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<ns0:Description>
<ns0:Id>20250AB__112995AMD</ns0:Id>
<ns0:VersionNum>95</ns0:VersionNum>
<ns0:History>
<ns0:Action>
<ns0:ActionText>INTRODUCED</ns0:ActionText>
<ns0:ActionDate>2025-02-20</ns0:ActionDate>
</ns0:Action>
<ns0:Action>
<ns0:ActionText>AMENDED_ASSEMBLY</ns0:ActionText>
<ns0:ActionDate>2025-04-22</ns0:ActionDate>
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<ns0:Action>
<ns0:ActionText>AMENDED_ASSEMBLY</ns0:ActionText>
<ns0:ActionDate>2025-06-02</ns0:ActionDate>
</ns0:Action>
<ns0:Action>
<ns0:ActionText>AMENDED_SENATE</ns0:ActionText>
<ns0:ActionDate>2025-06-30</ns0:ActionDate>
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<ns0:Action>
<ns0:ActionText>AMENDED_SENATE</ns0:ActionText>
<ns0:ActionDate>2025-07-17</ns0:ActionDate>
</ns0:Action>
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<ns0:LegislativeInfo>
<ns0:SessionYear>2025</ns0:SessionYear>
<ns0:SessionNum>0</ns0:SessionNum>
<ns0:MeasureType>AB</ns0:MeasureType>
<ns0:MeasureNum>1129</ns0:MeasureNum>
<ns0:MeasureState>AMD</ns0:MeasureState>
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<ns0:AuthorText authorType="LEAD_AUTHOR">Introduced by Assembly Member Celeste Rodriguez</ns0:AuthorText>
<ns0:AuthorText authorType="COAUTHOR_ORIGINATING">(Coauthor: Assembly Member Schiavo)</ns0:AuthorText>
<ns0:Authors>
<ns0:Legislator>
<ns0:Contribution>LEAD_AUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Celeste Rodriguez</ns0:Name>
</ns0:Legislator>
<ns0:Legislator>
<ns0:Contribution>COAUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Schiavo</ns0:Name>
</ns0:Legislator>
</ns0:Authors>
<ns0:Title> 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. </ns0:Title>
<ns0:RelatingClause>public health</ns0:RelatingClause>
<ns0:GeneralSubject>
<ns0:Subject>Birth defects monitoring.</ns0:Subject>
</ns0:GeneralSubject>
<ns0:DigestText>
<html:p>Existing law states that it is the intent of the Legislature to maintain an ongoing program of birth defects monitoring statewide, and 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.</html:p>
<html:p>This bill would state that it is additionally the
intent of the Legislature to enable and maintain an ongoing program to monitor conditions, as defined, that occur during the 12-month period after an individual’s birth statewide. The bill would authorize a local health officer to maintain a system for the collection of specified information within the local health jurisdiction related to birth defects and conditions. The bill would authorize a local health officer to require providers and laboratories, as specified, in addition to the facilities listed above, within the local health jurisdiction to either make available or to transmit to the local health department information related to birth defects and conditions, as specified. The bill would authorize a local health officer to enter into contracts for implementation of programs to collect
information regarding, and to monitor, birth defects and conditions in their jurisdiction.</html:p>
<html:p>
Existing law limits access to confidential information related to birth defects to authorized program staff and persons with a valid scientific interest, as specified, and prohibits that information from being admissible, disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, as specified. Existing law provides that, except as otherwise provided by statute, all relevant evidence is admissible. The California Constitution provides for the Right to Truth-In-Evidence, which requires a
<ns0:Fraction>
<ns0:Numerator>2</ns0:Numerator>
<ns0:Denominator>3</ns0:Denominator>
</ns0:Fraction>
vote of the Legislature to exclude any relevant evidence from any criminal proceeding, as specified.
</html:p>
<html:p>
This bill would expand the scope of the confidentiality provisions described above to include
additional conditions, thereby prohibiting the use of additional information in criminal proceedings. Because that prohibition would affect the admissibility of relevant evidence in criminal proceedings, the bill would require a
<ns0:Fraction>
<ns0:Numerator>2</ns0:Numerator>
<ns0:Denominator>3</ns0:Denominator>
</ns0:Fraction>
vote of the Legislature.
