ Parkinson’s disease registries, federal Parkinson’s disease control agencies, local health officers, or health researchers for the purposes of determining the sources of Parkinson’s disease and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:

(A) Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.

(B) Provide documentation to the department that demonstrates to the department’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.

(5) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.

(6) The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.

(7) The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.

(8) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.

(9) Nothing in this subdivision shall prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.

(10) Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.

(g) For the purpose of this section, “Parkinson’s disease” means a chronic and progressive neurologic disorder resulting from deficiency of the neurotransmitter dopamine as the consequence of degenerative, vascular, or inflammatory changes in the area of the brain called the basal ganglia. It is characterized by tremor at rest, slow movements, rigidity of movement, droopy posture, muscle weakness, and unsteady or shuffling gait.

(h) Nothing in this section shall preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with Parkinson’s disease to maintain their own facility-based Parkinson’s disease registries.

division: 102. VITAL RECORDS AND HEALTH STATISTICS

part: 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE


text:
(a) Beginning January 1, 2018, the department shall collect data on the incidence of Parkinson’s disease in California. The program shall be known, and may be cited, as the Richard Paul Hemann Parkinson’s Disease Program.

(b) The department shall establish a system for the collection of information determining the incidence and prevalence of Parkinson’s disease. The department shall designate Parkinson’s disease as a disease required to be reported in the state or any part of the state. All cases of Parkinson’s disease diagnosed or treated in California shall be reported to the department.

(c) The department shall provide notification of the mandatory reporting of Parkinson’s disease on its Internet Web site and shall also provide that information to associations representing physicians and hospitals and directly to the Medical Board of California at least 90 days prior to requiring information be reported.

(d) Beginning July 1, 2018, a hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment to Parkinson’s disease patients shall report each case of Parkinson’s disease to the department in a format prescribed by the department.

(e) If the hospital or other facility fails to report in a format prescribed by the department, the department’s authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other facility shall reimburse the department or the authorized representative for its costs to access and report the information.

(f) All physicians, hospitals, outpatient clinics, and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with Parkinson’s disease shall grant to the department or the authorized representative access to all records that would identify cases of Parkinson’s disease or would establish characteristics of Parkinson’s disease, treatment of Parkinson’s disease, or medical status of any identified Parkinson’s disease patient. Willful failure to grant access to those records shall be punishable by a civil penalty of up to five hundred dollars ($500) each day access is refused. Any civil penalties collected pursuant to this subdivision shall be deposited by the department in the General Fund.

(g) Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as “confidential information.”

(h) The program shall be under the direction of the director, who may enter into contracts, grants, or other agreements as are necessary for the conduct of the program. The award of these contracts, grants, or funding agreements shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. This chapter shall be implemented only to the extent funds are made available for its purposes.

history: (History: Added by Stats. 2017, Ch. 52, Sec. 12. (SB 97) Effective July 10, 2017.)

path: 102. VITAL RECORDS AND HEALTH STATISTICS > 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE > 1.6. Richard Paul Hemann Parkinson’s Disease Program


text:
(a) Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information collected by the department pursuant to Section 103870.

(b) The department may enter into agreements to furnish confidential information to other states’ Parkinson’s disease registries, federal Parkinson’s disease control agencies, local health officers, or health researchers for the study of Parkinson’s disease. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:

(1) Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.

(2) Provide documentation to the department that demonstrates to the department’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.

(c) Notwithstanding any other law, a disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.

(d) The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.

(e) The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.

(f) Notwithstanding any other law, the confidential information shall not be available for subpoena, shall not be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding. The confidential information shall not be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.

(1) This subdivision does not prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.

(2) Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to his or her own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.

(g) For the purposes of this section, “Parkinson’s disease” means a chronic and progressive neurologic disorder resulting from deficiency of the neurotransmitter dopamine as the consequence of degenerative, vascular, or inflammatory changes in the area of the brain called the basal ganglia. It is characterized by tremor at rest, slow movements, rigidity of movement, droopy posture, muscle weakness, and unsteady or shuffling gait.

(h) This section does not preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with Parkinson’s disease to maintain their own facility-based Parkinson’s disease registries.

chapter: 1.6. Richard Paul Hemann Parkinson’s Disease Program


text:
(a) The department shall collect data on the incidence of neurodegenerative disease in California.

(b) The department shall establish a system for the collection of information determining the incidence and prevalence of neurodegenerative diseases, including, but not limited to, amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. The department shall designate the specified neurodegenerative diseases as a disease required to be reported in the state or any part of the state. All cases of neurodegenerative disease diagnosed or treated in California shall be reported to the department.

(c) The department shall provide notification of the mandatory reporting of neurodegenerative disease on its internet website and shall also provide that information to associations representing physicians and hospitals and directly to the Medical Board of California at least 90 days prior to requiring information be reported.

(d) A hospital, facility, physician and surgeon, or other health care provider diagnosing or providing treatment for a patient with a neurodegenerative disease shall report each case of a neurodegenerative disease to the department in a format prescribed by the department.

(e) If the hospital or other facility fails to report in a format prescribed by the department, the department’s authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other facility shall reimburse the department or the authorized representative for its costs to access and report the information.

(f) A physician and surgeon, hospital, outpatient clinic, and any other facility, individual, or agency providing diagnostic or treatment services to a patient with a neurodegenerative disease shall grant to the department or the authorized representative access to all records that would identify a case of a neurodegenerative disease or would establish characteristics of a neurodegenerative disease, treatment of a neurodegenerative disease, or medical status of any identified patient with a neurodegenerative disease. Willful failure to grant access to those records shall be punishable by a civil penalty of up to five hundred dollars ($500) each day access is refused. Any civil penalties collected pursuant to this subdivision shall be deposited by the department in the General Fund.

(g) Except as otherwise provided in this chapter, all information collected pursuant to this section shall be confidential. For purposes of this chapter, this information shall be referred to as “confidential information.”

(h) The program shall be under the direction of the director, who may enter into contracts, grants, or other agreements as are necessary for the conduct of the program. The award of these contracts, grants, or funding agreements shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. This chapter shall be implemented only to the extent funds are made available for its purposes.

(i) For the purposes of this section, “neurodegenerative disease” may also include, but need not be limited to, Alzheimer’s disease, multiple sclerosis, and Huntington’s disease.

history: (History: Amended by Stats. 2023, Ch. 522, Sec. 1. (AB 424) Effective January 1, 2024. Repealed as of January 1, 2028, pursuant to Section 103871.2.)

path: 102. VITAL RECORDS AND HEALTH STATISTICS > 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE > 1.7. California Neurodegenerative Disease Registry Program


text:
(a) A person with a valid scientific interest who is engaged in demographic, epidemiological, or other similar studies related to health who meets qualifications as determined by the department, and who agrees, in writing, to maintain confidentiality, may be authorized access to confidential information collected by the department pursuant to Section 103871.

(b) The department may enter into agreements to furnish confidential information to other states’ neurodegenerative disease registries, federal neurodegenerative disease control agencies, local health officers, or health researchers for the study of neurodegenerative diseases. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers, shall also do both of the following:

(1) Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.

(2) Provide documentation to the department that demonstrates to the department’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.

(c) Notwithstanding any other law, a disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed.

(d) The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.

(e) (1) The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include all of the following information:

(A) Name of the person authorizing access.

