CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Assembly Bill No. 1129Introduced by Assembly Member Celeste Rodriguez(Coauthor: Assembly Member Schiavo)February 20, 2025 An act to amend Sections 103825, 103835, 103840, 103845, 103850, 103855, 124977, 124991, and 125002 of, and to add Sections 103827 and 103832 to, the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 1129, as introduced, Celeste Rodriguez. Birth defects monitoring.Existing law requires the State Public Health Officer to maintain a system for the collection of information related to birth defects, as specified. Existing law requires the officer to require general acute care hospitals and physician-owned or physician-operated clinics that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services to make available to the department the medical records of children suspected or diagnosed as having birth defects, as specified. Existing law authorizes the department to enter into a contract for the establishment and implementation of the birth defects monitoring program.This bill would authorize a local health officer to maintain a system for the collection of information related to birth defects and other birth anomalies. The bill would authorize a local health officer to require laboratories, as specified, in addition to the facilities listed above, to either make available or to transmit to the local health department birth defects and other birth anomalies information, as specified. The bill would authorize a local health officer to enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.Existing law requires the State Department of Public Health to collect and store any umbilical cord blood samples it receives from hospitals for storage and research and states the intent of the Legislature that pregnancy blood samples be stored and made available to any researcher who is approved by the department for specified purposes.This bill would exempt umbilical cord and pregnancy blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes from the provisions described above.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 103825 of the Health and Safety Code is amended to read:103825. The Legislature hereby finds and declares that birth defects, defects and other anomalies present at, or caused by, birth, stillbirths, and miscarriages represent problems of public health importance about which too little is known; that these conditions lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs; and that a system to obtain more information about these conditions could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in enacting this section to accomplish all of the following:(a) To enable and maintain an ongoing program of birth defects and other birth anomalies monitoring statewide. Birth defect as used in this chapter means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(b) To provide information on the incidence, prevalence, and trends of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(c) To provide information to determine whether environmental hazards are associated with birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(d) To provide information as to other possible causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(e) To develop prevention strategies for reducing the incidence of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(f) To conduct interview studies about the causes of birth defects. defects and other birth anomalies.(g) To affirm the authority of the state department to contract with a qualified entity to operate the birth defects defects and other birth anomalies monitoring program statewide.(h) To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and other birth anomalies in their local health jurisdiction in order to supplement state efforts or in the absence of state efforts in their jurisdiction.SEC. 2. Section 103827 is added to the Health and Safety Code, to read:103827. For the purposes of this chapter, the following terms have the following meanings:(a) Birth anomalies means defects, conditions, or disorders affecting a fetus, a newborn, or an infant that result congenitally, at the birth event, or that are suspected to be caused by, or related to, the pregnancy, the birth event, or the birthing process, in conformity with one or more of the following:(1) The list of Birth Defects Descriptions for National Birth Defects Prevention Network (NBDPN) Core, Recommended, and Extended Conditions issued by the federal Centers for Disease Control and Prevention (CDC).(2) Medical eligibility for the California Childrens Services Program or its High-Risk Infant Follow-Up (HRIF) program.(3) As dictated by the needs of, and response to, a public health or environmental emergency.(b) Birth defect means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(c) Reporting institutions means health facilities, as that term is defined in Section 103830, and laboratories that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.SEC. 3. Section 103832 is added to the Health and Safety Code, to read:103832. (a) A local health officer may maintain a system for the collection of information necessary to accomplish the purposes of this chapter.(b) Information about birth defects and other birth anomalies may be reported using either of the following systems at the discretion of the director or the local health officer:(1) A system that requires reporting institutions to make their records available for review and information collection by designated staff of the local birth defects and other birth anomalies monitoring program.(2) A system that requires reporting institutions, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.(c) A local health officer may require reporting institutions to make their records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected birth defects and other birth anomalies information to the local public health program pursuant to paragraph (2) of subdivision (b), or implement a hybrid of the two systems. A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their jurisdiction, but may supplement the activities for local uses and purposes.(d) Birth defects and other birth anomalies to be reported in a local health jurisdiction at the direction of the local health officer are determined at the discretion of the local health officer.SEC. 4. Section 103835 of the Health and Safety Code is amended to read:103835. (a) The state birth defects monitoring program shall operate statewide. It is the intent of the Legislature that the adequacy of program resources to support the state birth defects monitoring program shall be assessed annually, and that the annually to determine where and in which jurisdictions the state will offer its program. The annual assessment shall include a consideration of at least all the following factors:(a) (1) The numbers of births in the state.(b) (2) The scope of program activities.(c) (3) Any urgent situation requiring extraordinary commitment of present or planned program staff or resources.(b) A local health officer may require reporting institution participation in birth defects and other birth anomalies reporting, as needed, to assess and address the needs of the local health jurisdiction, to supplement the state birth defects monitoring program in jurisdictions where it is conducted, if needed, or for birth defects and other birth anomalies reporting in a local health jurisdiction where there are no state birth defects monitoring activities.SEC. 5. Section 103840 of the Health and Safety Code is amended to read:103840. (a) The director shall use the information collected pursuant to Section 103830 Sections 103830 and 103832 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence. The(b) A local health officer may require birth defects and other birth anomalies reporting in their jurisdiction and may use that information for similar purposes.(c) The departments and local health officers investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, but may include investigation of past exposures.SEC. 6. Section 103845 of the Health and Safety Code is amended to read:103845. The (a) For the statewide program, the director shall appoint an advisory committee to advise on the implementation of this chapter. Each of the disciplines of epidemiology, hospital administration, biostatistics, maternal and child health health, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.(b) A local health officer may use resources from their local health program or jurisdiction representing the disciplines listed in subdivision (a), and others as necessary, to formulate sound policy and health orders for birth defects and other birth anomalies information collection.SEC. 7. Section 103850 of the Health and Safety Code is amended to read:103850. (a) (1) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For(2) For the purposes of this chapter, this information shall be referred to as confidential information. Access(3) Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, director or the local health officer, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.