Tag: compliance

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FCPA Compliance Report

FCPA Compliance Report – Frank Orlowski on Navigating Challenges in Operating in Emerging Markets

Welcome to the award-winning FCPA Compliance Report, the longest-running podcast in compliance. In this episode, Tom Fox welcomes Frank Orlowski.

Frank Orlowski is a seasoned professional with a wealth of experience in managing emerging markets in the pharmaceutical industry, having spent over 25 years at Pfizer Pharmaceuticals. His extensive knowledge, particularly in South America, Middle East Asia, and Eastern Europe, where he faced difficulties in compliance, controls, and adhering to US accounting regulations, has shaped his perspective on managing emerging markets. Orlowski emphasizes the importance of understanding different cultures, regulations, and geopolitical issues when working in these markets. After retiring from Pfizer, he founded the Ation Advisory Group, where he leverages his expertise to assist companies in commercializing products in the life science industry. Join Tom Fox and Frank Orlowski on this episode of the FCPA Compliance Report podcast to gain more insights into managing emerging markets in the pharmaceutical industry.

Key Highlight:

  • Frank Orlowski’s Global Financial Expertise
  • Navigating Unique Obstacles in Emerging Markets
  • Navigating Cultural Differences in Emerging Market Compliance
  • Creative Employee Rewards and Engagement Strategies
  • Enhancing Healthcare Through Medtech Innovations
  • The Integrated Legal Division at Pfizer

Resources:

Frank Orlowski on LinkedIn

Tom Fox

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Adventures in Compliance

The Memoirs of Sherlock Holmes – The Final Problem

Welcome to a review of all the Sherlock Holmes stories that are collected in the work “The Memoirs of Sherlock Holmes.” They appeared in Strand Magazine from December 1892 to December 1893. Over the past 12 episodes, I have reviewed each story and mined them for leadership, compliance, and ethical lessons.  In this, we begin a two-part series looking at the last story from The Memoirs of Sherlock Holmes.

The intriguing concept of applying Sherlock Holmes’ methods to the work of compliance professionals is the focus of our discussion today. Tom Fox, a seasoned compliance professional, believes that the principles embodied by the iconic detective, such as ethical behavior, problem-solving abilities, continuous learning, and persistence, can greatly enhance the effectiveness of compliance professionals. Fox’s perspective is shaped by his extensive experience in the field, where he has seen the value of attention to detail, deductive reasoning, thorough research, collaboration, risk assessment, and discretion. Join Tom Fox in this episode of the Adventures in Compliance podcast as he delves deeper into how the methods of Sherlock Holmes can be applied to uphold ethical and legal standards in the world of compliance.

Key Highlights:

  • The Story
  • Reichenbach Falls Showdown
  • Lessons for Compliance Professionals

Resources:

The New Annotated Sherlock Holmes

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31 Days to More Effective Compliance Programs

31 Days to a More Effective Compliance Program: Day 7 – Compliance Program Use of Data Analytics

Matt Galvin, Counsel, Compliance & Data Analytics at the DOJ and one of the experts leading the DOJ’s data analytics initiative, highlighted in another talk the proactive use of data to generate cases related to the FCPA and emphasized that this is just the beginning. The DOJ expects companies to adopt a similar data-driven approach to compliance. In her speech, Argentieri stated, “Just as we are upping our game when it comes to data analytics, we expect companies to do the same.” This expectation extends beyond simply tracking trainings, policies, and investigations. The DOJ’s focus is on monitoring third parties throughout the lifespan of the relationship, not just during the onboarding process.

The DOJ’s increasing use of data analytics for proactive enforcement signifies a significant shift in their approach to combating white-collar crime. Companies must embrace this data-driven approach to compliance, continuously monitor high-risk transactions, and invest in the necessary resources and technology. By doing so, they can demonstrate effective compliance programs, uncover hidden financial irregularities, and improve overall efficiency.

Three key takeaways:

1. This also means that data analytics in the compliance function has moved from cutting edge to best practice. It soon may simply mean table stakes for compliance.

2. The DOJ is seeking to incentivize an acquiring company to timely disclose misconduct uncovered during the M&A process.

3. The DOJ has made it clear that under this new Mergers & Acquisitions Safe Harbor Policy, organizations that do not perform effective due diligence or self-disclose misconduct at an acquired entity will be subject to full successor liability.

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31 Days to More Effective Compliance Programs

31 Days to a More Effective Compliance Program: Day 3 – 2023 Evaluation of Compliance Programs: Messaging Apps, Internal Controls and Adequate Compensation

Messaging Apps

There was a significant addition to the language around messaging apps. The ECCP opened this section by noting, “Messaging applications have become ubiquitous in many markets and offer important platforms for companies to achieve growth and facilitate communication.” For any company under investigation or in a FCPA enforcement action, the DOJ will evaluate its “policies and mechanisms for identifying, reporting, investigating, and remediating potential misconduct and violations of law governing the use of personal devices, communications platforms, and messaging applications, including ephemeral messaging applications.”

