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Healthcare Regulation and Quality Improvement: Health Regulation Policy Analysis Paper

Health Regulation Policy Analysis Paper

The goal of the health regulation term paper is to develop an understanding of the process of regulatory action and implementation related to health care in the United States. Students will gain an understanding of regulatory agencies, rulemaking and implementation, stakeholders, and other concepts. Students will also develop writing skills through a process of drafts and revisions that will strengthen their ability to understand and communicate regulatory information to a lay audience.

All writing assignments must be submitted electronically via SafeAssign on the due date. Papers with high SafeAssign content (more than 25%) may be subject to grade reduction for lack of originality.

You may select one of the five regulatory agenda topics for your research paper:

Agency: Food and Drug Administration (FDA)

Establishing a List of Qualifying

Pathogens that have the Potential to Pose a Serious threat to Public Health Under the FDA Safety and Innovation Act (RIN: 0910-AG92).

These regulations were selected because they are in the final rule stage of rulemaking. You will learn more about the rulemaking process early in the lecture series.

  • Formatting of your paper must use American Psychological Association (APA) guidelines. Here is a resource you may use:
  • Papers are to be 8-12 pages of double-spaced type, not including cover page, graphs and charts, and bibliography. Any non-text items (graphs, charts, etc) should be created by the student and included in an appendix.
  • Margins – 1 inch on all sides
  • The paper should follow conventional structure for academic writing. Include an Introduction, Body, and Conclusion. The body of the paper should include subheadings that either adheres to the following outline, or subheadings of the students own choosing that included the information in the outline. The conclusion should restate the main points and tie together all the concepts presented in the body of the paper. Recommendations may be presented if appropriate.
  • Papers should reference a minimum of 8 sources. If you use a source and list it in your references you must include citations in the paper for that source.

There should be a logical flow to the content of the paper. Papers should include:


  • Introductions also include a thesis statement or research questionsthat the paper will address. Make sure the introduction introduces the regulation, not simply the topic.


The following sections should be included with properly formatted subheaders. Students may add additional subheadings if they feel it improves organization.


  • Define any terms. Answer the questions Who, What, When, Where, How, and Why


  • Discuss the potential market failure implications that you feel made this problem amenable to be addressed through regulation.


  • Are there any free market alternatives that have tried to or could address the issue? +Stakeholders
  • those who benefit and those who are impacted ‘negatively’. Consider the impact on the business of health care and/or other agencies potentially impacted by the regulation


  • Cost can be financial or non-financial. Consider costs disclosed in the regulation, but also those that are not directly incurred by the government (research, paperwork, training, preparation, etc based costs)
  • Non-financial costs may be time, societal, opportunity, or other indirectly experienced costs) +Impact and Effectiveness
  • This must be supported by researched evidence to support your position.
  • What conclusions can be drawn from this research?


  • What are your personal opinions on the topic after doing your research? What did you learn? How did you feel the writing process worked for you? What would you have done differently knowing what you know now?

Papers are to be submitted to SafeAssign. Students will submit their paper in drafts. The idea is to allow the student to receive feedback from the instructor in order that the student can produce the best product.

  • The first draft of the paper should be at least 6 pages, and include citations. The more information you provide in this draft, the better your feedback will be from the instructor and your peer reader.
  • The second draft must contain a minimum of 8 pages double spaced. The maximum final paper page count is 12 pages double spaced. Students should have completed the majority of their writing by the submission of the second draft.
  • The third (final) draft is for additional revision and polishing of the paper. You will not have an opportunity to revise the third draft after submission. Make sure your previous drafts give you ample opportunity to receive and implement feedback.

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