[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53921-53924]
From the Federal Register Online via the Government Publishing 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: http://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 http://www.regulations.gov, 
including any personal information provided.
     Docket: For access to the docket to read background 
documents or comments received go to http://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 http://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 http://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, http://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