Privacy Impact Assessment

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

0920-20NT

Question

04/16/20

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

0920-20NT

2a Name:

Form Date

Using Real-time Prescription and Insurance Claims Data to Supp
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

Medical Epidemiologist

POC Name

Kathy Byrd

POC Organization Centers for Disease Control and P
POC Email

gdn8@cdc.gov

POC Phone

404.639.3083
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

N/A

10

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

New information collection

11 Describe the purpose of the system.

The Antiretroviral Improvement among Medicaid Enrollees
(AIMS) study is a cluster-randomized controlled Data-to-Care
intervention with targeted provider- and patient-level support.
The targeted population are persons with HIV who are enrolled
in Virginia Medicaid and who have either never filled an
(Antiretoviral) ARV prescription or who are > 30 to < 90 days
late filling their ARV prescription. Data will be collected to
determine study eligibility, to conduct patient- and providerlevel interventions and to determine study outcomes.
Virginia Medicaid: Contains demographics and medical
diagnosis, procedure and pharmacy claims for Virginia
Medicaid enrollees. Virginia Medicaid also includes identifying
information such as; Social Security Number (SSN), Name, Date
of Birth (DOB), Phone numbers, and Mailing Address. Data will
be securely transferred from Department of Medical Assistance
Services (DMAS--VA Medicaid) to the Virginia Department of
Health (VDH) server where they will be matched to the VDH
Care Marker data to determine study eligibility. No PII will be
accessed outside of the DMAS or VDH servers and none will be
sent to CDC.

VDH Care Marker database: Contains information on all people
with HIV in Virginia and includes HIV surveillance data (e.g., HIV
viral load), care reports for persons receiving (AIDS Drug
Assistance Program) ADAP benefits, vital status, demographics
and some care utilization data (e.g., dates of medical visit, ARV
Describe the type of information the system will
prescriptions). Data will be matched to the Medicaid data to
collect, maintain (store), or share. (Subsequent
determine study eligibility. No PII will be accessed outside of
12
questions will identify if this information is PII and ask the DMAS or VDH servers and none will be sent to CDC.
about the specific data elements.)
Phase I and Phase II patient-level semi-structured interviews: A
one-time Phase I and/or Phase II semi-structured interview will
be administered for participants of the patient-level
intervention. All data from the Phase I and II interviews will be
entered directly into VDH’s REDCap system, a system with its
own approved PIA.
Clinician consultation: A one-time peer-to-peer clinician
consultation will be administered for the provider-level
intervention. All data from the consultation will be entered into
VDH REDCap, a system with a currently approved PIA.
PositiveLinks mobile app: Data from the app (e.g., participants’
response rates for daily queries about medication, mood and
stress, posts to the community message board) will be
downloaded through the app’s administrative web portal.

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Virginia Commonwealth University (VCU -- grantee) will
construct de-identified analytic datasets. All study data will be
de-identified and all PII elements will be removed from the
original data, and a new de-identified analytic dataset will be
created in accordance with HIPAA regulations and 45 CFR
164.514. Only de-identified analytic datasets will be sent to
CDC. CDC will not be able to re-identify participants in the deidentified analytic dataset. These datasets will be sent to CDC
through the CDC Secure Data Network.

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

Two databases used in this study (Virginia Medicaid and
Virginia Care Marker) routinely contain personally identifiable
information. These existing data are not collected for the
purpose of this study but are routinely collected by DMAS for
payment of administrative insurance claims and VDH for HIV
surveillance. The study will use identifiable information to: link
the VA Medicaid and Care Marker databases (e.g., name, social
security number, phone number, date of birth, mailing
address); to identify persons for intervention (e.g., identifiable
data will be used to determine persons late filling ARV
prescriptions); and to facilitate the collection of response data
(e.g., names, telephone numbers and mailing address will be
used to contact participants for patient- and provider-level
interventions, name of participants’ Medicaid Managed Care
Organization will be used to refer participants to appropriate
resources). These identifiable data will remain on the DMAS
and VDH servers (which routinely contain this information)—
no identifiable data will be downloaded to VCU servers and
none will be sent to CDC.
Yes

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

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

Other...