(b) The department or the local health officer, as appropriate, shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Subjects, or the institutional review board in the local health jurisdiction if the research is conducted at the direction of the local health officer. Satisfaction of the terms of the directors rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 or 103832 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department or the local health officer, as appropriate, that the entity has established the procedures and ability to maintain the confidentiality of the information.(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.(e) The furnishing of confidential information to the department or its department, the local health officer, or their authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.(f) Whenever When state program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall This section does not prohibit the publishing by the department or by a local jurisdiction of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. department or the local health officer. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department department, a local jurisdiction, or any person.(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.SEC. 8. Section 103855 of the Health and Safety Code is amended to read:103855. (a) The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.(b) Notwithstanding any state law, a local health officer may enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.SEC. 9. Section 124977 of the Health and Safety Code is amended to read:124977. (a) It is the intent of the Legislature that, unless otherwise specified, the state genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the statewide Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. The funds shall not be used to support birth defects and other birth anomalies information collection or research activities in a local health jurisdiction initiated by the jurisdictions health officer.(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.(E) The regulations shall become effective immediately upon filing by the Secretary of State.(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.SEC. 10. Section 124991 of the Health and Safety Code is amended to read:124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.(2) The department may limit the number of umbilical cord blood samples the program collects each year.(3) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:(1) Umbilical cord blood.(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.(3) Newborn blood collected by the Genetic Disease Screening Program.(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(h) (1) For purposes of ensuring the security of a donors personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:(A) Determine whether the requested personal information is needed to conduct the research.(B) Permit access to personal information only if it is needed for the research activity.(C) Permit access only to the minimum personal information necessary for the research activity.(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the departments process of protecting personal information, including, but not limited to, the departments costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.SEC. 11. Section 125002 of the Health and Safety Code is amended to read:125002. (a) (1) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.(2) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the departments approved researchers.(2) Protocol review for scientific merit by the department or another entity authorized by the department.(3) Protocol review by the State Committee for the Protection of Human Subjects.(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:(1) The research project was approved by the State Committee for the Protection of Human Subjects.(2) The research projects protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION Assembly Bill No. 1129Introduced by Assembly Member Celeste Rodriguez(Coauthor: Assembly Member Schiavo)February 20, 2025 An act to amend Sections 103825, 103835, 103840, 103845, 103850, 103855, 124977, 124991, and 125002 of, and to add Sections 103827 and 103832 to, the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGESTAB 1129, as introduced, Celeste Rodriguez. Birth defects monitoring.Existing law requires the State Public Health Officer to maintain a system for the collection of information related to birth defects, as specified. Existing law requires the officer to require general acute care hospitals and physician-owned or physician-operated clinics that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services to make available to the department the medical records of children suspected or diagnosed as having birth defects, as specified. Existing law authorizes the department to enter into a contract for the establishment and implementation of the birth defects monitoring program.This bill would authorize a local health officer to maintain a system for the collection of information related to birth defects and other birth anomalies. The bill would authorize a local health officer to require laboratories, as specified, in addition to the facilities listed above, to either make available or to transmit to the local health department birth defects and other birth anomalies information, as specified. The bill would authorize a local health officer to enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.Existing law requires the State Department of Public Health to collect and store any umbilical cord blood samples it receives from hospitals for storage and research and states the intent of the Legislature that pregnancy blood samples be stored and made available to any researcher who is approved by the department for specified purposes.This bill would exempt umbilical cord and pregnancy blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes from the provisions described above.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: NO Local Program: NO
CALIFORNIA LEGISLATURE 20252026 REGULAR SESSION
Assembly Bill
No. 1129
Introduced by Assembly Member Celeste Rodriguez(Coauthor: Assembly Member Schiavo)February 20, 2025
Introduced by Assembly Member Celeste Rodriguez(Coauthor: Assembly Member Schiavo)
February 20, 2025
An act to amend Sections 103825, 103835, 103840, 103845, 103850, 103855, 124977, 124991, and 125002 of, and to add Sections 103827 and 103832 to, the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
AB 1129, as introduced, Celeste Rodriguez. Birth defects monitoring.
Existing law requires the State Public Health Officer to maintain a system for the collection of information related to birth defects, as specified. Existing law requires the officer to require general acute care hospitals and physician-owned or physician-operated clinics that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services to make available to the department the medical records of children suspected or diagnosed as having birth defects, as specified. Existing law authorizes the department to enter into a contract for the establishment and implementation of the birth defects monitoring program.This bill would authorize a local health officer to maintain a system for the collection of information related to birth defects and other birth anomalies. The bill would authorize a local health officer to require laboratories, as specified, in addition to the facilities listed above, to either make available or to transmit to the local health department birth defects and other birth anomalies information, as specified. The bill would authorize a local health officer to enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.Existing law requires the State Department of Public Health to collect and store any umbilical cord blood samples it receives from hospitals for storage and research and states the intent of the Legislature that pregnancy blood samples be stored and made available to any researcher who is approved by the department for specified purposes.This bill would exempt umbilical cord and pregnancy blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes from the provisions described above.
Existing law requires the State Public Health Officer to maintain a system for the collection of information related to birth defects, as specified. Existing law requires the officer to require general acute care hospitals and physician-owned or physician-operated clinics that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services to make available to the department the medical records of children suspected or diagnosed as having birth defects, as specified. Existing law authorizes the department to enter into a contract for the establishment and implementation of the birth defects monitoring program.
This bill would authorize a local health officer to maintain a system for the collection of information related to birth defects and other birth anomalies. The bill would authorize a local health officer to require laboratories, as specified, in addition to the facilities listed above, to either make available or to transmit to the local health department birth defects and other birth anomalies information, as specified. The bill would authorize a local health officer to enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.
Existing law requires the State Department of Public Health to collect and store any umbilical cord blood samples it receives from hospitals for storage and research and states the intent of the Legislature that pregnancy blood samples be stored and made available to any researcher who is approved by the department for specified purposes.
