Privacy Act of 1974; Department of Homeland Security ALL-034 Emergency Care Medical Records System of Records Notice, 53921-53924 [2011-22169]
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Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
RECORD SOURCE CATEGORIES:
that national security could be
threatened.
SYSTEM MANAGER AND ADDRESS:
Deputy Director, Individual
Assistance, Disaster Assistance
Directorate, Federal Emergency
Management Agency, 500 C Street, SW.,
Washington, DC 20472.
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NOTIFICATION PROCEDURE:
Individuals seeking notification of
and access to any record contained in
this system of records, or seeking to
contest its content, may submit a
request in writing to FEMA’s FOIA
Officer, 500 C Street, SW., Attn: FOIA
Coordinator, Washington, DC 20472.
When seeking records about yourself
from this system of records or any other
Departmental system of records your
request must conform with the Privacy
Act regulations set forth in 6 CFR part
5. You must first verify your identity,
meaning that you must provide your full
name, current address and date and
place of birth. You must sign your
request, and your signature must either
be notarized or submitted under
28 U.S.C. 1746, a law that permits
statements to be made under penalty of
perjury as a substitute for notarization.
While no specific form is required, you
may obtain forms for this purpose from
the Chief Privacy Officer and Chief
Freedom of Information Act Officer,
https://www.dhs.gov or 1–866–431–0486.
In addition you should provide the
following:
• An explanation of why you believe
the Department would have information
on you;
• Identify which component(s) of the
Department you believe may have the
information about you;
• Specify when you believe the
records would have been created;
• Provide any other information that
will help the FOIA staff determine
which DHS component agency may
have responsive records; and
• If your request is seeking records
pertaining to another living individual,
you must include a statement from that
individual certifying his/her agreement
for you to access his/her records.
Without this bulleted information the
component(s) may not be able to
conduct an effective search, and your
request may be denied due to lack of
specificity or lack of compliance with
applicable regulations.
RECORD ACCESS PROCEDURES:
See ‘‘Notification procedure’’ above.
CONTESTING RECORD PROCEDURES:
See ‘‘Notification procedure’’ above.
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Records are obtained from registrants
of NEFRLS and individuals searching
NEFRLS, LEOs, and the third party
authentication service indicating an
individual has been approved or not
approved.
EXEMPTIONS CLAIMED FOR THE SYSTEM:
None.
Dated: July 25, 2011.
Mary Ellen Callahan,
Chief Privacy Officer, Department of
Homeland Security.
[FR Doc. 2011–22167 Filed 8–29–11; 8:45 am]
BILLING CODE 9110–17–P
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2011–0081]
Privacy Act of 1974; Department of
Homeland Security ALL—034
Emergency Care Medical Records
System of Records Notice
Privacy Office, DHS.
Notice of Privacy Act system of
AGENCY:
ACTION:
records.
In accordance with the
Privacy Act of 1974, the Department of
Homeland Security proposes to
establish a new Department of
Homeland Security system of records
titled, ‘‘Department of Homeland
Security/ALL—034 Emergency Care
Medical Records System of Records
Notice.’’ This system of records will
allow the Department of Homeland
Security Office of Health Affairs to
collect and maintain records on
individuals who receive emergency care
from Department Emergency Medical
Services providers. Individuals in this
system include anyone who experiences
a medical emergency and is treated by
an on-duty Departmental Emergency
Medical Services medical care provider.
This newly established system will be
included in the Department of
Homeland Security’s inventory of
record systems.
DATES: Submit comments on or before
September 29, 2011. This new system
will be effective September 29, 2011.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2011–0081 by one of the following
methods:
• Federal e-Rulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 703–483–2999.
• Mail: Mary Ellen Callahan, Chief
Privacy Officer, Privacy Office,
SUMMARY:
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53921
Department of Homeland Security,
Washington, DC 20528.
• Instructions: All submissions
received must include the agency name
and docket number for this rulemaking.
All comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
• Docket: For access to the docket to
read background documents or
comments received go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
questions please contact: Mary Ellen
Callahan (703–235–0780), Chief Privacy
Officer, Privacy Office, Department of
Homeland Security, Washington, DC
20528.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with the Privacy Act of
1974, 5 U.S.C. 552a, the Department of
Homeland Security (DHS) Office of
Health Affairs (OHA) proposes to
establish a new DHS system of records
titled, ‘‘DHS/ALL—034 Emergency Care
Medical Records.’’
The Assistant Secretary for Health
Affairs and Chief Medical Officer
(ASHA/CMO) exercises oversight over
all medical and public health activities
of DHS, with the exception of U.S. Coast
Guard (USCG) medical and public
health activities. Throughout its
components, the DHS workforce
includes approximately 3,500
Emergency Medical Service (EMS)
healthcare providers rendering
emergency medical care in the prehospital environment, primarily to DHS
employees and, when necessary, to
individuals encountered in the course of
duty in need of emergency care. These
DHS EMS healthcare providers are
employed by the following DHS
components: U.S. Customs and Border
Protection (CBP), U.S. Immigration and
Customs Enforcement (ICE), the United
States Secret Service (USSS),
Transportation Security Administration
(TSA), U.S. Citizenship and
Immigration Services (USCIS), Federal
Law Enforcement Training Center
(FLETC), Federal Emergency
Management Agency (FEMA), and
Science & Technology Directorate (S&T).