(B) Name, title, address, and organizational affiliation of persons given access.

(C) Dates of access.

(D) Specific purpose for which information is to be used.

(2) The record of access shall be open to public inspection during normal operating hours of the department.

(f) Notwithstanding any other law, the confidential information shall not be available for subpoena, shall not be disclosed, discoverable, or compelled to be produced in any civil or administrative proceeding, or other similar proceeding. The confidential information shall not be deemed admissible as evidence in any civil or administrative proceeding, or other similar tribunal or court for any reason.

(1) This subdivision does not prohibit the department from publishing reports and statistical compilations that do not identify individual cases or individual sources of information.

(2) Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to the individual’s own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of Part 4 of Division 3 of the Civil Code.

(g) This section does not preempt the authority of a facility or an individual providing diagnostic or treatment services to a patient with a neurodegenerative disease to maintain their own facility-based neurodegenerative disease registry.

history: (History: Added by Stats. 2021, Ch. 143, Sec. 20. (AB 133) Effective July 27, 2021. Repealed as of January 1, 2028, pursuant to Section 103871.2.)

chapter: 1.7. California Neurodegenerative Disease Registry Program


text: This chapter shall remain in effect only until January 1, 2028, and as of that date is repealed.

history: (History: Added by Stats. 2021, Ch. 143, Sec. 20. (AB 133) Effective July 27, 2021. Repealed as of January 1, 2028, by its own provisions. Note: Repeal affects Chapter 1.7, commencing with Section 103871.)


text:
(a) The department shall conduct a program of epidemiological assessments of the incidence of cancer. The program shall encompass all areas of the state for which cancer incidence data are available. The program shall include the monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment generally.

(b) The program shall be under the direction of the director, who may enter into contracts as are necessary for the conduct of the program and may accept, on behalf of the state, grants of public or private funds for the program. The director shall analyze available incidence data and prepare reports and perform studies as necessary to identify cancer hazards to the public health and their remedies.

(c) It is the intent of the Legislature that an appropriation be included in each Budget Act in an amount sufficient to provide for the annual cost of the program.

chapter: 2. Ken Maddy California Cancer Registry

path: 102. VITAL RECORDS AND HEALTH STATISTICS > 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE > 2. Ken Maddy California Cancer Registry


text:
(a) The director shall establish a statewide system for the collection of information determining the incidence of cancer, using population-based regional cancer registries modeled after the Cancer Surveillance Program of Orange County. As of the effective date of this section, the director shall begin phasing in the statewide cancer reporting system. By July 1, 1988, all county or regional registries shall be implemented or initiated. By July 1, 1990, the statewide cancer reporting system shall be fully operational. Within 60 days of the effective date of this section, the director shall submit an implementation and funding schedule to the Legislature.

(b) The department may designate any demographic parts of the state as regional cancer incidence reporting areas and may establish regional cancer registries, with the responsibility and authority to carry out the intent of this section in designated areas. Designated regional registries shall provide the department, on a timely basis, cancer incidence data, as designated by the department. The department may establish a competitive process to receive applications for, and issue, the award of a contract, grant, or allocation of funds, including, but not limited to, a cooperative agreement, subvention agreement, or any other agreement allowed by law, to an agency, including, but not limited to, a health systems agency, single county health department, multicounty health department grouping, or nonprofit professional association to operate the statewide cancer reporting system and to enter into contracts, or issue grants or funding allocations to other agencies representing a designated cancer reporting region for the purposes of collecting and collating cancer incidence data. The award of these contracts, grants, or funding allocations shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. The department shall include appropriate terms and conditions in a contract, grant, or funding allocation to ensure the proper use of state funds, including provision for reimbursement of allowable costs, financial reporting, program performance reporting, monitoring of subgrants, subcontracts, or suballocations to an agency representing a designated cancer reporting region, retention and access requirements for records, data use and management, independent auditing, termination, and disposition of assets acquired under the contract, grant, or funding allocation.

(c) The director shall designate cancer as a disease required to be reported in the state or any demographic parts of the state in which cancer information is collected under this section. All cancers diagnosed or treated in the reporting area shall thereafter be reported to the representative of the department authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative.

(d) (1) Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area shall report each case of cancer to the department or the authorized representative of the department in a format prescribed by the department. If the hospital or other facility fails to report in a format prescribed by the department, the department’s authorized representative may access the information from the hospital or the facility and report it in the appropriate format. In these cases, the hospital or other health facility shall reimburse the department or the authorized representative for its cost to access and report the information.

(2) Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients shall report each cancer case to the department or the authorized representative of the department, except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnoses or treatment of that instance of cancer.

(3) (A) A pathologist or pathology laboratory diagnosing a reportable case of cancer shall report cancer diagnoses to the department utilizing the College of American Pathologists cancer protocols or any other standardized format approved by the department.

(B) Reporting shall be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal that the department shall provide for pathologists’ use. If a pathologist fails to report electronically and with an approved format, the department’s authorized representative may access the information from the pathologist in an appropriate alternative format. In these cases, the pathologist shall reimburse the department or the authorized representative for its cost to access and report the information.

(C) A pathologist shall not be responsible for acquiring missing or inaccessible patient demographic information not provided to them beyond the content of the required cancer-specific data elements.

(D) For purposes of reports submitted pursuant to this paragraph, the department shall prescribe the data required to be included in the report, work collaboratively with stakeholders to designate a standardized electronic format for submission, and designate an internet web portal for electronic submission.

(E) This paragraph shall not be interpreted to require a pathologist to submit the same pathology report to the department, regardless of format, more than once, unless deemed necessary by the department or its authorized representative. If the department deems a pathologist noncompliant with this paragraph, the department shall notify the pathologist of the deficiencies and provide an opportunity to cure those deficiencies. The department shall not impose fines or other penalties solely based on a pathologist’s failure to comply with this paragraph.

(e) Any hospital or other facility that is required to reimburse the department or its authorized representative for the cost to access and report the information pursuant to subdivision (d) shall provide payment to the department or its authorized representative within 60 days of the date this payment is demanded. In the event any hospital or other facility fails to make the payment to the department or its authorized representative within 60 days of the date the payment is demanded, the department or its authorized representative may, at its discretion, assess a late fee not to exceed 112 percent per month of the outstanding balance. Further, in the event that the department or its authorized representative takes a legal action to recover its costs and any associated fees, and the department or its authorized representative receives a judgment in its favor, the hospital or other facility shall also reimburse the department or its authorized representative for any additional costs it incurred to pursue the legal action. Late fees and payments made to the department by hospitals or other facilities pursuant to this subdivision shall be considered as reimbursements of the additional costs incurred by the department.

(f) All physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals, or agencies providing diagnostic or treatment services to patients with cancer shall grant to the department or the authorized representative access to all records that would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer, or medical status of any identified cancer patient. Willful failure to grant access to those records shall be punishable by a fine of up to five hundred dollars ($500) each day access is refused. Any fines collected pursuant to this subdivision shall be deposited in the General Fund.

(g) (1) Except as otherwise provided in this section, all information collected pursuant to this section shall be confidential. For purposes of this section, this information shall be referred to as “confidential information.”

(2) The department and any regional cancer registry designated by the department shall use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect.

(3) Persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health who meet qualifications as determined by the department, and who agree, in writing, to maintain confidentiality, may be authorized access to confidential information.

