Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law requires a pathologist diagnosing cancer to report cancer diagnoses to the department. Existing law requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal provided by the department. If a pathologist fails to report electronically and with an approved format, existing law authorizes the departments authorized representative to access the information from the pathologist in an appropriate alternative format. Existing law does not require the same pathology report to be submitted more than once, or by any other means if submitted to the department electronically.

This bill would authorize the department to require that the same pathology report be submitted more than once if deemed necessary by the department or its authorized representative and would require the department to notify a pathologist of any deficiencies should the department deem a pathologist noncompliant with this provision. The bill would also require the department to provide the pathologist an opportunity to cure the deficiencies. This bill would prohibit the department from imposing a fine or other penalty solely based on a pathologists failure to comply with this provision.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected if the original disclosure is for research that requires researchers to participate in data sharing with specified entities, provided the disclosed data does not include individually identifiable data that could be reasonably used to identify or reidentify the data with an individual person. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the confidential information.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law requires a pathologist diagnosing cancer to report cancer diagnoses to the department. Existing law requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal provided by the department. If a pathologist fails to report electronically and with an approved format, existing law authorizes the departments authorized representative to access the information from the pathologist in an appropriate alternative format. Existing law does not require the same pathology report to be submitted more than once, or by any other means if submitted to the department electronically.

This bill would authorize the department to require that the same pathology report be submitted more than once if deemed necessary by the department or its authorized representative and would require the department to notify a pathologist of any deficiencies should the department deem a pathologist noncompliant with this provision. The bill would also require the department to provide the pathologist an opportunity to cure the deficiencies. This bill would prohibit the department from imposing a fine or other penalty solely based on a pathologists failure to comply with this provision.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected if the original disclosure is for research that requires researchers to participate in data sharing with specified entities, provided the disclosed data does not include individually identifiable data that could be reasonably used to identify or reidentify the data with an individual person. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the confidential information.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law requires a pathologist diagnosing cancer to report cancer diagnoses to the department. Existing law requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal provided by the department. If a pathologist fails to report electronically and with an approved format, existing law authorizes the departments authorized representative to access the information from the pathologist in an appropriate alternative format. Existing law does not require the same pathology report to be submitted more than once, or by any other means if submitted to the department electronically.

This bill would authorize the department to requires that the same pathology report be submitted more than once if deemed necessary by the department or its authorized representative and would require the department to notify a pathologist of any deficiencies should the department deem a pathologist noncompliant with this provision. The bill would also require the department to provide the pathologist an opportunity to cure the deficiencies. This bill would prohibit the department from imposing a fine or other penalty solely based on a pathologists failure to comply with this provision.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected if the original disclosure is for research that requires researchers to participate in data sharing with specified entities, provided the disclosed data does not include individually identifiable data that could be reasonably used to identify or reidentify the data with an individual person. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the confidential information.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law requires a pathologist diagnosing cancer to report cancer diagnoses to the department. Existing law requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal provided by the department. If a pathologist fails to report electronically and with an approved format, existing law authorizes the departments authorized representative to access the information from the pathologist in an appropriate alternative format. Existing law does not require the same pathology report to be submitted more than once, or by any other means if submitted to the department electronically.

This bill would require pathology labs diagnosing or treating reportable cases of cancer to also report those diagnoses to the department. The bill would also instead authorize the department to requires that the same pathology report to be submitted more than once if deemed necessary by the department or its authorized representative and would require the department to notify a pathologist of any deficiencies should the department deem a pathologist noncompliant with this provision. The bill would also require the department to provide the pathologist an opportunity to cure the deficiencies. This bill would prohibit the department from imposing a fine or other penalty solely based on a pathologists failure to comply with this provision.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected if the original disclosure is for research that requires researchers to participate in data sharing with specified entities, provided the disclosed data does not include individually identifiable data that could be reasonably used to identify or reidentify the data with an individual person. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the confidential information.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law authorizes the department to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries to provide cancer incidence data.

This bill would require, rather than authorize, that the department designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries. The bill would require the director to maintain a statewide registry infrastructure that maximizes and strengthens Californias existing regional registry infrastructure funding through the National Cancer Institutes Surveillance, Epidemiology, and End Results (SEER) Program.

Existing law requires a pathologist diagnosing cancer to report cancer diagnoses to the department. Existing law requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal provided by the department. If a pathologist fails to report electronically and with an approved format, existing law authorizes the departments authorized representative to access the information from the pathologist in an appropriate alternative format. Existing law does not require the same pathology report to be submitted more than once, or by any other means if submitted to the department electronically.

This bill would require pathology labs diagnosing or treating reportable cases of cancer to also report those diagnoses to the department. The bill would also instead authorize the same pathology report to be submitted more than once if deemed necessary by the department or its authorized representative. representative and require the department to notify a pathologist of any deficiencies should the department deem a pathologist noncompliant with this provision. The bill would also require the department to provide the pathologist an opportunity to cure the deficiencies. This bill would prohibit the department from imposing a fine or other penalty solely based on a pathologists failure to comply with this provision.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected for specified purposes, including research. if the original disclosure is for research that requires researchers to participate in data sharing with specified entities, provided the disclosed data does not include individually identifiable data that could be reasonably used to identify or reidentify the data with an individual person. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the confidential information.

Existing law provides that it is the intent of the Legislature that the department, in establishing a cancer registry system, maximize the use of available federal funds.

This bill would instead require the department to partner with the established regional registries to maximize the use of available federal funds.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law authorizes the department to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries to provide cancer incidence data.

This bill would require, rather than authorize, that the department designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries. The bill would require the director to maintain a statewide registry infrastructure that maximizes and strengthens Californias existing regional registry infrastructure funding through the National Cancer Institutes Surveillance, Epidemiology, and End Results (SEER) Program.

Existing law requires a pathologist diagnosing cancer to report cancer diagnoses to the department. Existing law requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal provided by the department. If a pathologist fails to report electronically and with an approved format, existing law authorizes the departments authorized representative to access the information from the pathologist in an appropriate alternative format. Existing law does not require the same pathology report to be submitted more than once, or by any other means if submitted to the department electronically.

This bill would require pathology labs diagnosing or treating reportable cases of cancer to also report those diagnoses to the department. The bill would also instead authorize the same pathology report to be submitted more than once if deemed necessary by the department or its authorized representative.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected for specified purposes, including research. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the information.

Existing law provides that it is the intent of the Legislature that the department, in establishing a cancer registry system, maximize the use of available federal funds.

This bill would instead require the department to partner with the established regional registries to maximize the use of available federal funds.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law authorizes the department to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries to provide cancer incidence data.

This bill would require, rather than authorize, that the department designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries. The bill would require the director to maintain a statewide registry infrastructure that maximizes and strengthens Californias existing regional registry infrastructure funding through the National Cancer Institutes Surveillance, Epidemiology, and End Results (SEER) Program.

Existing law requires a pathologist diagnosing cancer to report cancer diagnoses to the department. Existing law requires the reporting to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet web portal provided by the department. If a pathologist fails to report electronically and with an approved format, existing law authorizes the departments authorized representative to access the information from the pathologist in an appropriate alternative format. Existing law does not require the same pathology report to be submitted more than once, or by any other means if submitted to the department electronically.

This bill would require pathology labs diagnosing or treating reportable cases of cancer to also report those diagnoses to the department. The bill would also instead authorize the same pathology report to be submitted more than once if deemed necessary by the department or its authorized representative.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected for specified purposes, including research. The bill would also authorize the sharing of information with federal or federally designated data repositories, and other bona fide researchers, if the data does not include any identifiable information. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the information.

Existing law requires the department to maintain an accurate record, containing specified information, of all persons given access to the confidential information.

This bill would clarify that this recordkeeping responsibility does not extend to federal or federally designated data repositories and other bona fide researchers that were provided the data.

Existing law provides that it is the intent of the Legislature that the department, in establishing a cancer registry system, maximize the use of available federal funds.

This bill would instead require the department to partner with the established regional registries to maximize the use of available federal funds.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law authorizes the department to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries to provide cancer incidence data.

This bill would require, rather than authorize, that the department designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries. The bill would require the director to maintain a statewide registry infrastructure that maximizes and strengthens Californias existing regional registry infrastructure funding through the National Cancer Institutes Surveillance, Epidemiology, and End Results (SEER) Program.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited. Existing law authorizes the department to enter into agreements to furnish confidential information to other entities, as specified. Before disclosing the information, existing law requires the requesting entities agree in writing to maintain the confidentiality of the information, and in the case of researchers, to follow additional specified conditions.

This bill would authorize the sharing of information collected for specified purposes, including research. The bill would also authorize the sharing of information with federal or federally designated data repositories, and other bona fide researchers, if the data does not include any identifiable information. The bill would also clarify only researchers with a valid scientific interest in the information are required to meet the additional conditions prior to the disclosure of the information.

Existing law provides that it is the intent of the Legislature that the department, in establishing a cancer registry system, maximize the use of available federal funds.

This bill would instead require the department to maximize the use of available federal funds and would provide examples of federal funding for cancer registries. partner with the established regional registries to maximize the use of available federal funds.

Existing law requires the State Department of Public Health to establish a statewide system for the collection of information determining the incidence of cancer, known as the Ken Maddy California Cancer Registry. Existing law authorizes the department to designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries to provide cancer incidence data.

This bill would require, rather than authorize, that the department designate any demographic parts of the state as regional cancer incidence reporting areas and establish regional cancer registries. The bill would require the director to maintain a statewide registry infrastructure that maximizes and strengthens Californias existing regional registry infrastructure funding through the National Cancer Institutes Surveillance, Epidemiology, and End Results (SEER) Program.