This bill would exempt umbilical cord and pregnancy blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes from the provisions described above.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 103825 of the Health and Safety Code is amended to read:103825. The Legislature hereby finds and declares that birth defects, defects and other anomalies present at, or caused by, birth, stillbirths, and miscarriages represent problems of public health importance about which too little is known; that these conditions lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs; and that a system to obtain more information about these conditions could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in enacting this section to accomplish all of the following:(a) To enable and maintain an ongoing program of birth defects and other birth anomalies monitoring statewide. Birth defect as used in this chapter means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(b) To provide information on the incidence, prevalence, and trends of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(c) To provide information to determine whether environmental hazards are associated with birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(d) To provide information as to other possible causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(e) To develop prevention strategies for reducing the incidence of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(f) To conduct interview studies about the causes of birth defects. defects and other birth anomalies.(g) To affirm the authority of the state department to contract with a qualified entity to operate the birth defects defects and other birth anomalies monitoring program statewide.(h) To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and other birth anomalies in their local health jurisdiction in order to supplement state efforts or in the absence of state efforts in their jurisdiction.SEC. 2. Section 103827 is added to the Health and Safety Code, to read:103827. For the purposes of this chapter, the following terms have the following meanings:(a) Birth anomalies means defects, conditions, or disorders affecting a fetus, a newborn, or an infant that result congenitally, at the birth event, or that are suspected to be caused by, or related to, the pregnancy, the birth event, or the birthing process, in conformity with one or more of the following:(1) The list of Birth Defects Descriptions for National Birth Defects Prevention Network (NBDPN) Core, Recommended, and Extended Conditions issued by the federal Centers for Disease Control and Prevention (CDC).(2) Medical eligibility for the California Childrens Services Program or its High-Risk Infant Follow-Up (HRIF) program.(3) As dictated by the needs of, and response to, a public health or environmental emergency.(b) Birth defect means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(c) Reporting institutions means health facilities, as that term is defined in Section 103830, and laboratories that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.SEC. 3. Section 103832 is added to the Health and Safety Code, to read:103832. (a) A local health officer may maintain a system for the collection of information necessary to accomplish the purposes of this chapter.(b) Information about birth defects and other birth anomalies may be reported using either of the following systems at the discretion of the director or the local health officer:(1) A system that requires reporting institutions to make their records available for review and information collection by designated staff of the local birth defects and other birth anomalies monitoring program.(2) A system that requires reporting institutions, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.(c) A local health officer may require reporting institutions to make their records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected birth defects and other birth anomalies information to the local public health program pursuant to paragraph (2) of subdivision (b), or implement a hybrid of the two systems. A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their jurisdiction, but may supplement the activities for local uses and purposes.(d) Birth defects and other birth anomalies to be reported in a local health jurisdiction at the direction of the local health officer are determined at the discretion of the local health officer.SEC. 4. Section 103835 of the Health and Safety Code is amended to read:103835. (a) The state birth defects monitoring program shall operate statewide. It is the intent of the Legislature that the adequacy of program resources to support the state birth defects monitoring program shall be assessed annually, and that the annually to determine where and in which jurisdictions the state will offer its program. The annual assessment shall include a consideration of at least all the following factors:(a) (1) The numbers of births in the state.(b) (2) The scope of program activities.(c) (3) Any urgent situation requiring extraordinary commitment of present or planned program staff or resources.(b) A local health officer may require reporting institution participation in birth defects and other birth anomalies reporting, as needed, to assess and address the needs of the local health jurisdiction, to supplement the state birth defects monitoring program in jurisdictions where it is conducted, if needed, or for birth defects and other birth anomalies reporting in a local health jurisdiction where there are no state birth defects monitoring activities.SEC. 5. Section 103840 of the Health and Safety Code is amended to read:103840. (a) The director shall use the information collected pursuant to Section 103830 Sections 103830 and 103832 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence. The(b) A local health officer may require birth defects and other birth anomalies reporting in their jurisdiction and may use that information for similar purposes.(c) The departments and local health officers investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, but may include investigation of past exposures.SEC. 6. Section 103845 of the Health and Safety Code is amended to read:103845. The (a) For the statewide program, the director shall appoint an advisory committee to advise on the implementation of this chapter. Each of the disciplines of epidemiology, hospital administration, biostatistics, maternal and child health health, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.(b) A local health officer may use resources from their local health program or jurisdiction representing the disciplines listed in subdivision (a), and others as necessary, to formulate sound policy and health orders for birth defects and other birth anomalies information collection.SEC. 7. Section 103850 of the Health and Safety Code is amended to read:103850. (a) (1) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For(2) For the purposes of this chapter, this information shall be referred to as confidential information. Access(3) Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, director or the local health officer, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.(b) The department or the local health officer, as appropriate, shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Subjects, or the institutional review board in the local health jurisdiction if the research is conducted at the direction of the local health officer. Satisfaction of the terms of the directors rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 or 103832 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department or the local health officer, as appropriate, that the entity has established the procedures and ability to maintain the confidentiality of the information.(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.(e) The furnishing of confidential information to the department or its department, the local health officer, or their authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.(f) Whenever When state program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall This section does not prohibit the publishing by the department or by a local jurisdiction of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. department or the local health officer. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department department, a local jurisdiction, or any person.(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.SEC. 8. Section 103855 of the Health and Safety Code is amended to read:103855. (a) The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.(b) Notwithstanding any state law, a local health officer may enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.SEC. 9. Section 124977 of the Health and Safety Code is amended to read:124977. (a) It is the intent of the Legislature that, unless otherwise specified, the state genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the statewide Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. The funds shall not be used to support birth defects and other birth anomalies information collection or research activities in a local health jurisdiction initiated by the jurisdictions health officer.(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.(E) The regulations shall become effective immediately upon filing by the Secretary of State.(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.SEC. 10. Section 124991 of the Health and Safety Code is amended to read:124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.(2) The department may limit the number of umbilical cord blood samples the program collects each year.(3) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:(1) Umbilical cord blood.(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.(3) Newborn blood collected by the Genetic Disease Screening Program.(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(h) (1) For purposes of ensuring the security of a donors personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:(A) Determine whether the requested personal information is needed to conduct the research.(B) Permit access to personal information only if it is needed for the research activity.(C) Permit access only to the minimum personal information necessary for the research activity.(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the departments process of protecting personal information, including, but not limited to, the departments costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.SEC. 11. Section 125002 of the Health and Safety Code is amended to read:125002. (a) (1) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.(2) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the departments approved researchers.(2) Protocol review for scientific merit by the department or another entity authorized by the department.(3) Protocol review by the State Committee for the Protection of Human Subjects.(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:(1) The research project was approved by the State Committee for the Protection of Human Subjects.(2) The research projects protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 103825 of the Health and Safety Code is amended to read:103825. The Legislature hereby finds and declares that birth defects, defects and other anomalies present at, or caused by, birth, stillbirths, and miscarriages represent problems of public health importance about which too little is known; that these conditions lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs; and that a system to obtain more information about these conditions could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in enacting this section to accomplish all of the following:(a) To enable and maintain an ongoing program of birth defects and other birth anomalies monitoring statewide. Birth defect as used in this chapter means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(b) To provide information on the incidence, prevalence, and trends of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(c) To provide information to determine whether environmental hazards are associated with birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(d) To provide information as to other possible causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(e) To develop prevention strategies for reducing the incidence of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(f) To conduct interview studies about the causes of birth defects. defects and other birth anomalies.(g) To affirm the authority of the state department to contract with a qualified entity to operate the birth defects defects and other birth anomalies monitoring program statewide.(h) To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and other birth anomalies in their local health jurisdiction in order to supplement state efforts or in the absence of state efforts in their jurisdiction.
SECTION 1. Section 103825 of the Health and Safety Code is amended to read:
### SECTION 1.
103825. The Legislature hereby finds and declares that birth defects, defects and other anomalies present at, or caused by, birth, stillbirths, and miscarriages represent problems of public health importance about which too little is known; that these conditions lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs; and that a system to obtain more information about these conditions could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in enacting this section to accomplish all of the following:(a) To enable and maintain an ongoing program of birth defects and other birth anomalies monitoring statewide. Birth defect as used in this chapter means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(b) To provide information on the incidence, prevalence, and trends of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(c) To provide information to determine whether environmental hazards are associated with birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(d) To provide information as to other possible causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(e) To develop prevention strategies for reducing the incidence of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(f) To conduct interview studies about the causes of birth defects. defects and other birth anomalies.(g) To affirm the authority of the state department to contract with a qualified entity to operate the birth defects defects and other birth anomalies monitoring program statewide.(h) To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and other birth anomalies in their local health jurisdiction in order to supplement state efforts or in the absence of state efforts in their jurisdiction.
