Tag: compliance

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Compliance Tip of the Day

Compliance Tip of the Day: AI Governance Framework

Welcome to “Compliance Tip of the Day,” the podcast where we bring you daily insights and practical advice on navigating the ever-evolving landscape of compliance and regulatory requirements.

Whether you’re a seasoned compliance professional or just starting your journey, our aim is to provide you with bite-sized, actionable tips to help you stay on top of your compliance game.

Join us as we explore the latest industry trends, share best practices, and demystify complex compliance issues to keep your organization on the right side of the law.

Tune in daily for your dose of compliance wisdom, and let’s make compliance a little less daunting, one tip at a time.

In today’s episode, we begin a weeklong look at some of the ways generative AI is changing compliance and risk management. Today, we consider how to approach a comprehensive AI governance framework.

For more information on the Ethico ROI Calculator and a free White Paper on the ROI of Compliance, click here.

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Blog

AI in Compliance Week: Part 2 – A Comprehensive Governance Approach

We continue our weeklong exploration of issues related to using Generative AI in compliance by examining some AI governance issues. In the rapidly evolving landscape of AI, the importance of robust governance frameworks cannot be overstated. The need for comprehensive governance structures to ensure compliance, ethical alignment, and trustworthiness has become paramount as AI systems become increasingly integrated into compliance. Today, we will consider the critical areas of compliance governance and ethics governance and present a holistic approach to mitigating the risks associated with these issues.

MIA AI Governance: The Problems

Missing compliance governance can have far-reaching consequences, undermining the integrity of an entire AI-driven initiative. Businesses must ensure alignment with enterprise-wide governance, compliance, and control (GRC) frameworks. This includes aligning with model risk management practices and embedding robust compliance checks throughout the AI model lifecycle. By promoting awareness of how the AI model works at your organization, you can minimize information asymmetries between development teams, users, and target audiences, fostering a culture of transparency and accountability.

The lack of ethical governance can lead to misalignment with an organization’s values, brand identity, or social responsibility. The answer is that companies should develop comprehensive AI ethics governance methods, including defining ethical principles, establishing an AI ethics review board, and creating a compliance program that addresses ethical concerns. Adopting frameworks like Ethically Aligned AI Design (EAAID) can help integrate ethical considerations into the design process while incorporating AI governance benchmarks beyond traditional measurements to encompass social and moral accountability.

Another outcome of the lack of trustworthy or responsible AI governance can result in unintentional and significant damage. To address this, compliance professionals should help develop accountable and trustworthy AI governance methods that augment enterprise-wide GRC structures. This can include establishing a committee such as an AI Advancement Council or similar structure in your company to oversee mission priorities and strategic AI advancement planning, collaborating with service line leaders and program offices to align with ethical AI guidelines and practices, and developing compliance programs to guide conformance with ethical AI principles and relevant legislation. Finally, implementing AI-independent verification and validation processes can help identify and manage unintentional outcomes.

The Solution

By addressing the critical areas of compliance governance and ethics governance through a more holistic approach, businesses can create a comprehensive framework that mitigates the risks associated with the absence of these crucial elements. This approach ensures that AI systems comply with relevant regulations and standards and align with your company’s values, ethical principles, and the pursuit of trustworthy and responsible AI. As the AI landscape evolves, this comprehensive governance framework will be essential in navigating the complexities and safeguarding the integrity of AI-driven initiatives.

Here are some key steps compliance professionals and businesses can think through to facilitate AI governance in your company:

  1. Establish a Centralized AI Governance Body:
    • Create an AI Governance Council that oversees your organization’s AI strategy, policies, and practices.
    • Ensure the council includes representatives from various stakeholder groups, such as legal, compliance, ethics, risk management, IT, and other subject matter experts.
    • Empower the council to develop and enforce AI governance frameworks, guidelines, and processes.
  2. Conduct AI Risk Assessments:
    • Identify and assess the risks associated with the organization’s AI initiatives, including compliance, ethical, and other compliance-related risks.
    • Prioritize the risks based on their potential impact and likelihood of occurrence.
    • Develop mitigation strategies and action plans to address the identified risks.
  3. Align AI Governance with Enterprise-wide Frameworks:
    • Ensure the AI governance framework is integrated with the organization’s existing GRC and Risk Management processes.
    • Establish clear lines of accountability and responsibility for AI-related activities across the organization.
    • Integrate AI governance into the organization’s broader risk management and compliance programs.
  4. Implement Compliance Governance Processes:
    • Develop and enforce AI-specific compliance controls, policies, and procedures.
    • Embed compliance checks throughout the AI model lifecycle, from development to deployment and monitoring.
    • Provide training and awareness programs to educate employees on AI compliance requirements.
  5. Establish Ethics Governance Mechanisms:
    • Define the organization’s AI ethics principles, values, and code of conduct.
    • Create an AI Ethics Review Board to assess and monitor the ethical implications of AI initiatives.
    • Implement processes for ethical AI design, such as the Ethically Aligned AI Design methodology.
    • Incorporate ethical AI benchmarks and accountability measures into the organization’s performance management and reporting processes.
  6. Implement Reliance-Related Governance:
    • Develop responsible and trustworthy AI governance practices that align with the organization’s enterprise-wide GRC frameworks.
    • Establish an AI Advancement Council to oversee strategic AI planning and alignment with ethical guidelines.
    • Implement AI-independent verification and validation processes to identify and manage unintended outcomes.
    • Provide comprehensive training and awareness programs on AI risk management for employees, contractors, and other stakeholders.
  7. Foster a Culture of AI Governance:
    • Promote a culture of accountability, transparency, and continuous improvement around AI governance.
    • Encourage cross-functional collaboration and communication to address AI-related challenges and opportunities.
    • Review and update the AI governance framework regularly to adapt to evolving regulatory requirements, technological advancements, and organizational needs.

By following these steps, organizations can implement a comprehensive governance framework that addresses compliance, ethics, and reliance-related governance. This framework enables organizations to harness the power of AI while mitigating the associated risks. 

AI Governance Resources

There are several notable resources the compliance professional can tap into around this issue of AI governance practices. The Partnership on AI Partnership on AI is a multi-stakeholder coalition of leading technology companies, academic institutions, and nonprofit organizations. It has been at the forefront of developing best practices and guidelines for the responsible development and deployment of AI systems. It has published influential reports and frameworks, such as the Tenets of Responsible AI and the Model Cards for Model Reporting, which have been widely adopted across the industry.

The Algorithmic Justice League (ALJ) is a nonprofit organization dedicated to raising awareness about AI’s social implications and advocating algorithmic justice. It has developed initiatives such as the Algorithmic Bias Bounty Program, encouraging researchers and developers to identify and report biases in AI systems. The AJL has highlighted the importance of addressing algorithmic bias and discrimination in AI.

IEEE Global Initiative on Ethics of Autonomous and Intelligent Systems is a multidisciplinary effort to develop standards, guidelines, and best practices for the ethical design, development, and deployment of autonomous and intelligent systems. It has produced key documents and reports, such as the Ethically Aligned Design framework, which guides the incorporation of ethical considerations into AI development.

The AI Ethics & Governance Roundtable is an initiative led by the University of Cambridge’s Leverhulme Centre for the Future of Intelligence. It brings together industry, academia, and policymaking experts to discuss emerging issues, share best practices, and develop collaborative solutions for AI governance. The roundtable’s insights and recommendations have influenced AI governance frameworks and policies at the organizational and regulatory levels.

These examples demonstrate the power of industry collaboration in advancing AI governance practices. By pooling resources, expertise, and diverse perspectives, these initiatives have developed comprehensive frameworks, guidelines, and standards being adopted across the AI ecosystem. Compliance professionals should avail themselves of these resources to prepare your company to take the next brave steps in the intersection of compliance, governance, and AI.

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Trekking Through Compliance

Trekking Through Compliance: Episode 9 – Compliance Lessons from Dagger of the Mind

In this episode of Trekking Through Compliance, we consider the episode Dagger of the Mind, which aired on November 3, 1966, with a Star Date of 2715.1.

The Enterprise makes a supply run to planet Tantalus V, a colony where the criminally insane are confined for treatment. The facility’s director is Dr. Tristan Adams, a psychiatrist famous for advocating more humane treatment of such patients. After the Enterprise delivers supplies and receives cargo from Tantalus, a man emerges from the container taken aboard and assaults a technician. Reaching the bridge, the intruder demands asylum, but Spock subdues him with a Vulcan nerve pinch. In Sickbay, the intruder identifies himself as Simon van Gelder, and a computer check reveals that he is not a patient but Dr. Adams’ assistant.

Gelder becomes increasingly frantic on the Enterprise van, warning that the landing party is in danger. Spock learns that the neural neutralizer can empty a mind of thoughts, leaving only an unbearable feeling of loneliness, and that Adams has been using it on inmates and staff to regain control of their minds.

