Privacy Impact Assessment

Save

Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

0920-18MY

2a Name:

Network Epidemiology of Syphilis Transmission (NEST)
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.

Initiation
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

Project Officer

POC Name

Robert Kirkcaldy, MD, MPH

POC Organization NCHHSTP/DSTDP/ESB
POC Email

[email protected]

POC Phone

(404) 639-8659
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

Page 1 of 9

Save
8c

Briefly explain why security authorization is not
required

This is an information collection, not a system.

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

No changes. This is a new information collection.

11 Describe the purpose of the system.

The Network Epidemiology of Syphilis Transmission (NEST)
study and information collection will inform development of
methodologies for collection of complex sexual network data
among men who have sex with men (MSM) at high risk for
syphilis in the United States. NEST will address knowledge gaps
about the epidemiology of syphilis among MSM in the United
States.
NEST awardees will collect PII for the purpose of contacting
participants for follow-up visits. Information being collected
will include: name, date of birth, email address, mailing
address, phone number, social media handles (Facebook,
Instagram, Twitter, Snapchat), medical record number, and
STD surveillance ID. Participants will describe their recent
sexual network and might provide names or nicknames of
recent partners to the local study site.

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.)

PII will not be transmitted to the CDC. Data that will be sent to
CDC include:
(1) Epidemiological data such as age, sex, gender, race,
ethnicity, clinical data, sexual activity, drug use, HIV status from
men who have sex with men (MSM) who are at high risk for
syphilis and enrolled in the study.
(2) STI lab test results for syphilis, gonorrhea, chlamydia, and
HIV.
All study participants and named sexual partners will be
assigned unique non-identifiable study participant IDs. These
unique study participant IDs will not include medical record
numbers or PII. The key to link data will only be available at the
local level.

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?

The purpose of the study is to design interventions to reduce
the spread of syphilis. The study will collect longitudinal
survey data from study participants. Men who have sex with
men (MSM) who are at high risk for syphilis will be enrolled into
the study. Data will be collected from enrolled MSM during a
standardized survey interview at each study visit. The
standardized interview will ascertain basic demographic
information such as Name (only collected locally), DOB(only
collected locally), age, country of residence, race, ethnicity;
information about healthcare access and utilization; and sexual
behavioral information including sexual network information
(all elements collected locally only) such as names of contacts,
phone numbers, social media handle, e-mail.
Yes
No

Page 2 of 9

Save

Indicate the type of PII that the system will collect or
15
maintain.

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

Social Media Handles

STD surveillance ID

Other...

Other...

Other...

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?

19

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

500-4,999
The primary use of the PII is to allow local sites to contact
participants for follow-up visits.
The secondary use of the PII is to allow the local sites to track
changes in sexual network structure and partnerships over
time.

20 Describe the function of the SSN.

N/A, SSN's are not collected

20a Cite the legal authority to use the SSN.

N/A, SSN's are not collected

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

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

Yes
No

Page 3 of 9

Save
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.

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.

This is a new Information Collection Request.
Yes

24 Is the PII shared with other organizations?

No
Within HHS
Other Federal
Agency/Agencies
State or Local
Agency/Agencies

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

Private Sector
Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Not applicable
Understanding (MOU), or Information Sharing
Agreement (ISA)).
24c

Describe the procedures for accounting for
disclosures

N/A No data are shared or disclosed.

Page 4 of 9

Save

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

At the beginning of the study eligible participants will be asked
to review and sign a study consent form that informs
participants that personal identifying information will be
collected and every effort will be made to keep this
information confidential. This information will be kept secure,
accessed, and retained by the recruiting sites and not
transmitted to the CDC.
Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Mandatory

Participants may withdraw or revoke their permission to use
and disclose PII and health information at any time. This will be
Describe the method for individuals to opt-out of the done by sending a written notice to the local site researchers.
collection or use of their PII. If there is no option to
Contact information for local site researchers will be included
27
object to the information collection, provide a
in the study consent form. If participants withdraw their
reason.
permission, no new information identifying the participant will
be gathered after that and the participant will no longer be
able to stay in the study.
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.

There are no major changes expected for this information
collection, however, individuals can be contacted via phone or
email by local study staff to notify them of any major changes
to the system.

Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

Study participants will be instructed to contact an individual in
the Office of Responsible Research Practices at each local site if
they have any questions about their rights as a participant or
concerns that their PII may have been inappropriately
obtained, used, or disclosed. Contact information will be
included in the study consent form.

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 PII collected is held at the local sites. The local sites will
confirm the accuracy of the information each time they contact
a participant by phone, e-mail, and/or during study visits.
If local site staff are unable to contact the participant after
multiple attempts, the participant will be withdrawn from
future study visits.
Users

Local Site Staff involved in the Study
for collecting and entering the data.

Administrators
31

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

Developers
Contractors
Others

Page 5 of 9

Save
The CDC study team have defined that roles and
responsibilities to access PII is limited to only study
Describe the procedures in place to determine which investigators (Co-PIs, Program Director, and Program Manager)
32 system users (administrators, developers,
will have access to recruitment/retention, survey and interview
contractors, etc.) may access PII.
data.
The study data manager has a defined role that will only have
access to survey and interview data.

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.

Access to sensitive Personally Identifiable Information (PII) will
be restricted to individuals trained in human subject
protections who are listed on the Institutional Review Board
(IRB) protocol. All PII is collected for a specific and identifiable
purpose with access restricted to specific job tasks and
individuals who perform those tasks. Access to PII in study data
collected for the purposes of analysis is limited to the study
investigators and data manager.

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.

CDC personnel are required to complete the annual OCISO
Security Awareness Training to make them aware of their
responsibilities for protecting the information being collected
and maintained.
Local study staff will undergo data security and confidentiality
training annually and will sign a confidentiality statement
before access to study data is authorized. All local study staff
will be knowledgeable about local data security policy and
procedures and researchers will ensure that the written data
security policy is easily accessible.

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

Details of training is under the auspices of each local site.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?
Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Yes
No
CDC uses the CDC Records Control Schedule for determining
retention and destruction of PII, specifically, section 04-4-40
Surveillance Report of STD Activity, which prescribes that
records be retained and destroyed when no longer needed for
administrative or research purposes or when 30 years old,
whichever comes first.

Page 6 of 9

Save
Technical
Access to the server is controlled using individual access
controls and only authorized users will have access to the data.

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

Administrative
CDC will not receive or store PII.
The CDC study team have defined that roles and
responsibilities to access PII is limited to only study
investigators (Co-PIs, Program Director, and Program Manager)
will have access to recruitment/retention, survey and interview
data.
The study data manager has a defined role that will only have
access to survey and interview data.
CDC personnel are required to complete the annual OCISO
Security Awareness Training to make them aware of their
responsibilities for protecting the information being collected
and maintained.
Local study staff will undergo data security and confidentiality
training annually and will sign a confidentiality statement
before access to study data is authorized. All local study staff
will be knowledgeable about local data security policy and
procedures and researchers will ensure that the written data
security policy is easily accessible.
Physical
CDC data will be stored on an ITSO supported server housed in
the Application Hosting Branch (AHB). This facility is protected
by Guards at the front gate entrance to the campus, additional
protections include Personal Identification Verification (PIV)
card access to the building and rooms where the servers are
located. Guards are also located inside the campus and
buildings to control ingress and egress.

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

Page 7 of 9

Save
Reviewer Questions
4

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

Answer
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

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

Page 8 of 9

Save
OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2018.07.19
16:39:51 -04'00'

HHS Senior
Agency Official
for Privacy

Page 9 of 9