Under existing law, the information collected under the registry is confidential, except as otherwise provided, and any disclosure of information is to include only information necessary for the stated purpose of the disclosure. Under existing law, any further disclosure other than the approved purpose is prohibited.

This bill would authorize the sharing of information collected for specified purposes, including research.

Existing law provides that it is the intent of the Legislature that the department, in establishing a cancer registry system, maximize the use of available federal funds.

This bill would instead require the department to maximize the use of available federal funds and would provide examples of federal funding for cancer registries.

 UNFINISHED BUSINESS  

Bill No: SB 344

Author: Rubio (D)

Amended: 9/7/23

Vote: 21

SENATE HEALTH COMMITTEE: 12-0, 3/29/23

AYES: Eggman, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

SENATE JUDICIARY COMMITTEE: 11-0, 4/18/23

AYES: Umberg, Wilk, Allen, Ashby, Caballero, Durazo, Laird, McGuire, Min, Niello, Wiener

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/18/23

AYES: Portantino, Jones, Ashby, Bradford, Seyarto, Wahab, Wiener

SENATE FLOOR: 40-0, 5/25/23

AYES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASSEMBLY FLOOR: 79-0, 9/12/23 - See last page for vote

SUBJECT: Ken Maddy California Cancer Registry

SOURCE: American Cancer Society Cancer Action Network

City of Hope

Public Health Institute

University of Southern California

DIGEST:

This bill revises provisions of law related to the Ken Maddy California Cancer Registry to make various changes, including to permit individuals who are authorized to access the confidential data in cancer registries to participate in data sharing with other authorized individuals.

Assembly Amendments delete several provisions from the bill, including a requirement that the California Department of Public Health maintain a statewide registry infrastructure that strengthens the existing regional registry infrastructure, and restore a provision of existing law to ensure the record of access to confidential information is open to public inspection.

ANALYSIS:

Existing law:

1. Requires the California Department of Public Health (CDPH) to establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries (known as the Ken Maddy California Cancer Registry, or CCR). Permits CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries. Requires designated regional registries to provide CDPH, on a timely basis, cancer incidence data. [HSC §103885]
2. Requires CDPH to 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. Requires all cancers diagnosed or treated in the reporting area to be reported to the representative of CDPH authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative. [HSC §103885(c)]
3. Requires any hospital or other facility providing therapy to cancer patients, and any physician, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients, to report each case of cancer to CDPH or the authorized representative of CDPH. [HSC §103885(d)]
4. Requires all information collected pursuant to the CCR to be confidential, and requires CDPH to use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect. [HSC §103885(g)(1),(2)]
5. Permits 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 CDPH, and who agree, in writing, to maintain confidentiality, to be authorized access to confidential information. [HSC §103885(g)(3)]
6. Permits CDPH and any regional cancer registry designated by CDPH to 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. Requires the requesting entity to agree in writing to maintain the confidentiality of the information before confidential information is disclosed, and in the case of researchers, to do both of the following:
   1. Obtain approval of their committee for the protection of human subjects, as specified; and,
   2. Provide documentation to CDPH that demonstrates to CDPH’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information. [HSC §103885(g)(4)
7. Requires CDPH to maintain an accurate record of all persons who are given access to confidential information. [HSC §103885(g)(7)]

This bill:

1. Requires, in addition to the existing requirement that a pathologist report cancer diagnoses by electronic means, a pathology laboratory diagnosing cancer report cancer diagnoses by electronic means.
2. Requires CDPH, for purposes of the requirement in 1) above, to notify a pathologist of any deficiencies it identifies and provide an opportunity to cure those deficiencies, and prohibits CDPH from imposing fines or other penalties solely based on a pathologist’s failure to comply with the reporting requirement.
3. Establishes an exemption from a provision of law prohibiting any further disclosure of information collected by a regional cancer registry after an initial authorized disclosure, by allowing future disclosure if 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.
4. Makes minor, technical changes to the body of law governing cancer reporting registries.

Comments

1. Author’s statement. According to the author, California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The CCR is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to CDPH for an average of one-and-a-half to two years. This bill will improve the effectiveness of the CCR by shortening delays and streamlining ePath reporting, resulting in improved cancer research and more advancements in cancer treatment and care.
2. CCR. In 1985, the California Legislature passed a law making cancer a reportable disease, although regional cancer registries existed before it was made a mandatory reportable disease. Today there are three regional registries: the Greater Bay Area Cancer Registry, the Los Angeles County Cancer Surveillance Program operated by the University of Southern California, and the Cancer Registry of Greater California (which covers all other counties). The CCR is California’s statewide cancer surveillance system, which collects all the data from the regional registries into a statewide database. The CCR and regional registries use the data to write summary reports that inform the public, local health workers, educators, and legislators about the status of cancer. Researchers may examine these data to identify areas that have high cancer rates and areas where people might benefit from cancer screening and education programs, or to look at trends in cancer diagnosis. Other uses include, but are not limited to, measuring the success of cancer screening programs; examining disparities in cancer risk, treatment and survival; examining treatment choices and other predictors of survival; responding to public concerns and questions about cancer; and, conducting research to find the causes and cures of cancer. The CCR and regional registries are permitted to release patient contact information to qualified researchers, who may contact patients to find out if they want to participate in a research study. However, information is only released to qualified researchers under tightly controlled circumstances where the research has first been approved by the Committee for the Protection of Human Subjects.
3. SEER program and the National Program of Cancer Registries. The SEER Program of the National Cancer Institute (NCI) is the authoritative source of information on cancer incidence and survival for the nation as a whole. SEER currently collects and publishes cancer incidence and survival data from population-based registries covering approximately 48% of the U.S. population. NCI staff work with the North American Association of Central Cancer Registries to guide all state registries to achieve data content and compatibility acceptable for pooling data and improving national estimates. The SEER team is developing computer applications to unify cancer registration systems and to analyze and disseminate population-based data. Use of surveillance data for research is being improved through web-based access to the data and analytic tools, and linking with other national data sources.

The National Program of Cancer Registries (NPCR) is a program established by the Centers for Disease Control and Prevention to provide funding and technical assistance to statewide, population-based cancer registries. NPCR supports states and territories to improve existing cancer registries; plan and implement registries where none existed; develop model legislation and regulations for states to enhance the viability of registry operations; set standards for data completeness, timeliness, and quality; provide training for registry personnel; and, help establish a computerized reporting and data processing system. In 2006, NPCR launched the Electronic Pathology (ePath) Implementation Project to test a model for automated electronic capture and reporting of cancer registry data to central cancer registries. Following initial pilot programs, ePath has expanded to all 50 states and includes many more national and regional laboratories. In California, AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required pathologists to use ePath to report cancer diagnoses beginning on January 1, 2019.

Related/Prior Legislation

AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required, beginning January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to CDPH utilizing electronic means in a standardized format approved by CDPH.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Assembly Appropriations Committee, CDPH estimates annual General Fund costs of approximately $221,000 for one staff position to support management of new compliance requirements for pathologists, including defining and implementing new compliance standards within reporting requirements and identifying and correcting deficiencies.

SUPPORT: (Verified 9/7/23)

American Cancer Society Cancer Action Network (co-source)

City of Hope (co-source)

Public Health Institute (co-source)

University of Southern California (co-source)

California Medical Association

California Professional Firefighters

Susan G. Komen

OPPOSITION: (Verified 9/7/23)

California Department of Finance

ARGUMENTS IN SUPPORT: This bill is co-sponsored by the American Cancer Society Cancer Action Network, City of Hope, Public Health Institute, and the University of Southern California. The sponsors state that AB 2325 from 2016 was enacted to ensure real time reporting through ePath. If fully and completely implemented, the real time benefit of electronic reporting will have significant benefits for clinical trials, but failure to fully implement ePath means a two-year delay in reporting of a cancer case, which eliminates the value of the data for clinical trial enrollment. Further, provisions in current law limit the CCR, including the regional registries, to allow data re-disclosure by approved cancer researchers to comply with National Institutes of Health data sharing requirements with federal data repositories and controlled data sharing with other legitimate research endeavors. This bill will help address this problem by updating procedures that ensure that approved researchers have access to timely data while ensuring necessary data protections and privacy are strengthened and maintained

ARGUMENTS IN OPPOSITION: The California Department of Finance opposes this bill because the additional workload associated with this bill creates new General Fund costs for CDPH that are not included in the Administration’s spending plan.

ASSEMBLY FLOOR: 79-0, 9/12/23

AYES: Addis, Aguiar-Curry, Alanis, Alvarez, Arambula, Bains, Bauer-Kahan, Bennett, Berman, Boerner, Bonta, Bryan, Calderon, Juan Carrillo, Wendy Carrillo, Cervantes, Chen, Connolly, Megan Dahle, Davies, Dixon, Essayli, Flora, Mike Fong, Vince Fong, Friedman, Gabriel, Gallagher, Garcia, Gipson, Grayson, Haney, Hart, Holden, Hoover, Irwin, Jackson, Kalra, Lackey, Lee, Low, Lowenthal, Maienschein, Mathis, McCarty, McKinnor, Muratsuchi, Stephanie Nguyen, Ortega, Pacheco, Papan, Jim Patterson, Joe Patterson, Pellerin, Petrie-Norris, Quirk-Silva, Ramos, Rendon, Reyes, Luz Rivas, Rodriguez, Blanca Rubio, Sanchez, Santiago, Schiavo, Soria, Ta, Ting, Valencia, Villapudua, Waldron, Wallis, Ward, Weber, Wicks, Wilson, Wood, Zbur, Robert Rivas

NO VOTE RECORDED: Jones-Sawyer

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

9/12/23 19:39:39

**** END ****

SENATE THIRD READING

STR Bill Id:SB 344

Author:(Rubio)

As Amended Ver:September 7, 2023

Majority vote

SUMMARY

Makes changes to the Ken Maddy California Cancer Registry (CCR) and requires a pathology laboratory diagnosing a reportable case of cancer to report cancer diagnoses to the Department of Public Health (DPH) by electronic means. Permits broader disclosure of cancer registry information that does not contain individually identifiable data, as specified (including if the original disclosure with researchers under the direction and control of the originally approved data recipient who remains the researcher responsible for data security and integrity).