103825. The Legislature hereby finds and declares that birth defects, defects and other anomalies present at, or caused by, birth, stillbirths, and miscarriages represent problems of public health importance about which too little is known; that these conditions lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs; and that a system to obtain more information about these conditions could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in enacting this section to accomplish all of the following:(a) To enable and maintain an ongoing program of birth defects and other birth anomalies monitoring statewide. Birth defect as used in this chapter means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(b) To provide information on the incidence, prevalence, and trends of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(c) To provide information to determine whether environmental hazards are associated with birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(d) To provide information as to other possible causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(e) To develop prevention strategies for reducing the incidence of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(f) To conduct interview studies about the causes of birth defects. defects and other birth anomalies.(g) To affirm the authority of the state department to contract with a qualified entity to operate the birth defects defects and other birth anomalies monitoring program statewide.(h) To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and other birth anomalies in their local health jurisdiction in order to supplement state efforts or in the absence of state efforts in their jurisdiction.
103825. The Legislature hereby finds and declares that birth defects, defects and other anomalies present at, or caused by, birth, stillbirths, and miscarriages represent problems of public health importance about which too little is known; that these conditions lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs; and that a system to obtain more information about these conditions could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in enacting this section to accomplish all of the following:(a) To enable and maintain an ongoing program of birth defects and other birth anomalies monitoring statewide. Birth defect as used in this chapter means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(b) To provide information on the incidence, prevalence, and trends of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(c) To provide information to determine whether environmental hazards are associated with birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(d) To provide information as to other possible causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(e) To develop prevention strategies for reducing the incidence of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.(f) To conduct interview studies about the causes of birth defects. defects and other birth anomalies.(g) To affirm the authority of the state department to contract with a qualified entity to operate the birth defects defects and other birth anomalies monitoring program statewide.(h) To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and other birth anomalies in their local health jurisdiction in order to supplement state efforts or in the absence of state efforts in their jurisdiction.
103825. The Legislature hereby finds and declares that birth defects, defects and other anomalies present at, or caused by, birth, stillbirths, and miscarriages represent problems of public health importance about which too little is known; that these conditions lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs; and that a system to obtain more information about these conditions could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in enacting this section to accomplish all of the following:
(a) To enable and maintain an ongoing program of birth defects and other birth anomalies monitoring statewide. Birth defect as used in this chapter means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.
(b) To provide information on the incidence, prevalence, and trends of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.
(c) To provide information to determine whether environmental hazards are associated with birth defects, defects and other birth anomalies, stillbirths, and miscarriages.
(d) To provide information as to other possible causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.
(e) To develop prevention strategies for reducing the incidence of birth defects, defects and other birth anomalies, stillbirths, and miscarriages.
(f) To conduct interview studies about the causes of birth defects. defects and other birth anomalies.
(g) To affirm the authority of the state department to contract with a qualified entity to operate the birth defects defects and other birth anomalies monitoring program statewide.
(h) To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and other birth anomalies in their local health jurisdiction in order to supplement state efforts or in the absence of state efforts in their jurisdiction.
SEC. 2. Section 103827 is added to the Health and Safety Code, to read:103827. For the purposes of this chapter, the following terms have the following meanings:(a) Birth anomalies means defects, conditions, or disorders affecting a fetus, a newborn, or an infant that result congenitally, at the birth event, or that are suspected to be caused by, or related to, the pregnancy, the birth event, or the birthing process, in conformity with one or more of the following:(1) The list of Birth Defects Descriptions for National Birth Defects Prevention Network (NBDPN) Core, Recommended, and Extended Conditions issued by the federal Centers for Disease Control and Prevention (CDC).(2) Medical eligibility for the California Childrens Services Program or its High-Risk Infant Follow-Up (HRIF) program.(3) As dictated by the needs of, and response to, a public health or environmental emergency.(b) Birth defect means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(c) Reporting institutions means health facilities, as that term is defined in Section 103830, and laboratories that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.
SEC. 2. Section 103827 is added to the Health and Safety Code, to read:
### SEC. 2.
103827. For the purposes of this chapter, the following terms have the following meanings:(a) Birth anomalies means defects, conditions, or disorders affecting a fetus, a newborn, or an infant that result congenitally, at the birth event, or that are suspected to be caused by, or related to, the pregnancy, the birth event, or the birthing process, in conformity with one or more of the following:(1) The list of Birth Defects Descriptions for National Birth Defects Prevention Network (NBDPN) Core, Recommended, and Extended Conditions issued by the federal Centers for Disease Control and Prevention (CDC).(2) Medical eligibility for the California Childrens Services Program or its High-Risk Infant Follow-Up (HRIF) program.(3) As dictated by the needs of, and response to, a public health or environmental emergency.(b) Birth defect means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(c) Reporting institutions means health facilities, as that term is defined in Section 103830, and laboratories that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.
103827. For the purposes of this chapter, the following terms have the following meanings:(a) Birth anomalies means defects, conditions, or disorders affecting a fetus, a newborn, or an infant that result congenitally, at the birth event, or that are suspected to be caused by, or related to, the pregnancy, the birth event, or the birthing process, in conformity with one or more of the following:(1) The list of Birth Defects Descriptions for National Birth Defects Prevention Network (NBDPN) Core, Recommended, and Extended Conditions issued by the federal Centers for Disease Control and Prevention (CDC).(2) Medical eligibility for the California Childrens Services Program or its High-Risk Infant Follow-Up (HRIF) program.(3) As dictated by the needs of, and response to, a public health or environmental emergency.(b) Birth defect means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(c) Reporting institutions means health facilities, as that term is defined in Section 103830, and laboratories that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.
103827. For the purposes of this chapter, the following terms have the following meanings:(a) Birth anomalies means defects, conditions, or disorders affecting a fetus, a newborn, or an infant that result congenitally, at the birth event, or that are suspected to be caused by, or related to, the pregnancy, the birth event, or the birthing process, in conformity with one or more of the following:(1) The list of Birth Defects Descriptions for National Birth Defects Prevention Network (NBDPN) Core, Recommended, and Extended Conditions issued by the federal Centers for Disease Control and Prevention (CDC).(2) Medical eligibility for the California Childrens Services Program or its High-Risk Infant Follow-Up (HRIF) program.(3) As dictated by the needs of, and response to, a public health or environmental emergency.(b) Birth defect means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.(c) Reporting institutions means health facilities, as that term is defined in Section 103830, and laboratories that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.