OHA administers oversight of DHS
EMS healthcare providers through its
Medical Quality Management (MQM)
program, to ensure DHS EMS providers
deliver consistent, quality medical care.
To support MQM, OHA operates the
electronic Patient Care Record (ePCR),
an electronic encounter-based database
designed for EMS management. After
administering emergency care, DHS
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Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
EMS medical care providers manually
enter emergency medical care
information into ePCR. ePCR captures
all aspects of patient care, from the
initial dispatch of a vehicle and
personnel to a designated site,
demographics, vital signs (initial
assessment), treatment, and transfer of
care and/or patient transport. The
system captures patient data such as
name, date of birth, and medical
information. Concurrent with the
publication of this notice, DHS is
publishing a Privacy Impact Assessment
(PIA) describing the ePCR system. This
PIA will be available at the DHS Privacy
Office Web site at https://www.dhs.gov/
privacy. ePCR improves MQM at the
Department by allowing OHA to track
and trend data quality, including
documentation review, clinical
performance, and performance
improvement initiatives. This system
assists OHA in assessing overall quality
of care provided while ensuring that a
high standard of care is continually met.
This includes electronic data in ePCR
operated by OHA as well as those same
EMS encounter records when kept by
the EMS provider, in paper form.
Individuals covered by this system
include members of the public who are
treated by on-duty DHS Emergency
Medical Services (EMS) healthcare
provider. When patients are DHS or
other federal employees, their records
are considered part of the OPM/GOVT–
10—Employee Medical File System
Records, 71 FR 3560 (Jun. 19, 2006.)
When patients are not Federal
employees, such as members of the
public, their records are considered part
of this system.
OHA has primary responsibility
within the Department for ‘‘ensuring
internal and external coordination of all
medical preparedness and response
activities of the Department, including
training, exercises, and equipment
support.’’ See Section 516(c)(3) of the
Post Katrina Emergency Management
and Reform Act, Public Law109–295, 6
U.S.C. 321e(c). In addition, the
Secretary has delegated to OHA
responsibility for providing oversight
for all medical and health activities of
the Department. See DHS Delegation to
the Assistant Secretary of Health Affairs
and Chief Medical Officer, No. 5001
(signed July 28, 2008). As per internal
DHS directive, OHA ensures the MQM
program is appropriately implemented
within the department and that health
care service standards are consistently
applied across the department. This
includes exercising oversight for
development of quality assurance
activities (quality improvement, risk
management documentation, and
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Jkt 223001
medical record management) within
DHS. The responsibility of MQM
necessitates a patient care reporting
system to gather records of pre-hospital
emergency medical care rendered by
DHS employees, as part of their official
DHS duties.
Due to the sensitive and private
nature of patient medical records, ePCR
has been evaluated to identify risks and
corresponding mitigation strategies.
Risks may include unauthorized
disclosures, incorrect data entry,
software viruses, unauthorized access to
the system, sharing of data with private
sector entities, and data security
breaches. Mitigation activities involve
privacy and security awareness training
for all users, enforcement of role-based
access to varied aspects of ePCR (e.g.,
end-users have access only to their
component-specific patient data and
any other patient encounter reports for
which they have been identified as
providing care).
Designated persons (Component
Medical Director, Component EMS
Coordinators, and ePCR Administrator)
within the components will have full
administrative review access to all
records for quality assurance purposes.
The OHA Medical Quality Management
Branch and the OHA Medical First
Responder Coordination Branch will
have rights to run ad hoc reports and
query data as it relates to quality
assurance tracking and trending
indicators (completeness of record,
adherence to standards of care/protocols
and training) on all component data.
Audit logs are periodically reviewed for
inconsistencies. Any inconsistencies are
immediately addressed through the
Component Medical Director, EMS
coordinators, or Component Information
Technology (IT) and Security
Compliance Officer to correct or resolve
any issues and concerns. The purpose of
ePCR is to support OHA’s MQM
program, and this purpose is supported
by routine uses for sharing this data for
notification of medical hazard, worker’s
compensation claims, through formal
legal channels, and other limited
administrative purposes.
This newly established system will be
included in DHS’s inventory of record
systems.
II. Privacy Act
The Privacy Act embodies fair
information practice principles in a
statutory framework governing the
means by which the U.S. Government
collects, maintains, uses, and
disseminates individuals’ records. The
Privacy Act applies to information that
is maintained in a ‘‘system of records.’’
A ‘‘system of records’’ is a group of any
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records under the control of an agency
for which information is retrieved by
the name of an individual or by some
identifying number, symbol, or other
identifying particular assigned to the
individual. In the Privacy Act, an
individual is defined to encompass U.S.
citizens and lawful permanent
residents. As a matter of policy, DHS
extends administrative Privacy Act
protections to all individuals where
systems of records maintain information
on U.S. citizens, lawful permanent
residents, and visitors.
Below is the description of the DHS/
OHA–002 Emergency Care Medical
Records System of Records.
In accordance with 5 U.S.C. 552a(r),
DHS has provided a report of this
system of records to the Office of
Management and Budget and to
Congress.
