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Attachment C PIA.pdf

Evaluating the implementation and impact of an opioid medication management program, in a hospital discharge setting, to reduce falls in older adults

PIA

OMB: 0920-1285

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Privacy Impact Assessment Form
v 1.47.4
Status Draft

Form Number

F-33127

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-4081881-815547

2a Name:

8/6/2019 2:03:22 PM

STEADI Older Adult Hospital Discharge Opioid Prescribing
(OAHDOP)
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.

Implementation
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

Behavioral Scientist

POC Name

Gwendolyn Bergen

POC Organization CDC/ONDIEH/NCIPC/DUIP
POC Email

[email protected]

POC Phone

770.488.1394
New
Existing
Yes
No
November 5, 2019
Not Applicable

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11 Describe the purpose of the system.

The purpose of the system is to collect information to
determine the impact of performing medication management
for opioids as part of hospital discharge on older adult readmissions and falls and injuries related to falls.
The information system will collect, maintain and store
patient's name, email address, phone number, medical notes,
date of birth, and mailing address. Other data includes clinical
data, patient reports and data from primary care physicians.

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.)
Users for this system are authenticated via Active Directory
(AD) and User Ids and passwords are stored in the system. AD
is a separate system with its own PIA.

STEADI Older Adult Hospital Discharge Opioid Prescribing
(OAHDOP) is a full moderate information system that Evaluate
the ability to influence opioid prescribing patterns and use
among older adults following discharge from an inpatient
setting. Clinical work-flow data collected will be stored and
managed within the UCSF electronic medical record as
standard parts of the UCSF Epic EHR. Data collected will take
the form of flow sheets, standard reports used to manage
clinical work, and data extracts contained in epic standard data
tables (e.g. Clarity data warehouses).
The information system will collect, maintain and store
patient's name, email address, phone number, medical notes,
date of birth, and mailing address. Other data includes clinical
data, patient reports and data from primary care physicians.

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

Patient reported data will be collected directly from patients
via in-person interviews, phone and electronic mail surveys
sent at regular intervals after discharge from the hospital. This
data will be collected under existing approvals by the UCSF
Institutional Review Board (the UCSF body charged with
ensuring data security and privacy, as well as patient safety
and protections under research protocols). Data from these
activities will be housed in UCSF’s highly secure data
infrastructure (details of which can be found at:
https://myresearch.ucsf.edu/myresearch). Data collected from
patients will be stored temporarily.
Data from Primary Care Physicians will be collected via direct
contact with a small sample of physicians, either from faxed
surveys, emailed surveys, or phone calls. Clinical data, medical
and patient reports from these activities will be housed in the
same infrastructure as patient data stated above. The data will
be stored temporarily until the contract ends. This information
will be shared only with the CDC.
Users for this system are authenticated via Active Directory
(AD) and User credentials, Ids and passwords are stored in the
system. AD is a separate system with its own PIA.

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

Yes
No

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15

Indicate the type of PII that the system will collect or
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
User credentials (Ids and passwords)

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 Clinical Providers

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 is used primarily for contact and follow-up.
N/A

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, Section 301, "Research and
and disclosure specific to the system and program.
Investigation" (42 U.S.C. 241).

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.

09-20-0136, Epidemiologic Studies and
Surveillance of Disease Problems

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.

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?

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.

The OMB information collection approval number and
expiration date is pending.
Yes
No
During the initial process, potential participants are contacted
and notified of what will be collected, and written consent will
be obtained. If they object they cannot fill out the survey. Also
during the survey the participant can change his/her mind and
elect not to complete the survey.
Voluntary
Mandatory
Individuals can opt-out by simply choosing not to participate
in the survey. In addition, individuals will be advised that they
can at any time opt-out of the study or refuse to answer any
questions they do not wish to answer.

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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.

The process to notify and obtain consent from the individuals
whose PII is in the system when major changes occur to the
system will be notified by email or regular mail when there are
any major changes to the system.

Individuals with concerns about PII, inappropriate attainment,
use or disclosure as well as inaccuracy of their PII may report
Describe the process in place to resolve an
individual's concerns when they believe their PII has their concerns to the STEADI OAHDOP Information System
29 been inappropriately obtained, used, or disclosed, or Security Officer (ISSO) or the Contracting Officer's
that the PII is inaccurate. If no process exists, explain Representative (COR) for the contract. They may also report the
incident to the Project Director for the contract that supports
why not.
the task. The Project Director point of contact and phone
number is Jeffrey Toole at 703-801-0144.
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.

31

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

The database/web administrator periodically reviews and
compares the PII contained in the system against the
spreadsheets/database to ensure the data's integrity,
availability, accuracy and relevancy.
Users

To conduct interviews or manage the
data collection process.

Administrators

Administrators have full rights to
maintain and support the overall
system.

Developers
Contractors

In-direct contractors need access to
manage the data collection process.

Others
Describe the procedures in place to determine which Contractor uses the concept of Role-Based Access Control
32 system users (administrators, developers,
(RBAC) to give the appropriate permissions associated with
contractors, etc.) may access PII.
each role. RBAC uses the security principle of least privilege to
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 least privilege model will be used to allow those with
access to PII to be able to access the minimum amount of PII
needed to perform their job. Users must request access to
specific files needed and that is the only access they are
permitted. No one is granted more access than is necessary to
perform their job.

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 personnel having system access are required to take the
Privacy and IT Security Awareness training upon hire and
annually thereafter. This training has been reviewed and is
compatible with CDC requirements to make them aware of
their responsibilities for protecting the information being
collected and maintained.

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

All system users are required to complete annual training
requirements that consist of HIPAA, and Ethics and
Compliance.

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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 (NI-442-09-1 and in accordance
with contractual agreement. Record copy of study reports are
maintained in the agency from two to three years in
accordance with retention schedules. Source documents for
the 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 tapes, burning or shredding paper materials or
transferring records to the Federal Records Center when no
longer needed for evaluation and analysis. Records are
retained for 20 years; for longer periods if further study is
needed.
PII will be secured using the following:

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

Administrative controls include a system security plan,
contingency plan, regular back-up files and storage of backups
off-site, role-base security awareness training, least privilege
access (enforced through Active directory groups), separate
user and privileged accounts for administrators, policies and
procedures for retention and destruction of PII and a corporate
incident response team and incident response plan.
Technical controls include identification and authentication
using unique user IDs, passwords, and smart cards, use of
firewalls and intrusion detection and prevention systems, virus
scanning software on all computers and a security information
and event management solution.
Physical controls include guards, identification badges, key
cards and closed circuit TV.

General Comments

OPDIV Senior Official
for Privacy Signature

signed by Jarell
Jarell Oshodi Digitally
Oshodi -S
Date: 2019.08.07 15:17:58
-S
-04'00'

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File Modified2019-08-07
File Created2016-03-30

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