</html:p>
<html:p>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.</html:p>
<html:p>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 conditions or for other purposes
from the provisions described above.</html:p>
</ns0:DigestText>
<ns0:DigestKey>
<ns0:VoteRequired>TWO_THIRDS</ns0:VoteRequired>
<ns0:Appropriation>NO</ns0:Appropriation>
<ns0:FiscalCommittee>NO</ns0:FiscalCommittee>
<ns0:LocalProgram>NO</ns0:LocalProgram>
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<ns0:MeasureIndicators>
<ns0:ImmediateEffect>NO</ns0:ImmediateEffect>
<ns0:ImmediateEffectFlags>
<ns0:Urgency>NO</ns0:Urgency>
<ns0:TaxLevy>NO</ns0:TaxLevy>
<ns0:Election>NO</ns0:Election>
<ns0:UsualCurrentExpenses>NO</ns0:UsualCurrentExpenses>
<ns0:BudgetBill>NO</ns0:BudgetBill>
<ns0:Prop25TrailerBill>NO</ns0:Prop25TrailerBill>
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<ns0:Bill id="bill">
<ns0:Preamble>The people of the State of California do enact as follows:</ns0:Preamble>
<ns0:BillSection id="id_EC9935F5-D59D-4619-A54E-AE5B88FB4C44">
<ns0:Num>SECTION 1.</ns0:Num>
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Section 103825 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Fragment>
<ns0:LawSection id="id_DA47A205-8F9C-4E52-8A56-0E49628CC118">
<ns0:Num>103825.</ns0:Num>
<ns0:LawSectionVersion id="id_BAE2DE93-AAE3-46CD-A6FF-2898071B8B41">
<ns0:Content>
<html:p>The Legislature finds and declares that birth defects, conditions, stillbirths, and miscarriages represent problems of public health importance about which too little is known, that birth defects, conditions, stillbirths, and miscarriages 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 birth defects, conditions, stillbirths, and miscarriages could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in amending this chapter to accomplish all of the following:</html:p>
<html:p>
(a)
<html:span class="EnSpace"/>
To enable and maintain an ongoing program to monitor
birth defects and conditions statewide.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
To provide information on the incidence, prevalence, and trends of birth defects, conditions, stillbirths, and miscarriages.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
To provide information to determine whether environmental hazards are associated with birth defects, conditions, stillbirths, and miscarriages.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
To provide information as to other possible causes of birth defects, conditions, stillbirths, and miscarriages.
</html:p>
<html:p>
(e)
<html:span class="EnSpace"/>
To develop prevention strategies for reducing the incidence of birth defects, conditions, stillbirths, and miscarriages.
</html:p>
<html:p>
(f)
<html:span class="EnSpace"/>
To conduct interview studies about the causes of
birth defects and conditions.
</html:p>
<html:p>
(g)
<html:span class="EnSpace"/>
To affirm the authority of the state department to contract with a qualified entity to operate the program to monitor birth defects and conditions statewide.
</html:p>
<html:p>
(h)
<html:span class="EnSpace"/>
To affirm the authority of local health officers to monitor the prevalence and incidence of birth defects and conditions in their local health jurisdictions in order to supplement state efforts or in the absence of state efforts in their jurisdiction.
</html:p>
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</ns0:LawSection>
</ns0:Fragment>
</ns0:BillSection>
<ns0:BillSection id="id_5F9B51ED-32E8-45A1-B13B-0A16A0A18A10">
<ns0:Num>SEC. 2.</ns0:Num>
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Section 103827 is added to the
<ns0:DocName>Health and Safety Code</ns0:DocName>
, to read:
</ns0:ActionLine>
<ns0:Fragment>
<ns0:LawSection id="id_1FB712AB-5384-4AAA-90EA-309D2FFF56C5">
<ns0:Num>103827.</ns0:Num>
<ns0:LawSectionVersion id="id_3B5321DB-DB68-4D1C-9DF0-C676B3433C3A">
<ns0:Content>
<html:p>For the purposes of this chapter, the following terms have the following meanings:</html:p>
<html:p>
(a)
<html:span class="EnSpace"/>
“Conditions” means conditions or disorders affecting an individual that occur during the 12-month period after an individual’s birth or are later diagnosed to have occurred during the 12-month period after the individual’s birth, in conformity with one or more of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
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).