(4) The department and any regional cancer registry designated by the department may enter into agreements to furnish confidential information to other states’ cancer registries, federal cancer control agencies, local health officers, or health researchers for the purposes of determining the sources of cancer and evaluating measures designed to eliminate, alleviate, or ameliorate their effect. Before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity shall agree in writing to maintain the confidentiality of the information, and in the case of researchers with a valid scientific interest as described in paragraph (3), shall also do both of the following:

(A) Obtain approval of their committee for the protection of human subjects established in accordance with Part 46 (commencing with Section 46.101) of Title 45 of the Code of Federal Regulations.

(B) Provide documentation to the department that demonstrates to the department’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information.

(5) Notwithstanding any other law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and not be further disclosed, unless the original disclosure is for research that requires the researchers to participate in data sharing with federal or federally designated data repositories or with researchers under the direction and control of the originally approved data recipient who remains the researcher responsible for data security and integrity provided the data being disclosed does not contain individually identifiable data that could be reasonably used to identify or reidentify the data with an individual person.

(6) The furnishing of confidential information to the department or its authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.

(7) The department shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the department.

(8) Notwithstanding any other law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.

(9) This subdivision does not prohibit the publication by the department of reports and statistical compilations that do not in any way identify individual cases or individual sources of information.

(10) Notwithstanding the restrictions in this subdivision, the individual to whom the information pertains shall have access to their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of Part 4 of Division 3 of the Civil Code.

(h) For the purpose of this section, “cancer” means either of the following:

(1) All malignant neoplasms, regardless of the tissue of origin, including malignant lymphoma, Hodgkin’s disease, and leukemia, but excluding basal cell and squamous cell carcinoma of the skin.

(2) All primary intracranial and central nervous system (CNS) tumors occurring in the following sites, irrespective of histologic type: brain, meninges, spinal cord, caudae equina, cranial nerves and other parts of the CNS, pituitary gland, pineal gland, and craniopharyngeal duct.

(i) This section does not preempt the authority of facilities or individuals providing diagnostic or treatment services to patients with cancer to maintain their own facility-based cancer registries.

(j) The department, in establishing a system pursuant to this section, shall maximize the use of available federal funds.

history: (History: Amended by Stats. 2023, Ch. 867, Sec. 1. (SB 344) Effective January 1, 2024.)


text:
(a) Every physician and surgeon shall report immediately to the local health officer in writing, the name, date of birth, and address of every patient at least 14 years of age or older whom the physician and surgeon has diagnosed as having a case of a disorder characterized by lapses of consciousness. However, if a physician and surgeon reasonably and in good faith believes that the reporting of a patient will serve the public interest, he or she may report a patient’s condition even if it may not be required under the department’s definition of disorders characterized by lapses of consciousness pursuant to subdivision (d).

(b) The local health officer shall report in writing to the Department of Motor Vehicles the name, age, and address, of every person reported to it as a case of a disorder characterized by lapses of consciousness.

(c) These reports shall be for the information of the Department of Motor Vehicles in enforcing the Vehicle Code, and shall be kept confidential and used solely for the purpose of determining the eligibility of any person to operate a motor vehicle on the highways of this state.

(d) The department, in cooperation with the Department of Motor Vehicles, shall define disorders characterized by lapses of consciousness based upon existing clinical standards for that definition for purposes of this section and shall include Alzheimer’s disease and those related disorders that are severe enough to be likely to impair a person’s ability to operate a motor vehicle in the definition. The department, in cooperation with the Department of Motor Vehicles, shall list those circumstances that shall not require reporting pursuant to subdivision (a) because the patient is unable to ever operate a motor vehicle or is otherwise unlikely to represent a danger that requires reporting. The department shall consult with professional medical organizations whose members have specific expertise in the diagnosis and treatment of those disorders in the development of the definition of what constitutes a disorder characterized by lapses of consciousness as well as definitions of functional severity to guide reporting so that diagnosed cases reported pursuant to this section are only those where there is reason to believe that the patients’ conditions are likely to impair their ability to operate a motor vehicle. The department shall complete the definition on or before January 1, 1992.

(e) The Department of Motor Vehicles shall, in consultation with the professional medical organizations specified in subdivision (d), develop guidelines designed to enhance the monitoring of patients affected with disorders specified in this section in order to assist with the patients’ compliance with restrictions imposed by the Department of Motor Vehicles on the patients’ licenses to operate a motor vehicle. The guidelines shall be completed on or before January 1, 1992.

(f) A physician and surgeon who reports a patient diagnosed as a case of a disorder characterized by lapses of consciousness pursuant to this section shall not be civilly or criminally liable to any patient for making any report required or authorized by this section.

path: 102. VITAL RECORDS AND HEALTH STATISTICS > 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE > 3. Disorders Characterized by Lapses of Consciousness


text:
(a) The Legislature finds and declares the following:

(1) The cause and the cure of Reyes Syndrome are unknown, and the number of incidences of this disease is also unknown.

(2) Where the scope of a medical problem is unknown, the amount of research funds is usually small. Therefore, it is necessary to define the extent of this medical problem.

(b) A physician and surgeon attending a patient diagnosed as having Reyes Syndrome shall report that condition, within seven days of the diagnosis, to the department on report forms prescribed by the department.

chapter: 4. Reyes Syndrome

path: 102. VITAL RECORDS AND HEALTH STATISTICS > 2. POPULATION AND PUBLIC HEALTH SURVEILLANCE > 4. Reyes Syndrome


text:
The Legislature finds and declares that high blood pressure, also known as hypertension, is a widespread and serious public health problem in California. This condition, when untreated, is a major contributor to heart disease, stroke, kidney disease, and related cardiovascular morbidity and mortality. Although high blood pressure can be effectively controlled through the use of now well established antihypertensive drugs, treatment is not always adequately utilized.

It is estimated that there are two million adults in California who have high blood pressure. It is further estimated, based on national data, that no more than 71 percent of all adult Californians with high blood pressure are aware of their condition, and that of those who are aware, only 40 percent are being effectively treated. Thus, of some two million California adults with high blood pressure, only about 568,000 have their condition adequately controlled. Unless the problem of uncontrolled high blood pressure among some 1,432,000 adults is promptly addressed, many of these individuals will experience preventable serious illness, disability and death. In addition, the state will continue to face unnecessary medical and welfare costs resulting from high blood pressure and its resulting effects. Consequently, it is necessary to provide for expanded statewide efforts, interface with relevant federal legislation, establish and maintain appropriate guidelines, and enhance high blood pressure control activities at the community level. Coordination of local and state efforts in the planning, implementation, and evaluation of high blood pressure control activities is required, in order to improve allocations and utilization of resources to control high blood pressure in the states population.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 5. Effective January 1, 1996.)

part: 1. CHRONIC DISEASE

chapter: 1. Cardiovascular Disease

path: 103. DISEASE PREVENTION AND HEALTH PROMOTION > 1. CHRONIC DISEASE > 1. Cardiovascular Disease


text:
The department shall conduct a program for the control of high blood pressure. The program shall include, but not be limited to, all of the following:

(a) Support of local community high blood pressure control programs to improve the quality and distribution of high blood pressure control services.

(b) Promotion of consumer participation in high blood pressure control efforts.

(c) Statewide coordination of high blood pressure control activities.

