Article 1.5. Local Authority to Monitor Birth Conditions

101071.

The Legislature finds and declares that in addition to the findings and declarations in Section 103825, conditions and disorders affecting an individual that occur during the 12-month period after an individual’s birth additionally represent problems of public health importance about which too little is known and that these conditions and disorders lead to severe mental anguish on the part of parents and relatives and frequently to high medical care costs, and that a system to obtain more information about these conditions and disorders could result in development of preventive measures to decrease their incidence in the future. Therefore, it is the intent of the Legislature in adding this article to accomplish all of the following:

(a) To authorize local health jurisdictions to initiate and maintain programs to monitor birth conditions in their local health jurisdictions.

(b) To provide information gathered at the local level on the incidence, prevalence, and trends of birth conditions.

(c) To provide information gathered at the local level to determine whether environmental hazards are associated with birth conditions.

(d) To provide information gathered at the local level as to other possible causes of birth conditions.

(e) To develop prevention strategies for reducing the incidence of birth conditions.

(f) To conduct interview studies at the local level about the causes of birth conditions.

(g) To affirm the authority of local health officers to monitor the prevalence and incidence of birth conditions in their local health jurisdictions.

101071.1.

For the purposes of this article, the following terms have the following meanings:

(a) “Condition” means a condition or disorder affecting an individual that is present at an individual’s birth or during the 12-month period after the birth or is later diagnosed to have been present at the individual’s birth or during the 12-month period after the birth in conformity with either of the following:

(1) Medical eligibility for the California Children’s Services Program or its High Risk Infant Follow-Up (HRIF) program.

(2) As dictated by the needs of, and response to, a local public health or environmental emergency declared by the county.

(b) “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 conditions, genetic counseling, or prenatal or general diagnostic services.

101071.2.

(a) A local health officer may maintain a system for the collection of information within their local health jurisdiction that is necessary to accomplish the purposes of this article, subject to adequate funding.

(b) Information about birth conditions may be reported using either of the following systems at the discretion of the local health officer:

(1) 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 conditions.

(2) 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.

(c) (1) A local health officer may issue a written order to reporting institutions within their local health jurisdiction that, consistent with Section 103830, requires institutions to do any of the following:

(A) Make their related records available to authorized local program staff pursuant to paragraph (1) of subdivision (b).

(B) Report selected information about birth conditions to the local public health program pursuant to paragraph (2) of subdivision (b).

(C) Implement a hybrid of the systems described in subparagraphs (A) and (B).

(2) A local health officer shall not impede or contradict activities of the state birth defects monitoring program in their local health jurisdiction.

(d) (1) The birth 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.

(2) Local health 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.

(e) (1) 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 condition unless the patient or their parent or guardian gives consent to the reporting institution to collect additional data to report to the local health officer.

(2) A local health officer shall use collected data consistently with the purposes described in Section 101071, 101071.4, or 103825 or for the purpose of facilitating access to care for an individual with a birth condition as described in this article.

(f) The state is not responsible for any aspect of birth condition monitoring and reporting conducted at the local level consistent with this article.

101071.3.

A local health officer may require reporting institutions within their local health jurisdiction to participate in the reporting of birth conditions, as needed, to assess and address the needs of the local health jurisdiction.

101071.4.

(a) A local health officer may require the reporting of birth conditions in their jurisdiction and may use that information to conduct studies to investigate the causes of birth conditions and to determine and evaluate measures designed to prevent their occurrence.

(b) A local health officer’s investigation of poor reproductive outcomes shall not be limited to geographic, temporal, or occupational associations, and may include investigation of past exposures within the local jurisdiction.

101071.5.

A local health officer may use resources, subject to their availability, from their local health program or jurisdiction representing the disciplines described in Section 103845 and others, as necessary, to formulate sound policy and health orders for information collected regarding birth conditions.

101071.6.

(a) For purposes of Section 103850, a local health officer may also grant access to confidential information to, and may determine the qualifications of, authorized program staff and persons with a valid scientific interest in the data described in this article for purposes of having access to confidential information if the staff or persons are engaged in demographic, epidemiological, or other similar studies related to health and who agree, in writing, to maintain confidentiality.

(b) (1) The local health officer shall maintain an accurate record of all persons who are given access to confidential information. The record shall include all of the following:

(A) The name of the person authorizing access.

(B) The name, title, address, and organizational affiliation of persons given access.

(C) The dates of access.

(D) The specific purpose for which information is to be used.

(2) The record of access shall be open to public inspection during normal operating hours of the department.

(c) (1) Prior to any research proposed to be conducted by persons other than program staff that use confidential information in the system, the institutional review board in the local health jurisdiction shall review and approve the proposal.

(2) Satisfaction of the terms of the local health officer’s rules for data access establish a valid scientific interest for purposes of subdivision (a) and entitle the researcher to review records collected pursuant to Section 101071.2 and to contact case subjects and controls.

(3) Before confidential information is disclosed pursuant to this section to any other person, agency, or organization, the requesting entity shall demonstrate to the local health officer that the entity has established the procedures and ability to maintain the confidentiality of the information.

(d) 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.

(e) The furnishing of confidential information to 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 is not a waiver of any privilege or a violation of a confidential relationship.

(f) Notwithstanding any other law, the confidential information shall not 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 the information be admissible as evidence in any civil, criminal, administrative, or other tribunal or court for any reason. This section does not prohibit the publishing by a local jurisdiction of reports and statistical compilations relating to birth conditions that do not in any way identify individual cases or individual sources of information.

(g) A 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 local health officer. The person shall also be subject to a civil penalty of five hundred dollars ($500). The penalty provided in this section does not restrict any remedy, provisional or otherwise, provided by law for the benefit of a local jurisdiction or any person.

(h) 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 Part 4 of Division 3 of the Civil Code.

101071.7.

Notwithstanding any state law, a local health officer may enter into contracts for the implementation of programs to monitor birth conditions and to collect information regarding those conditions in their jurisdiction.

101071.8.

The state genetic disease testing program funds described in Section 124977 shall not be used to support information collection or research of birth conditions in a local health jurisdiction initiated by the jurisdiction’s health officer.

101071.9.

(a) This article does not apply to the administration of the Birth Defects Monitoring Program (Chapter 1 (commencing with Section 103825) of Part 2 of Division 102) or Genetic Prevention Services (Chapter 1 (commencing with Section 124975) of Part 5 of Division 106).

(b) The Birth Defects Monitoring Program (Chapter 1 (commencing with Section 103825) of Part 2 of Division 102) and Genetic Prevention Services (Chapter 1 (commencing with Section 124975) of Part 5 of Division 106) do not apply to the administration of local birth conditions monitoring and reporting programs described in this article.