Privacy Impact Assessment (per Terms of Clearance)

Save

Privacy Impact Assessment Form
v 1.21
Status

Form Number

00000

Form Date

Question

Answer

1

OPDIV:

CDC/NCHHSTP/DHAP

2

PIA Unique Identifier:

0920-17AX

2a Name:

11/30/17

Mobile Messaging Intervention to Present New HIV Prevention O
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

Gordon Mansergh, PhD

POC Organization DHPIRS/PRB
POC Email

[email protected]

POC Phone

404.639.6135
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

Page 1 of 8

Save
8c

Briefly explain why security authorization is not
required

N/A

10

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

N/A

11 Describe the purpose of the system.

The purpose of this research study is to test the efficacy of a
smartphone-based sexual health and HIV prevention
messaging intervention for men who have sex with men
(MSM), known as M3 through a randomized controlled trial.
The study will evaluate whether M3 smartphone-based
intervention is an effective HIV-prevention strategy by
assessing whether exposure to the messaging intervention
results in improvements in men’s self-reported sexual health
and HIV prevention behaviors, attitudes, and beliefs.

The information collected will include: pre-exposure
prophylaxis (PrEP); antiretroviral (ARV) usage; condom efficacy;
and frequency of HIV/STD testing. Names, email addresses
and/or telephone numbers will be collected and stored.
Although Emory will conduct the data collection the
Describe the type of information the system will
instrument is developed and owned by CDC. The participant/
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask unique identification number will be automatically generated
once respondent log on to complete the survey. Data will be
about the specific data elements.)
sent to CDC in a de-identified and de-linked format. No PII will
be transmitted to CDC.

Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

M3 is a mobile-messaging intervention application.
Information collected will include several types of sensitive
information—including participant HIV status, ART and PrEP
use, HIV and STI testing, and sex behaviors—from men who
have sex with men (MSM)M3. The initial steps of the data
collection process will involve participant screening and
consent to complete a brief online questionnaire, which will
require eligible participants to provide contact information
(name, phone number and email address). Data will be
collected through an online behavioral assessment, to be
completed in 3-month intervals over the 9 month study period.
All participants will be assigned a unique identification number
for the study, so that each person’s data will be identified only
by study participant ID. Identification data will be maintained
by Emory for purposes of follow-up with participants. CDC will
not have access to PII maintained by Emory.

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

Yes
No

Page 2 of 8

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
Name, phone number, Email
and address collected are
not included in the Emory or
CDC data sets. They are kept
separate from data at all
times, and are never linked
to the data.

Taxpayer ID

Other...

Other...

Other...

Other...

Employees
Public Citizens
16

Business Partners/Contacts (Federal, state, local agencies)

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

Vendors/Suppliers/Contractors
Patients
Other

17 How many individuals' PII is in the system?

18 For what primary purpose is the PII used?

19

500-4,999
The primary purpose for the PII is to follow-up with participants
on assessment intervals and provide remuneration for
participation.

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

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

21

Identify legal authorities governing information use
Public Health Service Act, Title III, Section 301
and disclosure specific to the system and program.

22

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

Yes
No

Page 3 of 8

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.

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

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.

0920-17AX
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
N/A
Understanding (MOU), or Information Sharing
Agreement (ISA)).
24c

Describe the procedures for accounting for
disclosures

TBD

Page 4 of 8

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

Users are informed that their personal information will be
collected prior to their volunteering to participate in the study.
Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
27
object to the information collection, provide a
reason.

Mandatory
Participants must consent to being a part of the study and are
informed on the consent document that they can opt out at
any time. However, failure to provide the PII might impact their
ability to continue participation.

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
When majors changes occur, participants will be notified by
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe email or phone/text.
why they cannot be notified or have their consent
obtained.
Individuals should reasonably identify the record and specify
the information being contested, the corrective action sought,
and the reasons for requesting the correction, along with
supporting information to show how the record is inaccurate,
incomplete, untimely, or irrelevant. In the event of a suspected
Describe the process in place to resolve an
data breach, the reporting jurisdiction must report the incident
individual's concerns when they believe their PII has to the Emory University's with complete information detailing
29 been inappropriately obtained, used, or disclosed, or the nature of the suspected breach. Emory has procedures in
that the PII is inaccurate. If no process exists, explain place to respond to a breach and is required to notify the
why not.
Project Officer who reports the suspected incident to
NCHHSTP's Information Security Office and works with the
Emory until the matter has been resolved. If, however, the
individual believes their PII is inaccurate, this should be
reported to Emory university for further investigation. CDC
does not receive or have access to the individual'`s PII.
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.

Data collection requirements as a whole are reviewed by CDC
and CDC-funded grantees annually. All PII data are maintained
at the local level by CDC-funded grantees and are not shared
with CDC. Review processes may vary as each health
department grantee will have jurisdiction-specific guidelines in
place for conducting internal reviews of PII in the system.
Users
Administrators

31

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

Developers
Contractors

Only study staff at Emory University
(the cooperative agreement awardee)
Access to PII within the SMART system is based on specific staff
Describe the procedures in place to determine which role (recruitment, retention, study coordination) based on the
32 system users (administrators, developers,
established operational protocol for the research project. CDC
contractors, etc.) may access PII.
never has access to the SMART system that is based and
managed locally at Emory for all study sites.
Others

Page 5 of 8

Save

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.

The SMART system retrieves only the minimum amount of
information required for follow-up data collection with study
participants who have agreed/consented to participate in the
study. Only the study coordinator, recruitment coordinator,
retention coordinator, and SMART network administrators
have access to the SMART system containing 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.

Emory study staff have undergone training by CITIprogram on
“Human Subjects Research — Social-BehavioralEducational” (see www.citiprogram.org), a training that covers
privacy and confidentiality, related federal regulations, and
research ethics.
Project staff are required to take training conducted by
CITIprogram titled “Information Privacy and Security —
Information Security Module”, which covers Information
Security, securing identity, safer email use, and related
regulations.

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

Emory research staff are also informed of and required by the
Emory IRB system to implement IT policies and standards in
compliance with the Gramm-Leach-Bliley Act, which protects
personal identifying information such as names, addresses, and
other sensitive information.
Emory University study leadership has provided a multi-day
training -- to all personnel on this specific project across the 3
sites -- on data security, confidentiality, ethical issues, and
privacy of persons in the public and study participants, among
other critical research issues.

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.

Page 6 of 8

Save
Physical: Staff must gain access to the building through a
keycard. All records are stored in locked offices and in locked
filing cabinets. To access any computer linked to Emory’s
secured data server, one must have Emory log-in credentials.
Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Administrative: Limited to study staff only at Emory.
Technical: Emory's study staff gains access to Emory's SMART
system by proving their user-id and password. SMART is stored
on Emory’s secured network drive protected by a firewall and
requiring special access permission for staff through Emory’s IT
department.

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

Page 7 of 8

Save
Reviewer Questions
8

Answer

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

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2017.11.30
23:30:47 -05'00'

HHS Senior
Agency Official
for Privacy

Page 8 of 8