(d) Planning, including development, adoption, periodic review, and revision of a state plan for high blood pressure control; and assistance to local agencies in their planning efforts.

(e) Gathering, analysis, and dissemination of epidemiologic data and information on high blood pressure and its resulting effects, and support of high blood pressure research.

(f) Development and maintenance of a clearinghouse for high blood pressure information, materials, and services.

(g) Promotion of local and regional councils on high blood pressure control.

(h) Evaluation of high blood pressure control efforts.

(i) Education of patients, health professionals, and the general public.

division: 103. DISEASE PREVENTION AND HEALTH PROMOTION


text:
Local community high blood pressure control programs may include any or all of the following program components:

(a) Screening.

(b) Detection.

(c) Referral and followup.

(d) Diagnostic evaluation.

(e) Adherence management.

(f) Dropout retrieval.

(g) Patient education.

(h) Public education.

(i) Provider education.

(j) Such other components consistent with applicable federal program requirements as the department may deem desirable in controlling high blood pressure and are reflected in the state plan for high blood pressure control.


text:
(a) Every health studio, as defined in subdivision (h), shall acquire, maintain, and train personnel in the use of, an automatic external defibrillator pursuant to this section.

(b) An employee of a health studio who renders emergency care or treatment is not liable for civil damages resulting from the use, attempted use, or nonuse of an automatic external defibrillator, except as provided in subdivision (f).

(c) When an employee uses, does not use, or attempts to use an automatic external defibrillator consistent with the requirements of this section to render emergency care or treatment, the members of the board of directors of the facility shall not be liable for civil damages resulting from an act or omission in rendering the emergency care or treatment, including the use or nonuse of an automatic external defibrillator, except as provided in subdivision (f).

(d) Except as provided in subdivisions (f) and (g), when an employee of a health studio renders emergency care or treatment using an automatic external defibrillator, the owners, managers, employees, or otherwise responsible authorities of the facility shall not be liable for civil damages resulting from an act or omission in the course of rendering that emergency care or treatment, provided that the facility fully complies with subdivision (e).

(e) Notwithstanding Section 1797.196, in order to ensure public safety, a health studio shall do all of the following:

(1) Comply with all regulations governing the placement of an automatic external defibrillator.

(2) Ensure all of the following:

(A) The automatic external defibrillator is maintained and regularly tested according to the operation and maintenance guidelines set forth by the manufacturer, the American Heart Association, or the American Red Cross, and according to any applicable rules and regulations set forth by the governmental authority under the federal Food and Drug Administration and any other applicable state and federal authority.

(B) The automatic external defibrillator is checked for readiness after each use and at least once every 30 days if the automatic external defibrillator has not been used in the preceding 30 days. The health studio shall maintain records of these checks.

(C) A person who renders emergency care or treatment to a person in cardiac arrest by using an automatic external defibrillator activates the emergency medical services system as soon as possible, and reports the use of the automatic external defibrillator to the licensed physician and to the local EMS agency.

(D) For every automatic external defibrillator unit acquired, up to five units, no less than one employee per automatic external defibrillator unit shall complete a training course in cardiopulmonary resuscitation and automatic external defibrillator use that complies with the regulations adopted by the Emergency Medical Services Authority and the standards of the American Heart Association or the American Red Cross. After the first five automatic external defibrillator units are acquired, for each additional five automatic external defibrillator units acquired, a minimum of one employee shall be trained beginning with the first additional automatic external defibrillator unit acquired. Acquirers of automatic external defibrillator units shall have trained employees who should be available to respond to an emergency that may involve the use of an automatic external defibrillator unit during staffed operating hours. Acquirers of automatic external defibrillator units may need to train additional employees to ensure that a trained employee is available at all times.

(E) There is a written plan that exists that describes the procedures to be followed in the event of an emergency that may involve the use of an automatic external defibrillator, to ensure compliance with the requirements of this section. The written plan shall include, but not be limited to, immediate notification of 911 and trained office personnel at the start of automatic external defibrillator procedures.

(3) A health studio that allows its members access to its facility during times when it does not have an employee on the premises shall do all of the following:

(A) Require that all employees who work on the health studio’s premises complete a training course, within 30 days of beginning employment, in cardiopulmonary resuscitation and automated external defibrillator use, that complies with the regulations adopted by the Emergency Medical Services Authority, and the Standards of the American Heart Association or the American Red Cross.

(B) Ensure that a trained employee is on the health studio’s premises for no fewer than 50 hours per week.

(C) Inform a member, at the time the member contracts for the use of the health studio, that a trained employee will not be on the health studio’s premises at all times.

(D) Deny access to the health studio when an employee is not present if the health studio operates in a space that is larger than 6,000 square feet.

(f) Subdivisions (b), (c), and (d) do not apply in the case of personal injury or wrongful death that results from gross negligence or willful or wanton misconduct on the part of the person who uses, attempts to use, or maliciously fails to use an automatic external defibrillator to render emergency care or treatment.

(g) A health studio that allows its members access to its facilities during operating hours when employees trained in the use of automatic external defibrillators are not on the facility premises, waives the provisions of subdivision (d) and the affirmative defense of primary assumption of the risk, whether express or implied, as to a claim arising out of the absence of trained staff.

(h) For purposes of this section, “health studio” means a facility permitting the use of its facilities and equipment or access to its facilities and equipment, to individuals or groups for physical exercise, body building, reducing, figure development, fitness training, or any other similar purpose, on a membership basis. “Health studio” does not include a hotel or similar business that offers fitness facilities to its registered guests for a fee or as part of the hotel charges.

history: (History: Amended by Stats. 2019, Ch. 637, Sec. 7. (AB 1818) Effective January 1, 2020.)


text: The department may enter into contracts with local public and private nonprofit agencies for the purpose of operating community high blood pressure control programs.


text: The department shall establish standards for applications for funding, review of proposals, funding awards, technical assistance, monitoring, and evaluation of local programs as it may deem necessary for the implementation of this chapter.


text:
No services provided pursuant to this chapter shall substitute for other obligations of a unit of local government, including those required by state law.

Funds appropriated to carry out the purposes of this chapter shall be supplemental to those available from the federal government and shall not duplicate, nor shall they replace, any commitments made by the federal government to support high blood pressure control, including any formula allocations for which California would be eligible whether or not this chapter is enacted into law.


text: Local community high blood pressure control programs funded pursuant to this chapter shall make maximum use of third party payments and other resources to support their efforts.


text: The department may receive and expend funds for high blood pressure control pursuant to this chapter from federal and other available sources and may use such funds, along with available state funds, to support a unified high blood pressure control program.


text: It is the intent of the Legislature that the department shall utilize available federal funds for carrying out the purposes of this chapter.


text:
(a) The Legislature hereby requests the University of California to establish and administer the Breast Cancer Research Program, which is created by this act, as a comprehensive grant and contract program to support research efforts into the cause, cure, treatment, earlier detection, and prevention of breast cancer. It is the intent of the Legislature that this program incorporate the principles and organizational elements specified in this act, including, but not limited to, a research program office with a director and other necessary staff, a Breast Cancer Research Council, and research review panels.

(b) For the purposes of this section:

(1) “Breast cancer research” includes, but is not limited to, research in the fields of biomedical science and engineering, the social, economic and behavioral sciences, epidemiology, technology development and translation, and public health.

