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Instructions:
Governmental Agencies that Oversee Health Care Products
Agency
Overview
HCS/490
Version 2
1
University of Phoenix Material
Agency Overview
Overview
There are several governmental agencies that oversee, regulate, assess, and approve
health care products and services that are utilized by health care consumers. The U.S.
Department of Health and Human Services is a key organization within the U.S.
government. The following link may be used to access the website for this
department: http://www.hhs.gov/
The U.S. Department of Health and Human Services is comprised of the following key
agencies:
· Office of the Secretary
· Administration for Children & Families
· Administration on Aging
· Agency for Health Care Research & Quality
· Agency for Toxic Substances & Disease
· Centers for Disease Control & Prevention
· Centers for Medicare & Medicaid Services ( http://www.cms.hhs.gov/ )
· Food & Drug Administration ( http://www.fda.gov/default.htm )
· Health Resources & Services Administration
· Indian Health Service
· National Institutes of Health
· Office of Inspector General
· Substance Abuse & Mental Health Services Administration
There are a variety of products and services regulated and overseen by the agencies
that comprise the U.S. Department of Health and Human Services. A comprehensive
review of the strategic focus of each agency is beyond the scope of this introductory
guidance document.
Two of the key agencies that provide oversight of health care products and services are
the Food & Drug Administration (FDA) and the Centers for Medicare & Medicaid
Services (CMS). A brief overview of each of these agencies is provided to facilitate your
initial review of their websites and to assist in your efforts to evolve an understanding of
the types of health care products and services each of these two key governmental
agencies oversee on behalf of the consumer. This information is of value to you as you
begin to define and assemble the content that comprises the Week Five Learning Team
assignment.
Centers for Medicare & Medicaid Services (CMS; http://www.cms.hhs.gov/ )
CMS is an agency that is part of the U.S. Department of Health and Human Services. It
is responsible for administering the Medicare program. In addition, it cooperates with
state governments in the administration of Medicaid and the State Children’s Health
Insurance Program. Additional areas of focus and responsibility include oversight of the
administration of the Health Portability and Accountability Act (HIPAA), ensuring quality
standards within long-term care facilities and that apply to clinical laboratories.
Its website contains a wealth of information related to the aforementioned core areas of
focus of the CMS. You are encouraged to explore the content of the website, which
contains links concerning Medicare, Medicaid, and the Children’s Health Insurance
Program (CHIP), as well as regulations and guidance documents. These programs are
of relevance in the context of providing health care coverage to selected patient groups,
including those over the age of 65. As the demographics of the population shifts, with an
increasing number of older individuals comprising the overall population, the health care
services and products covered by the Medicare program are of interest and importance
within the overall health care environment to both consumers and health care providers.
Food & Drug Administration (FDA; http://www.fda.gov/default.htm )
The FDA is an agency of the U.S. Public Health Service, which is one of the agencies
that comprise the U.S. Department of Health and Human Services. There are a variety
of key areas of focus for which the FDA is responsible, including the approval of new
drugs—prescription, Rx-to-OTC switch products, and OTC products—medical devices,
and biological products; monitoring the safety of these products both before and after
approval; ensuring that advertising that applies to medications accurately reflects the
product characteristics as defined by the existing scientific and medical data; and
assessing the safety of food products, products containing tobacco, cosmetics, and food
additives.
There are numerous additional areas of responsibility that derive from the core
categories listed above, as well as others not listed. The FDA’s website contains a
substantial amount of information concerning the areas of focus over which the FDA
has responsibility. In the general area of health care products, the FDA has a significant
role in overseeing the approval of new medicines available to consumers and
formulates its recommendations for approval upon medical and scientific information
that relates to the efficacy and safety of the products. The FDA also has a substantial
role in ensuring that marketed prescription medicines are safe. They accomplish this
goal by monitoring the adverse events reported by health care providers and
consumers, which occur as a consequence of the use of any medicine.
One particularly useful section of the FDA’s website relates to the regulatory documents
that pertain to the scientific and medical review of approved prescription medicines:
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?CFID=35721176&CF
TOKEN=3c1f61a5bb189e67-875DFE7A-1372-5AE1-6AE3129AE91ACB51
This information is of value to the health care provider and the scientifically or medically
literate health care consumer, as the documents contain the scientific and medical
information upon which regulatory approval of any currently marketed prescription
medicine is based.
You are encouraged to explore the content of the website, which contains information
relating to prescription medicines, foods, vaccines, medical devices, cosmetics, and
tobacco products, among many others.
Home>Information Systems homework help>Case Study 4: Bin Laden
Points: 50 Case Study 4:
Bin Laden
Criteria
Unacceptable Bel
ow 60% F
Meets
Minimum
Expectations 6
0-69% D
Fair 70-
79% C
Proficient 80
-89% B
Exemplary 90
-100% A
1. Explain in
your own
words the
message of
each speech
in terms of
the future.
