2010 California Code
Health and Safety Code
Article 1. Hereditary Disorders Act

124975.  The Legislature hereby finds and declares that:
   (a) Each person in the State of California is entitled to health
care commensurate with his or her health care needs, and to
protection from inadequate health services not in the person's best
interests.
   (b) Hereditary disorders, such as sickle cell anemia, cystic
fibrosis, and hemophilia, are often costly, tragic, and sometimes
deadly burdens to the health and well-being of the citizens of this
state.
   (c) Detection through screening of hereditary disorders can lead
to the alleviation of the disability of some hereditary disorders and
contribute to the further understanding and accumulation of medical
knowledge about hereditary disorders that may lead to their eventual
alleviation or cure.
   (d) There are different severities of hereditary disorders, that
some hereditary disorders have little effect on the normal
functioning of individuals, and that some hereditary disorders may be
wholly or partially alleviated through medical intervention and
treatment.
   (e) All or most persons are carriers of some deleterious recessive
genes that may be transmitted through the hereditary process, and
that the health of carriers of hereditary disorders is substantially
unaffected by that fact.
   (f) Carriers of most deleterious genes should not be stigmatized
and should not be discriminated against by any person within the
State of California.
   (g) Specific legislation designed to alleviate the problems
associated with specific hereditary disorders may tend to be
inflexible in the face of rapidly expanding medical knowledge,
underscoring the need for flexible approaches to coping with genetic
problems.
   (h) State policy regarding hereditary disorders should be made
with full public knowledge, in light of expert opinion and should be
constantly reviewed to consider changing medical knowledge and ensure
full public protection.
   (i) The extremely personal decision to bear children should remain
the free choice and responsibility of the individual, and should not
be restricted by the state.
   (j) Participation of persons in hereditary disorders programs in
the State of California should be wholly voluntary, except for
initial screening for phenylketonuria (PKU) and other genetic
disorders treatable through the California newborn screening program.
All information obtained from persons involved in hereditary
disorders programs in the state should be held strictly confidential.
   (k) In order to minimize the possibility for the reoccurrence of
abuse of genetic intervention in hereditary disorders programs, all
programs offering screening programs for heredity disorders shall
comply with the principles established in the Hereditary Disorders
Act (Section 27). The Legislature finds it necessary to establish a
uniform statewide policy for the screening for heredity disorder in
the State of California.



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 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
under this section, data linkage, retrieval, data processing, data
entry, reinventory, 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 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.
   (7) 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 of the Birth Defects Monitoring Program. 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 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.
   (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.