(2) “Council” means the Breast Cancer Research Council.

(3) “Grantee” means any qualifying public, private, or nonprofit agency or individual, including, but not limited to, colleges, universities, hospitals, laboratories, research institutions, local health departments, voluntary health agencies, health maintenance organizations, corporations, students, fellows, entrepreneurs, and individuals conducting research in California.

(4) “Program” means the Breast Cancer Research Program.

(5) “University” means the University of California.

(c) It is the intent of the Legislature that this program be administered pursuant to the following principles:

(1) The university shall work in close collaboration with the council and seek the consent of the council before taking an action different from the action recommended by the council.

(2) The council shall develop the strategic objectives and priorities of the program, actively participate in the overall management of the program, and make final recommendations on which research grants should be funded based on the research priorities established for the program and the technical merits of the proposals as determined by peer review panels.

(3) The program shall fund innovative and creative research, with a special emphasis on research that complements, rather than duplicates, the research funded by the federal government and other entities.

(4) The university and the council shall work in close collaboration with the Breast Cancer Early Detection Program.

(5) All research funds shall be awarded on the basis of the research priorities established for the program and the scientific merit of the proposed research, as determined by an open, competitive peer review process that ensures objectivity, consistency, and high quality. All investigators, regardless of affiliation, shall have equal access and opportunity to compete for program funds.

(6) The peer review process for the selection of research grants awarded under this program shall be generally modeled on that used by the National Institutes of Health in its grantmaking process.

(7) An awardee shall be awarded grants for the full cost, both direct and indirect, of conducting the sponsored research consistent with those federal guidelines governing all federal research grants and contracts. All intellectual property assets developed under this program shall be treated in accordance with state and federal law.

(8) In establishing its research priorities, the council shall consider a broad range of cross-disciplinary breast cancer research, as defined in paragraph (1) of subdivision (b), including, but not limited to, research into the cause, cure, and prevention of breast cancer; translational and technological research, including research regarding the development and translation of technologies of earlier detection; research regarding the cultural, economic, and legal barriers to accessing the health care system for early detection and treatment of breast cancer; and research examining the link between breast cancer and environmental factors, including both natural and industrial chemicals, estrogen imitators, and electromagnetic fields.

(d) It is the intent of the Legislature that the university, as lead agency, do all of the following:

(1) Establish the Breast Cancer Research Council in accordance with the following:

(A) The council shall consist of at least 13 and no more than 15 members representing a range of expertise and experience, appointed by the President of the University of California. Individuals and organizations may submit nominations to the council, and the University of California shall solicit nominations from relevant organizations and individuals. The council shall be comprised of the following members:

(i) Four members from breast cancer survivor and breast cancer-related advocacy groups, including, but not limited to, the California Breast Cancer Organizations (CABCO).

(ii) Four members drawn from the ranks of scientists or clinicians, including one from an independent research university in California. The scientists shall have expertise covering the various fields of scientific endeavor, including, but not limited to, the fields of biomedical research and engineering, social, economic, and behavioral research, epidemiology, and public health.

(iii) Two members from nonprofit health organizations with a commitment to breast cancer research and control.

(iv) One member who is a practicing breast cancer medical specialist.

(v) Two members from private industry with a commitment to breast cancer research and control, including, but not limited to, entrepreneurs, or persons from the science or high technology industry or persons from the health care sector.

(vi) One ex officio, nonvoting member from the Breast Cancer Early Detection Program.

(B) If the president appoints more than 13 members, it is the intent of the Legislature that the proportional representation remain substantially the same as set forth in subparagraph (A).

(C) Members shall serve without compensation, but may receive reimbursement for travel and other necessary expenses actually incurred in the performance of their official duties. Any member of the Breast Cancer Research Council shall be ineligible to apply for or receive funding for breast cancer research from the Breast Cancer Research Program during his or her term of service on the council, and for one cycle immediately following his or her term of service on the council, if the council member helped plan that subsequent cycle.

(D) Membership shall be staggered in such a way as to maintain a full council while ensuring a reasonable degree of continuity of expertise and consistency of direction.

(2) Provide overall coordination of the program.

(3) Provide staff assistance to the program and council.

(4) Develop administrative procedures relative to the solicitation, review, and awarding of grants to ensure an impartial, high quality peer review system.

(5) Recruit and supervise research review panels. The membership of these panels shall vary depending on the subject matter of the proposals and the review requirements, and shall draw on the most qualified individuals. The work of the review panels shall be administered pursuant to policies and procedures established for the implementation of the program. In order to avoid conflicts of interest and to ensure access to qualified reviewers, the university may utilize reviewers not only from California but also from outside the state. When serving on review panels, institutions, corporations, or individuals who have submitted grant applications for funding by this program shall be governed by conflict-of-interest provisions consistent with the National Institutes of Health Manual (Chapter 4510 (item h)), and any applicable conflict-of-interest provisions in state law.

(6) Provide for periodic program evaluation to ensure that research funded is consistent with program goals.

(7) Maintain a system of financial reporting and accountability.

(8) Provide for the systematic dissemination of research results to the public and the health care community, and provide for a mechanism to disseminate the most current research findings in the areas of cause, treatment, cure, earlier detection, and prevention of breast cancer, in order that these findings may be applied to the planning, implementation, and evaluation of the breast cancer-related programs of the State Department of Health Services, including the Breast Cancer Early Detection Program authorized by this act.

(9) Develop policies and procedures to facilitate the translation of research results into commercial, alternate technological, and other applications wherever appropriate and consistent with state and federal law.

(10) Transmit annually on or before December 31, 2010, and every five years thereafter, a report to the Legislature on grants made, grants in progress, program accomplishments, and future program directions. Each report shall include, but not be limited to, the following information:

(A) The number and dollar amounts of research grants, including the amount allocated to indirect costs.

(B) The subject of research grants.

(C) The relationship between federal and state funding for breast cancer research.

(D) The relationship between each project and the overall strategy of the research program.

(E) A summary of research findings including discussion of promising new areas.

(F) The institutions and campuses receiving grant awards.

In addition, the first annual report shall include an evaluation and recommendations concerning the desirability and feasibility of requiring for-profit grantees to compensate the state in the event that a grant results in the development of a profitmaking product. This evaluation shall include, but not be limited to, the costs and benefits of requiring a for-profit grantee to repay the grant, to provide the product at cost to Medi-Cal and other state programs serving low-income breast cancer patients, and to pay the state a percentage of the royalties derived from the product.

(e) It is the intent of the Legislature that no more than 5 percent of the allocation to the university be used for the purposes of administration of this program.

(f) It is the intent of the Legislature that the responsibilities of the council shall include, but not be limited to, the following:

(1) Development and review of the strategic objectives and research priorities of the program.

(2) Delineation of resource allocation across the various priorities established for the program.

(3) Participation in periodic program and financial review, including the report transmitted pursuant to paragraph (10) of subdivision (d).

(4) Development and review of guidelines to ensure fairness, neutrality, and adherence to the principles of merit and quality in the conduct of the program.

(5) Development of appropriate linkages to nonacademic entities, including, but not limited to, voluntary organizations, health care delivery systems, industry, government agencies, research entrepreneurs, and public officials.

(6) Development and review of criteria and standards for granting awards.

(7) Oversight and review of the request for applications (RFA).

(8) Review of research review panel reports and recommendations for grant awards.