Weight: 20%
Did not submit or
incompletely
explained in your
own words the
message of each
speech in terms
of the future.
Insufficiently
explained in
your own
words the
message of
each speech in
terms of the
future.
Partially
explained
in your own
words the
message
of each
speech in
terms of
the future.
Satisfactorily
explained in
your own
words the
message of
each speech
in terms of
the future.
Thoroughly
explained in
your own
words the
message of
each speech
in terms of
the future.
2. Analyze
each speech
to consider
whether it
was one of
victory or
one of
realized risk.
Weight: 25%
Did not submit or
incompletely
analyzed each
speech to
consider whether
it was one of
victory or one of
realized risk.
Insufficiently
analyzed each
speech to
consider
whether it was
one of victory
or one of
realized risk.
Partially
analyzed
each
speech to
consider
whether it
was one of
victory or
one of
realized
risk.
Satisfactorily
analyzed
each speech
to consider
whether it
was one of
victory or
one of
realized risk.
Thoroughly
analyzed
each speech
to consider
whether it
was one of
victory or one
of realized
risk.
3. Determine Did not submit or Insufficiently Partially Satisfactorily Thoroughly
whether you
think the
killing of Bin
Laden has
lowered or
raised the
fear of
terrorism in
most U.S.
citizens.
Weight: 20%
incompletely
determined
whether you think
the killing of Bin
Laden has
lowered or raised
the fear of
terrorism in most
U.S. citizens.
determined
whether you
think the killing
of Bin Laden
has lowered or
raised the fear
of terrorism in
most U.S.
citizens.
determined
whether
you think
the killing
of Bin
Laden has
lowered or
raised the
fear of
terrorism in
most U.S.
citizens.
determined
whether you
think the
killing of Bin
Laden has
lowered or
raised the
fear of
terrorism in
most U.S.
citizens.
determined
whether you
think the
killing of Bin
Laden has
lowered or
raised the
fear of
terrorism in
most U.S.
citizens.
4. Give two
(2)
examples
illustrating
how killing
Bin Laden
has affected
al Qaeda.
Weight: 20%
Did not submit or
incompletely
gave two (2)
examples
illustrating how
killing Bin Laden
has affected al
Qaeda.
Insufficiently
gave two (2)
examples
illustrating how
killing Bin
Laden has
affected al
Qaeda.
Partially
gave two
(2)
examples
illustrating
how killing
Bin Laden
has
affected al
Qaeda.
Satisfactorily
gave two (2)
examples
illustrating
how killing
Bin Laden
has affected
al Qaeda.
Thoroughly
gave two (2)
examples
illustrating
how killing
Bin Laden
has affected
al Qaeda.
5. 3
references
Weight: 5%
No references
provided
Does not meet
the required
number of
references; all
references
poor quality
choices.
Does not
meet the
required
number of
references;
some
references
poor
quality
choices.
Meets
number of
required
references;
all
references
high quality
choices.
Exceeds
number of
required
references;
all references
high quality
choices.
6. Clarity,
writing
mechanics,
and
formatting
requirement
s Weight:
10%
Governmental Agencies that Oversee Health Care Products
Governmental Agencies that Oversee Health Care Products
RUBRIC |
||||||
Excellent Quality 95-100%
|
Introduction
45-41 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Literature Support 91-84 points The background and significance of the problem and a clear statement of the research purpose is provided. The search history is mentioned. |
Methodology 58-53 points Content is well-organized with headings for each slide and bulleted lists to group related material as needed. Use of font, color, graphics, effects, etc. to enhance readability and presentation content is excellent. Length requirements of 10 slides/pages or less is met. |
|||
Average Score 50-85% |
40-38 points More depth/detail for the background and significance is needed, or the research detail is not clear. No search history information is provided. |
83-76 points Review of relevant theoretical literature is evident, but there is little integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are included. Summary of information presented is included. Conclusion may not contain a biblical integration. |
52-49 points Content is somewhat organized, but no structure is apparent. The use of font, color, graphics, effects, etc. is occasionally detracting to the presentation content. Length requirements may not be met. |
|||
Poor Quality 0-45% |
37-1 points The background and/or significance are missing. No search history information is provided. |
75-1 points Review of relevant theoretical literature is evident, but there is no integration of studies into concepts related to problem. Review is partially focused and organized. Supporting and opposing research are not included in the summary of information presented. Conclusion does not contain a biblical integration. |
48-1 points There is no clear or logical organizational structure. No logical sequence is apparent. The use of font, color, graphics, effects etc. is often detracting to the presentation content. Length requirements may not be met |
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