Biomedical Engineering Reference
In-Depth Information
laws and regulations, so that responders to a mass-
casualty event will know which laws do and do
not apply in a given situation.
To the extent possible, existing laws and other
mechanisms should be used to the fullest and
should not impede the process of planning for
a mass-casualty event. It is therefore important
to examine existing State public health laws,
licensing/certification laws, interstate emergency
management compacts and mutual aid agreements,
and other legal and regulatory arrangements to
determine the extent to which they meet poten-
tial new threats. Any waivers granted are likely
to be targeted to the affected area for a tempo-
rary and specified period of time. In the case of
a mass-casualty event involving a communicable
agent that moves from region to region, it will be
important to have flexibility to extend or expand
such waivers.
Some of the Federal, State, and local laws and
regulations that govern the delivery of health and
medical care under normal conditions may need
to be modified or enhanced in the case of a
mass casualty event. These include laws to: ensure
access to emergency medical care; protect patient
privacy and confidentiality of medical information;
shield medical providers and other rescuers from
lawsuits; govern the development and use of health
and medical facilities; and regulate the number of
hours health and medical providers can work as
well as the conditions in which they work. Relevant
laws include but are not limited to the following:
•
Building codes and other facility standards.
•
Publicly funded health insurance laws
(including Medicare, Medicaid, and the State
Children's Health Insurance Program).
•
Laws pertaining to human subject research.
•
Laws and regulations governing the use and
licensure of drugs and devices.
In developing a comprehensive plan for the
delivery of health and medical care during a mass
casualty event, it is important to consider mecha-
nisms to allow for legal, regulatory, or accredita-
tion adjustments in the following areas:
•
Liability of providers and institutions for care
provided under stress with less than a full
complement of resources
. The plan may have
to provide for “hold harmless” agreements or
grant immunity from civil or criminal liability
under certain conditions.
•
Certification and licensing
. Although it is
important to ensure that providers are quali-
fied, it is also important to have flexibility in
granting temporary certification or licenses for
physicians, nurses, and others who are inactive,
retired, or certified or licensed in other States.
•
Scope of practice
. It may be necessary to grant
permission to certain professionals on a tempo-
rary and emergency basis to function outside
their legal scope of practice or above their level
of training.
•
Institutional autonomy
. If organizations and
institutions cede their authority in order to
participate in a unified incident management
system in a crisis, the plan may have to address
the legal implications for those organizations.
•
Emergency Medical Treatment and Active
Labor Act (EMTALA).
•
Health Insurance Portability and Accountability
Act (HIPAA).
•
Facility standards
. Standards of care that
pertain to space, equipment, and physical facil-
ities may have to be altered in both traditional
medical care facilities and alternate care sites
that are created in response to the event.
•
Federal Volunteer Protection Act.
•
Good Samaritan Law.
Additional types of laws and regulations that
relate to the delivery of health and medical care
include:
•
Patient privacy and confidentiality
. Provisions
of HIPAA and other laws and regulations that
require signed releases and other measures to
ensure privacy and confidentiality of a patient's
medical information may have to be altered.
•
80-hour work week rule for medical residents.
•
Occupational Safety and Health Administration
and other workplace regulations.