(9) Making of final recommendations on which grants are to be awarded.

(10) Development and review of oversight mechanisms for the dissemination of research results.

(11) Development and review of policies and liaison programs to facilitate the translation of research results into commercial, alternate technological, or other applications wherever appropriate.

(12) Establishment of its own internal rules of operation.

(13) Participation in the identification and recruitment of breast cancer advocates and survivors, clinicians, scientists, and persons from the science, high technology, or health care sector with relevant expertise for possible participation in a peer review panel. The council may propose to assign a member of the council to sit as a nonvoting member of the peer review panels.

history: (History: Amended by Stats. 2009, Ch. 386, Sec. 28. (AB 1182) Effective January 1, 2010.)

chapter: 2. Cancer

article: 1. The Breast Cancer Research Program

path: 103. DISEASE PREVENTION AND HEALTH PROMOTION > 1. CHRONIC DISEASE > 2. Cancer > 1. The Breast Cancer Research Program


text:
(a) (1) A provider or entity that participates in the grant made to the department by the federal Centers for Disease Control and Prevention breast and cervical cancer early detection program established under Title XV of the federal Public Health Service Act (42 U.S.C. Sec. 300k et seq.) in accordance with requirements of Section 1504 of that act (42 U.S.C. Sec. 300n) may only render screening services under the grant to an individual if the provider or entity determines that the individual’s family income does not exceed 200 percent of the federal poverty level.

(2) Providers, or the enrolling entity, shall make available to all applicants and beneficiaries, prior to or concurrent with enrollment, information on the manner in which to apply for insurance affordability programs, in a manner determined by the State Department of Health Care Services. The information shall include the manner in which applications can be submitted for insurance affordability programs, information about the open enrollment periods for the California Health Benefit Exchange, and the continuous enrollment aspect of the Medi-Cal program.

(b) (1) The department shall provide for breast cancer and cervical cancer screening services under the grant at the level of funding budgeted from state and other resources during the fiscal year in which the Legislature has appropriated funds to the department for this purpose. These screening services shall not be deemed to be an entitlement.

(2) The following individuals shall be eligible for breast cancer screening and diagnostic services pursuant to this section if they meet all other eligibility requirements:

(A) An individual of any age who is symptomatic.

(B) An individual whose age is within the age range for routine breast cancer screening, as recommended by the United States Preventive Services Task Force, subject to any federal action relating to breast cancer screening that overrides those recommendations.

(3) For purposes of this section, “symptomatic” means an individual presenting with an abnormality or change in the look or feel of the breast, including, but not limited to, a lump, a hard knot, thickening or swelling of the breast tissue, a change in the color, size, or shape of the breast, or any discharge from the nipple.

(c) To implement the federal breast and cervical cancer early detection program specified in this section, the department may contract, to the extent permitted by Section 19130 of the Government Code, with public and private entities, or utilize existing health care service provider enrollment and payment mechanisms, including the Medi-Cal program’s fiscal intermediary. However, the Medi-Cal program’s fiscal intermediary shall only be utilized if services provided under the program are specifically identified and reimbursed in a manner that does not claim federal financial reimbursement. Any contracts with, and the utilization of, the Medi-Cal program’s fiscal intermediary shall not be subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code. Contracts to implement the federal breast and cervical cancer early detection program entered into by the department with entities other than the Medi-Cal program’s fiscal intermediary shall not be subject to Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code.

(d) The department shall enter into an interagency agreement with the State Department of Health Care Services to transfer that portion of the grant made to the department by the federal Centers for Disease Control and Prevention breast and cervical cancer early detection program established under Title XV of the federal Public Health Service Act (42 U.S.C. Sec. 300k et seq.) to the State Department of Health Care Services. The department shall have no other liability to the State Department of Health Care Services under this article.

history: (History: Amended by Stats. 2016, Ch. 608, Sec. 1. (AB 1795) Effective January 1, 2017.)

path: 103. DISEASE PREVENTION AND HEALTH PROMOTION > 1. CHRONIC DISEASE > 2. Cancer > 1.3. Breast and Cervical Cancer Early Detection Program Grant


text: Notwithstanding Section 10231.5 of the Government Code, each year, by no later than January 10 and concurrently with the release of the May Revision, the State Department of Health Care Services shall provide the fiscal committees of the Legislature with an estimate package for the Every Woman Counts Program. This estimate package shall include all significant assumptions underlying the estimate for the Every Woman Counts Program’s current-year and budget-year proposals, and shall contain concise information identifying applicable estimate components, such as caseload; a breakout of costs, including, but not limited to, clinical service activities, including office visits and consults, screening mammograms, diagnostic mammograms, diagnostic breast procedures, case management, and other clinical services; policy changes; contractor information; General Fund, special fund, and federal fund information; and other assumptions necessary to support the estimate.

history: (History: Amended by Stats. 2025, Ch. 105, Sec. 25. (AB 144) Effective September 17, 2025.)

article: 1.3. Breast and Cervical Cancer Early Detection Program Grant


text:
(a) The State Department of Health Care Services shall develop and maintain the Breast and Cervical Cancer Treatment Program to expand and ensure quality breast and cervical cancer treatment for low-income uninsured and underinsured individuals who are diagnosed with breast or cervical cancer.

(b) To implement the program, the State Department of Health Care Services may contract with public or private entities, or utilize existing health care service provider enrollment and payment mechanisms, including the Medi-Cal program’s fiscal intermediary, only if services provided under the program are specifically identified and reimbursed in a manner that does not claim federal financial reimbursement. The utilization of the Medi-Cal program’s fiscal intermediary shall not be subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code. Contracts to implement the program entered into by the State Department of Health Care Services with entities other than the Medi-Cal program’s fiscal intermediary shall not be subject to Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code.

history: (History: Amended by Stats. 2012, Ch. 23, Sec. 20. (AB 1467) Effective June 27, 2012.)

path: 103. DISEASE PREVENTION AND HEALTH PROMOTION > 1. CHRONIC DISEASE > 2. Cancer > 1.5. Breast and Cervical Cancer Treatment Program


text:
For the purposes of this article, the following definitions shall apply:

(a) “Covered conditions” means breast or cervical cancer.

(b) “Breast cancer” includes primary, recurrent, and metastatic cancers of the breast, including, but not limited to, infiltrating or in situ.

(c) “Cervical cancer” includes all primary, recurrent, and metastatic cancers of the cervix, including, but not limited to, infiltrating or in situ, as well as cervical dysplasia.

(d) “Treatment services” means those health care services, goods, supplies, or merchandise medically necessary to treat the covered condition or conditions with which the individual made eligible under this article has been diagnosed.

(e) “Uninsured” means not covered for breast or cervical cancer treatment services by any of the following:

(1) No-cost full-scope Medi-Cal.

(2) Medicare.

(3) A health care service plan contract or policy of disability insurance.

(4) Any other form of health care coverage.

(f) “Underinsured” means either of the following:

(1) Covered for breast or cervical cancer treatment services by any health care insurance listed in paragraph (2), (3), or (4) of subdivision (e), but the sum of the individual’s insurance deductible, premiums, and expected copayments in the initial 12-month period that breast or cervical cancer treatment services are needed exceeds seven hundred fifty dollars ($750).