103827. For the purposes of this chapter, the following terms have the following meanings:
(a) Birth anomalies means defects, conditions, or disorders affecting a fetus, a newborn, or an infant that result congenitally, at the birth event, or that are suspected to be caused by, or related to, the pregnancy, the birth event, or the birthing process, in conformity with one or more of the following:
(1) The list of Birth Defects Descriptions for National Birth Defects Prevention Network (NBDPN) Core, Recommended, and Extended Conditions issued by the federal Centers for Disease Control and Prevention (CDC).
(2) Medical eligibility for the California Childrens Services Program or its High-Risk Infant Follow-Up (HRIF) program.
(3) As dictated by the needs of, and response to, a public health or environmental emergency.
(b) Birth defect means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.
(c) Reporting institutions means health facilities, as that term is defined in Section 103830, and laboratories that regularly provide services for the diagnosis or treatment of birth defects, genetic counseling, or prenatal diagnostic services.
SEC. 3. Section 103832 is added to the Health and Safety Code, to read:103832. (a) A local health officer may maintain a system for the collection of information necessary to accomplish the purposes of this chapter.(b) Information about birth defects and other birth anomalies may be reported using either of the following systems at the discretion of the director or the local health officer:(1) A system that requires reporting institutions to make their records available for review and information collection by designated staff of the local birth defects and other birth anomalies monitoring program.(2) A system that requires reporting institutions, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.(c) A local health officer may require reporting institutions to make their records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected birth defects and other birth anomalies information to the local public health program pursuant to paragraph (2) of subdivision (b), or implement a hybrid of the two systems. A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their jurisdiction, but may supplement the activities for local uses and purposes.(d) Birth defects and other birth anomalies to be reported in a local health jurisdiction at the direction of the local health officer are determined at the discretion of the local health officer.
SEC. 3. Section 103832 is added to the Health and Safety Code, to read:
### SEC. 3.
103832. (a) A local health officer may maintain a system for the collection of information necessary to accomplish the purposes of this chapter.(b) Information about birth defects and other birth anomalies may be reported using either of the following systems at the discretion of the director or the local health officer:(1) A system that requires reporting institutions to make their records available for review and information collection by designated staff of the local birth defects and other birth anomalies monitoring program.(2) A system that requires reporting institutions, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.(c) A local health officer may require reporting institutions to make their records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected birth defects and other birth anomalies information to the local public health program pursuant to paragraph (2) of subdivision (b), or implement a hybrid of the two systems. A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their jurisdiction, but may supplement the activities for local uses and purposes.(d) Birth defects and other birth anomalies to be reported in a local health jurisdiction at the direction of the local health officer are determined at the discretion of the local health officer.
103832. (a) A local health officer may maintain a system for the collection of information necessary to accomplish the purposes of this chapter.(b) Information about birth defects and other birth anomalies may be reported using either of the following systems at the discretion of the director or the local health officer:(1) A system that requires reporting institutions to make their records available for review and information collection by designated staff of the local birth defects and other birth anomalies monitoring program.(2) A system that requires reporting institutions, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.(c) A local health officer may require reporting institutions to make their records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected birth defects and other birth anomalies information to the local public health program pursuant to paragraph (2) of subdivision (b), or implement a hybrid of the two systems. A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their jurisdiction, but may supplement the activities for local uses and purposes.(d) Birth defects and other birth anomalies to be reported in a local health jurisdiction at the direction of the local health officer are determined at the discretion of the local health officer.
103832. (a) A local health officer may maintain a system for the collection of information necessary to accomplish the purposes of this chapter.(b) Information about birth defects and other birth anomalies may be reported using either of the following systems at the discretion of the director or the local health officer:(1) A system that requires reporting institutions to make their records available for review and information collection by designated staff of the local birth defects and other birth anomalies monitoring program.(2) A system that requires reporting institutions, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.(c) A local health officer may require reporting institutions to make their records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected birth defects and other birth anomalies information to the local public health program pursuant to paragraph (2) of subdivision (b), or implement a hybrid of the two systems. A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their jurisdiction, but may supplement the activities for local uses and purposes.(d) Birth defects and other birth anomalies to be reported in a local health jurisdiction at the direction of the local health officer are determined at the discretion of the local health officer.
103832. (a) A local health officer may maintain a system for the collection of information necessary to accomplish the purposes of this chapter.
(b) Information about birth defects and other birth anomalies may be reported using either of the following systems at the discretion of the director or the local health officer:
(1) A system that requires reporting institutions to make their records available for review and information collection by designated staff of the local birth defects and other birth anomalies monitoring program.
(2) A system that requires reporting institutions, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.
(c) A local health officer may require reporting institutions to make their records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected birth defects and other birth anomalies information to the local public health program pursuant to paragraph (2) of subdivision (b), or implement a hybrid of the two systems. A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their jurisdiction, but may supplement the activities for local uses and purposes.
(d) Birth defects and other birth anomalies to be reported in a local health jurisdiction at the direction of the local health officer are determined at the discretion of the local health officer.
SEC. 4. Section 103835 of the Health and Safety Code is amended to read:103835. (a) The state birth defects monitoring program shall operate statewide. It is the intent of the Legislature that the adequacy of program resources to support the state birth defects monitoring program shall be assessed annually, and that the annually to determine where and in which jurisdictions the state will offer its program. The annual assessment shall include a consideration of at least all the following factors:(a) (1) The numbers of births in the state.(b) (2) The scope of program activities.(c) (3) Any urgent situation requiring extraordinary commitment of present or planned program staff or resources.(b) A local health officer may require reporting institution participation in birth defects and other birth anomalies reporting, as needed, to assess and address the needs of the local health jurisdiction, to supplement the state birth defects monitoring program in jurisdictions where it is conducted, if needed, or for birth defects and other birth anomalies reporting in a local health jurisdiction where there are no state birth defects monitoring activities.
SEC. 4. Section 103835 of the Health and Safety Code is amended to read:
### SEC. 4.
103835. (a) The state birth defects monitoring program shall operate statewide. It is the intent of the Legislature that the adequacy of program resources to support the state birth defects monitoring program shall be assessed annually, and that the annually to determine where and in which jurisdictions the state will offer its program. The annual assessment shall include a consideration of at least all the following factors:(a) (1) The numbers of births in the state.(b) (2) The scope of program activities.(c) (3) Any urgent situation requiring extraordinary commitment of present or planned program staff or resources.(b) A local health officer may require reporting institution participation in birth defects and other birth anomalies reporting, as needed, to assess and address the needs of the local health jurisdiction, to supplement the state birth defects monitoring program in jurisdictions where it is conducted, if needed, or for birth defects and other birth anomalies reporting in a local health jurisdiction where there are no state birth defects monitoring activities.