Major Provisions

COMMENTS

CCR is a DPH program of the DPH and is a statewide, cancer surveillance system. Enacted into law in 1985 and modelled after a regional registry, CCR was established to monitor the burden of cancer in California. CCR's mission is to serve the public by collecting timely, standardized, statewide data across the cancer continuum to target action toward high impact data use. CCR is recognized for its high-quality data and routinely meets the standards of the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) Program, National Center for Disease Control and Prevention's (CDC's) National Program of Cancer Registries, and the North American Association of Central Cancer Registries. Since 2012, CCR has partnered with the California Cancer Reporting and Epidemiologic Surveillance Program at UC Davis Health to manage the day-to-day operations of CCR.

CCR is an integrated surveillance program that gathers data from physicians, pathologists, hospitals, and treatment facilities. CCR also works directly with regional registries (Los Angeles County Cancer Surveillance Program, California Registry of Greater California, and Bay Area Cancer Registry) whose data is reported directly to the CCR. The regional registries have been in existence since before the CCR and originally gathered data to conduct essential research of cancer occurrence and survival on a local level. With the CCR, the regional registries also report their data to make statewide research possible.

Funding of CCR. CCR is funded by both state and federal dollars. State funding comes from the General Fund, Proposition 99 Fund, and the Breast Cancer Research Fund, and federal funding comes from the CDC. According to DPH, for fiscal year 2022-2023, the total funding for the CCR is $10.670 million. $8.170 million is state funding and $2.5 million is federal funding (CDC's NPCR). It should also be noted that all of the regional registries and the CCR receive NCI SEER funding. They work together to draw down a significant portion of funding, without with none of their work would be possible.

According to the Author

California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The CCR is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to DPH for an average of one-and-a-half to two years. The author concludes this bill will improve the effectiveness of the CCR by shortening delays and streamlining ePath [discussed below] reporting, resulting in improved cancer research and more advancements in cancer treatment and care.

Arguments in Support

The Public Health Institute, American Cancer Society Cancer Action Network, City of Hope, and the University of Southern California are the cosponsors of this bill. They state this bill would improve the effectiveness of the CCR by easing implementation of electronic pathology reporting (ePath) and data sharing with qualified researchers. An integral part of the CCR are California's three designated regional cancer registries which provide critical support on local instances of disease. They are the first line in collecting the data that is used for research and clinical trials. Data collected by the regional registries make it possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to the CCR for an average of one-and-a-half to two years. In 2016, the Legislature passed, and Governor Brown signed AB 2325 to update the cancer registry to ensure real time reporting through ePath. This important update brought the CCR and cancer reporting in California into the modern era, with a goal to ensure the CCR will receive data in real time, allowing researchers to utilize more current data, as opposed to relying on older, outdated information. Additionally, the real-time benefit of reporting through ePath—if fully and completely implemented—will have significant benefits for clinical trials. Failure to fully implement ePath means a two-year delay in reporting of a cancer case, which eliminates that value of the data for clinical trial enrolment. Currently, only 3% of adults diagnosed with cancer participate in clinical trials, those numbers are much lower for those of racial and ethnic minorities. Unfortunately, researchers have found that the statutory provisions established in law through AB 2325 eight years ago have not kept up with the most effective standards and approaches for data collection and continue to require a manual process, delaying our ability to move forward with real time reporting that make clinical trials more accessible. Furthermore, provisions in current law limit the CCR, including the regional registries, to allow data re-disclosure by approved cancer researchers to comply with National Institutes of Health data sharing requirement with federal data repositories and controlled data sharing with other legitimate research endeavors. Outdated approaches to data collection and data sharing thwart vital research into cancer treatment and cures, preventing progress that would save lives. The supporters conclude this bill would help address this problem by updating procedures that ensure that approved researchers have access to timely data while ensuring necessary data protections and privacy are strengthened and maintained.

Arguments in Opposition

The Department of Finance in opposition writes that the additional workload associated with this bill creates new General Fund costs for DPH that are not included in the Administration's spending plan. In addition, this bill's provision to maximize and strengthen existing regional registries may result in additional unknown but potentially significant General Fund cost pressures in the future and could constrain DPH's ability to leverage Federal Funds to support the state registry.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, DPH estimates annual General Fund costs of approximately $221,000 for one staff position to support management of new compliance requirements for pathologists, including defining and implementing new compliance standards within reporting requirements and identifying and correcting deficiencies.

VOTES

SENATE FLOOR: 40-0-0

YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASM HEALTH: 15-0-0

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner, Wendy Carrillo, Flora, Vince Fong, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ASM APPROPRIATIONS: 11-0-5

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Wilson

ABS, ABST OR NV: Megan Dahle, Dixon, Mathis, Sanchez, Soria

UPDATED

VERSION: September 7, 2023

CONSULTANT: Rosielyn Pulmano / HEALTH / (916) 319-2097 FN: 0002056

SENATE THIRD READING

STR Bill Id:SB 344

Author:(Rubio)

As Amended Ver:September 5, 2023

Majority vote

SUMMARY

Makes changes to the Ken Maddy California Cancer Registry (CCR) and requires a pathology laboratory diagnosing a reportable case of cancer to report cancer diagnoses to the Department of Public Health (DPH) by electronic means. Permits broader disclosure of cancer registry information that does not contain individually identifiable data.

Major Provisions

COMMENTS

CCR is a DPH program of the DPH and is a statewide, cancer surveillance system. Enacted into law in 1985 and modelled after a regional registry, CCR was established to monitor the burden of cancer in California. CCR's mission is to serve the public by collecting timely, standardized, statewide data across the cancer continuum to target action toward high impact data use. CCR is recognized for its high-quality data and routinely meets the standards of the National Cancer Institute's (NCI) Surveillance, Epidemiology, and End Results (SEER) Program, National Center for Disease Control and Prevention's (CDC's) National Program of Cancer Registries, and the North American Association of Central Cancer Registries. Since 2012, CCR has partnered with the California Cancer Reporting and Epidemiologic Surveillance Program at UC Davis Health to manage the day-to-day operations of CCR.

CCR is an integrated surveillance program that gathers data from physicians, pathologists, hospitals, and treatment facilities. CCR also works directly with regional registries (Los Angeles County Cancer Surveillance Program, California Registry of Greater California, and Bay Area Cancer Registry) whose data is reported directly to the CCR. The regional registries have been in existence since before the CCR and originally gathered data to conduct essential research of cancer occurrence and survival on a local level. With the CCR, the regional registries also report their data to make statewide research possible. 

Funding of CCR. CCR is funded by both state and federal dollars. State funding comes from the General Fund, Proposition 99 Fund, and the Breast Cancer Research Fund, and federal funding comes from the CDC. According to DPH, for fiscal year 2022-2023, the total funding for the CCR is $10.670 million. $8.170 million is state funding and $2.5 million is federal funding (CDC's NPCR). It should also be noted that all of the regional registries and the CCR receive NCI SEER funding. They work together to draw down a significant portion of funding, without with none of their work would be possible.

According to the Author

California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The CCR is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to DPH for an average of one-and-a-half to two years. The author concludes this bill will improve the effectiveness of the CCR by shortening delays and streamlining ePath [discussed below] reporting, resulting in improved cancer research and more advancements in cancer treatment and care.

Arguments in Support

The Public Health Institute, American Cancer Society Cancer Action Network, City of Hope, and the University of Southern California are the cosponsors of this bill. They state, this bill would improve the effectiveness of the CCR by easing implementation of electronic pathology reporting (ePath) and data sharing with qualified researchers. An integral part of the CCR are California's three designated regional cancer registries which provide critical support on local instances of disease. They are the first line in collecting the data that is used for research and clinical trials. Data collected by the regional registries make it possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to the CCR for an average of one-and-a-half to two years. In 2016, the Legislature passed, and Governor Brown signed AB 2325 to update the cancer registry to ensure real time reporting through ePath. This important update brought the CCR and cancer reporting in California into the modern era, with a goal to ensure the CCR will receive data in real time, allowing researchers to utilize more current data, as opposed to relying on older, outdated information. Additionally, the real-time benefit of reporting through ePath – if fully and completely implemented – will have significant benefits for clinical trials. Failure to fully implement ePath means a two-year delay in reporting of a cancer case, which eliminates that value of the data for clinical trial enrolment. Currently, only 3% of adults diagnosed with cancer participate in clinical trials, those numbers are much lower for those of racial and ethnic minorities. Unfortunately, researchers have found that the statutory provisions established in law through AB 2325 eight years ago have not kept up with the most effective standards and approaches for data collection and continue to require a manual process, delaying our ability to move forward with real time reporting that make clinical trials more accessible. Furthermore, provisions in current law limit the CCR, including the regional registries, to allow data re-disclosure by approved cancer researchers to comply with National Institutes of Health data sharing requirement with federal data repositories and controlled data sharing with other legitimate research endeavors. Outdated approaches to data collection and data sharing thwart vital research into cancer treatment and cures, preventing progress that would save lives. The supporters conclude this bill would help address this problem by updating procedures that ensure that approved researchers have access to timely data while ensuring necessary data protections and privacy are strengthened and maintained.

