Assurance of confidentiality

Attachment 13

Assurance of Confidentiality for HIV/AIDS Surveillance

Medical Monitoring Project

0920-0740

ASSURANCE OF CONFIDENTIALITY

FOR THE NATIONAL HUMAN IMMUNODEFICIENCY VIRUS (HIV) SURVEILLANCE SYSTEM (NHSS) AND SURVEILLANCE-RELATED DATA (INCLUDING SURVEILLANCE INFORMATION, CASE INVESTIGATIONS SUPPLEMENTAL SURVEILLANCE PROJECTS, RESEARCH ACTIVITIES, AND EVALUATIONS)

The national HIV surveillance program is being coordinated by the HIV Incidence and Case Surveillance Branch (HICSB) and the Behavioral and Clinical Surveillance Branch (BCSB) of the Division of HIV/AIDS Prevention (DHAP), in the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), a component of the Centers for Disease Control and Prevention (CDC), an agency of the United States Department of Health and Human Services. The surveillance information requested by CDC consists of reports of persons with suspected or confirmed HIV infection at any clinical stage of disease, including children born to mothers infected with HIV, and reports of persons enrolled in studies designed to evaluate the surveillance program. The information collected by CDC is abstracted from laboratory, clinical, and other medical or public health records of suspected or confirmed HIV cases; and from surveys or investigations that interview persons in recognized HIV risk groups or known to have a diagnosis of HIV.

Surveillance data collection is conducted by state and territorial health departments which forward information to CDC after deleting patient and physician names and other identifying or locating information. Records maintained by CDC are identified by computer-generated codes, patient date of birth, and a state/city assigned patient identification number. The data are used for statistical summaries and research by CDC scientists and cooperating state and local health officials to understand and control the spread of HIV. In rare instances, expert CDC staff, at the invitation of state or local health departments, may participate in research or case investigations of unusual transmission circumstances or cases of potential threat to the public health. In these instances, CDC staff may collect and maintain information that could directly identify individuals.

Information collected by CDC under Section 304 and 306 of the Public Health Service Act (42 U.S.C. 242b and 242k) as part of the HIV surveillance system that would permit direct or indirect identification of any individual or institution on whom a record is maintained, and any identifiable information collected during the course of an investigation on either persons supplying the information or persons described in it, is collected with a guarantee that it will be held in confidence, will be used only for the purposes stated in this Assurance, and will not otherwise be disclosed or released without the consent of the individual or institution in accordance with Section 308 (d) of the Public Health Service Act (42 U.S.C. 242m(d)). This protection lasts forever, even after death. Information that could be used to identify any individual or institution on whom a record is maintained by CDC will be kept confidential. Full names, addresses, social security numbers, and telephone numbers will not be reported to this national HIV surveillance system. Medical, personal, and lifestyle information about the individual, and a computer-generated patient code will be collected.

Surveillance information reported to CDC will be used without identifiers primarily for statistical and analytic summaries and for evaluations of the surveillance program in which no individual or institution on whom a record is maintained can be identified, and secondarily, for special research investigations of the characteristics of populations suspected or confirmed to be at increased risk for infection with HIV and of the natural history and epidemiology of HIV. When necessary for confirming surveillance information or in the interest of public health and disease prevention, CDC may confirm information contained in case reports or may notify other medical personnel or health officials of such information; in each instance, only the minimum information necessary will be disclosed.

No CDC HIV surveillance or research information that could be used to identify any individual or institution on whom a record is maintained, either directly or indirectly, will be made available to anyone for non-public health purposes. In particular, such information will not be disclosed to the public; to family members; to parties involved in civil, criminal, or administrative litigation, or for commercial purposes; to agencies of the federal, state, or local government. Data will only be released to other components of CDC, or to agencies of the federal, state, or local government, or to select members of the public for public health purposes in accordance with the policies for data release established by the Council of State and Territorial Epidemiologists.

Information in this surveillance system will be kept confidential. Only authorized employees of DHAP in HICSB, BCSB, and in the Quantitative Sciences and Data Management Branch (QSDMB), their contractors, guest researchers, fellows, visiting scientists, authorized external collaborating researchers, research interns, and graduate students who participate in activities jointly approved by CDC and the sponsoring academic institution, and the like, will have access to the information. Authorized individuals are required to handle the information in accordance with procedures outlined in the Confidentiality Security Statement for the National Human Immunodeficiency Virus (HIV) Surveillance System (NHSS) and Surveillance-Related Data (including surveillance information, case investigations, supplemental surveillance projects, research activities, and evaluations).