PRIVACY IMPACT ASSESSMENT (PIA)

For the
Cardiac Analysis Software (Philips QLAB)

US Army Medical Command - DHP Funded Application

SECTION 1: IS A PIA REQUIRED?

a. Will this Department of Defense (DoD) information system or electronic collection of

information (referred to as an "electronic collection" for the purpose of this form) collect,
maintain, use, and/or disseminate PII about members of the public, Federal personnel,
contractors or foreign nationals employed at U.S. military facilities internationally? Choose
one option from the choices below. (Choose (3) for foreign nationals).

(1) Yes, from members of the general public.

(2) Yes, from Federal personnel* and/or Federal contractors.

(3) Yes, from both members of the general public and Federal personnel and/or Federal contractors.

(4) No

* "Federal personnel" are referred to in the DoD IT Portfolio Repository (DITPR) as "Federal employees."

b. If "No," ensure that DITPR or the authoritative database that updates DITPR is annotated
for the reason(s) why a PIA is not required. If the DoD information system or electronic
collection is not in DITPR, ensure that the reason(s) are recorded in appropriate
documentation.

c. If "Yes," then a PIA is required. Proceed to Section 2.

SECTION 2: PIA SUMMARY INFORMATION

a. Why is this PIA being created or updated? Choose one:

New DoD Information System New Electronic Collection

Existing DoD Information System Existing Electronic Collection

Significantly Modified DoD Information

System

b. Is this DoD information system registered in the DITPR or the DoD Secret Internet Protocol
Router Network (SIPRNET) IT Registry?

Yes, DITPR Enter DITPR System Identification Number

Yes, SIPRNET Enter SIPRNET Identification Number

No

c. Does this DoD information system have an IT investment Unique Project Identifier (UPI), required
by section 53 of Office of Management and Budget (OMB) Circular A-11?

Yes No

If "Yes," enter UPI

If unsure, consult the Component IT Budget Point of Contact to obtain the UPI.

d. Does this DoD information system or electronic collection require a Privacy Act System of
Records Notice (SORN)?

A Privacy Act SORN is required if the information system or electronic collection contains information about U.S. citizens
or lawful permanent U.S. residents that is retrieved by name or other unique identifier. PIA and Privacy Act SORN
information should be consistent.

Yes No

If "Yes," enter Privacy Act SORN Identifier

DoD Component-assigned designator, not the Federal Register number.

Consult the Component Privacy Office for additional information or
access DoD Privacy Act SORNs at: http://www.defenselink.mil/privacy/notices/

or

Date of submission for approval to Defense Privacy Office

Consult the Component Privacy Office for this date.
e. Does this DoD information system or electronic collection have an OMB Control Number?
Contact the Component Information Management Control Officer or DoD Clearance Officer for this information.
This number indicates OMB approval to collect data from 10 or more members of the public in a 12-month period
regardless of form or format.

Yes

Enter OMB Control Number

Enter Expiration Date

No

f. Authority to collect information. A Federal law, Executive Order of the President (EO), or DoD
requirement must authorize the collection and maintenance of a system of records.

(1) If this system has a Privacy Act SORN, the authorities in this PIA and the existing Privacy Act
SORN should be the same.

(2) Cite the authority for this DoD information system or electronic collection to collect, use, maintain
and/or disseminate PII. (If multiple authorities are cited, provide all that apply.)

(a) Whenever possible, cite the specific provisions of the statute and/or EO that authorizes
the operation of the system and the collection of PII.

(b) If a specific statute or EO does not exist, determine if an indirect statutory authority can
be cited. An indirect authority may be cited if the authority requires the operation or administration of
a program, the execution of which will require the collection and maintenance of a system of records.

(c) DoD Components can use their general statutory grants of authority (“internal
housekeeping”) as the primary authority. The requirement, directive, or instruction implementing the
statute within the DoD Component should be identified.

10 U.S.C. 3013, Secretary of the Army; 10 U.S.C. 1071-1085, Medical and Dental Care; 50 U.S.C
Supplement IV, Appendix 454, as amended, Persons liable for training and service; 42 U.S.C. Chapter
117, Sections 11131-11152, Reporting of Information; 10 U.S.C. 1097a and 1097b TRICARE prime and
TRICARE Program; 10 U.S.C. 1079, Contracts for Medical Care for Spouses and Children; U.S.C.
1079a, CHAMPUS; 10 U.S.C. 1086, Contracts for Health Benefits for Certain Members, Former
Members, and Their Dependents; E.O. 9397 (SSN); DoD Instruction 6015.23, Delivery of Healthcare at
Military Treatment Facilities (MTFs); DoD Directive 6040.37, Confidentiality of Medical Quality Assurance
(QA) Records; DoD 6010.8-R, Civilian Health and Medical Program of the Uniformed Services
(CHAPUS); Army Regulation 40-66, Medical Record Administration and Healthcare Documentation.
 g. Summary of DoD information system or electronic collection. Answers to these questions
should be consistent with security guidelines for release of information to the public.