III. Health Insurance Portability and
Accountability Act
For this collection of health
information, OHA and participating
components are not subject to the
provisions of the Health Insurance
Portability and Accountability Act
(HIPAA) of 1996 regulation, ‘‘Standards
for Privacy of Individually Identifiable
Health Information’’ (Privacy Rule), 45
CFR parts 160 and 164. OHA does not
meet the statutory definition of a
covered entity under HIPAA, 42 U.S.C.
1320d–1. Because OHA and
participating components are not a
covered entity, the restrictions
prescribed by the HIPAA Privacy Rule
are not applicable.
SYSTEM OF RECORDS
Department of Homeland Security (DHS)/
Office of Health Affairs (OHA)—002
Emergency Care Medical Records (ECMR)
SYSTEM NAME:
DHS/OHA—002 Emergency Care
Medical Records.
SECURITY CLASSIFICATION:
Unclassified.
SYSTEM LOCATION:
Records are maintained in the
electronic Patient Care Record (ePCR)
system at the OHA Headquarters in
Washington, DC.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:
Individuals covered by this system
include members of the public,
including federal contractors, who are
treated by an on-duty DHS Emergency
Medical Services (EMS) healthcare
provider. When patients are DHS or
other federal employees, their records
are considered part of the OPM/GOVT–
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10—Employee Medical File System
Records, 71 FR 35360 (Jun. 19, 2006.)
CATEGORIES OF RECORDS IN THE SYSTEM:
• Patient name.
• Patient case/identification number
(not Social Security Number).
• Account of the illness or injury.
• Date of birth and age.
• Gender.
• Location.
• Address (residential or business, if/
as relevant).
• Type of injury.
• Current medications.
• Allergies.
• Past medical history.
• Assessment of injury.
• Chief complaint.
• Vital signs.
• Treatment provided and/or
procedures.
• Transfer of care, refusal of care,
and/or transportation mode and
destination.
• Medication dispensed.
• Discharge instructions for follow-on
care.
• If necessary, patient’s guardian or
legal representative.
• Patient’s health insurance
information, if any.
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AUTHORITY FOR MAINTENANCE OF THE SYSTEM:
OHA has primary responsibility
within the Department for ‘‘ensuring
internal and external coordination of all
medical preparedness and response
activities of the Department, including
training, exercises, and equipment
support.’’ See Section 516(c)(3) of the
Post Katrina Emergency Management
and Reform Act, Pub. L. 109–295,
6 U.S.C. 321e(c). In addition, the
Secretary has delegated to OHA
responsibility for providing oversight
for all medical and health activities of
the Department. See DHS Delegation to
the Assistant Secretary of Health Affairs
and Chief Medical Officer, No. 5001
(signed July 28, 2008). As per internal
DHS directive, OHA ensures the MQM
program is appropriately implemented
within the department and that health
care service standards are consistently
applied across the department. This
includes exercising oversight for
development of quality assurance
activities (quality improvement, risk
management documentation, and
medical record management) within
DHS. The responsibility of MQM
necessitates a patient care reporting
system to gather records of pre-hospital
emergency medical care rendered by
DHS employees, as part of their official
DHS duties.
PURPOSE(S):
The purpose of this system is to
support MQM oversight to ensure
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consistent quality medical care and
standardize the documentation of care
rendered by DHS EMS medical care
providers in diverse environments.
ROUTINE USES OF RECORDS MAINTAINED IN THE
SYSTEM, INCLUDING CATEGORIES OF USERS AND
THE PURPOSES OF SUCH USES:
In addition to those disclosures
generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, all or a
portion of the records or information
contained in this system may be
disclosed outside DHS as a routine use
pursuant to 5 U.S.C. 552a(b)(3) as
follows:
A. To the Department of Justice (DOJ),
including U.S. Attorney Offices, or other
federal agency conducting litigation or
in proceedings before any court,
adjudicative or administrative body,
when it is necessary to the litigation and
one of the following is a party to the
litigation or has an interest in such
litigation:
1. DHS or any component thereof;
2. Any employee of DHS in his/her
official capacity;
3. Any employee of DHS in his/her
individual capacity where DOJ or DHS
has agreed to represent the employee; or
4. The U.S. or any agency thereof, is
a party to the litigation or has an interest
in such litigation, and DHS determines
that the records are both relevant and
necessary to the litigation and the use of
such records is compatible with the
purpose for which DHS collected the
records.
B. To a congressional office from the
record of an individual in response to
an inquiry from that congressional office
made at the request of the individual to
whom the record pertains.
C. To the National Archives and
Records Administration (NARA) or
other federal government agencies
pursuant to records management
inspections being conducted under the
authority of 44 U.S.C. 2904 and 2906.
D. To an agency, organization, or
individual for the purpose of performing
audit or oversight operations as
authorized by law, but only such
information as is necessary and relevant
to such audit or oversight function.
E. To appropriate agencies, entities,
and persons when:
1. DHS suspects or has confirmed that
the security or confidentiality of
information in the system of records has
been compromised;
2. DHS has determined that as a result
of the suspected or confirmed
compromise there is a risk of harm to
economic or property interests, identity
theft or fraud, or harm to the security or
integrity of this system or other systems
or programs (whether maintained by
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53923
DHS or another agency or entity) or
harm to the individual that rely upon
the compromised information; and
3. The disclosure made to such
agencies, entities, and persons is
reasonably necessary to assist in
connection with DHS’s efforts to
respond to the suspected or confirmed
compromise and prevent, minimize, or
remedy such harm.
