Essay on "Health Care Legislation"
Essay 3 pages (922 words) Sources: 3
[EXCERPT] . . . .
An entirely new stream for testing will need to be created, and the FDA will need to work with industry to understand how best to balance the needs of the industry with the needs of the American people to have safe medical care. The FDA will also need to hire more people to help this process run smoothly. As such, it is expected that the process will take some time to implement even once it becomes law.As for the actual text of the law, most laws are rather lengthy, verbose documents. The Patient Protection and Affordable Care Act is 906 pages long. Working with that format, the following text can be added either in a new law or as an addendum to existing FDA laws.
Sec. 1001. APPROVAL OF NANOTECHNOLOGY MEDICAL DEVICES
(a) APPLICATION OF EXISTING APPROVALS PROCESS
(1) The basic framework of the FDA approvals process for medical devices as per Sec. 1241 of the Food and Drug Administration Act is amended to allow for a special category of medical device approvals, for nanotechnology devices, using the definition of nanotechnology found in Sec. 0104-12 of this Act.
(2) Where the technology tested has been altered due to innovation or improvement, the FDA shall provide a pathway for the altered or improved device to continue from with the approvals process, without the need to return to the beginning of said process. The FDA shall write these provisions with the following considerations in mind:
(i) That the altered version of the technology does not represent a material change in the functionality.
(ii) That the altered version of the technology if in Stages 1 or 2
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(iii) That if the technology has been materially altered, the FDA should have the ability to use judgment in moving the technology through the process -- the FDA should use discretion in whether or not the technology needs to move back a stage as the result of the innovation or if it can proceed.
The solution here is that the FDA can have some discretion with respect to whether or not the change to the device should send it back to the beginning of the approval process. Unlike with drugs, these devices are subject to a rapid pace of change, and the regulator should be flexible enough to deal with that, so as not to stunt the pace of innovation in America's medical device industry.
References
Crasto, M. (2014). Nanotechnology, its applications in medicine, pharmaceuticals, and drug developments. New Drug Approvals. Retrieved June 10, 2014 from http://newdrugapprovals.org/2013/07/09/nanotechnology-its-applications-in-medicine-pharmaceuticalsdrug-developments/comment-page-1/
Walenta, C. (2010). Constitutional topic: How a bill becomes law. U.S. Constitution. Retrieved June… READ MORE
Quoted Instructions for "Health Care Legislation" Assignment:
“This paper to be done by username ***** or *****. If they are not available, then anyone with this course background can do.This is a nursing course that deals with Ethics, policy, Finance in the health care system. This assignment requires thought about public policy that is needed or needs to be changed that relates to nursing, healthcare, and /or the public. Policy changes can occur by working with members of your legislature, and state or national nurses associations, to introduce a new bill and/or change to a current law in your state of federal government. Examples of public policy includes any component of the current legislation governing healthcare, Medicare part D, Medicaid, nursing regulation, etc.
Direction In 700 word, propose a health policy change (that is currently a bill of law, a law, or may not exist at all) at the state or federal level that you believe needs to change and why.
1. the policy must NOT be a clinical care policy for individual care. the policy involved may include public or community health, legislative or regulatory, professional organization (nursing *****) advanced nursing practice, health plan, or hospital plan.
2. Include a specific section for the exact wording for the bill or change in wording of the law.
3. Include the plan for the implementation of your policy development, to lobby for passage, to next steps after passage. 4. Discuss who would be the champion for the bill/law change from your state advocates (legislators, federal legislators, local or national state nursing organization) are these individuals also influential in making changes occur? did you vote for the individual in office that you want to help you make change?
Resources: 1.Review different pieces of legislation for ideas on wording 2.Visit you state's legislative governmental affairs website to understand the process your policy could take if you wanted to introduce to into legislation.
Contents that should be included in this work:
1.Rationale/purpose/overall presentation, is comprehensive, support the purpose of the policy process that is actually conducted for a public health policy and clearly shows logical process of how development takes place.
2. Purpose and objectives of presentation are clearly defined. AT LEAST 3 LEARNERS OBJECTIVES ARE STATED IN BEHAVIORAL TERMS. 3. Paper includes a specific section for the exact wording for the bill or change in wording of the law. 4. Paper implementation plan including who would be the champion for the bill/law change from the state legislators/federal legislators/local or national state nursing organization. Are these individual also influencing making change now?
How to Reference "Health Care Legislation" Essay in a Bibliography
“Health Care Legislation.” A1-TermPaper.com, 2014, https://www.a1-termpaper.com/topics/essay/nanotechnology-medical/7485545. Accessed 28 Sep 2024.
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