253.12(3)(c) (c) The department shall, not more than 10 years from the date of receipt of a report under sub. (2), delete from any file of the department the name of an infant or child that is contained in the report.

253.12(4) (4) Council on birth defect prevention and surveillance. The council on birth defect prevention and surveillance shall meet at least 4 times per year and shall do all of the following:

253.12(4)(a) (a) Make recommendations to the department regarding the establishment of a registry that documents the diagnosis in the state of an infant or child who has a birth defect, as required under sub. (3) (a) 1. and regarding the rules that the department is required to promulgate under sub. (3) (a) 2. and 3. on the birth defects to be reported under sub. (2) and on the general content and format of the report under sub. (2) and procedures for submitting the report. The council shall also make recommendations regarding the content of a report that, because of the application of sub. (2) (d), does not contain the name of the subject of the report.

253.12(4)(b) (b) Coordinate with the early intervention interagency coordinating council to facilitate the delivery of early intervention services to children from birth to 3 years with developmental needs.

253.12(4)(d) (d) Beginning April 1, 2002, and biennially thereafter, submit to the appropriate standing committees under s. 13.172 (3) a report that details the effectiveness, utilization and progress of the registry established under sub. (3) (a) 1.

253.12(5)(a)(a) Any information contained in a report made to the department under sub. (2) that may specifically identify the subject of the report is confidential. The department may not release that confidential information except to the following, under the following conditions:

253.12(5)(a)1. 1. The parent or guardian of an infant or child for whom a report is made under sub. (2).

253.12(5)(a)2. 2. A local health officer, a local birth-to-3 coordinator or an agency under contract with the department to administer the children with special health care needs program, upon receipt of a written request and informed written consent from the parent or guardian of the infant or child. The local health officer may disclose information received under this subdivision only to the extent necessary to render and coordinate services and follow-up care for the infant or child or to conduct a health, demographic or epidemiological investigation. The local health officer shall destroy all information received under this subdivision within one year after receiving it.

253.12(5)(a)3. 3. A physician, hospital or pediatric specialty clinic reporting under sub. (2), for the purpose of verification of information reported by the physician, hospital or pediatric specialty clinic.

253.12(5)(a)4. 4. A representative of a federal or state agency upon written request and to the extent that the information is necessary to perform a legally authorized function of that agency, including investigation of causes, mortality, methods of prevention and early intervention, treatment or care of birth defects, associated diseases or disabilities. The information may not include the name or address of an infant or child with a condition reported under sub. (2). The department shall notify the parent or guardian of an infant or child about whom information is released under this subdivision, of the release. The representative of the federal or state agency may disclose information received under this paragraph only as necessary to perform the legally authorized function of that agency for which the information was requested.

253.12(5)(b)1. 1. The person proposing to conduct the research applies in writing to the department for approval to perform the research and the department approves the application. The application for approval shall include a written protocol for the proposed research, the person's professional qualifications to perform the proposed research and any other information requested by the department.

253.12(5)(b)2. 2. The research is for the purpose of studying birth defects surveillance and prevention.

253.12(5)(b)3. 3. If the research will involve direct contact with a subject of a report made under sub. (2) or with any member of the subject's family, the department determines that the contact is necessary for meeting the research objectives and that the research is in response to a public health need or is for the purpose of or in connection with birth defects surveillance or investigations sponsored and conducted by public health officials. The department must also determine that the research has been approved by a certified institutional review board or a committee for the protection of human subjects in accordance with the regulations for research involving human subjects required by the federal department of health and human services for projects supported by that agency. Contact may only be made with the written informed consent of the parent or guardian of the subject of the report and in a manner and method approved by the department.

253.12(5)(b)4. 4. The person agrees in writing that the information provided will be used only for the research approved by the department.

253.12(5)(b)5. 5. The person agrees in writing that the information provided will not be released to any person except other persons involved in the research.

253.12(5)(b)6. 6. The person agrees in writing that the final product of the research will not reveal information that may specifically identify the subject of a report made under sub. (2).

253.12(5)(b)7. 7. The person agrees in writing to any other conditions imposed by the department.

253.12(6) (6) Information not admissible. Information collected under this section is not admissible as evidence during the course of a civil or criminal action or proceeding or an administrative proceeding, except for the purpose of enforcing this section.

253.12(7) (7) Funding. From the appropriation account under s. 20.435 (1) (gm), the department shall allocate $95,000 annually for the birth defect prevention and surveillance system under this section.