BILL NUMBER: SB 164 AMENDED
BILL TEXT
AMENDED IN ASSEMBLY SEPTEMBER 7, 2007
AMENDED IN ASSEMBLY AUGUST 27, 2007
AMENDED IN ASSEMBLY JULY 17, 2007
AMENDED IN SENATE MAY 16, 2007
AMENDED IN SENATE APRIL 9, 2007
INTRODUCED BY Senator Migden
JANUARY 31, 2007
An act to amend Sections 124977 and 125002 of the Health and
Safety Code, relating to maternal and child health.
LEGISLATIVE COUNSEL'S DIGEST
SB 164, as amended, Migden. Prenatal screening.
Existing law imposes various responsibilities upon the State
Department of Public Health and prenatal care providers with respect
to prenatal care, screening, and counseling, and requires the
department to administer a statewide program for prenatal testing for
genetic disorders and birth defects, including, but not limited to,
ultrasound, amniocentesis, chorionic villus sampling, and blood
testing for genetic disorders and birth defects. Existing law
establishes the Birth Defects Monitoring Program in the department's
Maternal, Child, and Adolescent Health program, and requires the
Deputy Director for Maternal, Child, and Adolescent Health to
maintain a system for the collection of prescribed information on
birth defects. Existing law also provides for an increase in prenatal
screening fees to support the program activities and specifies the
steps for release of pregnancy blood samples for research purposes.
Existing law requires that those fees be deposited in the
continuously appropriated Genetic Testing Fund.
This bill would change the name of the Birth Defects Monitoring
Program to the Birth Defects Monitoring and Biomedical Resources
Program and would require the program to become part of the
Center for Family Health . The bill would require the
department to also charge investigators, who are approved by the
department to use pregnancy blood for research purposes, a fee for
costs related to data linkage, storage, retrieval, processing, data
entry, reinventory, and shipping of pregnancy
newborn blood samples or its
their components, and related data management, as
provided. The bill would change the name of the Birth Defects
Monitoring Program Fund to the Birth Defects Monitoring and
Biomedical Resources Program Fund and would require that the moneys
collected from the prenatal fee increase and the usage and retrieval
charge be deposited in the Birth Defects Monitoring and Biomedical
Resources Program Fund , which the bill would create,
to support the activities of the program, upon
appropriation by the Legislature. The bill would also specify that,
in addition to the fee imposed pursuant to those provisions, a
for-profit investigator approved by the department shall be required
to enter into a written contract or agreement that requires, as a
condition of accepting the sample, the payment to the department of a
specified percentage of net revenues, received by the investigator
that are based, in whole or in part, on samples the investigator
received from the program, as provided. The bill would require the
department to deposit any moneys received from a for-profit
investigator pursuant to those provisions into the Birth Defects
Monitoring and Biomedical Resources Program Investigation Account in
the fund, which the bill would create, and would require that those
moneys be available for expenditure by the department, upon
appropriation by the Legislature, for purposes of implementing and
administering of the program.
The bill would additionally require that the program develop
pregnancy blood collection and processing
protocols, determine conditions and recommendations for the duration
of pregnancy blood storage, establish exclusion
criteria for blood specimens, and institute safe and secure methods
for the disposal of specimens, as determined by the program. The bill
would require the department to store the pregnancy
blood for research purposes, as prescribed, and analyze the
costs of pregnancy blood storage, and annual data
linkage and management, and to adjust the fee accordingly.
Existing law prohibits the release of information identifying the
person whose pregnancy blood samples are stored, analyzed, or
otherwise shared for research purposes with nondepartment staff.
This bill would exempt from that prohibition the provision of
information identifying the person from whom the samples were
obtained to Birth Defects Monitoring and Biomedical Resources Program
contractors or other entities approved by the department.
The Committee for the Protection of Human Subjects (CPHS) serves
as the institutional review board for the California Health and Human
Services Agency for the purpose of assuring that research involving
human subjects is conducted ethically and with minimum risk to
participants.
This bill would require CPHS to determine if certain criteria are
met to ensure the confidentiality of a donor's personal information
before pregnancy any blood is
samples are released for research purposes, as
provided.
The bill would also authorize the department to bill investigators
who are approved by the department to use pregnancy blood for
research purposes for reasonable 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 investigator, removing personal information,
encrypting or otherwise securing personal information, or assigning
subject codes. The bill would also require the department, health
care providers, and local health departments to maintain the
confidentiality of patient information in the same manner as other
medical record information with patient identification as required by
existing law, and would require this information to be used only for
prescribed purposes.