124980.  The director shall establish any regulations and standards
for hereditary disorders programs as the director deems necessary to
promote and protect the public health and safety. Standards shall
include licensure of master level genetic counselors and doctoral
level geneticists. Regulations adopted shall implement the principles
established in this section. These principles shall include, but not
be limited to, the following:
   (a) The public, especially communities and groups particularly
affected by programs on hereditary disorders, should be consulted
before any regulations and standards are adopted by the department.
   (b) The incidence, severity, and treatment costs of each
hereditary disorder and its perceived burden by the affected
community should be considered and, where appropriate, state and
national experts in the medical, psychological, ethical, social, and
economic effects or programs for the detection and management of
hereditary disorders shall be consulted by the department.
   (c) Information on the operation of all programs on hereditary
disorders within the state, except for confidential information
obtained from participants in the programs, shall be open and freely
available to the public.
   (d) Clinical testing procedures established for use in programs,
facilities, and projects shall be accurate, provide maximum
information, and the testing procedures selected shall produce
results that are subject to minimum misinterpretation.
   (e) No test or tests may be performed on any minor over the
objection of the minor's parents or guardian, nor may any tests be
performed unless the parent or guardian is fully informed of the
purposes of testing for hereditary disorders and is given reasonable
opportunity to object to the testing.
   (f) No testing, except initial screening for phenylketonuria (PKU)
and other diseases that may be added to the newborn screening
program, shall require mandatory participation, and no testing
programs shall require restriction of childbearing, and participation
in a testing program shall not be a prerequisite to eligibility for,
or receipt of, any other service or assistance from, or to
participate in, any other program, except where necessary to
determine eligibility for further programs of diagnoses of or therapy
for hereditary conditions.
   (g) Pretest and posttest counseling services for hereditary
disorders shall be available through the program or a referral source
for all persons determined to be or who believe themselves to be at
risk for a hereditary disorder. Genetic counseling shall be provided
by a physician, a certified advanced practice nurse with a genetics
specialty, or other appropriately trained licensed health care
professional and shall be nondirective, shall emphasize informing the
client, and shall not require restriction of childbearing.
   (h) All participants in programs on hereditary disorders shall be
protected from undue physical and mental harm, and except for initial
screening for phenylketonuria (PKU) and other diseases that may be
added to newborn screening programs, shall be informed of the nature
of risks involved in participation in the programs, and those
determined to be affected with genetic disease shall be informed of
the nature, and where possible the cost, of available therapies or
maintenance programs, and shall be informed of the possible benefits
and risks associated with these therapies and programs.
   (i) All testing results and personal information generated from
hereditary disorders programs shall be made available to an
individual over 18 years of age, or to the individual's parent or
guardian. If the individual is a minor or incompetent, all testing
results that have positively determined the individual to either
have, or be a carrier of, a hereditary disorder shall be given
through a physician or other source of health care.
   (j) All testing results and personal information from hereditary
disorders programs obtained from any individual, or from specimens
from any individual, shall be held confidential and be considered a
confidential medical record except for information that the
individual, parent, or guardian consents to be released, provided
that the individual is first fully informed of the scope of the
information requested to be released, of all of the risks, benefits,
and purposes for the release, and of the identity of those to whom
the information will be released or made available, except for data
compiled without reference to the identity of any individual, and
except for research purposes, provided that pursuant to Subpart A
(commencing with Section 46.101) of Part 46 of Title 45 of the Code
of Federal Regulations entitled "Basic HHS Policy for Protection of
Human Subjects," the research has first been reviewed and approved by
an institutional review board that certifies the approval to the
custodian of the information and further certifies that in its
judgment the information is of such potentially substantial public
health value that modification of the requirement for legally
effective prior informed consent of the individual is ethically
justifiable.
   (k) A physician providing information to patients on expanded
newborn screening shall disclose to the parent the physician's
financial interest, if any, in the laboratory to which the patient is
being referred.
   ( l) An individual whose confidentiality has been breached as a
result of any violation of the provisions of the Hereditary Disorders
Act, as defined in subdivision (b) of Section 27, may recover
compensatory and civil damages. Any person who negligently breaches
the confidentiality of an individual tested under this article shall
be subject to civil damages of not more than ten thousand dollars
($10,000), reasonable attorney's fees, and the costs of litigation.
Any person who knowingly breaches the confidentiality of an
individual tested under this article shall be subject to payment of
compensatory damages, and in addition, may be subject to civil
damages of fifty thousand dollars ($50,000), reasonable attorney's
fees, and the costs of litigation, or imprisonment in the county jail
of not more than one year. If the offense is committed under false
pretenses, the person may be subject to a fine of not more than one
hundred thousand dollars ($100,000), imprisonment in the county jail
of not more than one year, or both. If the offense is committed with
the intent to sell, transfer, or use individually identifiable health
information for commercial advantage, personal gain, or malicious
harm, the person may be subject to a fine of not more than two
hundred fifty thousand dollars ($250,000), imprisonment in the county
jail of not more than one year, or both.
   (m) "Genetic counseling" as used in this section shall not include
communications that occur between patients and appropriately trained
and competent licensed health care professionals, such as
physicians, registered nurses, and physicians assistants who are
operating within the scope of their license and qualifications as
defined by their licensing authority.



124981.  (a) No person shall use the title of genetic counselor
unless the person has applied for and obtained a license from the
department.
   (b) The applicant for a genetic counselor license shall meet
minimum qualifications that include, but are not limited to, both of
the following:
   (1) Has earned a master's degree or above from a program
specializing in or having substantial course content in genetics.
   (2) Has demonstrated competence by an examination administered or
approved by the department.
   (c) The license shall be valid for three years unless at any time
during that period it is revoked or suspended. The license may be
renewed prior to the expiration of the three-year period.
   (d) To qualify to renew the license, a licenseholder shall have
completed 45 hours of continuing education units during the
three-year license renewal period. At least 30 hours of the
continuing education units shall be in genetics.
   (e) The license fee for an original license and license renewal
shall not exceed two hundred dollars ($200).
   (f) Until the department has finalized regulations that are needed
to implement subdivision (b), the department shall license, upon
application and payment of the application fee specified in
subdivision (e), a genetic counselor applicant who meets the
requirements of subdivision (b), is currently credentialed and in
good standing with the American Board of Genetic Counseling, and has
no history of disciplinary action by the board. When the department
has finalized the regulations needed to implement subdivision (b),
genetic counselors who have received a license pursuant to this
subdivision shall be subject to the regulations implementing this
section and Sections 124980 and 124982, and this subdivision shall
become inoperative.
   (g) The department may revoke the license of a genetic counselor
who is licensed pursuant to subdivision (f) if either of the
following occur:
   (1) The counselor loses his or her credential granted by the
American Board of Genetic Counseling or is placed on probationary
status.
   (2) The counselor has been convicted of a felony charge that is
substantially related to the qualifications, functions, or duties of
a genetic counselor. A plea of guilty or nolo contendere to a felony
charge shall be deemed a conviction for the purposes of this
paragraph.
   (h) This section shall remain in effect only until January 1,
2014, and as of that date is repealed, unless a later enacted
statute, that is enacted before January 1, 2014, deletes or extends
that date.
   (i) The amendments made to this section by the act adding this
subdivision shall become operative on July 1, 2011.