Other...

Other...

Other...

Other...

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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
To determine participant eligibility (e.g., identifiable data will
be used to determine persons late filling ARV prescriptions and
to link the DMAS and VDH Care Marker datasets).
To facilitate the collection of response data (e.g., names and
telephone numbers will be used to contact participants for
patient- and provider-level interventions, name of participants’
Medicaid Managed Care Organization will be used to refer
participants to appropriate resources).

20 Describe the function of the SSN.

A validated HIV case identification algorithm will be applied to
the Virginia Medicaid database to identify persons with HIV
who have either never filled an ARV prescription or have not
filled an ARV prescription within >30 to < 90 days of the
expected fill date. These individuals will be considered
preliminarily eligible for study participation. Deterministic and
probabilistic methods will be used to match this list with the
Virginia Care Markers databases. Social security number along
with other PII (e.g., name, date of birth, address) will be used to
make the match between the databases. Individuals that are
matched across the two databases (indicating that the persons
are both enrolled in Medicaid and confirmed HIV positive) are
eligible for study participation.

20a Cite the legal authority to use the SSN.

Section 1211 of the Tax Reform Act of 1976: https://
aspe.hhs.gov/report/personal-privacy-information-society/
restrictions-use-ssn

Consistent with Section 301(d) of the Public Health Service Act,
a Certificate of Confidentiality (CoC) applies to this research
because this research is funded or supported by CDC and the
following are true: the research involves Human Subjects as
defined by 45 CFR Part 46; the research involves information
about an individual for which there is at least a very small risk,
Identify legal authorities governing information use that some combination of the information, a request for the
21
information, and other available data sources could be used to
and disclosure specific to the system and program.
deduce the identity of an individual. The Certificate of
Confidentiality protects the privacy of subjects by limiting the
disclosure of identifiable, sensitive information; the research
team cannot be forced (e.g., court subpoena) to disclose
identifying information from study participants for any civil,
criminal, administrative, legislative, or other proceeding,
whether at the federal, state, or local level.
22

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

Yes
No

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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: "Epidemio

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.

Pending
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
All PII will remain within the DMAS an
Agency/Agencies
Private Sector

VCU will have access to PII on the
DMAS and VDH servers to

Virginia Commonwealth University (VCU) has been given
DMAS and VDH affiliate status which allows them to access the
Describe any agreements in place that authorizes the Virginia Medicaid and VDH Care Marker databases on the VDH
information sharing or disclosure (e.g. Computer
and DMAS servers, respectively. Data necessary for the study
24b Matching Agreement, Memorandum of
will be placed in study specific files on the secure DMAS and
Understanding (MOU), or Information Sharing
VDH servers by DMAS and VDH personnel. VCU will only have
Agreement (ISA)).
access to the study files. VCU has access to these data through
study-specific amendments to existing cross-agency and crossinstitutional data use agreements.

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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

Is the submission of PII by individuals voluntary or
mandatory?

Only de-identified analytic datasets will be transferred and
downloaded onto Virginia Commonwealth University (VCU)
servers. VCU personnel will not be able to re-identify
participants in the de-identified analytic dataset. The dataset
will be protected from improper use and disclosure through
use of university-wide data security standards as outlined in
the VCU Research Data Ownership, Retention, Access, and
Security policy. Only authorized persons at VCU will have
access to these data.
The Virginia Medicaid and Care Marker databases are existing
data that are not collected for the purpose of this study but are
routinely collected by DMAS and VDH for payment of
administrative insurance claims and HIV surveillance. For the
patient- and provider-level intervention, participants will be
informed that participation is voluntary, and they are at liberty
not to answer any questions and may end participation at any
time. We will indicate that participation is voluntary and will
not affect provision of any public benefits. Participants will be
informed that there is no monetary incentive to participate and
will be given as much time as necessary to decide whether to
participate.
Voluntary
Mandatory

The Virginia Medicaid and Care Marker databases are existing
Describe the method for individuals to opt-out of the data that are not collected for the purpose of this study but are
routinely collected by Virginia Department of Medical
collection or use of their PII. If there is no option to
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Assistance Services (DMAS) and Virginia Department of Health
object to the information collection, provide a
(VDH) for payment of administrative insurance claims and HIV
reason.
surveillance. Participation in the patient- and provider-level
interventions is voluntary.
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.