F. To contractors and their agents,
grantees, experts, consultants, and
others performing or working on a
contract, service, grant, cooperative
agreement, or other assignment for DHS,
when necessary to accomplish an
agency function related to this system of
records. Individuals provided
information under this routine use are
subject to the same Privacy Act
requirements and limitations on
disclosure as are applicable to DHS
officers and employees.
G. To appropriate federal, State, local,
tribal, or foreign governmental agencies
or multilateral governmental
organizations for the purpose of
protecting the vital interests of a data
subject or other persons or to comply
with laws governing reporting of
communicable disease, including to
assist such agencies or organizations in
preventing exposure to or transmission
of a communicable or quarantinable
disease or to combat other significant
public health threats; appropriate notice
will be provided of any identified health
threat or risk.
H. To hospitals, physicians, medical
laboratories and testing facilities, and
other medical service providers, for the
purpose of diagnosing and treating
medical conditions or arranging the care
of patients who have been treated by
DHS EMS providers.
I. To foreign governments for the
purpose of coordinating and conducting
the removal or return of aliens from the
United States to other nations when
disclosure of information about the
alien’s health is necessary or advisable
to safeguard the public health, to
facilitate transportation of the alien, to
obtain travel documents for the alien, to
ensure continuity of medical care for the
alien, or is otherwise required by
international agreement or law.
J. To immediate family members and
attorneys or other agents acting on
behalf of a patient to assist those
individuals in determining the current
medical condition and/or location of a
patient to whom DHS has provided
emergency medical care, provided they
can present adequate verification of a
familial or agency relationship with the
patient.
K. To independent standardization
and medical quality management
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Federal Register / Vol. 76, No. 168 / Tuesday, August 30, 2011 / Notices
repositories, such as the National
Emergency Medical Services
Information System (NEMSIS), in deidentified, aggregate form only, to
promote DHS compliance with
emergency medical care industry
standards and best practices.
L. To any person who is responsible
for the care of the individual, to the
extent necessary to assure payment of
benefits to which the individual is
entitled, when an individual to whom a
record pertains is mentally incompetent
or under other legal disability.
M. To the patient’s health insurance
company to facilitate any payment and
billing negotiations between the patient,
the insurance carrier and the agency.
DISCLOSURE TO CONSUMER REPORTING
AGENCIES:
None.
POLICIES AND PRACTICES FOR STORING,
RETRIEVING, ACCESSING, RETAINING, AND
DISPOSING OF RECORDS IN THE SYSTEM:
STORAGE:
Records in this system are stored
electronically or on paper in secure
facilities in a locked drawer behind a
locked door. The records are stored on
magnetic disc, tape, digital media, and
CD–ROM.
RETRIEVABILITY:
Records may be retrieved by any of
the fields listed in the Categories of
Records listed above.
SAFEGUARDS:
Records in this system are
safeguarded in accordance with
applicable rules and policies, including
all applicable DHS automated systems
security and access policies. Strict
controls have been imposed to minimize
the risk of compromising the
information that is being stored. Access
to the computer system containing the
records in this system is limited to those
individuals who have a need to know
the information for the performance of
their official duties and who have
appropriate clearances or permissions.
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RETENTION AND DISPOSAL:
Based on the most conservative
industry standards advised to
implement Medical Quality
Management, OHA will propose a
retention schedule of ten (10) years from
the date of the EMS provider encounter.
Records will be retained pending the
final approval by the National Archives
and Records Administration of this
records schedule.
SYSTEM MANAGER AND ADDRESS:
Director, Workforce Health and
Medical Support Division, Office of
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Jkt 223001
Health Affairs, Department of Homeland
Security, Washington, DC 20528.
NOTIFICATION PROCEDURE:
Individuals seeking notification of
and access to any record contained in
this system of records, or seeking to
contest its content, may submit a
request in writing to the Headquarters
FOIA Officer, whose contact
information can be found at https://
www.dhs.gov/foia under ‘‘contacts.’’ If
an individual believes more than one
component maintains Privacy Act
records concerning him or her the
individual may submit the request to
the Chief Privacy Officer and Chief
Freedom of Information Act Officer,
Department of Homeland Security, 245
Murray Drive, SW., Building 410,
STOP–0655, Washington, DC 20528.
When seeking records about yourself
from this system of records or any other
Departmental system of records your
request must conform with the Privacy
Act regulations set forth in 6 CFR part
5. You must first verify your identity,
meaning that you must provide your full
name, current address and date and
place of birth. You must sign your
request, and your signature must either
be notarized or submitted under 28
U.S.C. 1746, a law that permits
statements to be made under penalty of
perjury as a substitute for notarization.
While no specific form is required, you
may obtain forms for this purpose from
the Chief Privacy Officer and Chief
Freedom of Information Act Officer,
https://www.dhs.gov or 1–866–431–0486.
In addition you should provide the
following:
• An explanation of why you believe
the Department would have information
on you;
• Identify which component(s) of the
Department you believe may have the
information about you;
• Specify when you believe the
records would have been created;
• Provide any other information that
will help the FOIA staff determine
which DHS component agency may
have responsive records; and
• If your request is seeking records
pertaining to another living individual,
you must include a statement from that
individual certifying his/her agreement
for you to access his/her records.