Vote: majority. Appropriation: no. Fiscal committee: yes.
State-mandated local program: no.
THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS:
SECTION 1. Section 124977 of the Health
and Safety Code , as amended by Chapter 188 of the
Statutes of 2007, is amended to read:
124977. (a) It is the intent of the Legislature that, unless
otherwise specified, the 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
tests or activities 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 provision of law, any fees charged for
prenatal screening and followup services provided to persons enrolled
in the Medi-Cal program, health care service plan enrollees, or
persons covered by health insurance policies, shall be paid in full
and deposited in the Genetic Disease Testing Fund or the Birth
Defects Monitoring Fund consistent with this section, subject to all
terms and conditions of each enrollee's or insured's health care
service plan or insurance coverage, whichever is applicable,
including, but not limited to, copayments and deductibles applicable
to these services, and only if these copayments, deductibles, or
limitations are disclosed to the subscriber or enrollee pursuant to
the disclosure provisions of Section 1363.
(2) The department shall expeditiously undertake all steps
necessary to implement the fee collection process, including
personnel, contracts, and data processing, so as 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 under
this chapter.
(4) (A) The department shall charge
a an additional fee for prenatal screening to
support the pregnancy blood sample storage, testing, and research
activities of the Birth Defects Monitoring and Biomedical
Resources Program activities .
(5)
(B) The initial prenatal
screening fee increase for activities of the Birth Defects Monitoring
and Biomedical Resources Program shall be ten dollars
($10).
(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 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.
(C) The department shall also charge investigators who are
approved by the department a fee for costs related to data linkage,
storage, retrieval, processing, data entry, reinventory, and shipping
of newborn blood samples or their components and related data
management. The funds from fees collected pursuant to this
subparagraph may be charged and collected by the department or by an
entity authorized by the department to meet those costs.
(D) (i) In addition to the fee imposed pursuant to this paragraph,
a for-profit investigator approved by the department shall be
required to enter into a written agreement or contract that requires,
as a condition of accepting the sample, that the investigator pay
the following amounts to the department:
(I) Five percent of any net revenues in excess of five hundred
thousand dollars ($500,000) received by that investigator based, in
whole or in part, on samples the investigator received from the Birth
Defects Monitoring and Biomedical Resources Program.
(II) Twenty-five percent of any net licensing revenues in excess
of five hundred thousand dollars ($500,000) received by the
for-profit investigator that are associated with any drug or product
that is developed and based, in whole or in part, on samples the
investigator received from the Birth Defects Monitoring and
Biomedical Resources Program.
(ii) The department shall deposit any moneys received from a
for-profit investigator pursuant to clause (i) into the Birth Defects
Monitoring and Biomedical Resources Program Investigation Account,
which is hereby created in the Birth Defects Monitoring and
Biomedical Resources Program Fund. Moneys in that account, including,
notwithstanding Section 16305.7 of the Government Code, interest and
dividends earned on moneys in the account shall be available for
expenditure by the department, upon appropriation by the Legislature,
for purposes of implementing and administering the program.
(7)
(E) The Birth Defects Monitoring Program and
Biomedical Resources Fund is hereby created as a special fund
in the State Treasury. Fee revenues collected pursuant to this
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 of the Birth Defects Monitoring and Biomedical
Resources Program. Notwithstanding Section 16305.7 of the
Government Code, interest earned on funds in the Birth Defects
Monitoring Program and Bio medical Resources Fund shall be
deposited as revenue into the fund to support the Birth Defects
Monitoring and Biomedical Resources 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 shall not be 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). 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 and the Birth
Defects Monitoring and Biomedical Resources Program Fund for purposes
related to prenatal and newborn screening and for the expansion of
the Genetic Disease Screening Program In formation System,
including necessary data linkages, as determined by the department,
shall not be subject to any of the following:
(A) Division 25.2 (commencing with Section 38070), Chapter 2
(commencing with Section 10290), or Chapter 3 (commencing with
Section 12100) of Part 2 of Division 2 of the Public Contract Code.
(B) Article 4 (commencing with Section 19130) of Chapter 5 of Part
2 of Division 5 of Title 2 of the Government Code.
(C) Sections 4800 to 5180, inclusive, of the State Administrative
Manual, as those sections relate to approval of information
technology projects or approval of increases in the duration or costs
of information technology projects.
(D) Provision 4 of Item 4265-001-0001 of Section 2.00 of the
Budget Act of 2007, and related Budget Act provisions. 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. This paragraph shall apply to the design,
development, and implementation of any expansion, and to the
maintenance and operation of, the Genetic Disease Screening
Information System, including change requests, once the expansion is
implemented.