Arguments in Opposition

The Department of Finance in opposition writes that the additional workload associated with this bill creates new General Fund costs for DPH that are not included in the Administration's spending plan. In addition, this bill’s provision to maximize and strengthen existing regional registries may result in additional unknown but potentially significant General Fund cost pressures in the future and could constrain DPH’s ability to leverage Federal Funds to support the state registry.

FISCAL COMMENTS

According to the Assembly Appropriations Committee, DPH estimates annual General Fund costs of approximately $221,000 for one staff position to support management of new compliance requirements for pathologists, including defining and implementing new compliance standards within reporting requirements and identifying and correcting deficiencies.

VOTES

SENATE FLOOR: 40-0-0

YES: Allen, Alvarado-Gil, Archuleta, Ashby, Atkins, Becker, Blakespear, Bradford, Caballero, Cortese, Dahle, Dodd, Durazo, Eggman, Glazer, Gonzalez, Grove, Hurtado, Jones, Laird, Limón, McGuire, Menjivar, Min, Newman, Nguyen, Niello, Ochoa Bogh, Padilla, Portantino, Roth, Rubio, Seyarto, Skinner, Smallwood-Cuevas, Stern, Umberg, Wahab, Wiener, Wilk

ASM HEALTH: 15-0-0

YES: Wood, Waldron, Aguiar-Curry, Arambula, Boerner, Wendy Carrillo, Flora, Vince Fong, Maienschein, McCarty, Joe Patterson, Rodriguez, Santiago, Villapudua, Weber

ASM APPROPRIATIONS: 11-0-5

YES: Holden, Bryan, Calderon, Wendy Carrillo, Mike Fong, Hart, Lowenthal, Papan, Pellerin, Weber, Wilson

ABS, ABST OR NV: Megan Dahle, Dixon, Mathis, Sanchez, Soria

UPDATED

VERSION: September 5, 2023

CONSULTANT: Kristene Mapile / HEALTH / (916) 319-2097 FN: 0001601

Date of Hearing: August 16, 2023

ASSEMBLY COMMITTEE ON APPROPRIATIONS

Chris Holden, Chair

SBPCA Bill Id:SB 344

Author:(Rubio) – As Amended Ver:June 14, 2023

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

SUMMARY:

This bill revises provisions of law related to the California Cancer Registry (CCR).

Specifically, this bill:

1. Requires the California Department of Public Health (CDPH) to maintain a statewide registry infrastructure that maximizes and strengthens California’s existing regional registry infrastructure funded through the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) Program.
2. Requires, rather than permits, CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries.
   
3. Requires a pathology laboratory diagnosing or treating cancer to report cancer diagnoses to CDPH.
   
4. Requires a pathologist to submit a pathology report more than once if CDPH deems it necessary. Requires CDPH to take specified action if a pathologist does not comply with reporting requirements.
   
5. Establishes, for research under certain conditions, an exemption from a prohibition on disclosure of information collected by the registries, as specified.
6. Requires CDPH to partner with the established regional registries to maximize the use of available federal funds.

FISCAL EFFECT:

CDPH estimates annual General Fund costs of approximately $221,000 for one staff position to support management of new compliance requirements for pathologists, including defining and implementing new compliance standards within reporting requirements and identifying and correcting deficiencies.

COMMENTS:

1. Purpose. The Public Health Institute, American Cancer Society Cancer Action Network, City of Hope, and the University of Southern California are cosponsors of this bill. According to the author:

California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The [CCR] is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to DPH for an average of one-and-a-half to two years. SB 344 will improve the effectiveness of the CCR by shortening delays and streamlining ePath reporting, resulting in improved cancer research and more advancements in cancer treatment and care.

Sponsors state this bill would improve the effectiveness of the CCR by easing implementation of electronic pathology reporting (ePath) and data sharing with qualified researchers.

1. Background. The CCR is an integrated, statewide cancer surveillance system established in 1985 and modelled after a regional registry to monitor the burden of cancer in California. Since 2012, the CCR has partnered with the California Cancer Reporting and Epidemiologic Surveillance Program at UC Davis Health to manage its day-to-day operations. The CCR gathers data from physicians, pathologists, hospitals, and treatment facilities. Regional registries – Los Angeles County Cancer Surveillance Program, California Registry of Greater California, and Bay Area Cancer Registry – report data directly to the CCR. The regional registries, which existed before the CCR, originally gathered data to conduct essential research of cancer occurrence and survival at a local level. According to CDPH, the CCR reporting regions align with NCI/SEER contracts.

Analysis Prepared by: Allegra Kim / APPR. / (916) 319-2081

Date of Hearing: June 27, 2023

ASSEMBLY COMMITTEE ON HEALTH

Jim Wood, Chair

SBPCA Bill Id:SB 344

Author:(Rubio) – As Amended Ver:June 14, 2023

SENATE VOTE: 40-0

SUBJECT: Ken Maddy California Cancer Registry.

SUMMARY: Makes changes to the Ken Maddy California Cancer Registry (CCR) and requires, rather than permits, the Department of Public Health (DPH) to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries, as specified. Requires a pathology laboratory diagnosing or treating a reportable case of cancer to report cancer diagnoses to DPH by electronic means. Permits broader disclosure of cancer registry information that does not contain individually identifiable data. Specifically, this bill:

1. Requires the director of DPH to maintain a statewide registry infrastructure that maximizes and strengthens California’s existing regional registry infrastructure funded through the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) Program.
2. Requires, rather than permits, DPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries, as specified.
3. Requires a pathology laboratory diagnosing or treating a reportable case of cancer to report cancer diagnoses to DPH by electronic means.
4. Permits the submission of a pathology report more than once if DPH or its authorized representative deems this necessary. Requires, if DPH deems a pathologist noncompliant with reporting requirements, DPH to notify the pathologist of deficiencies and provide an opportunity to cure those deficiencies. Prohibits DPH from imposing fines or other penalties solely based on the pathologist’s failure to comply with reporting requirements.
5. Permits broader disclosure of cancer registry information if the original disclosure is for research that requires researchers to participate in data sharing with federal or federally designated data depositories and with other researchers 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. Requires DPH to partner with the established regional registries in establishing the CCR.
7. Makes other technical conforming changes.

EXISTING LAW:

1. Establishes the CCR which requires DPH to conduct a program of epidemiological assessments of the incidence of cancer. Requires the program to encompass all areas of the state for which cancer incidence data are available, and to include the monitoring of cancers associated with suspected carcinogens encountered by the general public both in occupational locations and in the environment generally. [Health and Safety Code (HSC) §103875]
   
2. Requires the program to be under the direction of the DPH Director, who may enter into contracts as necessary for the conduct of the program and may accept, on behalf of the state, grants of public or private funds for the program. Requires the director to analyze available incidence data and prepare reports and perform studies as necessary to identify cancer hazards to the public health and their remedies. [Id.]
   
3. Requires the Director of DPH to establish a system for the collection of information determining the incidence of canceer, using population-based canceer registries modeled after the Cancer Surveillance Program of Orange County. [HSC §103885]
4. Permits DPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish cancer registries, as specified. Requires designated regional registries to provide DPH, on a timely basis, cancer incidence data, as designated by DPH. [Id.]
5. Requires the following to report cancer cases to the CCR:
   1. Any hospital or other facility providing therapy to cancer patients within an area designated as a cancer reporting area;
   2. Any physician and surgeon, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients, except for those cases directly referred to a treatment facility or those previously admitted to a treatment facility for diagnoses or treatment of the cancer; and,
   3. On or after January 1, 2019, a pathologist diagnosing a cancer, as specified. Requires the reporting by a pathologist to be by electronic means, including, but not limited to, either directly from an electronic medical record or using a designated internet we portal. [Id.]
6. Requires all information collected under the CCR to be confidential. Requires DPH and any regional cancer registry designated by DPH to use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect. [Id.]
7. Authorizes 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 DPH, and who agree, in writing, to maintain confidentiality to access confidential information.
8. Permits DPH and any regional cancer registry designated by DPH to 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. Requires, before confidential information is disclosed to those agencies, officers, researchers, or out-of-state registries, the requesting entity to agree in writing to maintain the confidentiality of the information, and in the case of researchers, and to do both of the following:
   
   1. Obtain approval of their committee for the protection of human subjects, as specified; and,
      
   2. Provide documentation to DPH that demonstrates to DPH’s satisfaction that the entity has established the procedures and the ability to maintain the confidentiality of the information. [Id.]
      
9. Requires any disclosure to include only information necessary for the stated purpose of the requested disclosure, used for the approved purpose, and to not be further disclosed. [Id.]
   
10. Requires DPH to maintain an accurate record of all persons who are given access to confidential information, as specified. [Id.]
    
11. Specifies the intent of the Legislature, in establishing a cancer registy to maximize the use of available federal funds. [Id.]
    

FISCAL EFFECT: According to the Senate Appropriations Committee, DPH estimates ongoing annual costs of approximately $3.47 million (General Fund) to be allocated through contracts to provide sufficient funding to the California regional registries to meet the cost-share requirements of NCI’s SEER Program.

COMMENTS:

1. PURPOSE OF THIS BILL. According to the author, California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The CCR is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to DPH for an average of one-and-a-half to two years. The author concludes this bill will improve the effectiveness of the CCR by shortening delays and streamlining ePath [discussed below] reporting, resulting in improved cancer research and more advancements in cancer treatment and care.
2. BACKGROUND. CCR is a DPH program of the DPH and is a statewide, cancer surveillance system. Enacted into law in 1985 and modelled after a regional registry, CCR was established to monitor the burden of cancer in California. CCR’s mission is to serve the public by collecting timely, standardized, statewide data across the cancer continuum to target action toward high impact data use. CCR is recognized for its high-quality data and routinely meets the standards of the SEER program, CDC’s National Program of Cancer Registries (NPCR), and the North American Association of Central Cancer Registries. Since 2012, CCR has partnered with the California Cancer Reporting and Epidemiologic Surveillance Program at UC Davis Health to manage the day-to-day operations of CCR.
   
