Section DHS 116.05 - Confidentiality(1) RELEASE OF INFORMATION. The department shall keep Wisconsin birth defects prevention and surveillance system reports confidential and may release information from them only in accordance with s. 253.12(5), Stats., and following the procedures in s. 253.12(2), Stats.(2) ACCESS TO INFORMATION. (a) The department may release child-identifiable data only to persons specified in s. 253.12, Stats., and to the following persons:1. The parent or guardian of a child for whom a report was submitted under s. DHS 116.04(3), and following a written request. The department may require verification of the parent's or guardian's identity. The department shall send the requested information to the parent or guardian within 10 calendar days following receipt of the written request. Note: Written requests may be sent to the Wisconsin Children with Special Health Care Needs Program - Attention Birth Defects Registry, 1 West Wilson Street, P.O. Box 2659, Madison, WI 53701-2659. Questions may be directed to the CSHCN Program via telephone at 800-441-4576.
2. The local health officer, the local birth to 3 program, or an agency under contract with the department to administer the children with special health care needs program upon receipt of a written request for information and written informed consent from the parent or guardian of the child.3. A reporter specified under s. DHS 116.04(2) for the purpose of verifying information included in a report. 4.a. A representative of a federal or state agency, upon written request from the federal or state agency, and to the extent the information is necessary to perform a legally authorized function of that agency. In its written request, the agency shall provide the department with written evidence of its legally authorized function.b. The department shall review and approve or disapprove specific requests by an agency for child-identifiable data.c. The department shall notify the parent or guardian of a child about whom information is released under this subdivision on the same day that the information is being released to the agency and the purpose for which it is being released.5. A person performing research under par. (c).(b) The local health officer, the local birth to 3 program or an agency under contract with the department to administer the children with special health care needs program may disclose information it receives from the department under par. (a) 2. only to the extent necessary to render or coordinate necessary follow-up care or, for local public health officers, to conduct a health, demographic or epidemiological investigation. The local health officer shall destroy all information received from the department under this subdivision no later than 365 calendar days after receiving it.(c)1. The department may release child-identifiable information to a person requesting, in writing, information for the purpose of demographic, epidemiological, health or social services research specific to birth defects prevention and surveillance. The person proposing to conduct the research shall submit an application to the department that includes a written protocol for proposed research, the researcher's professional qualifications, a signed agreement to ensure data confidentiality and subject privacy, and any other information requested by the department. If the proposed research involves direct contact with a child or the child's family, the requester shall provide proof of approval 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. The contact may only be made with the written informed consent of the parent or guardian of the subject of the report and the department shall determine whether such contact is necessary to meet the research objectives.2. The department shall acknowledge the request within 10 calendar days after receiving the request, review the request and, if the request is approved, furnish the information within 30 calendar days after receipt of the approved request.3. Any person requesting information under this paragraph shall agree in writing to all of the following:a. That the information provided by the department will be used only for the research approved by the department.b. That the child-identifiable data provided by the department will not be released to any person except other persons involved in the research.c. That the final product of the research will not reveal information that may specifically identify the subject of a report under s. DHS 116.04.d. Any other conditions imposed by the department.(d) Any informed consent required under this subsection shall contain the name of the requestor, the name of the child whose record is to be disclosed, the purpose of or need for the disclosure, the specific information to be disclosed, the time period for which the consent is effective, the date on which the consent document is signed and the signature of a parent or guardian.(3) CHARGES FOR REQUESTED INFORMATION. The department may charge all requestors the total actual and necessary costs of producing the requested information.Wis. Admin. Code Department of Health Services DHS 116.05
CR 02-117: cr. Register March 2003 No. 569, eff. 4-1-03.Amended by, 2017 Wis. Act 59: am. (2) (a) (intro.), r. (4) Register October 2017 No. 742, eff. 11/1/2017