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Medical eligibility for the California Children’s Services Program or its High-Risk Infant Follow-Up (HRIF) program.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
As dictated by the needs of, and response to, a local public health or environmental emergency declared by the county.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
“Birth defect” means any medical problem of organ structure, function, or chemistry of possible genetic or prenatal origin.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
“Reporting institutions” means health facilities, as that term is
defined in Section 103830, providers, and laboratories that regularly provide services for the diagnosis or treatment of birth
defects or conditions, genetic counseling, or prenatal or general diagnostic services.
</html:p>
</ns0:Content>
</ns0:LawSectionVersion>
</ns0:LawSection>
</ns0:Fragment>
</ns0:BillSection>
<ns0:BillSection id="id_C3E6E546-6806-4527-AB4D-4FA780EC16B6">
<ns0:Num>SEC. 3.</ns0:Num>
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Section 103832 is added to the
<ns0:DocName>Health and Safety Code</ns0:DocName>
, to read:
</ns0:ActionLine>
<ns0:Fragment>
<ns0:LawSection id="id_2151C77D-679A-4DB8-95FD-1DB7AA4D161A">
<ns0:Num>103832.</ns0:Num>
<ns0:LawSectionVersion id="id_86645290-4765-47D1-92D4-D2F1E75F423B">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
A local health officer may maintain a system for the collection of information within the local health jurisdiction that is necessary to accomplish the purposes of this chapter, subject to adequate funding.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
Information about birth defects and conditions may be reported using either of the following systems at the discretion of the director or the local health officer:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
A system that requires reporting institutions within the local health
jurisdiction to make their records available for review and information collection by designated staff of the local program to monitor birth defects and conditions.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
A system that requires reporting institutions within the local health jurisdiction, including, but not limited to, providers and laboratories, to transmit specified data manually or electronically to the local health officer.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
A local health officer may require reporting institutions within the local health jurisdiction to make
their related records available to authorized local program staff pursuant to paragraph (1) of subdivision (b), require reporting of selected information about birth defects and conditions 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.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
The birth defects and conditions to be reported in a local health jurisdiction shall be at the direction of and at the discretion of the local health officer, subject to adequate funding.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Jurisdictions shall consider implementing the same reporting requirements
and workflows currently used by reporting institutions and shall consider less costly alternative methods if current reporting requirements and workflows would impose additional costs compared to alternative reporting requirements and workflows.
</html:p>
<html:p>
(e)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
A local health officer may only collect information as described in this section if it is unique demographic, diagnostic, or health data directly related to a birth defect or condition unless the patient or their parent or guardian gives consent to the officer for the collection of additional data.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
A local health officer shall use collected data consistently with the purposes described in Section 103825 or 103840 or for the purpose of facilitating access to care for an individual with a birth defect or
condition as described in this chapter.
</html:p>
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</ns0:LawSection>
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</ns0:BillSection>
<ns0:BillSection id="id_5154484D-C19E-4467-AB68-6F4B8574532D">
<ns0:Num>SEC. 4.</ns0:Num>
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Section 103835 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Fragment>
<ns0:LawSection id="id_1F86DE5B-FE11-47A9-8132-5DABB9167E18">
<ns0:Num>103835.</ns0:Num>
<ns0:LawSectionVersion id="id_62C15BC4-4773-463A-BD6F-49F524537DC7">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
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 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:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
The numbers of births in the state.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
The scope of program activities.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Any urgent situation requiring extraordinary commitment of present or planned program
staff or resources.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
A local health officer may require reporting institutions within the local health jurisdiction to participate in reporting of birth defects and conditions, 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 reporting of birth defects and conditions in a local health jurisdiction where there are no state birth defects monitoring activities.
</html:p>
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<ns0:BillSection id="id_1DEC3C2D-7719-4800-93F3-CB2ABD5B1A92">
<ns0:Num>SEC. 5.</ns0:Num>
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Section 103840 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Fragment>
<ns0:LawSection id="id_85627C4E-E990-4961-84A0-C1F9CA3C1D08">
<ns0:Num>103840.</ns0:Num>
<ns0:LawSectionVersion id="id_87D19D76-D36E-47F8-8846-AB19AFB342E3">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
The director shall use the information collected pursuant to Section 103830 and information available from other reporting systems and health providers to conduct studies to investigate the causes of birth defects, stillbirths, and miscarriages and to determine and evaluate measures designed to prevent their occurrence.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
A local health officer may require reporting of birth defects and conditions in their jurisdiction and may use that information for similar purposes.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
The department’s and local health officer’s investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or
occupational associations, but may include investigation of past exposures.