(2) Covered by share-of-cost or limited-scope Medi-Cal, if the individual is not otherwise eligible for treatment services under the Medi-Cal program pursuant to Section 14007.71 of the Welfare and Institutions Code.

history: (History: Amended by Stats. 2018, Ch. 34, Sec. 8. (AB 1810) Effective June 27, 2018.)

article: 1.5. Breast and Cervical Cancer Treatment Program


text:
(a) If an individual is made eligible for treatment services under this article due to a diagnosis of breast cancer, the treatment services shall be provided for the duration of the period of treatment, as long as the individual continues to meet all other eligibility requirements.

(b) If an individual is made eligible for treatment services under this article due to a diagnosis of cervical cancer, the treatment services shall be provided for the duration of the period of treatment, as long as the individual continues to meet all other eligibility requirements.

(c) If an individual is diagnosed with a reoccurrence of breast cancer or cervical cancer, whether at the original cancer site or a different cancer site, the individual shall be eligible for coverage for the duration of the period of treatment, as long as the individual continues to meet all other eligibility requirements.

history: (History: Amended by Stats. 2018, Ch. 34, Sec. 9. (AB 1810) Effective June 27, 2018.)


text:
An individual shall be eligible to receive treatment services pursuant to this article provided that all of the following criteria are met:

(a) The individual is a resident of California.

(b) The individual is uninsured or underinsured.

(c) The individual, who meets the income standards described in subdivision (d), was screened for breast or cervical cancer by a provider or entity participating in the Centers for Disease Control and Prevention breast and cervical cancer early detection program established under Title XV of the Public Health Service Act (42 U.S.C. Sec. 300k et seq.) in accordance with requirements of Section 1504 of that act (42 U.S.C. Sec. 300n) and needs treatment for breast or cervical cancer.

(d) As determined by the provider performing the screening and diagnosis, the individual has family income at or below 200 percent of the federal poverty level.

(e) The individual has filed a completed application for eligibility for treatment services under the Medi-Cal program pursuant to Section 14007.71 of the Welfare and Institutions Code, and has been found ineligible for benefits under that section.

history: (History: Repealed and added by Stats. 2001, Ch. 171, Sec. 9. Effective August 10, 2001. Operative January 1, 2002, by Sec. 59 of Ch. 171.)


text:
If an individual is underinsured, as defined in subdivision (f) of Section 104161, the State Department of Health Care Services shall be the payer of second resort for treatment services. To the extent necessary for the individual to obtain treatment services under any health care insurance listed in paragraph (2), (3), or (4) of subdivision (e) of Section 104161, the State Department of Health Care Services may do the following:

(a) Pay for the individual’s breast or cervical cancer copayments, premiums, and deductible.

(b) Provide only treatment services not otherwise covered by any health care insurance listed in paragraph (2), (3), or (4) of subdivision (e) of Section 104161.

history: (History: Amended by Stats. 2018, Ch. 34, Sec. 10. (AB 1810) Effective June 27, 2018.)


text: For the purposes of establishing eligibility for treatment services under this article, breast or cervical cancer screens performed by providers or entities not described in subdivision (c) of Section 104162 may be used only to the same extent the screens are used by the Medi-Cal program for the purpose of determining eligibility pursuant to Section 14007.71 of the Welfare and Institutions Code, as approved by the federal Health Care Financing Administration.

history: (History: Added by Stats. 2001, Ch. 171, Sec. 9. Effective August 10, 2001. Operative January 1, 2002, by Sec. 59 of Ch. 171.)


text: The State Department of Health Care Services shall provide for breast cancer and cervical cancer treatment services pursuant to this article at the level of funding budgeted from state and other resources during the fiscal year in which the Legislature has appropriated funds to the department for this purpose. These treatment services shall not be deemed to be an entitlement.

history: (History: Amended by Stats. 2012, Ch. 23, Sec. 22. (AB 1467) Effective June 27, 2012.)


text:
(a) The Human Leukocyte Antigen Testing Fund is hereby established in the State Treasury, to be administered by the State Department of Health Services. Moneys in the fund shall be subject to appropriation in the annual Budget Act, and shall be used to pay the costs of blood collection and human leukocyte antigen typing, also referred to as histocompatibility locus antigen (HLA) testing, for A, B, and DR antigens for use in bone marrow transplantation by California blood centers under contract with the federal National Marrow Donor Program provided for pursuant to Public Law 101-302.

(b) Moneys in the fund may only be expended if the individual being tested completes and signs an informed consent form authorizing the use of test results for participation in the federal program referred to in subdivision (a). The form shall require a declaration from the donor as to whether he or she has health plan benefits that would cover the cost of HLA testing. Moneys in the fund shall not be used to pay for the testing of a health plan enrollee if the health plan covers the cost of HLA testing for the enrollee.

history: (History: Amended by Stats. 2001, Ch. 159, Sec. 132. Effective January 1, 2002.)

path: 103. DISEASE PREVENTION AND HEALTH PROMOTION > 1. CHRONIC DISEASE > 2. Cancer > 1.7. Human Leukocyte Antigen Testing Fund


text: The Legislature finds and declares that decades after the war on cancer was declared, it remains an insidious killer of Californians. Simultaneously, cancer absorbs millions of dollars from California’s economy through health care costs, and takes an horrendous toll on the personal lives of citizens.

history: (History: Added by Stats. 1997, Ch. 756, Sec. 1. Effective January 1, 1998.)

article: 2. The Cancer Research Act of 1997

path: 103. DISEASE PREVENTION AND HEALTH PROMOTION > 1. CHRONIC DISEASE > 2. Cancer > 2. The Cancer Research Act of 1997


text: The Cancer Research Fund is hereby established in the State Treasury. Moneys in the fund shall be available for expenditure by the department, upon appropriation by the Legislature. The fund shall consist of money accepted by the department from grants and donations from private entities and of public moneys transferred to the fund. It is the intent of the Legislature that, after the initial appropriation made pursuant to Assembly Bill 1554 of the 1997–98 Regular Session, the fund be enhanced by annual allocations determined in subsequent budget acts.

history: (History: Amended by Stats. 2001, Ch. 246, Sec. 1. Effective September 5, 2001.)

article: 2. The Cancer Research Act of 1997


text:
(a) The moneys in the Cancer Research Fund, established pursuant to Section 104180, shall be expended for the purpose of cancer research.

(b) The State Department of Health Services shall establish and administer the Cancer Research Program created by this article in a manner that will ensure the participation of both private sector and public research organizations. The State Department of Health Services may contract with nonprofit organizations, foundations, or public entities to administer the Cancer Research Program created by this article. A nonprofit organization shall be established under Section 501(c)(3) of the Internal Revenue Code for the purpose of conducting public health research. A nonprofit organization, foundation, or public entity shall have prior experience administering research programs offering comprehensive grant and contract opportunities for research concerning public health and disease-related projects, with substantial participation by private entities and public research organizations. In addition, a nonprofit organization, foundation, or public entity shall have experience in seeking, combining, and maximizing private funding to supplement public funding of projects. It is the intent of the Legislature that this program incorporate the principles and organizational elements set forth in this article, including, but not limited to, a research program office with a director and other essential staff, a cancer research council, and a research peer review panel.

(c) For the purposes of this article, all of the following shall apply:

(1) “Cancer research” is research with respect to the cause and prevention, cure, diagnosis, and treatment of cancer, including, but not limited to, intramural and extramural research in the fields of biomedical science and engineering, economics, epidemiology, diet and lifestyle, public health, and technology development and translation, with emphasis on noninvasive treatments.