Without this bulleted information the
component(s) may not be able to
conduct an effective search, and your
request may be denied due to lack of
specificity or lack of compliance with
applicable regulations. Consistent with
6 CFR 5.22(f) Release of Medical
Records, and pursuant to 5 U.S.C.
552a(f)(3), where requests are made for
access to medical records, including
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Fmt 4703
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psychological records, the decision to
release directly to the individual, or to
withhold direct release, shall be made
by a medical practitioner. Where the
medical practitioner has ruled that
direct release will cause harm to the
individual who is requesting access,
normal release through the individual’s
chosen medical practitioner will be
recommended. Final review and
decision on appeals of disapprovals of
direct release will rest with the General
Counsel.
RECORD ACCESS PROCEDURES:
See ‘‘Notification procedure’’ above.
CONTESTING RECORD PROCEDURES:
See ‘‘Notification procedure’’ above.
RECORD SOURCE CATEGORIES:
Records are obtained from DHS EMS
medical care providers and their
patients, either in the care and custody
of the Department, at the DHS
workplace, or in conjunction with a
medical emergency where an on-duty
DHS EMS is the medical care provider.
EXEMPTIONS CLAIMED FOR THE SYSTEM:
None.
Dated: August 23, 2011.
Mary Ellen Callahan,
Chief Privacy Officer, Department of
Homeland Security.
[FR Doc. 2011–22169 Filed 8–29–11; 8:45 am]
BILLING CODE 4410–9K–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
[Docket No. USCG–2011–0821]
Merchant Mariner Medical Advisory
Committee
Coast Guard, DHS.
Notice of federal advisory
committee meeting.
AGENCY:
ACTION:
The Merchant Mariner
Medical Advisory Committee
(MMMAC) will hold its inaugural
meeting starting Monday, September 19,
and ending Wednesday September 21,
2011. The meetings will be open to the
public.
DATES: MMMAC will meet on Monday,
September 19, Tuesday, September 20,
and Wednesday, September 21, 2011
from 8:30 a.m. to 4:30 p.m. Please note
that the meeting may close early if the
committee has completed its business.
ADDRESSES: The meeting will be held at
the Calhoon Marine Engineers
Beneficial Association (MEBA)
Engineering School at 27050 Saint
Michaels Road, Easton, MD 21601.
SUMMARY:
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Agencies
[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53921-53924]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22169]
-----------------------------------------------------------------------
DEPARTMENT OF HOMELAND SECURITY
Office of the Secretary
[Docket No. DHS-2011-0081]
Privacy Act of 1974; Department of Homeland Security ALL--034
Emergency Care Medical Records System of Records Notice
AGENCY: Privacy Office, DHS.
ACTION: Notice of Privacy Act system of records.
-----------------------------------------------------------------------
SUMMARY: In accordance with the Privacy Act of 1974, the Department of
Homeland Security proposes to establish a new Department of Homeland
Security system of records titled, ``Department of Homeland Security/
ALL--034 Emergency Care Medical Records System of Records Notice.''
This system of records will allow the Department of Homeland Security
Office of Health Affairs to collect and maintain records on individuals
who receive emergency care from Department Emergency Medical Services
providers. Individuals in this system include anyone who experiences a
medical emergency and is treated by an on-duty Departmental Emergency
Medical Services medical care provider. This newly established system
will be included in the Department of Homeland Security's inventory of
record systems.
DATES: Submit comments on or before September 29, 2011. This new system
will be effective September 29, 2011.
ADDRESSES: You may submit comments, identified by docket number DHS-
2011-0081 by one of the following methods:
Federal e-Rulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Fax: 703-483-2999.
Mail: Mary Ellen Callahan, Chief Privacy Officer, Privacy
Office, Department of Homeland Security, Washington, DC 20528.
Instructions: All submissions received must include the
agency name and docket number for this rulemaking. All comments
received will be posted without change to https://www.regulations.gov,
including any personal information provided.
Docket: For access to the docket to read background
documents or comments received go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For questions please contact: Mary
Ellen Callahan (703-235-0780), Chief Privacy Officer, Privacy Office,
Department of Homeland Security, Washington, DC 20528.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with the Privacy Act of 1974, 5 U.S.C. 552a, the
Department of Homeland Security (DHS) Office of Health Affairs (OHA)
proposes to establish a new DHS system of records titled, ``DHS/ALL--
034 Emergency Care Medical Records.''
The Assistant Secretary for Health Affairs and Chief Medical
Officer (ASHA/CMO) exercises oversight over all medical and public
health activities of DHS, with the exception of U.S. Coast Guard (USCG)
medical and public health activities. Throughout its components, the
DHS workforce includes approximately 3,500 Emergency Medical Service
(EMS) healthcare providers rendering emergency medical care in the pre-
hospital environment, primarily to DHS employees and, when necessary,
to individuals encountered in the course of duty in need of emergency
care. These DHS EMS healthcare providers are employed by the following
DHS components: U.S. Customs and Border Protection (CBP), U.S.
Immigration and Customs Enforcement (ICE), the United States Secret
Service (USSS), Transportation Security Administration (TSA), U.S.
Citizenship and Immigration Services (USCIS), Federal Law Enforcement
Training Center (FLETC), Federal Emergency Management Agency (FEMA),
and Science & Technology Directorate (S&T).