</html:p>
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</ns0:LawSection>
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<ns0:BillSection id="id_1FAD3EB6-CE98-4AF1-84C4-7F6C1D7E1096">
<ns0:Num>SEC. 6.</ns0:Num>
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Section 103845 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Fragment>
<ns0:LawSection id="id_DB620952-B1D5-47DC-9F2F-9642AADFFF4D">
<ns0:Num>103845.</ns0:Num>
<ns0:LawSectionVersion id="id_25647036-7803-4106-B256-C242A5C6C92A">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
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, and public health shall be represented on the committee. At least one of the members shall be a representative of the manufacturing industry.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
A local health officer may use resources, subject to their availability, 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 information collected regarding birth defects and conditions.
</html:p>
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</ns0:LawSection>
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<ns0:BillSection id="id_673E8075-785B-449B-9175-010DFCE4046D">
<ns0:Num>SEC. 7.</ns0:Num>
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Section 103850 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:LawSection id="id_090BE4E2-6182-4FDE-9DC6-21B3C07BEE16">
<ns0:Num>103850.</ns0:Num>
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<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
All information collected pursuant to this chapter shall be confidential and shall be used solely for the purposes provided in this chapter.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
For the purposes of this chapter, this information shall be referred to as “confidential information.”
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
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 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.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
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, 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 director’s rules for data access shall be deemed to establish a valid scientific interest for purposes of subdivision (a), entitling the researcher to review records collected pursuant to Section 103830 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.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
Notwithstanding any other law, 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.
</html:p>
<html:p>
(e)
<html:span class="EnSpace"/>
The furnishing of confidential information to the 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.
</html:p>
<html:p>
(f)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(g)
<html:span class="EnSpace"/>
Notwithstanding any other law, no part of the confidential information shall be available for subpoena, nor shall it be disclosed, discoverable, or compelled to be produced in any civil, criminal, administrative, or other proceeding, nor shall this information be deemed admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason.
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.
</html:p>
<html:p>
(h)
<html:span class="EnSpace"/>
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 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, a local jurisdiction, or any person.
</html:p>
<html:p>
(i)
<html:span class="EnSpace"/>
Notwithstanding the restrictions in this section, an individual to whom the information pertains shall have access to their own information in accordance with Chapter 1 (commencing with Section 1798) of Title 1.8 of the Civil Code.
</html:p>
</ns0:Content>
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</ns0:LawSection>
</ns0:Fragment>
</ns0:BillSection>
<ns0:BillSection id="id_74B4D7FE-E793-4052-8EC8-0330AADB814B">
<ns0:Num>SEC. 8.</ns0:Num>
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Section 103855 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
</ns0:ActionLine>
<ns0:Fragment>
<ns0:LawSection id="id_DE451970-E2DA-4FE3-AC8E-AD383F4DBB78">
<ns0:Num>103855.</ns0:Num>
<ns0:LawSectionVersion id="id_6D0D4DE6-889E-4933-A321-281508D2D5A7">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
Notwithstanding any state law, a local health officer may
enter into contracts for the implementation of programs to monitor birth defects or conditions and to collect information regarding those defects or conditions in their jurisdiction.
