Policy and Regulation Facts Sheet: the 21st Century Cures Act – Best Samples

This article covers Policy and Regulation Facts Sheet: the 21st Century Cures Act.

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In this Assignment, you will study a recent nursing informatics-related healthcare policy, and you will share the relevant details via a fact sheet designed to inform and educate.

To Prepare:

Review the Resources on healthcare policy and regulatory/legislative topics related to health and nursing informatics.

Consider the role of the nurse informaticist in relation to a healthcare organization’s compliance with various policies and regulations, such as the Medicare Access and CHIP Reauthorization Act (MACRA).

Research and select one health or nursing informatics policy (within the past 5 years) or regulation for further study.

…

Solution

Policy and Regulation Facts Sheet: the 21st Century Cures Act

The 21st Century Cures Act (Cures Act) came to effect in 2016. The Act’s goal was to help speed up medical product production and bring novel technologies and inventions for fast and efficient use by patients in need (US Food and Drug Administration, 2016). The Act’s benefits include (GPO, 2016):

• The Act had a significant impact on the clinical use of biomarkers, surrogate endpoint, details about patients’ experiences, and observational data to speed up approval of drugs and medical devices.
• The Act considers a patient to be more than a source of clinical data. It enables a patient-centered approach to healthcare to improve and provide a better experience along a clinical journey.
• The Act encourages the capture, amplification, and reporting of patient’s views during drug development.

The Act’s Impact of Clinical Care include (Lye et al., 2018; GPO, 2016):

• The Act guides how medical cures are developed, including the order of need, number of patients, and patient input into the drug development.
• Medical data are collated and stored for future reference, inform future research and understanding on disease burden, avoid medical mistakes, and facilitate prioritized and efficient care practice.
• Health facilities are provided with effective medical devices from a collaboration between FDA and bright professionals to better medical diagnoses and treatments. 
• Free flow of information from health data systems to facilitate and inform effective healthcare services.

Healthcare Policies to Address 21st Century Cures Act

A hospital can take the following steps to address the 21st Century Cures Act:

• Update clinical decision support systems:  Big data systems, including health records management, must be updated to include all aspects of the clinical journey, e.g., diagnosis, signs and symptoms, physiological health, etc.
• Initiate proactive care coordinated with pharmacists across a facility to disseminate understanding of the Act and inherent clinical practice changes.
• Community collaboration: Hospital management should reach out to the community through local leaders to create awareness on available medical products and treatments.

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References

US Food and Drug Administration. (2016). 21st Century Cures Act. Retrieved 3 March 2021, from https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

United States Government Publishing Office (GPO) (2016). 21st Century Cures Act. H.R. 34, 114th Congress. 2016. Retrieved 24 March 2021, from https://www.gpo.gov/fdsys/pkg/BILLS-114hr34enr/pdf/BILLS-114hr34enr.pdf.

Lye, C. T., Forman, H. P., Daniel, J. G., & Krumholz, H. M. (2018). The 21st Century Cures Act and electronic health records one year later: will patients see the benefits?. Journal of the American Medical Informatics Association, 25(9), 1218-1220. https://doi.10.1093/jamia/ocy065

Question

In this Assignment, you will study a recent nursing informatics-related healthcare policy, and you will share the relevant details via a fact sheet designed to inform and educate.

To Prepare:

• Review the Resources on healthcare policy and regulatory/legislative topics related to health and nursing informatics.
• Consider the role of the nurse informaticist in relation to a healthcare organization’s compliance with various policies and regulations, such as the Medicare Access and CHIP Reauthorization Act (MACRA).
• Research and select one health or nursing informatics policy (within the past 5 years) or regulation for further study.

The Assignment: (1 page not including the title and reference page)

Create a 1-page fact sheet that your healthcare organization could hypothetically use to explain the health or nursing informatics policy/regulation you selected. Your fact sheet should address the following:

• Briefly and generally explain the policy or regulation you selected.
• Address the impact of the policy or regulation you selected on system implementation.
• Address the impact of the policy or regulation you selected on clinical care, patient/provider interactions, and workflow.
• Highlight organizational policies and procedures that are/will be in place at your healthcare organization to address the policy or regulation you selected. Be specific.
• Use APA format and include a title page, in-text citations, and reference page.
• Use the Safe Assign Drafts to check your match percentage before submitting your work.

By Day 5 of Week 11

Submit your completed Policy/Regulation Fact Sheet.

Submission and Grading Information

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To submit your completed Assignment for review and grading, do the following:

• Please save your Assignment using the naming convention “WK11Assgn+last name+first initial.(extension)” as the name.
• Click the Week 11Assignment Rubric to review the Grading Criteria for the Assignment.
• Click the Week 11 Assignment link. You will also be able to “View Rubric” for grading criteria from this area.
• Next, from the Attach File area, click on the Browse My Computer button. Find the document you saved as “WK11Assgn+last name+first initial.(extension)” and click Open.
• If applicable: From the Plagiarism Tools area, click the checkbox for I agree to submit my paper(s) to the Global Reference Database.
• Click on the Submit button to complete your submission.

Grading Criteria

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