Privacy Impact Assessment [reauthorization 2018]

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Privacy Impact Assessment Form
v 1.47.4
Status Draft

Form Number

F-99464

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-4704409-009420

2a Name:

12/3/2021 9:47:57 AM

National ART Surveillance System (NASS)
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Operations and Maintenance
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

No
Yes
No
Agency
Contractor
POC Title

ISSO

POC Name

Cynthia Allen

National Center for Chronic
POC Organization Disease Prevention and Health
Promotion
POC Email

CDL1@cdc.gov

POC Phone

770-488-5388
New
Existing
Yes
No

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April 8, 2022

8b Planned Date of Security Authorization

Not Applicable
11 Describe the purpose of the system.
Describe the type of information the system will
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask
about the specific data elements.)
Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.
14 Does the system collect, maintain, use or share PII?

15

Indicate the type of PII that the system will collect or
maintain.

The purpose of NASS is to collect data securely from every U.S.
clinic performing Assisted Reproductive Technology (ART)
NASS collects information about each ART cycle (i.e.,
procedure) that include basic patient, donor, and sperm
demographics; intended vs actual type of ART performed;
general reason for the ART cycle; patient’s history regarding
NASS is designed to provides information storage, processing,
and transmission capabilities to the NASS project where it
allows ART clinics to report required information to CDC
Yes
No
Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID
City, State, and/or Zip Code
Race/ethnicity
user id and password

Employees
Public Citizens
16

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?

18 For what primary purpose is the PII used?

1,000,000 or more
PII is used to determined treatment outcomes from infertility
clinics in the United States, and publishes an annual report.
PII/IIF data entered into NASS by clinics are maintained in the
project information system.

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19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

NA

20 Describe the function of the SSN.

NA

20a Cite the legal authority to use the SSN.

NA

21

Identify legal authorities governing information use Public Health Service Act, section 301, "Research and
and disclosure specific to the system and program.
Investigation," (42 U.S.C. 241); sections 304, 306 and 308(d)

22

Are records on the system retrieved by one or more
PII data elements?

Yes
No
Published:

Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.

Privacy Act System Notice 09-20-0136,
Epidemiologic Studies and Surveillance of
Disease Problems (HHS/CDC)

Published:

Published:
In Progress
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources
23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

24 Is the PII shared with other organizations?

0920-0556; 12/31/2024
Yes
No

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Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.

26

Is the submission of PII by individuals voluntary or
mandatory?

Clinics performing ART have tailored detailed informed
consents for ART procedures that can include information
about their requirements to comply with FCSRCA and CDC's
assurance of confidentiality in place for safeguards for
individuals and establishments against invasions of privacy, in
accordance with Section 308(d) of the Public Health Services
Act (42 USC 242m). No prior notice is otherwise given as
reporting by each ART clinic is required by law for purposes of
public health practice and surveillance.
Voluntary
Mandatory

There is no method for individuals to opt out of the use of their
PII because NASS data is not collected directly from individuals;
ART programs collect individual information for the purpose of
their standard clinical practices. Clinics are then required to
report certain data elements in NASS, but only as required by
Describe the method for individuals to opt-out of the CDC to fulfill FCSRCA requirements.
collection or use of their PII. If there is no option to
27
It is noted, however, that other than patient DOB, the NASS
object to the information collection, provide a
reporting system allows for clinics to indicate that the patient
reason.
refused to provide any information on race, ethnicity, or
residency pertaining to each of their ART cycles reported to
NASS. Nonetheless, CDC supports providing patients or an
accounting of the uses of their information, and many clinics
provide patients information sheets on the sues of their
information.
Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.

CDC publishes NASS reporting requirements and announces
major system changes in Federal Register Notices. The
information collected in NASS does not provide identifying
information that would allow for notification of individuals if
there were changes to disclosure or data; however the
assurance of confidentiality in place prohibits data that are
collected in NASS from disclosure.

On the public NASS web page, there are links with information
about contacting the NASS Help Desk or CDC with any
Describe the process in place to resolve an
individual's concerns when they believe their PII has questions or concerns, about the CDC contracts supporting
29 been inappropriately obtained, used, or disclosed, or NASS, about privacy and assurance of confidentiality, about
that the PII is inaccurate. If no process exists, explain the OMB approval, about the FCSRCA law, as well as links to
the Federal Register Notice about reporting requirements.
why not.
Individuals may also contact the ART clinic that they used for
their procedure with any concerns.

Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

NASS data are maintained in an information system that meets
FISMA requirements for safeguarding information
confidentiality, integrity, and availability. Review of PII accuracy
takes place in two stages, NASS embeds logic and skip patterns
to generate data alerts for reviewing and confirming of data
accuracy during data entry. Additionally, every year
approximately 5-10% of the reporting clinics are randomly
selected for data validation (35 ART clinics were selected for
validation in 2015); this review includes, but is not limited to
medical and laboratory records and comparison with data
reported in NASS. Finally, NASS data are collected under OMB
approval, which is must be renewed every three years,
including a review for relevancy.

