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Privacy Impact Assessment Form
v 1.43
Status Draft

Form Number

F-43856

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-7304408-829613

2a Name:

9/10/2013 8:15:33 AM

National Assisted Reproductive Technology (ART) Surveillance S
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)?

8b Planned Date of Security Authorization

No
Yes
No
Agency
Contractor
POC Title

Info Systems Security Officer

POC Name

Cindy Allen

POC Organization NCCDPHP
POC Email

[email protected]

POC Phone

(770) 488-5388
New
Existing
Yes
No
September 26, 2013
Not Applicable

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11 Describe the purpose of the system.

To collect annual clinic-specific and cycle-specific data from all
practicing assisted reproductive technology clinics in the US
and its territories.

NASS collects clinic-specific and cycle-specific data from all
practicing assisted reproductive technology (ART) clinics in the
Describe the type of information the system will
US and its territories for the annual successful rates report
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask publishing. This data collection is to fulfill the mandate of the
Fertility Clinic Success Rates and Certification Act of 1992.
about the specific data elements.)
Patients PII are collected with inform consent on voluntary
basis prior to the beginning of the treatment.
Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

The National Assisted Reproductive Technology is a
Surveillance System (ART) with an organized infrastructure that
enables the ongoing, systematic collection, management,
analysis, interpretation, and dissemination of health-related
data.
Yes

14 Does the system collect, maintain, use or share PII?

15

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

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
Patient zip code, country,
city and state of residence
patient ethnic background
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?

500-4,999
To determine treatment outcomes from infertility clinics in the
United States, and publishes an annual report.

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19

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

Research

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

Public Health Service Act, Section 301, "Research and
Identify legal authorities governing information use Investigation," (42 U.S.C. 241); and Sections 304, 306 and 308(d)
21
which discuss authority to maintain data and provide
and disclosure specific to the system and program.
assurances of confidentiality for health research and related
activities (42 U.S.C. 242 b, k, and m(d)).
22

Yes

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

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.

09-20-0136

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, August 31, 2015
Yes
No

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Within HHS
Identify with whom the PII is shared or disclosed and
24a
for what purpose.

Other Federal
Agency/Agencies
State or Local
Agency/Agencies
Private Sector

Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Understanding (MOU), or Information Sharing
Agreement (ISA)).
24c

Describe the procedures for accounting for
disclosures

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

Clinics specify in their informed consent that patient data is
subject to reporting to CDC.
Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Mandatory

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
27
Patients may decline the informed consent.
object to the information collection, provide a
reason.
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
No process in place
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.
reasonably identify the record and specify the information
being
contested, the corrective action sought, and the reasons
Describe the process in place to resolve an
for
requesting
the correction, along with supporting
individual's concerns when they believe their PII has
information
to
show how the record is inaccurate, incomplete,
29 been inappropriately obtained, used, or disclosed, or
untimely,
or
irrelevant.
that the PII is inaccurate. If no process exists, explain
PII is used for data gathering and analysis only; not used or
why not.
shared publicly, or obtained for providing services or benefits
to individuals or the public.
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.

The data are validated at the time they are collected, and are
used for statistical reporting only. They are maintained in an
information system that meets FISMA requirements for
safeguarding information confidentiality, integrity, and
availability. Assessments are completed annually

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31

Users

Typical users include analysts,
statisticians, research staff, and project
senior staff, as well as agency project.
The data, which may include IIF, are
used for statistical analysis and
reporting.

Administrators

System administrators have access to
the structures and hardware
supporting the information system
containing the IIF. They have access to
the data during routine operations
such as backups.

Developers

Developers have access to data stored
in databases or data files and/or used
for statistical analysis, which may
include IIF.

Contractors

Westat, a contractor, is performing the
ART project and operating the NASS
information system.

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

Others
Individuals are granted rights to NASS information by the
Describe the procedures in place to determine which project director who, in cooperation with the systems manager
32 system users (administrators, developers,
and other key personnel, determines the need to access PII
contractors, etc.) may access PII.
based on the role the user is assigned and the specific
requirements that role requires.

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 Westat employees are required to annually complete
Westat’s Information Security Awareness Training which covers
all aspects of systems and data security and confidentiality. All
systems and network staff must also complete Westat annual
contingency plan and disaster recovery training.

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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?

Systems and network infrastructure staff receive specific
security training based on the technology they support on an
ongoing basis and shall also receive additional security
training as necessary to meet contract requirements.
Additionally, all employees 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 Westat annual contingency plan and
disaster recovery training.
Yes
No
All PII/IIF is stored in a secured IT system or, if on physical
media, in locked containers and/or spaces when not in use.
Policies and procedures for handling IIF meet FISMA, NIST,
HHS, and CDC requirements and guidelines.

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

Upon completion of the contract, all data containing PII are
electronically archived and the tapes are securely stored
offsite. Westat’s standard retention period is three years. The
project director determines whether or not to extend the
retention period beyond the three years based on contract
requirements and/or study specific needs. The archives are
destroyed only upon project director ‘s approval.
Information is secured on the system through access controls.
Specifically, the NASS application and all other NASS related
applications that provide access to PII include strict user
authentication, which includes strong passwords that are
required to be changed periodically. Access to all databases is
restricted to designated internal Westat users and, additionally,
native access control features are implemented to further
enhance database protection. Furthermore, a comprehensive
firewall system with multiple firewalls, routers, and other
devices is configured and actively managed to ensure the
security of the Westat network infrastructure.

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

In addition to access controls, information is also secured
through personnel security awareness and training, regular
auditing of information and information management
processes, careful monitoring of a properly accredited NASS
information system, control of changes to the NASS,
appropriate handling and testing of contingencies and
contingency planning, ensuring that all users of the NASS are
properly identified and authorized for access, and that they are
aware of the rules and acknowledge that fact, by ensuring that
any incident is handled expeditiously, properly maintaining
the NASS and regulating the environment the system operates
in, controlling media, evaluating risks and planning for
information management and information system operations,
by ensuring that the system and any exchange of information
is protected, by maintaining the integrity of the NASS and the
information stored in it, and by adhering to the requirements
established in the contract and statement of work.

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Reviewer Questions

Answer

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Reviewer
Notes
10

Is the PII appropriately limited for use internally and with third parties?

Yes
No

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Reviewer Questions

Answer

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

Reviewer
Notes
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

General Comments

OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by Beverly E. Walker -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=100144034
3, cn=Beverly E. Walker -S
Date: 2013.12.17 19:28:02 -05'00'

HHS Senior
Agency Official
for Privacy

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