(1) Describe the purpose of this DoD information system or electronic collection and briefly
describe the types of personal information about individuals collected in the system.
The Philips QLAB software is designed to view and quantify image data acquired on Philips Medical Systems
ultrasound products. It is available as a stand-alone product that can function on a standard personal
computer or dedicated workstation and can be used for the off-line review and quantification of ultrasound
studies. This cardiac application software utilizes two dimensional and three dimensional ultrasound images
and allows the cardiologist to properly assess the anatomy and physiology of the heart; thus determining
patient diagnosis, prognosis and lifesaving intervention.

The QLAB software is on the the Xcelera Cardiology Picture Archiving and Communications System (PACS)
information system which is used by cardiology healthcare providers when conducting patient imaging
activities. Echocardiography and stress echocardiography data are captured on various cardiac ultrasound
systems and transferred to Xcelera for data quantification and reporting. The data and PII information are
stored in the Xcelera database system.

Personnel information collected includes full name, social security number or patient service number, date of
birth, gender, and medical information.

(2) Briefly describe the privacy risks associated with the PII collected and how these risks are
addressed to safeguard privacy.

h. With whom will the PII be shared through data exchange, both within your DoD Component and
outside your Component (e.g., other DoD Components, Federal Agencies)? Indicate all that apply.

Within the DoD Component.

Specify. The PII will be shared with health care providers within the medical treatment
facility using this software.
Other DoD Components.

Specify.
Other Federal Agencies.

Specify.
State and Local Agencies.

Specify.
 Contractor (Enter name and describe the language in the contract that safeguards PII.)

Specify. There are some providers and/or staff that are employed in a contractual basis.
There are clauses in their contracts requiring compliance with the Privacy Act and
Health Insurance Portability and Accountability Act (HIPAA) requirements to protect
the confidentiality of personal information.

Other (e.g., commercial providers, colleges).

Specify.

i. Do individuals have the opportunity to object to the collection of their PII?

Yes No

(1) If "Yes," describe method by which individuals can object to the collection of PII.
Individuals review and sign a Department of Defense (DD) Form 2005, Privacy Act Statement - Health Care
Records. This form is maintained in the individual's medical records. If the individual does not provide the
required PII, comprehensive care may not be possible, but care will not be denied.

(2) If "No," state the reason why individuals cannot object.

j. Do individuals have the opportunity to consent to the specific uses of their PII?

Yes No

(1) If "Yes," describe the method by which individuals can give or withhold their consent.
Individuals review and sign a Department of Defense (DD) Form 2005, Privacy Act Statement - Health Care
Records. This form is maintained in the individual's medical records. If individuals do not give their consent
to the specific uses of their PII, comprehensive care may not be possible, but care will not be denied.

(2) If "No," state the reason why individuals cannot give or withhold their consent.
k. What information is provided to an individual when asked to provide PII data? Indicate all that
apply.

Privacy Act Statement Privacy Advisory

Other None

Describe A Department of Defense (DD) Form 2005, Privacy Act Statement - Health Care Records, is provided
each to the patient at the point of care. This form is maintained in the individual's medical records.
applicable
format. PRIVACY ACT STATEMENT – HEALTH CARE RECORDS

1. AUTHORITY FOR COLLECTION OF INFORMATION INCLUDING SOCIAL SECURITY NUMBER

(SSN) Sections 133, 1071-87, 3012, 5031 and 8012, title 10, United States Code and Executive
Order 9397.

2. PRINCIPAL PURPOSES FOR WHICH INFORMATION IS INTENDED TO BE USED

INFORMATION
This form provides you the advice required by The Privacy Act of 1974. The personal information will
facilitate and document your health care. The Social Security Number (SSN) of member or sponsor is
required to identify and retrieve health care records.

3. ROUTINE USES
The primary use of this information is to provide, plan and coordinate health care. As prior to
enactment of the Privacy Act, other possible uses are to: Aid in preventive health and communicable
disease control programs and report medical conditions required by law to federal, state and local
agencies; compile statistical data; conduct research; teach; determine suitability of persons for
service or assignments; adjudicate claims and determine benefits; other lawful purposes, including
law enforcement and litigation; conduct authorized investigations; evaluate care rendered; determine
professional certification and hospital accreditation; provide physical qualifications of patients to
agencies of federal, state, or local government upon request in the pursuit of their official duties.

4. WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFECT ON INDIVIDUAL OF

NOT PROVIDING INFORMATION
In the case of military personnel, the requested information is mandatory because of the need to
document all active duty medical incidents in view of future rights and benefits. In the case of all other
personnel/beneficiaries, the requested information is voluntary. If the requested information is not
furnished, comprehensive health care may not be possible, but CARE WILL NOT BE DENIED.

This all inclusive Privacy Act Statement will apply to all requests for personal information made by
health care treatment personnel or for medical/dental treatment purposes and will become a
permanent part of your health care record.

Your signature merely acknowledges that you have been advised of the foregoing. If requested, a
copy of this form will be furnished to you.