Internal Compliance Controls

Under Section II, entitled Is the Corporation’s Compliance Program Adequately Resourced and Empowered to Function Effectively?  We find the new language, “In this regard, prosecutors should evaluate a corporation’s method for assessing and addressing applicable risks and designing appropriate controls to manage these risks.” This simple sentence packs quite a punch as it requires both appropriate internal compliance controls and then monitoring of those controls to see if they are managing the risks identified in the risk assessment.

Adequate Compensation and Salary/Bonus Review for Compliance

Under Section III, there is a significant new addition to the ECCP. It forces a company to adequately compensate those employees who investigate and pass judgment on misconduct. But it is more than simply adequate compensation, as it also requires a company not to retaliate via low salaries, limited raises, or other compensation for doing their jobs as compliance officers. In other words, if the CEO is being investigated by compliance, that same CEO should not be setting or reviewing the salary of the CCO or those doing the investigation. This mandates that the DOJ review the entire corporate organization on these issues.

Three key takeaways:

1. Communications compliance will be a key issue for compliance professionals going forward in 2024.

2. You must have both appropriate internal controls and ensure they are functioning.

3. In addition to adequate resources, a compliance function must be shown to adequately pay, promote, and protect those involved in compliance investigations.

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Daily Compliance News

Daily Compliance News: January 3, 2024 The Ungovernable Edition

Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen to the Daily Compliance News. All from the Compliance Podcast Network. Each day we consider four stories from the business world: compliance, ethics, risk management, leadership, or general interest for the compliance professional.

In today’s edition of Daily Compliance News:

  • More trouble ahead on the return-to-work front? (WaPo)
  • Senator Menendez draws more charges. (CNN)
  • Political protests are a compliance risk. (WSJ)
  • Can the Big 4 ever govern themselves? (FT)
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Compliance Into the Weeds

Compliance Into The Weeds: Key Compliance Issues for 2024

The award-winning Compliance into the Weeds is the only weekly podcast that takes a deep dive into a compliance-related topic, literally going into the weeds to more fully explore a subject. Looking for some hard-hitting insights on sanctions compliance? Look no further than Compliance into the Weeds! In this episode, Tom and Matt take a deep dive into issues Matt has on his radar for compliance professionals in 2024.

Matt Kelly is well known for zigging when everyone else is zagging. At the start of each year, he publishes a column that looks at key issues for compliance professionals in the year ahead. This podcast takes a deep dive into these issues. The rapidly evolving landscape of AI, cybersecurity, and governance is increasingly shaped by regulatory and compliance trends. In this context, industry experts Tom Fox and Matt Kelly offer insightful perspectives. We consider governmental oversight of AI, with more specific AI regulations in 2024, while also highlighting the potential of AI integration into compliance products and platforms. We also look at issues with the SEC, PCAOB, and DOJ.  Join Tom Fox and Matt Kelly as they delve deeper into these topics in this episode of the award-winning Compliance into the Weeds.

Key Highlights:

  • FEPA and its enforcement
  • NOCLAR and the PCAOB
  • SEC v. Solar Winds and its CISO
  • AI-Regulation and Business Use
  • SEC right to disgorgement 

Resources:

Matt Kelly on LinkedIn

Matt on Radical Compliance

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31 Days to More Effective Compliance Programs

31 Days to a More Effective Compliance Program: Day 1 – What 2023 Brought to Compliance

2023 was a very significant year for every compliance practitioner and compliance program. While there was a paucity of corporate enforcement actions under the Foreign Corrupt Practices Act (FCPA), there were significant announcements from the Department of Justice (DOJ) that directly impacted compliance professionals and compliance programs.

The first came in January, and it was an update to the Evaluation of Corporate Compliance Programs (2023 ECCP). Next, we heard speeches about the increased focus on clawbacks and other areas of consequence management. In October, Deputy Attorney General (DAG) Lisa Monaco introduced a new Mergers & Acquisitions Safe Harbor Policy in October. Finally, in late November, Acting Principal Deputy Assistant Attorney General Nicole M. Argentieri Delivered remarks at the 39th International Conference on the Foreign Corrupt Practices Act (FCPA) on the use of data analytics in a compliance program and DOJ expectations going forward.

The 2023 ECCP brought forward several new initiatives laid out in the 2020 Update to the Evaluation of Corporate Compliance Programs, including additions and deletions.

In October 2023, Deputy Attorney General Lisa Monaco announced a new policy regarding M&A. It is a Mergers & Acquisitions Safe Harbor policy that encourages companies to self-disclose criminal misconduct discovered by an acquiring company during the acquisition of a target company.

In November, Nicole Argentieri, Acting Assistant Attorney General for the Criminal Division, speaking at the ACI National FCPA, reported that the DOJ is stepping up its own use of data analytics to identify instances of corporate misconduct and will boost its cooperation with overseas law enforcement to bring more anti-corruption cases as well. The DOJ and SEC are increasingly focusing on data analytics for corporate compliance, signaling higher expectations for larger companies. Both agencies have successfully utilized data analytics in various areas, such as securities and healthcare fraud, and are actively improving their own capabilities in this field. She made several important points for all compliance professionals, which will be significant going forward into 2024 and beyond.