(2) “Department” means the State Department of Health Services.

(3) “Grantee” means any qualifying public, private, or nonprofit agency or individual, including, but not limited to, colleges, universities, hospitals, laboratories, research institutions, local health departments, voluntary health agencies, cancer registries, health maintenance organizations, publicly traded or private corporations, students, fellows, entrepreneurs, and individuals conducting research in this state. A grantee may also be a corporation that is headquartered in California and that will conduct a substantial majority of the grant’s research in this state.

(4) “Indirect costs” includes use allowance for research facilities, heating, lighting, library services, health and safety services, project administration, and building maintenance, as defined by federal cost accounting guidelines for federally sponsored research.

(5) “Program” means the Cancer Research Program.

(6) “Council” means the Cancer Research Council established pursuant to Section 104182.

article: 2. The Cancer Research Act of 1997


text: The department, in awarding grants under this program, shall not encumber money allocated in any fiscal year other than the fiscal year in which the appropriation was made beginning with nonobligated 2000–01 fiscal year funds, subject to receiving multiyear spending authority for those funds.

history: (History: Added by Stats. 1999, Ch. 751, Sec. 1. Effective January 1, 2000.)

article: 2. The Cancer Research Act of 1997


text: Notwithstanding subdivision (a) of Section 2.00 of the Budget Act of 2002 and any other provision of law, commencing with the appropriation for the 2002–03 fiscal year, and for each fiscal year thereafter, any amount appropriated to the department for the Cancer Research Program shall be available, for purposes of that program, for encumbrance for one fiscal year beyond the year of appropriation and for expenditure for three fiscal years beyond the year of encumbrance.

history: (History: Added by Stats. 2003, Ch. 230, Sec. 6. Effective August 11, 2003.)

article: 2. The Cancer Research Act of 1997


text:
(a) The Cancer Research Council is hereby established, to consist of 15 members appointed by the Director of Health Services representing a range of expertise and experience, and the chief of the California Cancer Registry as an ex officio, nonvoting member. The voting members shall be appointed by February 15, 1998, as follows:

(1) Nine members from persons recommended by relevant organizations, as follows:

(A) One member drawn from a cancer survivor group or cancer-related advocacy group.

(B) Five members drawn from the ranks of scientists or clinicians, two from public universities or research organizations, and three from private universities or research organizations. The scientists shall have expertise in one or more of the various fields of cancer research.

(C) One member who is a practicing cancer medical specialist from a health organization with a commitment to cancer research and control.

(D) Two members from private industry with an interest in cancer research and control, including, but not limited to, entrepreneurs or persons from the science or high technology industry.

(2) Three members nominated by the Senate Committee on Rules as follows:

(A) One member drawn from a cancer survivor group or cancer-related advocacy group.

(B) One member drawn from a health organization.

(C) One member drawn from private industry with an interest in cancer research or control.

(3) Three members nominated by the Speaker of the Assembly as follows:

(A) One member drawn from a cancer survivor group or cancer-related advocacy group.

(B) One member drawn from a health organization.

(C) One scientist or clinician who has expertise in one or more of the various fields of cancer research.

(b) It is the intent of the Legislature that the council contain the proportional representation of appointees described in subdivision (a) when the council approves the funding of research grants, and that vacancies affecting the proportional representation be filled before grants are approved, and within 45 days of the occurrence of a vacancy.

(c) Members shall serve without compensation, but may receive reimbursement for travel and other necessary expenses actually incurred in the performance of their official duties.

(d) All appointments shall be for a term of four years, except that, for purposes of the initial appointments, the Director of Health Services shall appoint five members to four-year terms, five members to three-year terms, and five members to two-year terms. Each of those groups of five members shall include three members appointed under paragraph (1) of subdivision (a), one member appointed under paragraph (2) of that subdivision, and one member appointed under paragraph (3) of that subdivision.

history: (History: Added by Stats. 1997, Ch. 755, Sec. 3. Effective January 1, 1998.)

article: 2. The Cancer Research Act of 1997


text: Not less than a majority of the appointed members of the Cancer Research Council shall be present and voting for approval and selection of research priorities under Section 104185 and ultimate recommendations to the State Department of Health Services regarding grantmaking decisions.

history: (History: Added by Stats. 1999, Ch. 751, Sec. 2. Effective January 1, 2000.)

article: 2. The Cancer Research Act of 1997


text:
(a) The department shall grant a minimum of 65 percent of any fiscal year appropriation that is awarded for research to cancer research proposals directly researching gender-specific cancers.

(b) Any amount of funding for gender-specific cancer research for any fiscal year, to the extent the amount is below the threshold minimum allocation for any fiscal year established pursuant to subdivision (a), shall be carried forward, upon approval of the council for the following fiscal year or years for gender-specific cancer research, to the extent allowed by the limitations on the appropriated funds subject to that allocation. Funding allocations carried over from any fiscal year under this subdivision shall be in addition to the funding allocation for gender-specific cancer research for fiscal years to which the additional allocation is transferred pursuant to this subdivision.

history: (History: Added by Stats. 1999, Ch. 751, Sec. 3. Effective January 1, 2000.)

article: 2. The Cancer Research Act of 1997


text:
(a) This program shall incorporate the principles and organizational elements set forth in this article, including, but not limited to, a research program office with a director and other essential staff, a research council, and a research peer review panel. No more than 10 percent of the annual allocation for this program, up to a maximum of five hundred thousand dollars ($500,000), shall be expended annually for the total administrative costs of the program. Administrative costs shall be kept to a strict minimum.

(b) The program shall be administered pursuant to the following principles:

(1) The department shall work in close collaboration with the council and seek the advice of the council before taking an action different from an action recommended by the council.

(2) The council shall participate in the development of the strategic objectives and priorities of the program based on the intent of this article and advise on what and how many research grants should be funded based on the research priorities that are established for the program and the technical merits of the proposals as determined by the peer review panels.

(3) The research priorities shall reflect, and the program shall fund, innovative and creative research, with a special emphasis on research that complements, rather than duplicates, the research funded by the federal government and other entities.

(4) All research funds shall be awarded on the basis of the priorities established for the program, statutorily or by the council, and the scientific merit and clinical applicability of the proposed research, as determined by an open, competitive peer review process that ensures objectivity, consistency, and high quality. All investigators, regardless of affiliation, shall have equal access and opportunity to compete for program funds.

(5) The peer review process for the selection of research grants awarded under this program shall be generally modeled on that used by the National Institute of Health in its grantmaking process, including the appeals process, but shall reflect in composition the creativity and diversity called for in this article and in the research priorities established in this article and by the council.

(6) A grantee shall be awarded grants for both direct and indirect costs of conducting the sponsored research consistent with those federal guidelines governing all federal research grants and contracts. All intellectual property assets developed under this program shall be treated in accordance with state and federal law.

(7) In establishing research priorities, the council shall consider a broad range of cross-disciplinary cancer research, as defined in paragraph (1) of subdivision (c) of Section 104181, including, but not limited to, research into the cause and prevention, cure, diagnosis, and treatment of cancer, emphasizing gender-specific cancers, based on magnitude of incidence and mortality, that have not previously received state funding.

article: 2. The Cancer Research Act of 1997