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Users

Administrators
31

Identify who will have access to the PII in the system
and the reason why they require access.

General users of the data include
scientific analysts, statisticians, project
senior staff and research staff for
statistical analysis and reporting.
System administrators have access to
data via the NASS website as site
administrators. The CDC consolidated
environment is hosted with

Developers

Contractors

Others

Direct and Indirect contractors are
responsible for the ART project along
with operating and maintaining the
information system. Direct and
Clinic staff and medical directors for
data entering/editing. These
individuals are not CDC credentialed.

Describe the procedures in place to determine which The ART project director is responsible for ensuring that
32 system users (administrators, developers,
personnel have controlled access only to what is relevant to
contractors, etc.) may access PII.
their specific work on ART. The project director oversees the

Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

Role based access controls are in place to ensure the concept
of “least privilege” is implemented. Based on project director’s
assessment of ‘need to know’, the network administrator
creates and implements network access groups. Examples of
such groups would be managers, systems staff, data
preparation personnel, help desk staff, statisticians working on
data validation etc. Each individual assigned to work on the
project is assigned to a group associated with their role. Access
rights are then derived from that role. The project network
directory structure is organized such that access to each
subfolder is restricted to one or more network access groups,
effectively ensuring that an individual’s access to data
containing PII is restricted only to network areas pertaining to
the tasks the individual is required to perform.

Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

All direct and indirect contractor are required to annually
complete Information Security Awareness Training which
covers all aspects of systems and data security and
confidentiality. All systems and network staff must also
complete Role-base security awareness training, annual
contingency plan and disaster recovery training. The ART
project director is responsible for ensuring all ART personnel
have contract-specific 308(d) assurance of confidentiality
training, review of 308(d) contract-specific clause, and annual
retraining.

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Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

All direct and indirect contractor system and network
infrastructure staff receive Role-Based security training on the
technology they support on an ongoing basis and shall also
receive additional security training as necessary to meeting
requirements. Additionally, all employees and contractor staff
assigned to work on the ART project who come in contact with
any NASS data are required to review and sign the Contractor’s
Pledge of 308(d) Confidentiality Safeguards for Individuals and
Establishments Against Invasions of Privacy. All systems and
network staff must also complete an annual contingency plan
and disaster recovery training.
Yes
No
All Information in Identifiable Form (IIF) is stored in a secured IT
system or, if on physical media, in locked containers and/or
spaces when not in use.

Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

All data containing PII are electronically archived and the tapes
are securely stored. Records are retained, stored, and
disposed of in accordance with CDC’s Scientific and Research
Project Records Control Schedule# N01-0064-1987-0001
Item 119-1. The de-identified datasets are permanent records.
No identifiable information will be retained or transferred to
the National Archives.

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Several controls are applied to protect system data.
Administrative controls include a security plan, contingency
plan, file back-up, least privilege, and training. Technical
controls include Usernames and Passwords and a second
authentication factor. Physical controls include ID Badges, Key
Cards, and Closed Circuit TV (CCTV). Please refer to the
Information System Security Plan (ISSP) for further details.

Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Administrative Controls:
Access to PII follows a least privilege model. NASS staff receive
study specific confidentiality training in addition to IRB
training. This training covers the procedures and practices
used to protect the confidentiality of the data collected. NASS
staff are required at all times to maintain and protect the study
data and confidential records that may come into their
presence and under their control. This training covers, but is
not limited to, the following areas of concern: restrictions on
use of information, enhanced protection of computerized files
as part of study implementation, dissemination of research
results, data sharing with other study partners, analytic data
access policies and procedures, instructions concerning
confidentiality procedures, procedures for traveling with
confidential study materials, loss of study materials containing
confidential data. Once confidentiality training is complete,
personnel must sign a confidentiality agreement that indicates
that signee has carefully read and understands the agreement
and the confidentiality of all records handled in regard to
NASS.
Technical Controls:
Access to PII follows a least privilege model. The PII will be
secured in NASS. The NASS System Security Plan describes the
user privileges and the IRB documents outline who should
have access to the PII maintained in the system. Secure logins
will be used to prevent unauthorized access from the
application. NASS enforces a limited number of invalid access
attempts by a user before lockout. Roles will be utilized to
prevent unnecessary viewing of PII. Storage will utilize FIPScompliant encryption. Server room remains locked at all times
through the use of RFID key cards and personal security
passcodes assigned to individual authorized IT staff with
proper security privileges.
Physical Controls:
Physical measures, policies, and procedures are in place at the
contractor’s facility to protect information, buildings, and
equipment from unauthorized intrusions, environmental
hazards, and natural hazards.

General Comments

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OPDIV Senior Official
for Privacy Signature

signed by Jarell
Jarell Oshodi Digitally
Oshodi -S
Date: 2022.03.22 14:59:41
-S
-04'00'

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