103835. (a) The state birth defects monitoring program shall operate statewide. It is the intent of the Legislature that the adequacy of program resources to support the state birth defects monitoring program shall be assessed annually, and that the annually to determine where and in which jurisdictions the state will offer its program. The annual assessment shall include a consideration of at least all the following factors:(a) (1) The numbers of births in the state.(b) (2) The scope of program activities.(c) (3) Any urgent situation requiring extraordinary commitment of present or planned program staff or resources.(b) A local health officer may require reporting institution participation in birth defects and other birth anomalies reporting, as needed, to assess and address the needs of the local health jurisdiction, to supplement the state birth defects monitoring program in jurisdictions where it is conducted, if needed, or for birth defects and other birth anomalies reporting in a local health jurisdiction where there are no state birth defects monitoring activities.
103835. (a) The state birth defects monitoring program shall operate statewide. It is the intent of the Legislature that the adequacy of program resources to support the state birth defects monitoring program shall be assessed annually, and that the annually to determine where and in which jurisdictions the state will offer its program. The annual assessment shall include a consideration of at least all the following factors:(a) (1) The numbers of births in the state.(b) (2) The scope of program activities.(c) (3) Any urgent situation requiring extraordinary commitment of present or planned program staff or resources.(b) A local health officer may require reporting institution participation in birth defects and other birth anomalies reporting, as needed, to assess and address the needs of the local health jurisdiction, to supplement the state birth defects monitoring program in jurisdictions where it is conducted, if needed, or for birth defects and other birth anomalies reporting in a local health jurisdiction where there are no state birth defects monitoring activities.
103835. (a) The state birth defects monitoring program shall operate statewide. It is the intent of the Legislature that the adequacy of program resources to support the state birth defects monitoring program shall be assessed annually, and that the annually to determine where and in which jurisdictions the state will offer its program. The annual assessment shall include a consideration of at least all the following factors:
(a)
(1) The numbers of births in the state.
(b)
(2) The scope of program activities.
(c)
(3) Any urgent situation requiring extraordinary commitment of present or planned program staff or resources.
(b) A local health officer may require reporting institution participation in birth defects and other birth anomalies reporting, as needed, to assess and address the needs of the local health jurisdiction, to supplement the state birth defects monitoring program in jurisdictions where it is conducted, if needed, or for birth defects and other birth anomalies reporting in a local health jurisdiction where there are no state birth defects monitoring activities.
SEC. 5. Section 103840 of the Health and Safety Code is amended to read:103840. (a) The director shall use the information collected pursuant to Section 103830 Sections 103830 and 103832 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence. The(b) A local health officer may require birth defects and other birth anomalies reporting in their jurisdiction and may use that information for similar purposes.(c) The departments and local health officers investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, but may include investigation of past exposures.
SEC. 5. Section 103840 of the Health and Safety Code is amended to read:
### SEC. 5.
103840. (a) The director shall use the information collected pursuant to Section 103830 Sections 103830 and 103832 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence. The(b) A local health officer may require birth defects and other birth anomalies reporting in their jurisdiction and may use that information for similar purposes.(c) The departments and local health officers investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, but may include investigation of past exposures.
103840. (a) The director shall use the information collected pursuant to Section 103830 Sections 103830 and 103832 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence. The(b) A local health officer may require birth defects and other birth anomalies reporting in their jurisdiction and may use that information for similar purposes.(c) The departments and local health officers investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, but may include investigation of past exposures.
103840. (a) The director shall use the information collected pursuant to Section 103830 Sections 103830 and 103832 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence. The(b) A local health officer may require birth defects and other birth anomalies reporting in their jurisdiction and may use that information for similar purposes.(c) The departments and local health officers investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, but may include investigation of past exposures.
103840. (a) The director shall use the information collected pursuant to Section 103830 Sections 103830 and 103832 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, defects and other birth anomalies, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence. The
(b) A local health officer may require birth defects and other birth anomalies reporting in their jurisdiction and may use that information for similar purposes.
(c) The departments and local health officers investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, but may include investigation of past exposures.
SEC. 6. Section 103845 of the Health and Safety Code is amended to read:103845. The (a) For the statewide program, the director shall appoint an advisory committee to advise on the implementation of this chapter. Each of the disciplines of epidemiology, hospital administration, biostatistics, maternal and child health health, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.(b) A local health officer may use resources from their local health program or jurisdiction representing the disciplines listed in subdivision (a), and others as necessary, to formulate sound policy and health orders for birth defects and other birth anomalies information collection.
SEC. 6. Section 103845 of the Health and Safety Code is amended to read:
### SEC. 6.
103845. The (a) For the statewide program, the director shall appoint an advisory committee to advise on the implementation of this chapter. Each of the disciplines of epidemiology, hospital administration, biostatistics, maternal and child health health, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.(b) A local health officer may use resources from their local health program or jurisdiction representing the disciplines listed in subdivision (a), and others as necessary, to formulate sound policy and health orders for birth defects and other birth anomalies information collection.
103845. The (a) For the statewide program, the director shall appoint an advisory committee to advise on the implementation of this chapter. Each of the disciplines of epidemiology, hospital administration, biostatistics, maternal and child health health, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.(b) A local health officer may use resources from their local health program or jurisdiction representing the disciplines listed in subdivision (a), and others as necessary, to formulate sound policy and health orders for birth defects and other birth anomalies information collection.
103845. The (a) For the statewide program, the director shall appoint an advisory committee to advise on the implementation of this chapter. Each of the disciplines of epidemiology, hospital administration, biostatistics, maternal and child health health, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.(b) A local health officer may use resources from their local health program or jurisdiction representing the disciplines listed in subdivision (a), and others as necessary, to formulate sound policy and health orders for birth defects and other birth anomalies information collection.
103845. The (a) For the statewide program, the director shall appoint an advisory committee to advise on the implementation of this chapter. Each of the disciplines of epidemiology, hospital administration, biostatistics, maternal and child health health, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.
(b) A local health officer may use resources from their local health program or jurisdiction representing the disciplines listed in subdivision (a), and others as necessary, to formulate sound policy and health orders for birth defects and other birth anomalies information collection.