OHA administers oversight of DHS EMS healthcare providers through
its Medical Quality Management (MQM) program, to ensure DHS EMS
providers deliver consistent, quality medical care. To support MQM, OHA
operates the electronic Patient Care Record (ePCR), an electronic
encounter-based database designed for EMS management. After
administering emergency care, DHS
[[Page 53922]]
EMS medical care providers manually enter emergency medical care
information into ePCR. ePCR captures all aspects of patient care, from
the initial dispatch of a vehicle and personnel to a designated site,
demographics, vital signs (initial assessment), treatment, and transfer
of care and/or patient transport. The system captures patient data such
as name, date of birth, and medical information. Concurrent with the
publication of this notice, DHS is publishing a Privacy Impact
Assessment (PIA) describing the ePCR system. This PIA will be available
at the DHS Privacy Office Web site at https://www.dhs.gov/privacy. ePCR
improves MQM at the Department by allowing OHA to track and trend data
quality, including documentation review, clinical performance, and
performance improvement initiatives. This system assists OHA in
assessing overall quality of care provided while ensuring that a high
standard of care is continually met.
This includes electronic data in ePCR operated by OHA as well as
those same EMS encounter records when kept by the EMS provider, in
paper form. Individuals covered by this system include members of the
public who are treated by on-duty DHS Emergency Medical Services (EMS)
healthcare provider. When patients are DHS or other federal employees,
their records are considered part of the OPM/GOVT-10--Employee Medical
File System Records, 71 FR 3560 (Jun. 19, 2006.) When patients are not
Federal employees, such as members of the public, their records are
considered part of this system.
OHA has primary responsibility within the Department for ``ensuring
internal and external coordination of all medical preparedness and
response activities of the Department, including training, exercises,
and equipment support.'' See Section 516(c)(3) of the Post Katrina
Emergency Management and Reform Act, Public Law109-295, 6 U.S.C.
321e(c). In addition, the Secretary has delegated to OHA responsibility
for providing oversight for all medical and health activities of the
Department. See DHS Delegation to the Assistant Secretary of Health
Affairs and Chief Medical Officer, No. 5001 (signed July 28, 2008). As
per internal DHS directive, OHA ensures the MQM program is
appropriately implemented within the department and that health care
service standards are consistently applied across the department. This
includes exercising oversight for development of quality assurance
activities (quality improvement, risk management documentation, and
medical record management) within DHS. The responsibility of MQM
necessitates a patient care reporting system to gather records of pre-
hospital emergency medical care rendered by DHS employees, as part of
their official DHS duties.
Due to the sensitive and private nature of patient medical records,
ePCR has been evaluated to identify risks and corresponding mitigation
strategies. Risks may include unauthorized disclosures, incorrect data
entry, software viruses, unauthorized access to the system, sharing of
data with private sector entities, and data security breaches.
Mitigation activities involve privacy and security awareness training
for all users, enforcement of role-based access to varied aspects of
ePCR (e.g., end-users have access only to their component-specific
patient data and any other patient encounter reports for which they
have been identified as providing care).
Designated persons (Component Medical Director, Component EMS
Coordinators, and ePCR Administrator) within the components will have
full administrative review access to all records for quality assurance
purposes. The OHA Medical Quality Management Branch and the OHA Medical
First Responder Coordination Branch will have rights to run ad hoc
reports and query data as it relates to quality assurance tracking and
trending indicators (completeness of record, adherence to standards of
care/protocols and training) on all component data. Audit logs are
periodically reviewed for inconsistencies. Any inconsistencies are
immediately addressed through the Component Medical Director, EMS
coordinators, or Component Information Technology (IT) and Security
Compliance Officer to correct or resolve any issues and concerns. The
purpose of ePCR is to support OHA's MQM program, and this purpose is
supported by routine uses for sharing this data for notification of
medical hazard, worker's compensation claims, through formal legal
channels, and other limited administrative purposes.
This newly established system will be included in DHS's inventory
of record systems.
II. Privacy Act
The Privacy Act embodies fair information practice principles in a
statutory framework governing the means by which the U.S. Government
collects, maintains, uses, and disseminates individuals' records. The
Privacy Act applies to information that is maintained in a ``system of
records.'' A ``system of records'' is a group of any records under the
control of an agency for which information is retrieved by the name of
an individual or by some identifying number, symbol, or other
identifying particular assigned to the individual. In the Privacy Act,
an individual is defined to encompass U.S. citizens and lawful
permanent residents. As a matter of policy, DHS extends administrative
Privacy Act protections to all individuals where systems of records
maintain information on U.S. citizens, lawful permanent residents, and
visitors.
Below is the description of the DHS/OHA-002 Emergency Care Medical
Records System of Records.
In accordance with 5 U.S.C. 552a(r), DHS has provided a report of
this system of records to the Office of Management and Budget and to
Congress.
III. Health Insurance Portability and Accountability Act
For this collection of health information, OHA and participating
components are not subject to the provisions of the Health Insurance
Portability and Accountability Act (HIPAA) of 1996 regulation,
``Standards for Privacy of Individually Identifiable Health
Information'' (Privacy Rule), 45 CFR parts 160 and 164. OHA does not
meet the statutory definition of a covered entity under HIPAA, 42
U.S.C. 1320d-1. Because OHA and participating components are not a
covered entity, the restrictions prescribed by the HIPAA Privacy Rule
are not applicable.
