Assurance of Confidentiality

ATTACHMENT A
CDC ASSURANCE OF CONFIDENTIALITY
FOR SURVEILLANCE OF PREGNANCY AND INFANT OUTCOMES FOLLOWING ZIKA VIRUS
INFECTION AND SURVEILLANCE-RELATED DATA (INCLUDING SURVEILLANCE
INFORMATION, CASE INVESTIGATIONS AND SUPPLEMENTAL SURVEILLANCE
PROJECTS, RESEARCH ACTIVITIES, AND EVALUATIONS)

Data for surveillance of pregnancy and infant outcomes following Zika virus infection in pregnancy is
being collected in U.S. states and territories through the U.S. Zika Pregnancy Registry, except in Puerto
Rico where these data are collected by CDC-funded Puerto Rico Department of Health contractor for the
Zika Active Pregnancy Surveillance System (ZAPSS)/Sistema de Vigilancia Activa de Zika en Embarazos,
and shared with CDC. The U.S. Zika Pregnancy Registry and ZAPSS is coordinated by the Pregnancy and
Birth Defects Task Force, Zika Virus Response, Emergency Operations Center, Centers for Disease
Control and Prevention (CDC), an agency of the United States Department of Health and Human
Services. (Attachment L). In addition, as part of an agreement to provide technical assistance to the
National Health Institute/Instituto Nacional de Salud (INS) in Colombia, INS is sharing de-identified
Colombian national data on Zika pregnancy, birth, and infant outcomes surveillance with CDC. The
information requested by and shared with CDC includes reports of pregnant women with suspected or
confirmed Zika virus disease and infants born to mothers with evidence of Zika virus infection, and
reports of persons participating in studies designed to evaluate the surveillance program and/or the
surveillance case definitions, or better characterize affected populations, inform prevention
interventions, and identify unmet needs for services. The information collected by and shared with CDC
is abstracted from laboratory, clinical, and other medical or public health records of suspected or
confirmed Zika virus cases among pregnant women and their infants; collected through case
investigations and from surveys of persons in recognized Zika virus risk groups or known to have a
diagnosis of Zika virus infection. The Pregnancy and Birth Defects Task Force, Zika Virus Response,
Emergency Operations Center requested and received authorization under 308(d) of the PHS Act (42
U.S.C 242m(d)) to give assurance of confidentiality for this data.
In the U.S., surveillance data collection is conducted by State and Territorial health departments which
communicate information to CDC, including patient and physician names and other identifying or
locating information. The data are used for de-identified case reports, statistical summaries and
research by CDC scientists and cooperating state and local health officials to understand and control the
spread of Zika virus infection to pregnant women and to infants through prenatal or perinatal
transmission. Because Zika virus is an emerging infection about which little is known, expert CDC staff,
at the invitation of state or local health departments, may participate in research or case investigations
or cases of potential threat to the public health. In these instances, CDC staff may collect and maintain
information that could directly identify individuals.
Surveillance information reported to CDC will be used 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 Zika virus and of the
natural history and epidemiology of Zika virus infection. Surveillance information may also be used in
de-identified case reports for illustrative purposes. When necessary for confirming surveillance
information or in the interest of public health and disease prevention, CDC may confirm information

contained in case reports with health care providers or may notify other medical personnel or health
officials of such information; in each instance, only the minimum information necessary will be
disclosed.
Information collected for Surveillance of Pregnancy and Infant Outcomes Following Zika Virus Infection
and Surveillance-Related Data will be kept confidential. Only authorized employees of the Centers for
Disease Control and certain persons with an official relationship with CDC would have access to
information collected under this assurance, with restrictions as follows. Authorized employees of the
Centers for Disease Control, CDC contractors, and fellows will have access to identifiable information.
In addition to authorized CDC employees, contractors and fellows, authorized non-employees, including
guest researchers, visiting scientists, and 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 de-identified information. Authorized individuals
are required to handle the information in accordance with procedures outlined in the Confidentiality
Security Statement for Surveillance of Pregnancy and Infant Outcomes Following Zika Virus Infection and
Surveillance-Related Data.
No CDC surveillance information from the U.S. Zika Pregnancy Registry, ZAPSS, Colombian national Zika
pregnancy, birth, and infant outcomes surveillance information shared by INS, 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 policies for data release that prevent direct or indirect identification of individual(s).
Information shared with CDC or collected by CDC under Sections 304, 306, and 307 of the Public Health
Service Act (42 U.S.C. 242b, 242k, and 242l) as part of the U.S. Zika Pregnancy Registry, the Puerto Rico
Zika Active Pregnancy Surveillance System (ZAPSS) or the collaboration with INS 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. Health
care providers will be asked to give their patients who are included in the U.S. Zika Pregnancy
Registry/ZAPSS a fact sheet about Zika pregnancy, birth, and infant outcomes surveillance that includes
notice of the Assurance of Confidentiality (Attachment P).