The Virginia Medicaid and Care Marker databases are existing
data that are not collected for the purpose of this study but are
routinely collected by DMAS and VDH for payment of
administrative insurance claims and HIV surveillance. Virginia
Medicaid and Care Marker already has obtained consent from
the individuals.

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.

The Virginia Medicaid and Care Marker databases are existing
data that are not collected for the purpose of this study but are
routinely collected by DMAS and VDH for payment of
administrative insurance claims and HIV surveillance, therefore,
an individual with concerns may contact Virginia Medicaid and
Care Marker for this process.

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 Virginia Medicaid and Care Marker databases are existing
data that are not collected for the purpose of this study but are
routinely collected by DMAS and VDH for payment of
administrative insurance claims and HIV surveillance, therefore
Virginia Medicaid and Care Marker ensure their data.

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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.

Developers
Contractors

VCU will have access to PII on the
DMAS and VDH servers to determine
Describe the procedures in place to determine which The VCU Statistician and Data Manager will have access to the
32 system users (administrators, developers,
PII to determine study eligibility. DMAS and VDH staff access to
contractors, etc.) may access PII.
PII is determined by DMAS and VDH agency policy.
Others

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.

Virginia Commonwealth University (VCU) has been given
DMAS and VDH affiliate status which allows them to access the
Virginia Medicaid and VDH Care Marker databases on the VDH
and DMAS servers, respectively. Data necessary for the study
will be placed in study specific files on the secure DMAS and
VDH servers by DMAS and VDH personnel. VCU will only have
access to the study files. DMAS and VDH staff access to PII is
determined by DMAS and VDH agency policy.

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 study staff will complete the computer-based Scientific
Integrity and Quality Training research ethics and compliance
training. CDC study staff will also complete the Information
Security Awareness Training annually.

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

Virginia Commonwealth University researchers are trainined in
and adhere to the "Responsible Conduct of Research", (https://
research.vcu.edu/responsible_conduct/data_collection.htm)
and "Research Data Ownership, Retention, Access, and
Security Policy Statement", (https://policy.vcu.edu/
universitywide-policies/policies/research-data-ownershipretention-access-and-security.html) to ensure the general
security and privacy of research respondents.

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
No identifiable data will be sent to CDC. Virginia
Commonwealth University will construct de-identified analytic
datasets. All study data will be de-identified and all PII
elements will be removed from the original data, and a new
de-identified analytic dataset will be created in accordance
with HIPAA regulations and 45 CFR 164.514. Only de-identified
analytic datasets will be sent to CDC. CDC will not be able to reidentify participants in the de-identified analytic dataset.

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Administrative Controls: No identifiable data will be sent to
CDC. Virginia Commonwealth University will construct deidentified analytic datasets. All study data will be de-identified
and all PII elements will be removed from the original data.
This information is only available to project staff. These data
can only be linked with effort because they are stored in
separate data files.

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

Technical Controls: The data collection contractor has several
security procedures in place to safeguard data. All electronic
data will be stored on secured servers and will be accessible
only to staff directly involved in the project. Also, all contractor
staff involved with the project will be required to sign a Data
Collector Confidentiality Agreement, which is a statement of
personal commitment to guard the confidentiality of data.
Physical Controls: No identifiable data will be stored at Virginia
Commonwealth University. The data collection contractor will
remotely access data at individual workstations physically
located in an office building with various levels of physical
access controls, including security guards, card access, and
locking department and office doors which are locked when
vacant. Only authorized project personnel will have access to
computer output.

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

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Reviewer Questions
6

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

Answer
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: 2020.08.18
for Privacy
15:00:04 -04'00'

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