System of Records
Department of Homeland Security (DHS)/Office of Health Affairs (OHA)--
002 Emergency Care Medical Records (ECMR)
System name:
DHS/OHA--002 Emergency Care Medical Records.
Security classification:
Unclassified.
System location:
Records are maintained in the electronic Patient Care Record (ePCR)
system at the OHA Headquarters in Washington, DC.
Categories of individuals covered by the system:
Individuals covered by this system include members of the public,
including federal contractors, who are treated by an on-duty DHS
Emergency Medical Services (EMS) healthcare provider. When patients are
DHS or other federal employees, their records are considered part of
the OPM/GOVT-
[[Page 53923]]
10--Employee Medical File System Records, 71 FR 35360 (Jun. 19, 2006.)
Categories of records in the system:
Patient name.
Patient case/identification number (not Social Security
Number).
Account of the illness or injury.
Date of birth and age.
Gender.
Location.
Address (residential or business, if/as relevant).
Type of injury.
Current medications.
Allergies.
Past medical history.
Assessment of injury.
Chief complaint.
Vital signs.
Treatment provided and/or procedures.
Transfer of care, refusal of care, and/or transportation
mode and destination.
Medication dispensed.
Discharge instructions for follow-on care.
If necessary, patient's guardian or legal representative.
Patient's health insurance information, if any.
Authority for maintenance of the system:
OHA has primary responsibility within the Department for ``ensuring
internal and external coordination of all medical preparedness and
response activities of the Department, including training, exercises,
and equipment support.'' See Section 516(c)(3) of the Post Katrina
Emergency Management and Reform Act, Pub. L. 109-295, 6 U.S.C. 321e(c).
In addition, the Secretary has delegated to OHA responsibility for
providing oversight for all medical and health activities of the
Department. See DHS Delegation to the Assistant Secretary of Health
Affairs and Chief Medical Officer, No. 5001 (signed July 28, 2008). As
per internal DHS directive, OHA ensures the MQM program is
appropriately implemented within the department and that health care
service standards are consistently applied across the department. This
includes exercising oversight for development of quality assurance
activities (quality improvement, risk management documentation, and
medical record management) within DHS. The responsibility of MQM
necessitates a patient care reporting system to gather records of pre-
hospital emergency medical care rendered by DHS employees, as part of
their official DHS duties.
Purpose(s):
The purpose of this system is to support MQM oversight to ensure
consistent quality medical care and standardize the documentation of
care rendered by DHS EMS medical care providers in diverse
environments.
Routine uses of records maintained in the system, including categories
of users and the purposes of such uses:
In addition to those disclosures generally permitted under 5 U.S.C.
552a(b) of the Privacy Act, all or a portion of the records or
information contained in this system may be disclosed outside DHS as a
routine use pursuant to 5 U.S.C. 552a(b)(3) as follows:
A. To the Department of Justice (DOJ), including U.S. Attorney
Offices, or other federal agency conducting litigation or in
proceedings before any court, adjudicative or administrative body, when
it is necessary to the litigation and one of the following is a party
to the litigation or has an interest in such litigation:
1. DHS or any component thereof;
2. Any employee of DHS in his/her official capacity;
3. Any employee of DHS in his/her individual capacity where DOJ or
DHS has agreed to represent the employee; or
4. The U.S. or any agency thereof, is a party to the litigation or
has an interest in such litigation, and DHS determines that the records
are both relevant and necessary to the litigation and the use of such
records is compatible with the purpose for which DHS collected the
records.
B. To a congressional office from the record of an individual in
response to an inquiry from that congressional office made at the
request of the individual to whom the record pertains.
C. To the National Archives and Records Administration (NARA) or
other federal government agencies pursuant to records management
inspections being conducted under the authority of 44 U.S.C. 2904 and
2906.
D. To an agency, organization, or individual for the purpose of
performing audit or oversight operations as authorized by law, but only
such information as is necessary and relevant to such audit or
oversight function.
E. To appropriate agencies, entities, and persons when:
1. DHS suspects or has confirmed that the security or
confidentiality of information in the system of records has been
compromised;
2. DHS has determined that as a result of the suspected or
confirmed compromise there is a risk of harm to economic or property
interests, identity theft or fraud, or harm to the security or
integrity of this system or other systems or programs (whether
maintained by DHS or another agency or entity) or harm to the
individual that rely upon the compromised information; and
3. The disclosure made to such agencies, entities, and persons is
reasonably necessary to assist in connection with DHS's efforts to
respond to the suspected or confirmed compromise and prevent, minimize,
or remedy such harm.
F. To contractors and their agents, grantees, experts, consultants,
and others performing or working on a contract, service, grant,
cooperative agreement, or other assignment for DHS, when necessary to
accomplish an agency function related to this system of records.
Individuals provided information under this routine use are subject to
the same Privacy Act requirements and limitations on disclosure as are
applicable to DHS officers and employees.
G. To appropriate federal, State, local, tribal, or foreign
governmental agencies or multilateral governmental organizations for
the purpose of protecting the vital interests of a data subject or
other persons or to comply with laws governing reporting of
communicable disease, including to assist such agencies or
organizations in preventing exposure to or transmission of a
communicable or quarantinable disease or to combat other significant
public health threats; appropriate notice will be provided of any
identified health threat or risk.