Three key takeaways:

1. 2023 was a key year for the DOJ’s evolution in its views on compliance programs.

2. Clawbacks, incentives, and consequence management have become more important.

3. The new DOJ safe harbor initiative for M&A raises many questions.

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31 Days to More Effective Compliance Programs

One Month to a More Effective Compliance Program: Day 18-Strategic Considerations for Implementing AI in Compliance

What are the key factors that impact these strategic considerations for implementing AI in compliance, exploring the tradeoffs, challenges, and importance of considering the impact on decision-making.

Key Considerations

1.     Understand the impact of AI on the company.

2.     Maintain an inventory of all tools used.

3.     Understand the tools for cost efficiency and risk avoidance.

4.     Involve all business sectors in AI discussions.

5.     Utilize AI for better data usage in compliance.

While implementing AI in compliance brings numerous benefits, there are tradeoffs and challenges to consider. One tradeoff is the need to balance exploration and innovation with rules and regulations. Another challenge is the selection of AI tools.

Implementing AI in compliance requires strategic considerations and decision-making. Understanding the impact of AI, maintaining an inventory of tools, considering cost efficiency and risk avoidance, involving all business sectors, and utilizing AI for better data usage are key factors to consider. Balancing exploration and rules, as well as selecting the right AI tools, are challenges that need to be addressed. By carefully navigating these considerations and challenges, companies can leverage AI to enhance their compliance programs and stay ahead in an ever-evolving regulatory landscape.

Three key takeaways:

1. What are the key factors that impact these strategic considerations for implementing AI in compliance?

2. Compliance professionals need to stay updated with the latest AI developments and trends, which requires continuous learning and keeping abreast of industry news and insights.

3. Understanding the impact of AI, maintaining an inventory of tools, considering cost efficiency and risk avoidance, involving all business sectors, and utilizing AI for better data usage are key factors to consider.

For More information on KonaAI, click here.

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31 Days to More Effective Compliance Programs

One Month to a More Effective Compliance Program: Day 17-Adapting Compliance Programs for Cloud Technologies

As organizations transition to remote work and embrace cloud technologies, it is crucial to adapt compliance programs to ensure regulatory obligations are met.

Companies are shifting away from traditional tools like Excel or SharePoint towards centralized systems that facilitate compliance monitoring. Compliance teams can no longer rely on face-to-face collaboration and need systems to manage communication, investigations, and case management. This shift towards virtual platforms for communication has also increased the need to capture and record voice data for compliance purposes.

Adapting compliance programs for remote work and cloud technologies is essential in the current business landscape. Compliance program visibility, capturing and recording communication data, leveraging cloud technologies, and embracing AI-driven compliance monitoring are key factors to consider. By balancing these factors and focusing on risk-based approaches, organizations can ensure they meet their regulatory obligations while enabling their compliance teams to focus on their core responsibilities. The future holds even more advancements in cloud technologies and AI, promising increased defensibility and improved compliance monitoring capabilities.

 Three key takeaways:

1. Companies are shifting away from traditional tools like Excel or SharePoint towards centralized systems that facilitate compliance monitoring.

2. You must focus on the explainability  and defensibility of your AI models.

3. By focusing on risk-based approaches, organizations can ensure they meet their regulatory obligations while enabling their compliance teams to focus on their core responsibilities.

For more information on KonaAI, click here.

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31 Days to More Effective Compliance Programs

One Month to a More Effective Compliance Program Through Data Analytics – Day 15: Data Analytics – Fuel that Powers Both Law and Compliance

Data analytics is revolutionizing the field of law and compliance, providing valuable insights and enhancing effectiveness. Data analytics is often referred to as the fuel that moves the compliance engine. It provides the necessary insights to make informed decisions and drive compliance programs effectively. By analyzing data, compliance professionals can gain a deeper understanding of their organization, such as the number of employees per region, which can inform communication strategies and training initiatives. Simply put, to become a better compliance professional, you must become a better businessperson.  This underscores the importance of understanding the business context and using data analytics as a tool to drive compliance efforts.

Data analytics is of utmost importance in the field of law and compliance. It provides valuable insights, enhances effectiveness, and drives compliance programs. Compliance professionals must strive to become better businesspeople and understand the role of data analytics as the fuel that moves the compliance engine. By leveraging data analytics, law firms like Thinkeen can offer innovative solutions for complex transactions. However, education and awareness about the importance of data analytics are still needed to fully harness its potential. Balancing tradeoffs and addressing challenges associated with data analytics are crucial for successful implementation. Ultimately, data analytics is a powerful tool that can transform the way laws and compliance are approached, leading to more effective and efficient outcomes.

Three key takeaways:

1. Data analytics is often referred to as the fuel that moves the compliance engine.

2. We need more education and awareness about the importance of understanding data so that you can extract the right information

3. Data analytics is a powerful tool that can transform the way laws and compliance are approached, leading to more effective and efficient outcomes.

For more information on KonaAI, click here.