SEC. 7. Section 103850 of the Health and Safety Code is amended to read:103850. (a) (1) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For(2) For the purposes of this chapter, this information shall be referred to as confidential information. Access(3) Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, director or the local health officer, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.(b) The department or the local health officer, as appropriate, shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Subjects, or the institutional review board in the local health jurisdiction if the research is conducted at the direction of the local health officer. Satisfaction of the terms of the directors rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 or 103832 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department or the local health officer, as appropriate, that the entity has established the procedures and ability to maintain the confidentiality of the information.(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.(e) The furnishing of confidential information to the department or its department, the local health officer, or their authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.(f) Whenever When state program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall This section does not prohibit the publishing by the department or by a local jurisdiction of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. department or the local health officer. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department department, a local jurisdiction, or any person.(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
SEC. 7. Section 103850 of the Health and Safety Code is amended to read:
### SEC. 7.
103850. (a) (1) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For(2) For the purposes of this chapter, this information shall be referred to as confidential information. Access(3) Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, director or the local health officer, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.(b) The department or the local health officer, as appropriate, shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Subjects, or the institutional review board in the local health jurisdiction if the research is conducted at the direction of the local health officer. Satisfaction of the terms of the directors rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 or 103832 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department or the local health officer, as appropriate, that the entity has established the procedures and ability to maintain the confidentiality of the information.(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.(e) The furnishing of confidential information to the department or its department, the local health officer, or their authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.(f) Whenever When state program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall This section does not prohibit the publishing by the department or by a local jurisdiction of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. department or the local health officer. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department department, a local jurisdiction, or any person.(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
103850. (a) (1) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For(2) For the purposes of this chapter, this information shall be referred to as confidential information. Access(3) Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, director or the local health officer, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.(b) The department or the local health officer, as appropriate, shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Subjects, or the institutional review board in the local health jurisdiction if the research is conducted at the direction of the local health officer. Satisfaction of the terms of the directors rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 or 103832 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department or the local health officer, as appropriate, that the entity has established the procedures and ability to maintain the confidentiality of the information.(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.(e) The furnishing of confidential information to the department or its department, the local health officer, or their authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.(f) Whenever When state program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall This section does not prohibit the publishing by the department or by a local jurisdiction of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. department or the local health officer. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department department, a local jurisdiction, or any person.(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
103850. (a) (1) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For(2) For the purposes of this chapter, this information shall be referred to as confidential information. Access(3) Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, director or the local health officer, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.(b) The department or the local health officer, as appropriate, shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Subjects, or the institutional review board in the local health jurisdiction if the research is conducted at the direction of the local health officer. Satisfaction of the terms of the directors rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 or 103832 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department or the local health officer, as appropriate, that the entity has established the procedures and ability to maintain the confidentiality of the information.(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.(e) The furnishing of confidential information to the department or its department, the local health officer, or their authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.(f) Whenever When state program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall This section does not prohibit the publishing by the department or by a local jurisdiction of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. department or the local health officer. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department department, a local jurisdiction, or any person.(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
103850. (a) (1) All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter. For
(2) For the purposes of this chapter, this information shall be referred to as confidential information. Access
(3) Access to confidential information shall be limited to authorized program staff, and persons with a valid scientific interest, who meet qualifications as determined by the director, director or the local health officer, who are engaged in demographic, epidemiological or other similar studies related to health, and who agree, in writing, to maintain confidentiality.
(b) The department or the local health officer, as appropriate, shall maintain an accurate record of all persons who are given access to confidential information. The record shall include: the name of the person authorizing access; name, title, address, and organizational affiliation of persons given access; dates of access; and the specific purpose for which information is to be used. The record of access shall be open to public inspection during normal operating hours of the state department.
(c) All research proposed to be conducted by persons other than program staff, using confidential information in the system, shall first be reviewed and approved by the director and the State Committee for the Protection of Human Subjects. Subjects, or the institutional review board in the local health jurisdiction if the research is conducted at the direction of the local health officer. Satisfaction of the terms of the directors rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 or 103832 and to contact case subjects and controls. Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the department or the local health officer, as appropriate, that the entity has established the procedures and ability to maintain the confidentiality of the information.
(d) Notwithstanding any other provision of law, any disclosure authorized by this section shall include only the information necessary for the stated purpose of the requested disclosure, and shall be made only upon written agreement that the information will be kept confidential, used for the approved purpose, and not be further disclosed.
(e) The furnishing of confidential information to the department or its department, the local health officer, or their authorized representative in accordance with this section shall not expose any person, agency, or entity furnishing the information to liability, and shall not be considered a waiver of any privilege or a violation of a confidential relationship.
(f) Whenever When state program staff, pursuing program objectives, deems it necessary to contact case subjects and controls, program staff shall submit a protocol describing the research to the director and to the State Committee for the Protection of Human Subjects. Once a protocol is approved by that committee, program staff shall be deemed to have established a bona fide research purpose, and shall be entitled to complete the approved project and contact case subjects and controls without securing any additional approvals or waivers from any entity.
(g) Notwithstanding any other provision of law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. Nothing in this section shall This section does not prohibit the publishing by the department or by a local jurisdiction of reports and statistical compilations relating to birth defects, stillbirth, or miscarriage that do not in any way identify individual cases or individual sources of information.
(h) Any person who, in violation of a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to any confidential information maintained by the department. department or the local health officer. That person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section shall not be construed as restricting any remedy, provisional or otherwise, provided by law for the benefit of the department department, a local jurisdiction, or any person.
(i) Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to his or her their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
SEC. 8. Section 103855 of the Health and Safety Code is amended to read:103855. (a) The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.(b) Notwithstanding any state law, a local health officer may enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.
SEC. 8. Section 103855 of the Health and Safety Code is amended to read:
### SEC. 8.
103855. (a) The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.(b) Notwithstanding any state law, a local health officer may enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.
103855. (a) The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.(b) Notwithstanding any state law, a local health officer may enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.
103855. (a) The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.(b) Notwithstanding any state law, a local health officer may enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.
103855. (a) The department may enter into a contract for the establishment and implementation of the birth defects monitoring program. The contract shall include provisions requiring full compliance with all the requirements of this chapter. The term of the contract may be in excess of one year, but no longer than three years. Funds shall be allocated in accordance with the state Budget Act. Funds withheld from the contractor at the conclusion of a fiscal year until specified tasks are completed shall be released promptly on proof of substantial completion, and shall not be offset against any funding for the subsequent fiscal year.
(b) Notwithstanding any state law, a local health officer may enter into contracts for implementation of programs to collect and monitor birth anomalies in their jurisdiction.
SEC. 9. Section 124977 of the Health and Safety Code is amended to read:124977. (a) It is the intent of the Legislature that, unless otherwise specified, the state genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the statewide Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. The funds shall not be used to support birth defects and other birth anomalies information collection or research activities in a local health jurisdiction initiated by the jurisdictions health officer.(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.(E) The regulations shall become effective immediately upon filing by the Secretary of State.(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.
SEC. 9. Section 124977 of the Health and Safety Code is amended to read:
### SEC. 9.
124977. (a) It is the intent of the Legislature that, unless otherwise specified, the state genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the statewide Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. The funds shall not be used to support birth defects and other birth anomalies information collection or research activities in a local health jurisdiction initiated by the jurisdictions health officer.(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.(E) The regulations shall become effective immediately upon filing by the Secretary of State.(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.
