Att 10 PIA_HOPS_1080

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Privacy Impact Assessment Form
v 1.47.4
Status Draft

Form Number

F-87704

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-7106604-395613

2a Name:

7/25/2017 8:18:17 AM

Discovere Registries (HOPS)
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

Security Steward

POC Name

Mwiche Longa Kaira

POC Organization NCHHSTP/OD
POC Email

nnh8@cdc.gov

POC Phone

404.639.8508
New
Existing
Yes
No
July 27, 2018
Not Applicable

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11 Describe the purpose of the system.

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.)
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?

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

The HOPS system is used to monitor trends in the
demographics (e.g. age, sex, race, ethnicity), symptoms (e.g. of
any illness), diagnoses (e.g. HIV related/Non-HIV related), and
treatments (e.g. HIV related and Non-HIV related) in a
population of HIV-infected outpatient clinics in five cities. The
system helps to describe how to improve medical
management of HIV infection in the United States. CDC
Epidemiologist use data to study factors associated with
clinical, immunologic, and virologic successes for HIV infected
patients such as reduced mortality, and emerging issues with
long-term HIV infection and the treatment. The data is
collected by the Cerner Corporation for a cohort of HIVinfected outpatient adults receiving care at HIV specialty clinics
in Denver, Chicago, Philadelphia, Stonybrook and Washington
DC.
The HIV Outpatient Study (HOPS) utilizes collected data in the
existing electronic charting systems of participating clinics,
and combines and harmonizes these data in a centralized
application, to obtain a complete record of prospective
outpatient visits to leading HIV clinicians.
The HOPS data is collected from HIV-infected outpatient adults
receiving care at HIV specialty clinics in: Denver, Chicago,
Philadelphia, Stonybrook and Washington DC. The medical
record abstraction data is on demographics, risk factors,
The objectives of the HOPS are to: HOPS data will be used to
develop guidelines and recommendations for clinicians, public
health departments, and other partners participating in the
Yes
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
Name and DOB are required to participate in the study as
well as sex, race, ethnicity, and gender. The other fields
collected are optional.

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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

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

500-4,999
The PII primary purpose is to monitor trends in the
demographics, symptoms, diagnoses, and treatments in a
population of HIV-infected outpatient clinics across the United
States.
The secondary uses of the PII: (1) Describe factors associated
with clinical, immunologic and virologic successes, as well as
improved survival, (2) Characterize (new) problems associated
with long-term HIV infection and its treatment and (3) Describe
HIV risk behaviors and other risk behaviors (e.g., tobacco use,
adherence to antiretroviral therapy) among HIV-infected
patients.

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
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 Promotion and Education Studies"

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.

24 Is the PII shared with other organizations?

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?

OMB No. 0920-1080, exp. 08/31/2018
Yes
No
Patients are approached by HOPS project clinic staff during
one of their routine clinic visits and invited to participate in the
HOPS. Patients, who have been actively recruited throughout
the study period for this ongoing project, sign informed
consents to have information collected from their physician
visits. The privacy section of the informed consent states that
“Your personal identifying information (including your name,
date of birth, and possibly your medical record number) will be
entered and kept in a private and secure database, separately
from your medical information”.
Voluntary
Mandatory

Patients recruited to participate in HOPS by their physicians are
provided with a consent form discussing the specifics of the
study. Persons electing to participate in the study sign a copy
Describe the method for individuals to opt-out of the of the consent form to be kept on file with the study site and
they are also given a copy to keep. The HOPS is completely
collection or use of their PII. If there is no option to
27
voluntary. Patients who are approached and decline
object to the information collection, provide a
participation in the HOPS are excluded from enrollment and
reason.
data collection. Because this is a voluntary collection,
respondents are free to withdraw from the study at any time.
Patients can withdraw at anytime from study either verbally or
in writing to either the study coordinator or physician.

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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.
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.
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.

Should “major” changes occur, patients participating in the
HOPS would be notified by study staff at the site of their
enrollment and of these changes and then given the option to
be re-consented indicating their acceptance of these changes
or discontinue their participation.
HOPS participant would be notified by study site principal
investigator if their PII has been “inappropriately obtained,
used, or disclosed”. The patient will then be given the option
to remain in or withdraw from the study.
The contractor is required to perform annual review visits at
each study site and abstracted data such as name and DOB are
evaluated for integrity and accuracy by comparing the
abstracted information to data contained in the original
medical record.
Users
Administrators

31

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

Developers
Contractors

For data analysis purposes

Others

CDC HOPS project personnel for data
analysis purposes

Describe the procedures in place to determine which All accounts created for the design and maintenance of the
32 system users (administrators, developers,
HOPS are approved by the HOPS Research Project Leader (RPL)
contractors, etc.) may access PII.
with the exception of the Discovere master system
Discovere requires each system user to have a unique log-in ID
and a private password. Users must enter their log-in ID and
password each time they access Discovere.

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.

Discovere uses a role-privilege based access model where each
role is comprised of a set of permissions. Each permission
allows access to particular functions or areas of the Discovere
web site. Access to system features and the corresponding
study information is restricted based on the roles associated
with each log-in ID.
Only a user with the system administrator role can change a
user’s role or make changes to the list of permission associated
with a user’s role. All users for the HOPS are personally known
to the Cerner Research Project Leader assigned to HOPS.

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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.

Collaborative Institutional Training Initiative (CITI) training and
or Office for Human Research Protections(OHRP) are required
for individuals interacting with participants and entering data.
Security and Privacy Awareness training is required for
associates who may need to access the data base to
troubleshoot, update, work on the Discovere database. This is
required before allowing access to Discovere and a log is kept
with training expiration dates.

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

Collaborative Institutional Training Initiative (CITI training)
training and/or Office for Human Research Protections (OHRP
training) are required for individuals interacting with
participants and entering data.

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

Technical
All PII pulled from the participant's medical record is stored
electronically in the Discovere database. Roll based access,
password protected workstations, database "time-outs" after
amount of idle time protect the stored PII. Unique user account
IDs are issued to all end users and they are instructed to not
share account information, passwords, or keep paper copies of
log-in information.
Administrative
Discovere acounts are disabled after 6 failed attempts to log in
and user must call project team to enable account again.
Cerner project team members are familiar with all end users
because it is a relatively small group. Role-based permissions
allow users to only perform tasks within the database that are
associated with their assigned role. Site level access ensures
end users are only able to view/edit data from participants at
their assigned site. User passwords expire after 30 days.
Physical
Physical copies of the signed informed consents are kept in a
secure location at each site. This physical security is verified at
the annual review visit. Cerner's facility has a 24x7 security
presence to ensure protection of PII. Cerner employs physical
and electronic patrol/access to location. Multiple access points
must be crossed to access the data center floor. Cerner utilizes
multiple overlapping security applications or countermeasures
to provide greater security. All security solutions work in
conjunction to create a holistic security model and support
strategy. Administrative access to the data centers is allowed
only by VPN and all connections are tracked and logged.
External application access across public networks is protected
by encryption. All network devices, security infrastructure
components, and server systems transfer logs to a centralized
repository for analysis, troubleshooting, compliance, and
auditing purposes.

General Comments

OPDIV Senior Official
for Privacy Signature

Beverly E.
Walker -S

Digitally signed by
Beverly E. Walker -S
Date: 2018.07.19 16:33:17
-04'00'

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