   CCR is an integrated surveillance program that gathers data from physicians, pathologists, hospitals, and treatment facilities. CCR also works directly with regional registries (Los Angeles County Cancer Surveillance Program, California Registry of Greater California, and Bay Area Cancer Registry) whose data is reported directly to the CCR. The regional registries have been in existence since before the CCR and originally gathered data to conduct essential research of cancer occurrence and survival on a local level. With the CCR, the regional registries also report their data to make statewide research possible. 
   1. Cancer Incidence in California. According to the most recent DPH report on cancer surveillance, “Cancer in California, 1988-2017”, approximately 1.5 million Californians alive today have been diagnosed with cancer at some point in their lives. In 2017, 169,629 new cancer cases and 59,547 cancer deaths occurred among Californians. Since 1988, overall cancer incidence and mortality rates significantly decreased in California by 13.9% and 33.4%, respectively. Other findings of the report are as follows:
      1. The most commonly diagnosed cancers among men were prostate, lung, colorectal, melanoma, and bladder. The most commonly diagnosed cancers among women were breast, lung, colorectal, corpus uterine, and thyroid. Men had higher cancer incidence (409.0 per 100,000) and mortality (160.0 per 100,000) rates than women (377.5 per 100,000 and 120.1 per 100,000, respectively). However, decreases in cancer incidence rates were greater among men (2% per year) than women (0.5% per year);
      2. The risk of certain types of cancer varied by age. Among children under 14 years, leukemia and brain tumors were the most commonly diagnosed cancers. Among adults aged 50 years and older, breast, prostate, lung, and colorectal were the most commonly diagnosed cancers. Non-Latino/Hispanic Whites had the highest cancer incidence rate (429.7 per 100,000) compared to Black/African Americans (401.5 per 100,000), American Indians (396.6), Latino/Hispanics (318.4 per 100,000), and Asian/Pacific Islanders (287.2 per 100,000). American Indians were the only racial/ethnic group for whom cancer incidence significantly increased by 2.7% per year. American Indians (176.5 per 100,000) and Black/African Americans (175.3 per 100,000) had the highest cancer mortality rates, followed by non-Latino/Hispanic Whites (147.9 per 100,000), Latino/Hispanics (118.5 per 100,000), and Asian/Pacific Islanders (102.4 per 100,000). American Indians were the only racial/ethnic group for whom cancer mortality significantly increased by 2.2% per year; and,
      3. The five-year cancer survival among California adults aged 20 years and older was 66.4%, whereas five-year cancer survival among children aged birth to 19 years was 83.3%. Among men, five-year survival was highest for prostate (96.8%), testicular (94.1%), and thyroid (93.8%) cancers and lowest for pancreatic (8.4%), lung (14.8%), and liver (17.5%) cancers. Among women, five-year survival was highest for thyroid (98.3%), melanoma (92.8%), and breast (90.1%) cancers and lowest for pancreatic (8.4%), liver (18.9%), and lung (21.3%) cancers. Five-year cancer survival increased among each racial/ethnic group in California between 1988 and 2012. However, Black/African Americans had the lowest cancer survival (61.6%) in 2012 compared to non-Latino/Hispanic Whites (67.2%), Latino/Hispanics (66.0%), and Asian/Pacific Islanders (64.9%).
   2. Background on the SEER program and the National Program of Cancer Registries. As noted in the Senate Health Committee analysis, the SEER Program of NCI is the authoritative source of information on cancer incidence and survival for the nation as a whole. SEER currently collects and publishes cancer incidence and survival data from population-based registries covering approximately 48% of the U.S. population. NCI staff work with the North American Association of Central Cancer Registries to guide all state registries to achieve data content and compatibility acceptable for pooling data and improving national estimates. The SEER team is developing computer applications to unify cancer registration systems and to analyze and disseminate population-based data. Use of surveillance data for research is being improved through web-based access to the data and analytic tools, and linking with other national data sources.
      
      The NPCR is a program established by the CDC to provide funding and technical assistance to statewide, population-based cancer registries. NPCR supports states and territories to improve existing cancer registries; plan and implement registries where none existed; develop model legislation and regulations for states to enhance the viability of registry operations; set standards for data completeness, timeliness, and quality; provide training for registry personnel; and, help establish a computerized reporting and data processing system. In 2006, NPCR launched the Electronic Pathology (ePath) Implementation Project to test a model for automated electronic capture and reporting of cancer registry data to central cancer registries. Following initial pilot programs, ePath has expanded to all 50 states and includes many more national and regional laboratories. In California, AB 2325 (Bonilla), Chapter 354, Statutes of 2016, required pathologists to use ePath to report cancer diagnoses beginning on January 1, 2019.
   3. Funding of CCR. CCR is funded by both state and federal dollars. State funding comes from the General Fund, Proposition 99 Fund, and the Breast Cancer Research Fund, and federal funding comes from the CDC. According to DPH, for fiscal year 2022-2023, the total funding for the CCR is $10.670 million. $8.170 million is state funding and $2.5 million is federal funding (CDC's NPCR). It should also be noted that all of the regional registries and the CCR receive NCI SEER funding. They work together to draw down a significant portion of funding, without with none of their work would be possible.
3. SUPPORT. The Public Health Institute, American Cancer Society Cancer Action Network, City of Hope, and the University of Southern California are the cosponsors of this bill. They state this bill would improve the effectiveness of the CCR by easing implementation of electronic pathology reporting (ePath) and data sharing with qualified researchers. An integral part of the CCR are California’s three designated regional cancer registries which provide critical support on local instances of disease. They are the first line in collecting the data that is used for research and clinical trials. Data collected by the regional registries make it possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to the CCR for an average of one-and-a-half to two years. In 2016, the Legislature passed, and Governor Brown signed AB 2325 to update the cancer registry to ensure real time reporting through ePath. This important update brought the CCR and cancer reporting in California into the modern era, with a goal to ensure the CCR will receive data in real time, allowing researchers to utilize more current data, as opposed to relying on older, outdated information. Additionally, the real-time benefit of reporting through ePath—if fully and completely implemented—will have significant benefits for clinical trials. Failure to fully implement ePath means a two-year delay in reporting of a cancer case, which eliminates that value of the data for clinical trial enrolment. Currently, only 3% of adults diagnosed with cancer participate in clinical trials, those numbers are much lower for those of racial and ethnic minorities. Unfortunately, researchers have found that the statutory provisions established in law through AB 2325 eight years ago have not kept up with the most effective standards and approaches for data collection and continue to require a manual process, delaying our ability to move forward with real time reporting that make clinical trials more accessible. Furthermore, provisions in current law limit the CCR, including the regional registries, to allow data re-disclosure by approved cancer researchers to comply with National Institutes of Health data sharing requirement with federal data repositories and controlled data sharing with other legitimate research endeavors. Outdated approaches to data collection and data sharing thwart vital research into cancer treatment and cures, preventing progress that would save lives. The supporters conclude this bill would help address this problem by updating procedures that ensure that approved researchers have access to timely data while ensuring necessary data protections and privacy are strengthened and maintained.
4. PREVIOUS LEGISLATION. AB requires pathologists to use ePath to report cancer diagnoses beginning on January 1, 2019.

REGISTERED SUPPORT / OPPOSITION:

Support

American Cancer Society Cancer Action Network (cosponsor)
City of Hope (cosponsor)
Public Health Institute (cosponsor)

University of Southern California (cosponsor)

University of California

Opposition

None on file.

Analysis Prepared by: Rosielyn Pulmano / HEALTH / (916) 319-2097

 THIRD READING  

Bill No: SB 344

Author: Rubio (D)

Amended: 4/20/23

Vote: 21

SENATE HEALTH COMMITTEE: 12-0, 3/29/23

AYES: Eggman, Nguyen, Glazer, Gonzalez, Grove, Hurtado, Limón, Menjivar, Roth, Rubio, Wahab, Wiener

SENATE JUDICIARY COMMITTEE: 11-0, 4/18/23

AYES: Umberg, Wilk, Allen, Ashby, Caballero, Durazo, Laird, McGuire, Min, Niello, Wiener

SENATE APPROPRIATIONS COMMITTEE: 7-0, 5/18/23

AYES: Portantino, Jones, Ashby, Bradford, Seyarto, Wahab, Wiener

SUBJECT: Ken Maddy California Cancer Registry

SOURCE: American Cancer Society Cancer Action Network

City of Hope

Public Health Institute

University of Southern

DIGEST

:

This bill revises provisions of law related to the Ken Maddy California Cancer Registry to make various changes, including to permit individuals who are authorized to access the confidential data in cancer registries to participate in data sharing with other authorized individuals.