</html:p>
</ns0:Content>
</ns0:LawSectionVersion>
</ns0:LawSection>
</ns0:Fragment>
</ns0:BillSection>
<ns0:BillSection id="id_C7D240EF-8ED8-4082-99FC-858DF4E004ED">
<ns0:Num>SEC. 9.</ns0:Num>
<ns0:ActionLine action="IS_AMENDED" ns3:href="urn:caml:codes:HSC:caml#xpointer(%2Fcaml%3ALawDoc%2Fcaml%3ACode%2Fcaml%3ALawHeading%5B%40type%3D'DIVISION'%20and%20caml%3ANum%3D'106.'%5D%2Fcaml%3ALawHeading%5B%40type%3D'PART'%20and%20caml%3ANum%3D'5.'%5D%2Fcaml%3ALawHeading%5B%40type%3D'CHAPTER'%20and%20caml%3ANum%3D'1.'%5D%2Fcaml%3ALawHeading%5B%40type%3D'ARTICLE'%20and%20caml%3ANum%3D'1.'%5D%2Fcaml%3ALawSection%5Bcaml%3ANum%3D'124977.'%5D)" ns3:label="fractionType: LAW_SECTION" ns3:type="locator">
Section 124977 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Fragment>
<ns0:LawSection id="id_4682C98F-9F8F-49B9-9018-06D97A4F1AB7">
<ns0:Num>124977.</ns0:Num>
<ns0:LawSectionVersion id="id_647E44E6-BB85-4297-8CAF-BDA65EC53598">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
(A)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
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 information collection or research of birth defects or conditions in a local health jurisdiction initiated by the jurisdiction’s health officer.
</html:p>
<html:p>
(7)
<html:span class="EnSpace"/>
(A)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
(A)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
(A)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(D)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(E)
<html:span class="EnSpace"/>
The regulations shall become effective immediately upon filing by the Secretary of State.
</html:p>
<html:p>
(F)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
(A)
<html:span class="EnSpace"/>
The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
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.
</html:p>
</ns0:Content>
</ns0:LawSectionVersion>
</ns0:LawSection>
</ns0:Fragment>
</ns0:BillSection>
<ns0:BillSection id="id_DC29E3BF-9224-4A5D-B4E1-AEA940A24FCB">
<ns0:Num>SEC. 10.</ns0:Num>
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Section 124991 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
</ns0:ActionLine>
<ns0:Fragment>
<ns0:LawSection id="id_291929DE-2170-410E-9827-D672CD7935A2">
<ns0:Num>124991.</ns0:Num>
<ns0:LawSectionVersion id="id_F6778EF3-9E29-4120-BDE6-9AD14CD5604F">
<ns0:Content>
<html:p>
(a)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
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:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
The department may limit the number of umbilical cord blood samples the program collects each year.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
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 conditions or for other purposes.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
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 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.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
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:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Umbilical cord blood.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Newborn blood collected by the Genetic Disease Screening Program.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
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 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).
</html:p>
<html:p>
(e)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(f)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(g)
<html:span class="EnSpace"/>
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:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Research to identify risk factors for children’s and women’s diseases.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Research to develop and evaluate screening tests.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Research to develop and evaluate prevention strategies.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Research to develop and evaluate treatments.
</html:p>
<html:p>
(h)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
For purposes of ensuring the security of a donor’s 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:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
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:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
Determine whether the requested personal information is needed to conduct the research.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
Permit access to personal information only if it is needed for the research activity.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
Permit access only to the minimum personal information necessary for the research activity.
</html:p>
<html:p>
(D)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(E)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(i)
<html:span class="EnSpace"/>
In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the department’s process of protecting personal information, including, but not limited to, the department’s 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.
</html:p>
<html:p>
(j)
<html:span class="EnSpace"/>
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.
</html:p>
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</ns0:LawSection>
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</ns0:BillSection>
<ns0:BillSection id="id_EC032D7B-7EB0-4814-8A7B-662F2CB5D819">
<ns0:Num>SEC. 11.</ns0:Num>
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Section 125002 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:LawSection id="id_F9C1207F-641B-48A0-997D-A8B92F8DE755">
<ns0:Num>125002.</ns0:Num>
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(a)
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(1)
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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.
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(2)
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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 conditions or for other
purposes.
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(b)
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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:
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(1)
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Research to identify risk factors for children’s and women’s diseases.
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(2)
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Research to develop and evaluate screening tests.
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(3)
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Research to develop and evaluate prevention strategies.
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(4)
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Research to develop and evaluate treatments.
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(c)
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Before any pregnancy blood samples are released for research purposes, all of the
following conditions must be met:
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(1)
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Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the department’s approved researchers.
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(2)
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Protocol review for scientific merit by the department or another entity authorized by the department.
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(3)
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Protocol review by the State Committee for the Protection of Human Subjects.
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(d)
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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.
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(e)
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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.
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(f)
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Until 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:
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(1)
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The research project was approved by the State Committee for the Protection of Human Subjects.
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(2)
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The research project’s 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.
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(3)
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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.
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(4)
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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.
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(g)
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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.
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