(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 Program Information System contracts
and shall not be 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 policies, procedures,
regulations or manuals authorized by those laws.
(4) The expenditure of funds from the Genetic Disease Testing Fund
for the expansion of the Genetic Disease Branch
Screening Program Information System to include cystic
fibrosis and biotinidase may be implemented through the amendment of
the Genetic Disease Branch Screening Program
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. 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
Program Information System, including change requests, once the
expansion is implemented.
(d) (1) 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. 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. 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. Notwithstanding Section 11346.1 and Section 11349.6 of the
Government Code, the department shall submit these regulations
directly to the Secretary of State for filing. The regulations shall
become effective immediately upon filing by the Secretary of State.
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) The Office of Administrative Law shall provide for the
printing and publication of these regulations in the California Code
of Regulations. 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.
SECTION 1. 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 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
tests or activities 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 provision of law, any fees charged for
prenatal screening and followup services provided to persons enrolled
in the Medi-Cal program, health care service plan enrollees, or
persons covered by health insurance policies, shall be paid in full
directly to the Genetic Disease Testing Fund, subject to all terms
and conditions of each enrollee's or insured's health care service
plan or insurance coverage, whichever is applicable, including, but
not limited to, copayments and deductibles applicable to these
services, and only if these copayments, deductibles, or limitations
are disclosed to the subscriber or enrollee pursuant to the
disclosure provisions of Section 1363.
(2) The department shall expeditiously undertake all steps
necessary to implement the fee collection process, including
personnel, contracts, and data processing, so as to initiate the fee
collection process at the earliest opportunity.
(3) The director shall convene, in the most cost-efficient manner
and using existing resources, a working group comprised of health
insurance, health care service plan, hospital, consumer, and
department representatives to evaluate newborn and prenatal screening
fee billing procedures, and recommend to the department ways to
improve these procedures in order to improve efficiencies and enhance
revenue collections for the department and hospitals. In performing
its duties, the working group may consider models in other states.
The working group shall make its recommendations by March 1, 2005.
(4) 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 under
this chapter.
(5) (A) The department shall charge an additional fee for prenatal
screening to support the pregnancy blood sample storage, testing,
and research activities of the Birth Defects Monitoring and
Biomedical Resources Program activities.
(B) The prenatal screening fee increase for activities of the
Birth Defects Monitoring and Biomedical Resources Program shall be
ten dollars ($10).
(C) The department shall also charge investigators who are
approved by the department a fee for costs related to data linkage,
storage, retrieval, processing, data entry, reinventory, and shipping
of pregnancy blood or its components and related data management.
The funds from fees collected pursuant to this subparagraph may be
charged and collected by the department or by an entity authorized by
the department to meet those costs.
(D) (i) In addition to the fee imposed pursuant to this paragraph,
a for-profit investigator approved by the department shall be
required to enter into a written agreement or contract that requires,
as a condition of accepting the sample, that the investigator pay
the following amounts to the department:
(I) Five percent of any net revenues in excess of two hundred
fifty thousand dollars ($250,000) received by that investigator
based, in whole or in part, on samples the investigator received from
the Birth Defects Monitoring and Biomedical Resources Program.
(II) Twenty-five percent of any net licensing revenues in excess
of two hundred fifty thousand dollars ($250,000) received by the
for-profit investigator that are associated with any drug or product
that is developed and based, in whole or in part, on samples the
investigator received from the Birth Defects Monitoring and
Biomedical Resources Program.
(ii) The department shall deposit any moneys received from a
for-profit investigator pursuant to clause (i) into the Birth Defects
Monitoring and Biomedical Resources Program Investigation Account,
which is hereby created in the Birth Defects Monitoring and
Biomedical Resources Program Fund. Moneys in that account, including,
notwithstanding Section 16305.7 of the Government Code, interest and
dividends earned on moneys in the account shall be available for
expenditure by the department, upon appropriation by the Legislature,
for purposes of implementing and administering the program.
(E) The funds from fees collected pursuant to this paragraph shall
be deposited into the Birth Defects Monitoring and Biomedical
Resources Program Fund, which is hereby created as a special fund in
the State Treasury, to be used by the department, upon appropriation
by the Legislature, to carry out the purposes of the Birth Defects
Monitoring and Biomedical Resources Program. Notwithstanding Section
16305.7 of the Government Code, interest earned on the moneys in the
fund shall also be deposited as revenue into the fund to support the
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
and the Birth Defects Monitoring and Biomedical Resources Program
Fund for purposes related to prenatal and newborn screening and for
the expansion of the Genetic Disease Branch Screening Information
System, including necessary data linkages, as determined by the
department, shall not be subject to any of the following:
(A) Division 25.2 (commencing with Section 38070), Chapter 2
(commencing with Section 10290), or Chapter 3 (commencing with
Section 12100) of Part 2 of Division 2 of the Public Contract Code.
