Rasmussen College Module 03 Compliance Policies Compliance Policies Discussion

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Introduction:

As a medical professor responsible for creating assignments and evaluation for medical college students, I understand the importance of following healthcare regulations and guidelines in clinical trials. Clinical trials require heavy regulation to ensure that patients are provided with proper consent and treatments. In this context, I will provide answers to questions related to monitoring regulation and writing compliance policies.

1. What are the governing agencies and their roles in Clinical Trials?

Clinical trials are governed by several agencies that play a vital role in ensuring patient safety and medical efficacy. These agencies include:

a. Food and Drug Administration (FDA): The FDA regulates clinical trials and ensures that all drugs and treatments are safe and effective for public use.

b. National Institutes of Health (NIH): The NIH oversees clinical trials and provides funding for research related to developing new medical treatments and drugs.

c. Office for Human Research Protections (OHRP): The OHRP sets regulations and guidelines for clinical trials to ensure patient safety and provides oversight for Institutional Review Boards (IRB).

d. Institutional Review Boards (IRB): IRBs review and approve clinical trial protocols to ensure that they meet all ethical and regulatory guidelines.

Examples of Clinical Trials:

One of the recent examples of clinical trials is the Pfizer-BioNTech COVID-19 vaccine trial, which was conducted on a large scale to test the efficacy of the vaccine against the virus. Another example is the clinical trial of CAR T-cell therapy for lymphoma, which involves genetically modifying T-cells to target cancer cells.

Reasons for Choosing Governing Agencies and Examples:

I chose these governing agencies and examples because they represent the key regulatory bodies involved in clinical trials and highlight the importance of following proper guidelines and regulations to ensure patient safety.

2. What are the policies for the two compliance plans?

The two compliance plans that I have developed as a Compliance Officer for a medical facility are:

a. HIPAA Compliance Plan: This plan focuses on protecting patient data and ensuring that all employees follow HIPAA regulations. The policies for this plan include:

– Compliance Standards: All employees are required to comply with HIPAA regulations to protect patient data and privacy.
– High-Level Responsibility: The Chief Compliance Officer is responsible for ensuring that all policies and procedures related to HIPAA compliance are followed.
– Education: All employees receive HIPAA training to understand the regulations and guidelines related to patient data protection.
– Communication: Employees must be proactive in reporting any potential breaches of patient data.
– Monitoring/Auditing: A tracking system is implemented to monitor any potential breaches of patient data.
– Enforcement/Discipline: Employees found violating HIPAA regulations may face disciplinary action.
– Response/Prevention: In case of a breach, the medical facility will take necessary measures to prevent further breaches and prevent damage to patients.

b. Fraud and Abuse Compliance Plan: This plan focuses on preventing fraud and abuse in healthcare and ensuring that all employees follow federal and state regulations related to fraud and abuse. The policies for this plan include:

– Compliance Standards: All employees are required to comply with federal and state regulations related to fraud and abuse.
– High-Level Responsibility: The Chief Compliance Officer is responsible for ensuring that all policies and procedures related to fraud and abuse are followed.
– Education: All employees receive training to understand the regulations and guidelines related to fraud and abuse prevention.
– Communication: Employees must be proactive in reporting any potential fraud or abuse activities.
– Monitoring/Auditing: The medical facility implements a monitoring and auditing system to detect any potential fraud or abuse activities.
– Enforcement/Discipline: Employees found violating the regulations related to fraud and abuse may face disciplinary action or legal punishment.
– Response/Prevention: The medical facility takes necessary measures to prevent further fraudulent or abusive activities and prevent damage to patients and the healthcare system.

Reasons for Choosing Policies:

I chose these policies because they represent the key compliance elements related to HIPAA and fraud and abuse prevention. These policies ensure that all employees are aware of their responsibilities and follow regulations to maintain patient safety and protect the healthcare system from fraudulent or abusive activities.

In conclusion, as a medical professor, I understand the importance of following healthcare regulations and guidelines in clinical trials. I have provided answers related to monitoring regulation and compliance policies, highlighting the crucial role of governing agencies and the importance of developing policies that maintain patient safety and protect the healthcare system.