H. To hospitals, physicians, medical laboratories and testing
facilities, and other medical service providers, for the purpose of
diagnosing and treating medical conditions or arranging the care of
patients who have been treated by DHS EMS providers.
I. To foreign governments for the purpose of coordinating and
conducting the removal or return of aliens from the United States to
other nations when disclosure of information about the alien's health
is necessary or advisable to safeguard the public health, to facilitate
transportation of the alien, to obtain travel documents for the alien,
to ensure continuity of medical care for the alien, or is otherwise
required by international agreement or law.
J. To immediate family members and attorneys or other agents acting
on behalf of a patient to assist those individuals in determining the
current medical condition and/or location of a patient to whom DHS has
provided emergency medical care, provided they can present adequate
verification of a familial or agency relationship with the patient.
K. To independent standardization and medical quality management
[[Page 53924]]
repositories, such as the National Emergency Medical Services
Information System (NEMSIS), in de-identified, aggregate form only, to
promote DHS compliance with emergency medical care industry standards
and best practices.
L. To any person who is responsible for the care of the individual,
to the extent necessary to assure payment of benefits to which the
individual is entitled, when an individual to whom a record pertains is
mentally incompetent or under other legal disability.
M. To the patient's health insurance company to facilitate any
payment and billing negotiations between the patient, the insurance
carrier and the agency.
Disclosure to consumer reporting agencies:
None.
Policies and practices for storing, retrieving, accessing, retaining,
and disposing of records in the system:
Storage:
Records in this system are stored electronically or on paper in
secure facilities in a locked drawer behind a locked door. The records
are stored on magnetic disc, tape, digital media, and CD-ROM.
Retrievability:
Records may be retrieved by any of the fields listed in the
Categories of Records listed above.
Safeguards:
Records in this system are safeguarded in accordance with
applicable rules and policies, including all applicable DHS automated
systems security and access policies. Strict controls have been imposed
to minimize the risk of compromising the information that is being
stored. Access to the computer system containing the records in this
system is limited to those individuals who have a need to know the
information for the performance of their official duties and who have
appropriate clearances or permissions.
Retention and disposal:
Based on the most conservative industry standards advised to
implement Medical Quality Management, OHA will propose a retention
schedule of ten (10) years from the date of the EMS provider encounter.
Records will be retained pending the final approval by the National
Archives and Records Administration of this records schedule.
System Manager and address:
Director, Workforce Health and Medical Support Division, Office of
Health Affairs, Department of Homeland Security, Washington, DC 20528.
Notification procedure:
Individuals seeking notification of and access to any record
contained in this system of records, or seeking to contest its content,
may submit a request in writing to the Headquarters FOIA Officer, whose
contact information can be found at https://www.dhs.gov/foia under
``contacts.'' If an individual believes more than one component
maintains Privacy Act records concerning him or her the individual may
submit the request to the Chief Privacy Officer and Chief Freedom of
Information Act Officer, Department of Homeland Security, 245 Murray
Drive, SW., Building 410, STOP-0655, Washington, DC 20528.
When seeking records about yourself from this system of records or
any other Departmental system of records your request must conform with
the Privacy Act regulations set forth in 6 CFR part 5. You must first
verify your identity, meaning that you must provide your full name,
current address and date and place of birth. You must sign your
request, and your signature must either be notarized or submitted under
28 U.S.C. 1746, a law that permits statements to be made under penalty
of perjury as a substitute for notarization. While no specific form is
required, you may obtain forms for this purpose from the Chief Privacy
Officer and Chief Freedom of Information Act Officer, https://www.dhs.gov or 1-866-431-0486. In addition you should provide the
following:
An explanation of why you believe the Department would
have information on you;
Identify which component(s) of the Department you believe
may have the information about you;
Specify when you believe the records would have been
created;
Provide any other information that will help the FOIA
staff determine which DHS component agency may have responsive records;
and
If your request is seeking records pertaining to another
living individual, you must include a statement from that individual
certifying his/her agreement for you to access his/her records.
Without this bulleted information the component(s) may not be able
to conduct an effective search, and your request may be denied due to
lack of specificity or lack of compliance with applicable regulations.
Consistent with 6 CFR 5.22(f) Release of Medical Records, and pursuant
to 5 U.S.C. 552a(f)(3), where requests are made for access to medical
records, including psychological records, the decision to release
directly to the individual, or to withhold direct release, shall be
made by a medical practitioner. Where the medical practitioner has
ruled that direct release will cause harm to the individual who is
requesting access, normal release through the individual's chosen
medical practitioner will be recommended. Final review and decision on
appeals of disapprovals of direct release will rest with the General
Counsel.
Record access procedures:
See ``Notification procedure'' above.
Contesting record procedures:
See ``Notification procedure'' above.
Record source categories:
Records are obtained from DHS EMS medical care providers and their
patients, either in the care and custody of the Department, at the DHS
workplace, or in conjunction with a medical emergency where an on-duty
DHS EMS is the medical care provider.
Exemptions claimed for the system:
None.
Dated: August 23, 2011.
Mary Ellen Callahan,
Chief Privacy Officer, Department of Homeland Security.
[FR Doc. 2011-22169 Filed 8-29-11; 8:45 am]
BILLING CODE 4410-9K-P