ANALYSIS:

Existing law:

1. Requires the California Department of Public Health (CDPH) to establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries (known as the Ken Maddy California Cancer Registry, or CCR). Permits CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries. Requires designated regional registries to provide CDPH, on a timely basis, cancer incidence data. [HSC §103885]
2. Requires CDPH to 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. Requires all cancers diagnosed or treated in the reporting area to be reported to the representative of CDPH authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative. [HSC §103885(c)]
3. Requires any hospital or other facility providing therapy to cancer patients, and any physician, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients, to report each case of cancer to CDPH or the authorized representative of CDPH. [HSC §103885(d)]
4. Requires all information collected pursuant to the CCR to be confidential, and requires CDPH to use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect. [HSC §103885(g)(1),(2)]
5. Permits 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 CDPH, and who agree, in writing, to maintain confidentiality, to be authorized access to confidential information. [HSC §103885(g)(3)]
6. Permits CDPH and any regional cancer registry designated by CDPH to 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. Requires the requesting entity to agree in writing to maintain the confidentiality of the information before confidential information is disclosed, and in the case of researchers, to do both of the following:
   1. Obtain approval of their committee for the protection of human subjects, as specified; and,
   2. Provide documentation to CDPH that demonstrates to CDPH’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information. [HSC §103885(g)(4)
7. Requires CDPH to maintain an accurate record of all persons who are given access to confidential information. [HSC §103885(g)(7)]

This bill:

1. Requires CDPH to maintain a statewide registry infrastructure that maximizes and strengthens California’s existing regional registry infrastructure funded through the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program.
2. Requires, rather than permits, CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas, and requires, rather than permits, CDPH to establish regional cancer registries.
3. Requires, in addition to the existing requirement that a pathologist report cancer diagnoses by electronic means, a pathology laboratory diagnosing or treating cancer report cancer diagnoses by electronic means.
4. Establishes an exemption from a provision of law prohibiting any further disclosure of information collected by a regional cancer registry after an initial authorized disclosure, by allowing future disclosure if the information is utilized for the continuation of the original disclosure, and one of the following criteria is met:
   1. The original disclosure is for research that requires the researchers to participate in data sharing with other approved individuals or entities, as specified; or,
   2. The information is shared with other authorized individuals or entities, as specified, and approved by CDPH.
5. Requires any information shared pursuant to 4) above to adhere to the original approved requirements relative to usage and disclosure.
6. Repeals a requirement that the record of access to confidential information, which CDPH is required to maintain as to all persons who are given access to confidential information, be open to public inspection during normal operating hours of CDPH.
7. Requires CDPH to partner with established regional registries to maximize the use of available federal funds.
8. Makes minor, technical changes to the body of law governing cancer reporting registries.

Comments

1. Author’s statement. According to the author, California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The California Cancer Registry is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to CDPH for an average of one-and-a-half to two years. This bill will improve the effectiveness of the CCR by shortening delays and streamlining ePath reporting, resulting in improved cancer research and more advancements in cancer treatment and care.
2. CCR. In 1985, the California Legislature passed a law making cancer a reportable disease, although regional cancer registries existed before it was made a mandatory reportable disease. Today there are three regional registries: the Greater Bay Area Cancer Registry, the Los Angeles County Cancer Surveillance Program operated by the University of Southern California, and the Cancer Registry of Greater California (which covers all other counties). The CCR is California’s statewide cancer surveillance system, which collects all the data from the regional registries into a statewide database. The CCR and regional registries use the data to write summary reports that inform the public, local health workers, educators, and legislators about the status of cancer. Researchers may examine these data to identify areas that have high cancer rates and areas where people might benefit from cancer screening and education programs, or to look at trends in cancer diagnosis. Other uses include, but are not limited to, measuring the success of cancer screening programs; examining disparities in cancer risk, treatment and survival; examining treatment choices and other predictors of survival; responding to public concerns and questions about cancer; and, conducting research to find the causes and cures of cancer. The CCR and regional registries are permitted to release patient contact information to qualified researchers, who may contact patients to find out if they want to participate in a research study. However, information is only released to qualified researchers under tightly controlled circumstances where the research has first been approved by the Committee for the Protection of Human Subjects.
3. SEER program and the National Program of Cancer Registries. The SEER Program of the National Cancer Institute (NCI) is the authoritative source of information on cancer incidence and survival for the nation as a whole. SEER currently collects and publishes cancer incidence and survival data from population-based registries covering approximately 48% of the U.S. population. NCI staff work with the North American Association of Central Cancer Registries to guide all state registries to achieve data content and compatibility acceptable for pooling data and improving national estimates. The SEER team is developing computer applications to unify cancer registration systems and to analyze and disseminate population-based data. Use of surveillance data for research is being improved through web-based access to the data and analytic tools, and linking with other national data sources.

The National Program of Cancer Registries (NPCR) is a program established by the Centers for Disease Control and Prevention to provide funding and technical assistance to statewide, population-based cancer registries. NPCR supports states and territories to improve existing cancer registries; plan and implement registries where none existed; develop model legislation and regulations for states to enhance the viability of registry operations; set standards for data completeness, timeliness, and quality; provide training for registry personnel; and, help establish a computerized reporting and data processing system. In 2006, NPCR launched the Electronic Pathology (ePath) Implementation Project to test a model for automated electronic capture and reporting of cancer registry data to central cancer registries. Following initial pilot programs, ePath has expanded to all 50 states and includes many more national and regional laboratories. In California, AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required pathologists to use ePath to report cancer diagnoses beginning on January 1, 2019.

Related/Prior Legislation

AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required, beginning January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to CDPH utilizing electronic means in a standardized format approved by CDPH.

FISCAL EFFECT: Appropriation: No Fiscal Com.: Yes Local: No

According to the Senate Appropriations Committee, CDPH estimates ongoing annual costs of approximately $3.47 million (General Fund) to be allocated through contracts to provide sufficient funding to the California regional registries to meet the cost-share requirements of the SEER Program.

SUPPORT: (Verified 5/19/23)

American Cancer Society Cancer Action Network (co-source)

City of Hope (co-source)

Public Health Institute (co-source)

University of Southern California (co-source)

California Medical Association

Susan G. Komen

OPPOSITION: (Verified 5/19/23)

None received

ARGUMENTS IN SUPPORT: This bill is co-sponsored by the American Cancer Society Cancer Action Network, City of Hope, Public Health Institute, and the University of Southern California. The sponsors state that AB 2325 from 2016 was enacted to ensure real time reporting through ePath. If fully and completely implemented, the real time benefit of electronic reporting will have significant benefits for clinical trials, but failure to fully implement ePath means a two-year delay in reporting of a cancer case, which eliminates the value of the data for clinical trial enrollment. Further, provisions in current law limit the CCR, including the regional registries, to allow data re-disclosure by approved cancer researchers to comply with National Institutes of Health data sharing requirements with federal data repositories and controlled data sharing with other legitimate research endeavors. This bill will help address this problem by updating procedures that ensure that approved researchers have access to timely data while ensuring necessary data protections and privacy are strengthened and maintained.

Prepared by: Vincent D. Marchand / HEALTH / (916) 651-4111

5/20/23 12:44:36

**** END ****

SENATE COMMITTEE ON APPROPRIATIONS

Senator Anthony Portantino, Chair

2023 - 2024 Regular Session

SB 344 (Rubio) - Ken Maddy California Cancer Registry

Bill Summary:

SB 344 would revise provisions of law related to the Ken Maddy California Cancer Registry.

Fiscal Impact:

The California Department of Public Health estimates ongoing annual costs of approximately $3.47 million (General Fund) to be allocated through contracts to provide sufficient funding to the California regional registries to meet the cost-share requirements of the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program.

Background:

Current law requires the California Department of Public Health (CDPH) to establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries (known as the Ken Maddy California Cancer Registry, or CCR). Current law permits CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries and requires designated regional registries to provide CDPH, on a timely basis, cancer incidence data.

The CCR and regional registries use the data to write summary reports that inform the public, local health workers, educators, and legislators about the status of cancer. Researchers may examine these data to identify areas that have high cancer rates and areas where people might benefit from cancer screening and education programs, or to look at trends in cancer diagnosis. Other uses include, but are not limited to, measuring the success of cancer screening programs; examining disparities in cancer risk, treatment and survival; examining treatment choices and other predictors of survival; responding to public concerns and questions about cancer; and, conducting research to find the causes and cures of cancer. The CCR and regional registries are permitted to release patient contact information to qualified researchers, who may contact patients to find out if they want to participate in a research study. However, information is only released to qualified researchers under tightly controlled circumstances where the research has first been approved by the Committee for the Protection of Human Subjects.

Proposed Law:

Specific provisions of the bill would:

• Require CDPH to maintain a statewide registry infrastructure that maximizes and strengthens California’s existing regional registry infrastructure funded through the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program.
• Require, rather than permit, CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas; and requires, rather than permits, CDPH to establish regional cancer registries.
• Require, in addition to the existing requirement that a pathologist report cancer diagnoses by electronic means, a pathology laboratory diagnosing or treating cancer to report cancer diagnoses by electronic means.
• Establish an exemption from a provision of law prohibiting any further disclosure of information collected by the registries after an initial authorized disclosure, by allowing further disclosure under specific criteria.
• Require CDPH to partner with established regional registries to maximize the use of available federal funds.

-- END --

SENATE JUDICIARY COMMITTEE

Senator Thomas Umberg, Chair

2023-2024 Regular Session

Bill No: SB 344 (Author:Rubio)

Version: March 30, 2023

Hearing Date: April 18, 2023

Fiscal: Yes

Urgency: No

AMConsultant:

SUBJECT

Ken Maddy California Cancer Registry

DIGEST

This bill revises provisions of law related to the Ken Maddy California Cancer Registry (CCR) to, among other things, allow disclosure of data in the registries if the information is utilized for the continuation of the original approved disclosure and is shared with other authorized individuals and approved by the State Department of Public Health (CDPH).

EXECUTIVE SUMMARY

According to the author and sponsors this bill will improve the effectiveness of the CCR by shortening delays and streamlining ePath reporting, resulting in improved cancer research and more advancements in cancer treatment and care. Specifically, the bill authorizes information in the CCR to be further disclosed by authorized users if it is utilized for the continuation of the original disclosure, and the original disclosure is for research that requires the researchers to participate in data sharing with other approved individuals or the information is shared with other authorized individuals and approved by the State Department of Public Health (CDPH). Additionally, the bill provides that the requirement on CDPH to maintain an accurate record of all persons who are given access to confidential information under the CCR does not extend to federal or federally designated data repositories and other authorized researchers to whom data is provided.