124977. (a) It is the intent of the Legislature that, unless otherwise specified, the state genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the statewide Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. The funds shall not be used to support birth defects and other birth anomalies information collection or research activities in a local health jurisdiction initiated by the jurisdictions health officer.(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.(E) The regulations shall become effective immediately upon filing by the Secretary of State.(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.
124977. (a) It is the intent of the Legislature that, unless otherwise specified, the state genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the statewide Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. The funds shall not be used to support birth defects and other birth anomalies information collection or research activities in a local health jurisdiction initiated by the jurisdictions health officer.(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.(E) The regulations shall become effective immediately upon filing by the Secretary of State.(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.
124977. (a) It is the intent of the Legislature that, unless otherwise specified, the state genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.
(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.
(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.
(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.
(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.
(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).
(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.
(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the statewide Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. The funds shall not be used to support birth defects and other birth anomalies information collection or research activities in a local health jurisdiction initiated by the jurisdictions health officer.
(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.
(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.
(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.
(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.
(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.
(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.
(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.
(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.
(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.
(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.
(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.
(E) The regulations shall become effective immediately upon filing by the Secretary of State.
(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.
(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.
(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.
(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.
SEC. 10. Section 124991 of the Health and Safety Code is amended to read:124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.(2) The department may limit the number of umbilical cord blood samples the program collects each year.(3) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:(1) Umbilical cord blood.(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.(3) Newborn blood collected by the Genetic Disease Screening Program.(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(h) (1) For purposes of ensuring the security of a donors personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:(A) Determine whether the requested personal information is needed to conduct the research.(B) Permit access to personal information only if it is needed for the research activity.(C) Permit access only to the minimum personal information necessary for the research activity.(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the departments process of protecting personal information, including, but not limited to, the departments costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.
SEC. 10. Section 124991 of the Health and Safety Code is amended to read:
### SEC. 10.
124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.(2) The department may limit the number of umbilical cord blood samples the program collects each year.(3) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:(1) Umbilical cord blood.(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.(3) Newborn blood collected by the Genetic Disease Screening Program.(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(h) (1) For purposes of ensuring the security of a donors personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:(A) Determine whether the requested personal information is needed to conduct the research.(B) Permit access to personal information only if it is needed for the research activity.(C) Permit access only to the minimum personal information necessary for the research activity.(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the departments process of protecting personal information, including, but not limited to, the departments costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.
124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.(2) The department may limit the number of umbilical cord blood samples the program collects each year.(3) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:(1) Umbilical cord blood.(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.(3) Newborn blood collected by the Genetic Disease Screening Program.(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(h) (1) For purposes of ensuring the security of a donors personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:(A) Determine whether the requested personal information is needed to conduct the research.(B) Permit access to personal information only if it is needed for the research activity.(C) Permit access only to the minimum personal information necessary for the research activity.(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the departments process of protecting personal information, including, but not limited to, the departments costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.
124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.(2) The department may limit the number of umbilical cord blood samples the program collects each year.(3) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:(1) Umbilical cord blood.(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.(3) Newborn blood collected by the Genetic Disease Screening Program.(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(h) (1) For purposes of ensuring the security of a donors personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:(A) Determine whether the requested personal information is needed to conduct the research.(B) Permit access to personal information only if it is needed for the research activity.(C) Permit access only to the minimum personal information necessary for the research activity.(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the departments process of protecting personal information, including, but not limited to, the departments costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.
124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:
(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.
(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.
(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.
(2) The department may limit the number of umbilical cord blood samples the program collects each year.
(3) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.
(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.
(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.
(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.
(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:
(1) Umbilical cord blood.
(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.
(3) Newborn blood collected by the Genetic Disease Screening Program.
(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).
(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.
(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.
(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:
(1) Research to identify risk factors for childrens and womens diseases.
(2) Research to develop and evaluate screening tests.
(3) Research to develop and evaluate prevention strategies.
(4) Research to develop and evaluate treatments.
(h) (1) For purposes of ensuring the security of a donors personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:
(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.
(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.
(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.
(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:
(A) Determine whether the requested personal information is needed to conduct the research.
(B) Permit access to personal information only if it is needed for the research activity.
(C) Permit access only to the minimum personal information necessary for the research activity.
(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.
(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.
(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the departments process of protecting personal information, including, but not limited to, the departments costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.
(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.
SEC. 11. Section 125002 of the Health and Safety Code is amended to read:125002. (a) (1) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.(2) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the departments approved researchers.(2) Protocol review for scientific merit by the department or another entity authorized by the department.(3) Protocol review by the State Committee for the Protection of Human Subjects.(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:(1) The research project was approved by the State Committee for the Protection of Human Subjects.(2) The research projects protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
SEC. 11. Section 125002 of the Health and Safety Code is amended to read:
### SEC. 11.
125002. (a) (1) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.(2) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the departments approved researchers.(2) Protocol review for scientific merit by the department or another entity authorized by the department.(3) Protocol review by the State Committee for the Protection of Human Subjects.(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:(1) The research project was approved by the State Committee for the Protection of Human Subjects.(2) The research projects protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
125002. (a) (1) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.(2) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the departments approved researchers.(2) Protocol review for scientific merit by the department or another entity authorized by the department.(3) Protocol review by the State Committee for the Protection of Human Subjects.(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:(1) The research project was approved by the State Committee for the Protection of Human Subjects.(2) The research projects protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
125002. (a) (1) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.(2) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:(1) Research to identify risk factors for childrens and womens diseases.(2) Research to develop and evaluate screening tests.(3) Research to develop and evaluate prevention strategies.(4) Research to develop and evaluate treatments.(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the departments approved researchers.(2) Protocol review for scientific merit by the department or another entity authorized by the department.(3) Protocol review by the State Committee for the Protection of Human Subjects.(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:(1) The research project was approved by the State Committee for the Protection of Human Subjects.(2) The research projects protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.
125002. (a) (1) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.
(2) This subdivision does not apply to umbilical cord blood samples collected under the supervision of a local health officer in a local health jurisdiction for the purpose of monitoring birth defects or other birth anomalies or for other purposes.
(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:
(1) Research to identify risk factors for childrens and womens diseases.
(2) Research to develop and evaluate screening tests.
(3) Research to develop and evaluate prevention strategies.
(4) Research to develop and evaluate treatments.
(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:
(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the departments approved researchers.
(2) Protocol review for scientific merit by the department or another entity authorized by the department.
(3) Protocol review by the State Committee for the Protection of Human Subjects.
(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.
(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.
(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:
(1) The research project was approved by the State Committee for the Protection of Human Subjects.
(2) The research projects protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.
(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.
(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.
(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.