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COMPLIANCE AUDITS AND REVIEWS: A STEP-BY-STEP GUIDE

In today’s regulatory landscape, it’s more crucial than ever for organizations to have a robust compliance program in place. But how do you ensure that your organization is compliant with the latest regulations and laws? The answer lies in regular compliance audits and reviews.

Strengthening Your Compliance Program


A recent report highlighted several key recommendations for enhancing compliance, including:

  • Utilizing outside resources to address government inquiries
  • Implementing a “rapid response protocol” to address government inquiries
  • Formalizing a process to make compliance a part of the annual review process
  • Creating more effective channels of communication to assure awareness of compliance policy changes and legal developments

Key Takeaways


  • Enhance your Compliance Committee charter, agendas, and minutes
  • Update CEO/Executive Team on program status and issues
  • Periodically update the Board on compliance matters
  • Ensure the Compliance Officer has independent authority to retain outside counsel

Training and Education


Annual Compliance Education Plan/Curriculum

Develop an annual compliance education plan/curriculum Retain training materials and track completion Document methods to determine effectiveness of training

Communication


Multiple, Well-Publicized Communication Channels

Establish multiple, well-publicized communication channels for employees, Board members, and FDRs (Foreign Data Recipients) Implement a system to track reports and follow up on compliance issues Develop a policy or statement of non-retaliation

Auditing and Monitoring


Regular Risk Assessments and Compliance Program Effectiveness

Conduct regular risk assessments and monitor compliance program effectiveness Implement corrective action plans designed to correct and prevent future occurrences

Rapid Response to Compliance Issues


  • Develop investigation protocols for government inquiries
  • Implement a policy for document holds and records retention
  • Revisit policy revisions and education to prevent recurrence of non-compliant behavior

Practical Considerations and Application


Scope, Frequency, and Criteria for Review

Determine the scope, frequency, and criteria for review Identify who will conduct reviews and how results will be used

Best Practices in Compliance


Katten’s experience in representing health systems, hospitals, and life science companies has shown that having a robust compliance program in place can make all the difference. Our team of experts is well-versed in conducting internal investigations, government investigations, and qui tam suits.

If you have any questions or would like to learn more about how Katten can help your organization strengthen its compliance program, please don’t hesitate to reach out.

Contact Us


Ethan E. Rii, Esq. Partner Katten Muchin Rosenman LLP ethan.rii@kattenlaw.com