124981.  (a) No person shall use the title of genetic counselor
unless the person has applied for and obtained a license from the
department.
   (b) The applicant for a genetic counselor license shall meet
minimum qualifications that include, but are not limited to, both of
the following:
   (1) Has earned a master's degree or above from a program
specializing in or having substantial course content in genetics.
   (2) Has demonstrated competence by an examination administered or
approved by the department.
   (c) The license shall be valid for three years unless at any time
during that period it is revoked or suspended. The license may be
renewed prior to the expiration of the three-year period.
   (d) To qualify to renew the license, a licenseholder shall have
completed 45 hours of continuing education units during the
three-year license renewal period. At least 30 hours of the
continuing education units shall be in genetics.
   (e) The license fee for an original license and license renewal
shall not exceed two hundred dollars ($200).
   (f) This section shall become operative on January 1, 2014.



124982.  (a) The department shall issue a temporary genetic
counselor license to a person to practice as a licensed genetic
counselor who meets all of the following:
   (1) The requirements for licensure set forth in subdivision (b) of
Section 124981, except passing the certification examination as
required by paragraph (2) of subdivision (b) of Section 124981.
   (2) Either of the following requirements:
   (A) The person meets the requirements to apply for and has applied
for the first available certification examination offered. The
department may require an applicant for a temporary genetic counselor
license to provide documentation of acceptance for the examination.
   (B) The person meets the requirements to apply for the
certification examination and plans to apply to sit for the
examination in the year following the year of the first available
examination. The department shall require the applicant to provide
documentation showing registration for the examination, when the
documentation is received by the applicant. After the applicant takes
the exam, the department shall require the applicant to provide
documentation showing that the applicant took the examination.
   (3) Payment of a fee of two hundred dollars ($200).
   (b) A temporary genetic counselor license shall be valid for 24
months and shall not be extended or renewed.
   (c) Notwithstanding subdivision (a), a temporary license issued
pursuant to this section shall expire upon any of the following
events, whichever occurs earlier:
   (1) The issuance of a license pursuant to Section 124981.
   (2) Thirty days after notification of the department that an
applicant has failed the certification examination.
   (3) The expiration date on the temporary license.
   (d) A person holding a temporary genetic counselor license issued
pursuant to this section, shall be required to work under the
supervision of a licensed genetic counselor or a licensed physician
and surgeon.
   (e) The department may revoke the temporary license of a genetic
counselor licensed pursuant to this section if the person has been
convicted of a felony charge that is substantially related to the
qualifications, functions, or duties of a genetic counselor. A plea
of guilty or nolo contendere to a felony charge shall be deemed a
conviction for the purposes of this subdivision.
   (f) This section shall become operative on July 1, 2011.




124985.  A violation of any of the provisions of the Hereditary
Disorders Act (Section 27) or any of the regulations adopted pursuant
to that act shall be punishable as a misdemeanor.



124990.  For the purposes of the Hereditary Disorders Act (Section
27), hereditary disorders programs shall include, but not be limited
to, all antenatal, neonatal, childhood, and adult screening programs,
and all adjunct genetic counseling services.



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.
   (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
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 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.
   (h) (1) 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:
   (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
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.
   (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.



124995.  The following programs shall comply with the regulations
established pursuant to the Hereditary Disorders Act (Section 27):
   (a) The California Children's Services Program under Article 5
(commencing with Section 123800) of Chapter 3 of Part 2.
   (b) Prenatal testing programs for newborns under Sections 125050
to 125065, inclusive.
   (c) Medical testing programs for newborns under the Maternal and
Child Health Program Act (Section 27).
   (d) Programs of the genetic disease unit under Section 125000.
   (e) Child health disability prevention programs under Article 6
(commencing with Section 124025) of Chapter 3 of Part 2 and Section
120475.
   (f) Genetically handicapped person's programs under Article 1
(commencing with Section 125125) of Chapter 2.
   (g) Medi-Cal Benefits Program under Article 4 (commencing with
Section 14131) of Chapter 7 of Part 3 of Division 9 of the Welfare
and Institutions Code.



124996.  (a) The Genetic Disease Testing Fund is continued in
existence as a special fund in the State Treasury. The department may
charge a fee for any activities carried out pursuant to the
Hereditary Disorders Act, including licensing activities conducted
pursuant to Section 124980. All moneys collected by the department
under the act shall be deposited in the Genetic Disease Testing Fund,
that is continuously appropriated to the department to carry out the
purposes of the act.
   (b) It is the intent of the Legislature that the program carried
out pursuant to the act be fully supported from fees collected under
the act.
   (c) The director shall adopt regulations establishing the amount
of fees for activities carried out pursuant to the act.
   (d) The "Hereditary Disorders Act" or "act" referred to in this
section is the act described in subdivision (b) of Section 27.