(B) Article 4 (commencing with Section 19130) of Chapter 5 of Part
2 of Division 5 of Title 2 of the Government Code.
(C) Sections 4800 to 5180, inclusive, of the State Administrative
Manual, as those sections relate to approval of information
technology projects or approval of increases in the duration or costs
of information technology projects.
(D) Provision 4 of Item 4265-001-0001 of Section 2.00 of the
Budget Act of 2007, and related Budget Act provisions. 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. This paragraph shall apply to the design,
development, and implementation of any expansion, and to the
maintenance and operation of, the Genetic Disease Branch Screening
Information System, including change requests, once the expansion is
implemented.
(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 shall not be 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
policies, procedures, regulations or manuals authorized by those
laws.
(4) 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 and biotinidase 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. 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) 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. 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. 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. 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. The regulations shall become effective
immediately upon filing by the Secretary of State. 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) The Office of Administrative Law shall provide for the
printing and publication of these regulations in the California Code
of Regulations. 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. 2. Section 125002 of the Health and Safety Code is amended to
read:
125002. (a) 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 and Biomedical Resources
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. Center for Family Health.
(b) The Birth Defects Monitoring and Biomedical Resources Program
shall develop blood collection and processing protocols, determine
conditions and duration of pregnancy blood
storage, establish exclusion criteria for pregnancy
blood specimens, and institute safe and secure methods of
disposing of specimens, as determined by the program. In addition,
the Birth Defects Monitoring and Biomedical Resources Program or
another entity authorized by the department shall store the
pregnancy blood for research purposes from all or a
statistically representative sample population of pregnant women who
provided a positive consent.
(c) The department shall analyze the costs of pregnancy
blood storage and data linkage and management annually, and
the amount of the fee shall be adjusted by the department to meet
the costs of the Birth Defects Monitoring and Biomedical Resources
Program activities.
(d) It is the intent of the Legislature that pregnancy
blood samples, taken for prenatal screening, any blood
samples taken on behalf of the Genetic Disease Screening Program
shall be stored and used only for the
following purposes:
(1) Research to identify risk factors for children's and women's
diseases.
(2) Research to develop and evaluate screening tests.
(3)
Research to develop and evaluate prevention strategies.
(4) Research to develop and evaluate treatments.
(e) 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 department's 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 (CPHS), as described in subdivision (i).
(f) When pregnancy blood samples are stored,
analyzed, or otherwise shared for research purposes with
nondepartment staff, no information may be released identifying the
person from whom the samples were obtained, except that information
may be provided to Birth Defects Monitoring and Biomedical Resources
Program contractors or to other entities approved by the department.
Contractors and other entities approved by the department pursuant to
this subdivision shall comply with the confidentiality requirements
regarding patient information prescribed in subdivision (h).
(g) Since the pregnancy blood samples described
in this section will be stored by the Birth Defects Monitoring and
Biomedical Resources Program or another entity authorized by the
State Department of Health Services, Section 103850, pertaining to
confidentiality of information, is applicable.
(h) The department, health care providers, and local health
departments shall maintain the confidentiality of patient information
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 children's and women's
diseases.
(2) Research to develop and evaluate screening tests.
(3) Research to develop and evaluate prevention strategies.
(4) Research to develop and evaluate treatments.
(i) (1) In conducting the protocol review required by paragraph
(3) of subdivision (e), CPHS shall determine if all of the following
criteria have been met:
(A) The Birth Defects Monitoring and Biomedical Resources Program
contractors 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 Birth Defects Monitoring and Biomedical Resources Program
contractors 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 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 Birth Defects Monitoring and Biomedical Resources Program
contractors or other entities approved by the department have
provided sufficient written assurances that the personal information
will not be reused or disclosed to any other person or entity, or
used in any 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 necessary personal
information needed 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 still 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.
(j) In addition to the fee described in subparagraph (C) of
paragraph (5) of subdivision (b), the department may bill an
investigator 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 investigator, removing personal information,
encrypting or otherwise securing personal information, or assigning
subject codes.
(k) Nothing in this section shall 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 the data security requirements set forth in this section are
satisfied.