Added by Stats. 1995, Ch. 415, Sec. 8. Effective January 1, 1996.
The Legislature hereby finds and declares that:
California Health and Safety Code — §§ 124975-124996
Added by Stats. 1995, Ch. 415, Sec. 8. Effective January 1, 1996.
The Legislature hereby finds and declares that:
Amended by Stats. 2024, Ch. 598, Sec. 1. (SB 1099) Effective January 1, 2025.
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.
shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.
samples or their components, and related data management.
storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.
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.
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.
contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.
(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.
(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.
(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.
(E) The regulations shall become effective immediately upon filing by the Secretary of State.
(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.
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.
Amended by Stats. 2004, Ch. 228, Sec. 6.3. Effective August 16, 2004.
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:
(
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.
Amended by Stats. 2025, Ch. 105, Sec. 40. (AB 144) Effective September 17, 2025.
genetics.
Amended by Stats. 2025, Ch. 105, Sec. 41. (AB 144) Effective September 17, 2025.
for the examination.
(ii) The department shall solicit input from affected stakeholders before raising fees under this paragraph.
124981.
subdivision.
Added by Stats. 1995, Ch. 415, Sec. 8. Effective January 1, 1996.
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.
Added by Stats. 1995, Ch. 415, Sec. 8. Effective January 1, 1996.
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.
Amended by Stats. 2024, Ch. 598, Sec. 2. (SB 1099) Effective January 1, 2025.
(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.
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.
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.
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:
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).
tests.
(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.
the research can be conducted without social security numbers.
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.
Amended by Stats. 2015, Ch. 303, Sec. 352. (AB 731) Effective January 1, 2016.
The following programs shall comply with the regulations established pursuant to the Hereditary Disorders Act, as defined in Section 27:
Section 125000.
Added by renumbering Section 125005 by Stats. 2000, Ch. 941, Sec. 4. Effective January 1, 2001.