Att 5b_PIA

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

0920-19BG

2a Name:

11/16/2018

Web-based Approaches to Reach Black or African American and
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

Robin MacGowan

POC Organization NCHHSTP/DHPIRS/PRB
POC Email

[email protected]

POC Phone

404-639-1920
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

Not applicable.

10

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

Not applicable.

11 Describe the purpose of the system.

The purpose of this information collection is to assess the
effectiveness of mailing out rapid Human Immunodeficiency
Virus (HIV) self-testing kits and providing access to Internetbased prevention mobile applications and websites as a public
health strategy for increasing Black and Hispanic/Latino men
who have sex with men (MSM) linkage to appropriate
prevention and care services.

Personally identifiable information (PII) including name, E-mail
Address, Phone Number, Mailing Address, Military Status, Date
Describe the type of information the system will
of Birth, Employment Status, Age, Race/Ethnicity, City/Zip
collect, maintain (store), or share. (Subsequent
Code, Sex, Sex at Birth, Sexual Orientation, Education Level,
12
questions will identify if this information is PII and ask and Annual Income Information will be collected.
about the specific data elements.)
Respondents also will receive unique identification nonidentifiable codes.
Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

All collected, maintained, and shared PII will be used to mail
HIV testing kits and ensure receipt of those kits. PII will also
allow study staff and partners to contact study participants for
video counseling and other supportive services.
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

City/Zip Code

Age

Sex/Sex at Birth

Race/Ethnicity

Sexual Orientation,
Education Level, Annual
income Information

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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
PII data will be used to determine eligibility for this study.
PII data also will be used to maintain contact with participants
once enrolled in the study, mail out HIV testing kits, schedule
and conduct follow-up HIV video counseling, and initiate
participants engagement with the health Mpowerment
website.

20 Describe the function of the SSN.

Not applicable.

20a Cite the legal authority to use the SSN.

Not applicable.

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.

SORN 09-20-0160, "Records of Subjects in Health

Published:
Published:
In Progress

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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.

To be determined.
Yes

24 Is the PII shared with other organizations?

No
Within HHS

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

Other Federal
Agency/Agencies
State or Local
PII will be shared or disclosed in acco
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

PII will be shared or disclosed with
other study sites hosted by

An MOU, signed by Emory University, the University of North
Carolina--Chapel Hill, and the University of Michigan,
authorizes data and information sharing for the purposes of
this study.
Not applicable.

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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

At the beginning of the study eligible participants will be asked
to review and electronically 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. The consent form will include an
explanation of the study, risks and benefits of participation,
duration of participation, contact information for individuals
who can answer questions about the research study regarding
participant rights and protections, the voluntary nature of
participation, and the right to withdraw without penalty.
Participant are provided with information to contact study staff
if clarification is needed regarding consent processes.
Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Mandatory

Describe the method for individuals to opt-out of the
Participants can opt out of all PII questions that are not
collection or use of their PII. If there is no option to
27
eligibility related. Also, participants can opt out of participating
object to the information collection, provide a
in the study altogether or withdraw from the study at any time.
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
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.

All participants will be allowed to track study progress and to
correspond with study management if any changes are made
to the system. They will be able to contact the Emory study
team or the Emory Institutional Review Board (IRB).
Study participants will be provided contact information and
instruction to contact either the grantee principal investigators
as well as the Emory human subjects staff if they have any
questions about their rights as a participant or concerns that
their PII may have been inappropriately obtained, used, or
disclosed:

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 Emory IRB
404-712-0720 or 877-503-9797
why not.
[email protected]
Emory Study Team
404-727-4340
[email protected]
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.

Participants will be able to update PII at each interval of study
participation when filling out surveys for data collection
purposes.
Users
Administrators

31

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

Study site administrators will have
access to PII to contact study

Developers
Contractors
Others

Study staff assisting administrators
may also have limited access to PII in

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The ability to designate specific roles in Emory's digital study
software allows users to control permissions and accessibility
to participant information. Staff accessing the system will be
Describe the procedures in place to determine which limited by which PII data is necessary to perform the duties of
32 system users (administrators, developers,
their position. Users also are limited to a reporting-only role,
contractors, etc.) may access PII.
allowing for study oversight through real-time aggregate
reporting, but no access to protected health information (PHI).
The Centers for Disease Control and Prevention (CDC) lacks
access to these 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 PII will be restricted to individuals trained in
human subject protections. PII is collected for a specific and
identifiable purpose with access restricted to specific job tasks
and individuals who perform those tasks.
Assigned user permissions will be determined by their roles to
perform different actions and need to view PII.

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 research personnel employed by Emory and subcontractors
under this contract will have completed Collaborative
Institutional Training Initiative (CITI) training before they are
permitted to participate in research or view PII. All study staff
will be trained on relevant study procedures prior to
interacting with participants involved in study activities.

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

Emory researchers and study staff will participate in internal
training on study instruments, procedures, and reporting
regulations, which includes privacy awareness and
confidentiality training. Graduate research assistants also must
sign a code of conduct to ensure participants' safety and
privacy.

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
Records are retained and disposed of in accordance with the
CDC Records Control Schedule 04-4-22 Family of HIV Surveys,
Division of HIV/AIDS Prevention/Surveillance and
Epidemiology, (N1-442-02-3-4, Item 1) and Division of HIV/
AIDS Prevention/Surveillance and Epidemiology, (N1-442-02-3,
Item 1). Record copy of study reports are maintained in agency
records from two to three years in accordance with retention
schedules. Source documents for computer are disposed of
when no longer needed by program officials. Personal
identifiers may be deleted from records when no longer
needed in the study as determined by the system manager,
and as provided in the signed consent form, as appropriate.
Disposal methods include erasing computer disks or tapes,
burning or shredding paper materials or transferring records to
the Federal Records Center when no longer needed for
evaluation and analysis. Cut off closed grant, contract, or
cooperative agreement files at the end of the calendar year in
which the project ends or a final report is written and destroy
six years after cut off.

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Physical
All printed records will be securely stored in locked file
cabinets within locked offices and monitored during access. No
names or other identifying information appear on data
documents or in data files, as the re-contact information will be
stored separately. Only designated staff 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.

Technical
PII is stored in a database that provides staff with the minimum
amount of data needed to perform tasks associated with their
position. The application securely maintains participant
information behind a firewall rendered over a Secure Sockets
Layer (SSL) certificate for administrator-only access. All
passwords are stored encrypted within the database, which
also uses database level encryption to prevent information
copying from one database to another. Web application also
uses an automatic logout feature after a certain period of
inactivity.
Administrative
All respondents will receive unique identification nonidentifiable codes, which will be stored separately from PII on a
password protected computer. These codes will be used as the
de-identified data set that will later be shared with CDC. CDC
does not have access to the database. All staff collecting data
will participate in a training that will review protections for
privacy and confidentiality of all data, including PII. Only
Principal Investigators may handle requests to examine data
collected during this study.

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

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Reviewer Questions

Answer

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

OPDIV Senior Official
for Privacy Signature

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2019.03.04
for Privacy
13:38:10 -05'00'

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