This bill is sponsored by the American Cancer Society Cancer Action Network, City of Hope, Public Health Institute, and the University of Southern California. The bill is supported by Susan G. Komen and Stanford Health Care. There is no known opposition. The bill passed the Senate Health Committee on a vote of 12 to 0.

PROPOSED CHANGES TO THE LAW

Existing law:

• 1. Requires the California Department of Public Health (CDPH) to establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries (known as the Ken Maddy California Cancer Registry, or CCR).
     • 1. Permits CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries.
       2. Requires designated regional registries to provide CDPH, on a timely basis, cancer incidence data. (Health & Saf. Code § 103885.)
  2. Requires any hospital or other facility providing therapy to cancer patients, and any physician, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients, to report each case of cancer to CDPH or the authorized representative of CDPH. (Id. at subd. (d).)
  3. Requires all information collected pursuant to the CCR to be confidential, and requires CDPH to use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect. (Id. at para. (1) & (2) of subd. (g).)
  4. Authorizes persons with a valid scientific interest who are engaged in demographic, epidemiological, or other similar studies related to health to access confidential information if they meet certain qualifications and agree, in writing, to maintain confidentiality of that information.
  5. Authorizes CDPH and any regional cancer registry designated by CDPH to 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. Requires the requesting entity to agree in writing to maintain the confidentiality of the information before confidential information is disclosed, and in the case of researchers, to do both of the following:
     • 1. obtain approval of their committee for the protection of human subjects, as specified; and
       2. provide documentation to CDPH that demonstrates to CDPH’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information. (Id. at para. (4) of subd. (g).)
  6. Provides that any disclosure of information can only include the information necessary for the stated purpose of the requested disclosure, only be used for the approved purposes, and cannot be further disclosed. (Id. at para. (4) of subd. (g).)
  7. Provides that the furnishing of confidential information to CDPH or its authorized representative in accordance with these provisions does not expose any person, agency, or entity furnishing information to liability, and is not to be considered a waiver of any privilege or a violation of a confidential relationship. (Id. at para. (6) of subd. (g).)
  8. Requires CDPH to maintain an accurate record of all persons who are given access to confidential information. (Id. at para. (7) of subd. (g).)

This bill:

1. Requires the Director of CDPH to maintain a statewide registry infrastructure that maximizes and strengthens California’s existing regional registry infrastructure funded through the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program.
2. Requires, instead of authorizing, CDPH to both designate any demographic parts of the state as a regional cancer incidence reporting area and establish regional cancer registries.
3. Requires a pathology laboratory diagnosing or treating a reportable case of cancer to report that cancer diagnose to CDPH.
4. Authorizes further disclosure of information if it is utilized for the continuation of the original disclosure, and one of the following criteria is met:
   1. the original disclosure is for research that requires the researchers to participate in data sharing with other approved individuals; or
   2. the information is shared with other authorized individuals and approved by the department.
5. Requires that any information shared pursuant to 4) adhere to the original approved requirements relative to usage and disclosure.
6. Provides that the recordkeeping responsibility described in 8) above does not apply to federal or federally designated data repositories and other bonafide researchers to whom data is provided.

COMMENTS

1. State need for the bill

The author writes:

California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The California Cancer Registry is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to the department for an average of one-and-a-half to two years. SB 344 will improve the effectiveness of the California Cancer Registry by shortening delays and streamlining ePath reporting, resulting in improved cancer research and more advancements in cancer treatment and care.

1. Background

The Senate Committee on Health analysis provides a detailed background on the California Cancer Registry, the SEER program, and the National Program of Cancer Registries:

In 1985, the California Legislature passed a law making cancer a reportable disease, although regional cancer registries existed before it was made a mandatory reportable disease. Today there are three regional registries: the Greater Bay Area Cancer Registry, the Los Angeles County Cancer Surveillance Program operated by the University of Southern California, and the Cancer Registry of Greater California (which covers all other counties). The CCR is California’s statewide cancer surveillance system, which collects all the data from the regional registries into a statewide database. The CCR and regional registries use the data to write summary reports that inform the public, local health workers, educators, and legislators about the status of cancer. Researchers may examine these data to identify areas that have high cancer rates and areas where people might benefit from cancer screening and education programs, or to look at trends in cancer diagnosis. Other uses include, but are not limited to, measuring the success of cancer screening programs; examining disparities in cancer risk, treatment and survival; examining treatment choices and other predictors of survival; responding to public concerns and questions about cancer; and, conducting research to find the causes and cures of cancer. The CCR and regional registries are permitted to release patient contact information to qualified researchers, who may contact patients to find out if they want to participate in a research study. However, information is only released to qualified researchers under tightly controlled circumstances where the research has first been approved by the Committee for the Protection of Human Subjects.

The SEER Program of the National Cancer Institute (NCI) is the authoritative source of information on cancer incidence and survival for the nation as a whole. SEER currently collects and publishes cancer incidence and survival data from population-based registries covering approximately 48% of the U.S. population. NCI staff work with the North American Association of Central Cancer Registries to guide all state registries to achieve data content and compatibility acceptable for pooling data and improving national estimates. The SEER team is developing computer applications to unify cancer registration systems and to analyze and disseminate population-based data. Use of surveillance data for research is being improved through web-based access to the data and analytic tools, and linking with other national data sources.

The National Program of Cancer Registries (NPCR) is a program established by the Centers for Disease Control and Prevention to provide funding and technical assistance to statewide, population-based cancer registries. NPCR supports states and territories to improve existing cancer registries; plan and implement registries where none existed; develop model legislation and regulations for states to enhance the viability of registry operations; set standards for data completeness, timeliness, and quality; provide training for registry personnel; and, help establish a computerized reporting and data processing system. In 2006, NPCR launched the Electronic Pathology (ePath) Implementation Project to test a model for automated electronic capture and reporting of cancer registry data to central cancer registries. Following initial pilot programs, ePath has expanded to all 50 states and includes many more national and regional laboratories. In California, AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required pathologists to use ePath to report cancer diagnoses beginning on January 1, 2019.^[1]

1. Bill authorizes additional sharing of confidential information

The bill provides that an authorized disclosure of information may be further disclosed if the information utilized for the continuation of the purpose for which the original disclosure was approved, and either limited circumstance is met: (1) the original disclosure is for research that requires the researchers to participate in data sharing with other approved individuals; or (2) the information is shared with other authorized individuals and approved by the CDPH. Any information shared under this authorization is required to adhere to the original approved requirements related to usage and disclosure. The bill also provides that the recordkeeping responsibility of CDPH regarding maintaining an accurate record of all persons who are given access to confidential information in the CCR does not extend to federal or federally designated data repositories and other bona fide researchers to whom data is provided.

According to the author and sponsors these changes will improve the effectiveness of the CCR by shortening delays and streamlining ePath reporting, resulting in improved cancer research and more advancements in cancer treatment and care. They note that the National Institute of Health (NIH) Policy for Data Management and Sharing requires that any NIH funded or conducted research, in whole or in part, that results in the generation of scientific data must comply with data sharing requirements, which is defined as the act of making scientific data available for use by others, including the larger research community, institutions, the public, and via online repositories. The goal of the bill is to align CCR data sharing policies and practices with NIH policies that generally require study data to be largely shareable without restrictions. They posit that the current non-redisclosure policy and recordkeeping provisions in California law hamper the ability of California researchers to participate in, and California data to be used in, NIH funded research, potentially hampering the ability to prevent and treat cancer not only in this state but across the nation.

1. Proposed amendments

The author may wish to make the following clarifying amendments to the bill. First, the author may wish to include “or entities” after “individuals” under the two limited circumstance for further disclosure to ensure the statute is not interpreted to only authorize further disclosure to an individual and not an entity, such as a cancer registry. Additionally, the author may wish to delete the limitation on CDPH’s requirement to maintain an accurate record of all persons given access to confidential information to as the language it was cross-referencing was removed by the amendments made in the Senate Health Committee.

The specific amendments are as follows:

Amendment 1

On page 7, in line 22, after “individuals” add:

or entities

Amendment 2

On page 7, in line 23, after “individuals” add:

or entities

Amendment 3

On page 8, delete lines 2 through 4.

1. Statements in support

The sponsors of the bill, the American Cancer Society Cancer Action Network, the

City of Hope, the Public Health Institute, and the University of Southern California, write in support stating:

[T]he real-time benefit of reporting through ePath—if fully and completely implemented—will have significant benefits for clinical trials. Failure to fully implement ePath means a two-year delay in reporting of a cancer case, which eliminates that value of the data for clinical trial enrolment. Currently, only 3% of adults diagnosed with cancer participate in clinical trials, those numbers are much lower for those of racial and ethnic minorities.

Furthermore, provisions in current law limit the CCR, including the regional registries, to allow data re-disclosure by approved cancer researchers to comply with National Institutes of Health data sharing requirement with federal data repositories and controlled data sharing with other legitimate research endeavors. Outdated approaches to data collection and data sharing thwart vital research into cancer treatment and cures, preventing progress that would save lives. SB 344 will help address this problem by updating procedures that ensure that approved researchers have access to timely data while ensuring necessary data protections and privacy are strengthened and maintained.

SUPPORT

American Cancer Society Cancer Action Network (sponsor)

City of Hope (sponsor)

Public Health Institute (sponsor)

University of Southern California (sponsor)

Stanford Health Care

Susan G. Komen

OPPOSITION

None known

RELATED LEGISLATION

Pending Legislation: None known.

