Remember to submit your work following the file naming convention FirstInitial.LastName_M01.docx. For example, J.Smith_M01.docx. Remember that it is not necessary to manually type in the file extension; it will automatically append.

Start by reading and following these instructions:

1. Quickly skim the questions or assignment below and the assignment rubric to help you focus.
2. Read the required chapter(s) of the textbook and any additional recommended resources. Some answers may require you to do additional research on the Internet or in other reference sources. Choose your sources carefully.
3. Consider the course discussions so far and any insights gained from it.
4. Create your Assignment submission and be sure to cite your sources if needed, use APA style as required, and check your spelling.

Assignment:

The Future of Healthcare Informatics

Write an essay addressing each of the following points/questions. Be sure to completely answer all the questions for each number item. There should be three sections, one for each item number below, as well the introduction (heading is the title of the essay) and conclusion paragraphs. Separate each section in your paper with a clear heading that allows your professor to know which bullet you are addressing in that section of your paper. Support your ideas with at least three (3) citations in your essay. Make sure to reference the citations using the APA writing style for the essay. The cover page and reference page do not count towards the minimum word amount. Review the rubric criteria for this assignment.

1. Identify the current role of the informatics nurse and predict the future role of the informatics nurse, based on scholarly sources.
2. Explain what is meant by connected health. Provide three examples of connected health in today’s healthcare environment. Explain the benefits and drawbacks of each.
3. In what ways has informatics impacted public health – please provide at least three examples.

Assignment Expectations:

Length: 500 words per essay prompt/section (1500 total for this assignment)

Structure: Include a title page and reference page in APA style. These do not count towards the minimal word amount for this assignment. All APA Papers should include an introduction and conclusion. 

References: Use the appropriate APA style in-text citations and references for all resources utilized to answer the questions. Include at least three (3) scholarly sources to support your claims.

Rubric: This assignment uses a rubric for scoring. Please review it as part of your assignment preparation and again prior to submission to ensure you have addressed its criteria at the highest level.

Format: Save your assignment as a Microsoft Word document (.doc or .docx) or a PDF document (.pdf)

File name: Name your saved file according to your first initial, last name, and the module number (for example, “RHall Module 1.docx”)

Use your completed strategy map to formulate functional-level strategy for the primary business functions included in your plan. Functional-level strategies are the action plans used by departments within organizations to support the execution of business-level strategy at the managerial level. Create a 500-750 word action plan that addresses the following:

1. Identify which management tactics and strategies you will implement to meet your strategic goals for each of the stakeholders, departments, or business functions impacted by your plan: MBO, MBM, single-use or standing plans, competitive advantage, contingency planning, building scenarios, crisis planning, and innovation.

2. Provide an explanation of how you will apply managerial decision-making methods throughout your action plan.

3. Which business functions will be impacted by your action plan? What tactics will you use to manage implementation across business functions? What can you do to enhance collaboration/cross-functionality to ensure the success of your plan?

4. Identify leadership strategies you plan to implement throughout the execution of your action plan. In particular, explain which strategies you would implement to foster team collaboration among the multiple stakeholders who must collaborate to successfully implement the plan. Why do you think these will be successful?

1-AG 

                                                    Process and Regulations of Fast Track

    New pharmacological agents go a long way in clinical trials and approvals from the Food and Drug Administration before entering a wide market and becoming available to needy patients in the United States. At the same time, for promising drugs that can significantly improve the results of existing therapy or fill a missing niche, this process can be accelerated using the Fast Track protocol (Woo & Robinson, 2015). The latter provides for the filing of a special application by a pharmacological company at the FDA office, which the latter examine within 60 days. If the medicine acquires Fast Track status, manufacturers receive a number of concessions, such as the right to more frequent correspondence and meetings with representatives of this state regulatory body and the possibility of cooperation in conducting a clinical trial. If convincing positive results are obtained, it is possible to obtain FDA approval after a single phase 2 clinical trial (Papadimitriou & Butler, 2017). In addition, the verification process of such a pharmacological agent is significantly reduced from 10 to 6 months.

                                                                    Medical Conditions

    In order to be able to obtain faster approval via the Fast Track protocol, the drug agent must meet a number of requirements. Specific medical conditions are not indicated, but it is prescribed that the effect of the drug should be aimed at treating a life-threatening or dangerous disease, such as heart failure (Papadimitriou & Butler, 2017). A prerequisite is either to improve the outcome of existing treatment, such as a reduction in mortality or disability, or a significant reduction in the toxicity of therapy (Woo & Robinson, 2015). In addition, medical conditions that do not have developed a pharmacological treatment, such as some rare and orphan diseases, are also eligible for faster approval from the FDA via the Fast Track protocol. Therefore, due to this possibility, patients will more quickly gain access to the most modern therapy and increase the chances of a more favorable outcome of treatment.                                                   

                                                                           References

Papadimitriou, L., & Butler, J. (2017). “Fast Track” Development and Approval Process for Heart Failure Therapeutics. Clinical Pharmacology & Therapeutics, 102(2), 184-186.

Woo, T. M., & Robinson, M. V. (2015). Pharmacotherapeutics for advanced practice nurse prescribers. FA Davis.

2-MV

The FDA made it possible for critically needed medications to be introduced to the US market promptly using the “Fast Track” procedure.  “Fast Track” is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need (Vaggelas & Seimetz, 2019).  With fast track, FDA is required by the statute to decide within 60 days of receipt of the request whether the conditions for fast track designation have been met (Vaggelas & Seimetz, 2019).  To be eligible for the fast track program, an applicant must submit a request with supporting documentation for fast track designation for the product and its proposed use (Darrow, Avorn, & Kesselheim, 2018).

The medical conditions that warrant “Fast Track” drugs are serious or life-threatening conditions and those conditions that result in unmet medical needs (Darrow et al., 2018).  Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.  Stroke, epilepsy, brain disorders, depression, AIDS, Alzheimer’s, heart failure, diabetes, and cancer are examples of serious conditions.  Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy (Darrow et al., 2018).

References

Darrow, J. J., Avorn, J., & Kesselheim, A. S. (2018). The FDA breakthrough-drug designation-four years of experience. N Engl J Med, 378(15), 1444-1453.

Vaggelas, A., & Seimetz, D. (2019). Expediting drug development: FDA’s new regenerative medicine advanced therapy designation. Therapeutic Innovation & Regulatory Science, 53(3), 364-373. doi: 10.1177/2168479018779373

Discuss the difference between a DNP and a PhD in nursing. Discuss which of these you would choose to pursue if you decide to continue your education to the doctoral level and explain why.

Can someone write a paper on a rare disease in APA format?