Prior Legislation:

AB 2325 (Bonilla, Ch. 354, Stats. 2016) required, beginning January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to the CDPH utilizing electronic means in a standardized format approved by CDPH.

PRIOR VOTES:

Senate Health Committee (Ayes 12, Noes 0)

**************

1. Sen. Comm. on Health analysis of SB 344 (2023-34 reg. sess.) as amended March 20, 2023 at pp. 3-4. ↑

SENATE COMMITTEE ON HEALTH

Senator Dr. Susan Talamantes Eggman, Chair

BILL NO: SB 344

SUBJECT: Ken Maddy California Cancer Registry

SUMMARY:

Revises provisions of law related to the Ken Maddy California Cancer Registry to make various changes, including to permit individuals who are authorized to access the confidential data in cancer registries to participate in data sharing with other authorized individuals.

Existing law:

1. Requires the California Department of Public Health (CDPH) to establish a statewide system for the collection of information determining the incidence of cancer, using population-based cancer registries (known as the Ken Maddy California Cancer Registry, or CCR). Permits CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas and to establish regional cancer registries. Requires designated regional registries to provide CDPH, on a timely basis, cancer incidence data. [HSC §103885]
2. Requires CDPH to 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. Requires all cancers diagnosed or treated in the reporting area to be reported to the representative of CDPH authorized to compile the cancer data, or any individual, agency, or organization designated to cooperate with that representative. [HSC §103885(c)]
3. Requires any hospital or other facility providing therapy to cancer patients, and any physician, dentist, podiatrist, or other health care practitioner diagnosing or providing treatment for cancer patients, to report each case of cancer to CDPH or the authorized representative of CDPH. [HSC §103885(d)]
4. Requires all information collected pursuant to the CCR to be confidential, and requires CDPH to use the information to determine the sources of malignant neoplasms and evaluate measures designed to eliminate, alleviate, or ameliorate their effect. [HSC §103885(g)(1),(2)]
5. Permits 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 CDPH, and who agree, in writing, to maintain confidentiality, to be authorized access to confidential information. [HSC §103885(g)(3)]
6. Permits CDPH and any regional cancer registry designated by CDPH to 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. Requires the requesting entity to agree in writing to maintain the confidentiality of the information before confidential information is disclosed, and in the case of researchers, to do both of the following:
   1. Obtain approval of their committee for the protection of human subjects, as specified; and,
   2. Provide documentation to CDPH that demonstrates to CDPH’s satisfaction that the entity has established the procedures and ability to maintain the confidentiality of the information. [HSC §103885(g)(4)
7. Requires CDPH to maintain an accurate record of all persons who are given access to confidential information. [HSC §103885(g)(7)]

This bill:

1. Requires CDPH to maintain a statewide registry infrastructure that maximizes and strengthens California’s existing regional registry infrastructure funded through the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) Program.
2. Requires, rather than permits, CDPH to designate any demographic parts of the state as regional cancer incidence reporting areas, and requires, rather than permits, CDPH to establish regional cancer registries.
3. Requires, in addition to the existing requirement that a pathologist report cancer diagnoses by electronic means, a pathology laboratory diagnosing or treating cancer report cancer diagnoses by electronic means.
4. Permits researchers with a valid scientific interest, who meet existing criteria to be authorized access to confidential information in cancer registries, to additionally share data with federal or federally designated data repositories and with other bona fide researchers if the data being shared does not contain individually identifiable data that could be reasonably used to identify or reidentify the data with an individual person.
5. Establishes an exemption from a provision of law prohibiting any further disclosure of information collected by a regional cancer registry after an initial authorized disclosure, by allowing future disclosure if one of the following criteria is met:
   1. The original disclosure is for research that requires the researchers to participate in data sharing with other approved individuals, as specified;
   2. The information is shared with other authorized individuals, as specified, and approved by CDPH; or,
   3. The information is utilized for the continuation of the original disclosure.
6. Requires any information shared pursuant to 5) above to adhere to the original approved requirements relative to usage and disclosure.
7. Specifies that existing law requiring CDPH to maintain an accurate record of all persons who are given access to confidential information does not extend to federal or federally designated data repositories and other bona fide researchers to whom data is provided pursuant to 4) above.
8. Requires CDPH to partner with established regional registries to maximize the use of available federal funds.
9. Makes minor, technical changes to the body of law governing cancer reporting registries.

FISCAL EFFECT:

This bill has not been analyzed by a fiscal committee.

COMMENTS:

1. Author’s statement. According to the author, California has the largest cancer registry in the nation and is recognized as one of the leading cancer registries in the world. The California Cancer Registry is a vast repository of cancer data that provides vital information to public health officers and researchers, helping to inform cancer treatment, prevention, and cures. With this data, it is possible to determine cancer risk factors and study groupings of cancers in communities. However, the means for collecting data has fallen woefully behind the times and has resulted in data not being reported to CDPH for an average of one-and-a-half to two years. This bill will improve the effectiveness of the CCR by shortening delays and streamlining ePath reporting, resulting in improved cancer research and more advancements in cancer treatment and care.
2. Background on CCR. In 1985, the California Legislature passed a law making cancer a reportable disease, although regional cancer registries existed before it was made a mandatory reportable disease. Today there are three regional registries: the Greater Bay Area Cancer Registry, the Los Angeles County Cancer Surveillance Program operated by the University of Southern California, and the Cancer Registry of Greater California (which covers all other counties). The CCR is California’s statewide cancer surveillance system, which collects all the data from the regional registries into a statewide database. The CCR and regional registries use the data to write summary reports that inform the public, local health workers, educators, and legislators about the status of cancer. Researchers may examine these data to identify areas that have high cancer rates and areas where people might benefit from cancer screening and education programs, or to look at trends in cancer diagnosis. Other uses include, but are not limited to, measuring the success of cancer screening programs; examining disparities in cancer risk, treatment and survival; examining treatment choices and other predictors of survival; responding to public concerns and questions about cancer; and, conducting research to find the causes and cures of cancer. The CCR and regional registries are permitted to release patient contact information to qualified researchers, who may contact patients to find out if they want to participate in a research study. However, information is only released to qualified researchers under tightly controlled circumstances where the research has first been approved by the Committee for the Protection of Human Subjects.
3. Background on SEER program and the National Program of Cancer Registries. The SEER Program of the National Cancer Institute (NCI) is the authoritative source of information on cancer incidence and survival for the nation as a whole. SEER currently collects and publishes cancer incidence and survival data from population-based registries covering approximately 48% of the U.S. population. NCI staff work with the North American Association of Central Cancer Registries to guide all state registries to achieve data content and compatibility acceptable for pooling data and improving national estimates. The SEER team is developing computer applications to unify cancer registration systems and to analyze and disseminate population-based data. Use of surveillance data for research is being improved through web-based access to the data and analytic tools, and linking with other national data sources.
   
   The National Program of Cancer Registries (NPCR) is a program established by the Centers for Disease Control and Prevention to provide funding and technical assistance to statewide, population-based cancer registries. NPCR supports states and territories to improve existing cancer registries; plan and implement registries where none existed; develop model legislation and regulations for states to enhance the viability of registry operations; set standards for data completeness, timeliness, and quality; provide training for registry personnel; and, help establish a computerized reporting and data processing system. In 2006, NPCR launched the Electronic Pathology (ePath) Implementation Project to test a model for automated electronic capture and reporting of cancer registry data to central cancer registries. Following initial pilot programs, ePath has expanded to all 50 states and includes many more national and regional laboratories. In California, AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required pathologists to use ePath to report cancer diagnoses beginning on January 1, 2019.
4. Double referral. This bill is double referred. Should it pass out of this committee, it will be referred to the Senate Judiciary Committee.
5. Prior legislation. AB 2325 (Bonilla, Chapter 354, Statutes of 2016) required, beginning January 1, 2019, a pathologist diagnosing cancer to report cancer diagnoses to CDPH utilizing electronic means in a standardized format approved by CDPH.
6. Support. This bill is co-sponsored by the American Cancer Society Cancer Action Network, City of Hope, Public Health Institute, and the University of Southern California. The sponsors state that AB 2325 from 2016 was enacted to ensure real time reporting through ePath. If fully and completely implemented, the real time benefit of electronic reporting will have significant benefits for clinical trials, but failure to fully implement ePath means a two-year delay in reporting of a cancer case, which eliminates the value of the data for clinical trial enrollment. Further, provisions in current law limit the CCR, including the regional registries, to allow data re-disclosure by approved cancer researchers to comply with National Institutes of Health data sharing requirements with federal data repositories and controlled data sharing with other legitimate research endeavors. This bill will help address this problem by updating procedures that ensure that approved researchers have access to timely data while ensuring necessary data protections and privacy are strengthened and maintained.
7. Language regarding data sharing is unclear. One of the goals of this legislation, according to the author and sponsors, is to enable the original authorized entity who requested data from the CCR to share that data with other authorized researchers or entities when the data sharing is required as part of the original research request or is otherwise for the same purpose as the original request. However, there are two different provisions in this bill where data sharing is permitted (on page 6, lines 31-36, and page 7, lines 20-31, which are described in 4) and 5) of “This bill” above, respectively). These provisions are not worded the same, and it is unclear why both of the provisions are necessary, since the language described in 5) of “This bill” would seemingly accomplish all of the data sharing desired by proponents. This language could benefit from additional clarity.

SUPPORT AND OPPOSITION:

Support: American Cancer Society Cancer Action Network (co-sponsor)

City of Hope (co-sponsor)

Public Health Institute (co-sponsor)

University of Southern California (co-sponsor)

Susan G. Komen

Oppose: None received

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