Kirk tests the neutralizer on himself, with Noel as the control. Adams appears, overpowers Noel, seizes the controls, increases the neutralizer’s intensity, and convinces Kirk that he has been madly in love with Noel for years. Adams inadvertently reactivates the neural neutralizer, emptying his Mind and killing him. On the Enterprise, Kirk is informed that van Gelder has destroyed the neural neutralizer. McCoy is surprised that loneliness could be lethal, but Kirk, after his experience, is not.

Commentary

Key compliance lessons from the episode include the importance of human rights and ethical treatment, whistleblower protection, oversight and accountability, due process and fair trials, data privacy, informed consent, and corporate social responsibility. The episode also highlights mental health issues and the first appearance of the Vulcan mind meld in Star Trek.

Key Highlights

  • Plot Summary of Dagger of the Mind
  • Behind the Scenes and Fun Facts
  • Compliance and Ethical Lessons from Dagger of the Mind

Resources

Excruciatingly Detailed Plot Summary by Eric W. Weisstein

MissionLogPodcast.com

Memory Alpha

 

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Compliance Tip of the Day

Compliance Tip of the Day: How AI is Transforming Risk Management

Welcome to “Compliance Tip of the Day,” the podcast where we bring you daily insights and practical advice on navigating the ever-evolving landscape of compliance and regulatory requirements.

Whether you’re a seasoned compliance professional or just starting your journey, our aim is to provide you with bite-sized, actionable tips to help you stay on top of your compliance game.

Join us as we explore the latest industry trends, share best practices, and demystify complex compliance issues to keep your organization on the right side of the law.

Tune in daily for your dose of compliance wisdom, and let’s make compliance a little less daunting, one tip at a time.

In today’s episode, we begin a week-long look at some of the ways Generative AI is changing compliance and Risk Management.

For more information on the Ethico ROI Calculator and a free White Paper on the ROI of Compliance, click here.

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FCPA Compliance Report

FCPA Compliance Report: Evie Wentink on Making Compliance Training Practical

Welcome to the award-winning FCPA Compliance Report, the longest running podcast in compliance.

In this edition of the FCPA Compliance Report,  Tom Fox has a fascinating visit with Iveta (Evie) Wentink, a 15-year compliance veteran. Evie has worked in the public and private sectors and has expertise in compliance training, hotlines, government contract compliance, data privacy, reporting, & due diligence.

Evie has one of the most unique opening lines for hotline training, which is ‘Do You Know Your Hotline Number?” This simple yet incredibly important question encapsulates Evie’s approach to compliance training: make it simple, direct, and practical for the listeners. (Or, as Carsten Tams would say, ‘It’s all about the UX’).

Our conversation focuses on the critical role of hotline numbers in corporate compliance programs, emphasizing the need for employees to know and trust the hotline. Evie shares insights from her career, highlights the significance of marketing compliance hotlines effectively, and discusses the broader culture of compliance and non-retaliation in organizations. She shares practical tips for improving hotline awareness and usage, making this episode a valuable resource for compliance professionals and organizations alike.

Highlights in this Episode:

  • Enhancing Trust through Active Compliance Reporting
  • Promoting Reporting Culture Through Creative Marketing
  • Ethical Culture: Encouraging Compliance Reporting Safely
  • Enhancing Compliance Programs Through Anonymous Hotlines

Resources:

Evie Wentink on LinkedIn

Evie’s Top 10 Compliance Back to Basics

Tom Fox

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YouTube

Twitter

LinkedIn

 

For more information on the Ethico ROI Calculator and a free White Paper on the ROI of Compliance, click here.

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Blog

AI in Compliance Week: Part 1 – Transforming Risk Management

Compliance professionals face increasing pressures to adapt and innovate in today’s rapidly evolving landscape. On a recent episode of Innovation in Compliance, I visited with Matt Lowe, the Chief Strategy Officer at MasterControl. We discussed how AI is revolutionizing quality management in the life sciences industry. With a background in engineering and extensive experience at MasterControl, Matt offered a unique perspective on integrating AI into compliance processes. We deeply explored how AI is poised to transform the compliance field.

Generative AI is being utilized to create comprehension-based testing automatically. This innovation significantly reduces the time required for compliance-focused training, transforming a process that once took hours into a task completed in minutes. This approach resonates with the broader compliance community, where efficiency and accuracy are paramount. By automating the generation of training materials, AI can help ensure that employees are adequately trained on your internal policies and procedures, helping your organization maintain compliance with regulatory standards.

Perhaps one of AI’s most exciting promises is the shift from reactive to predictive and preventative compliance. Traditionally, risk management has focused on identifying and correcting issues after they occur. However, AI offers the potential to predict and prevent problems before they arise. By analyzing vast amounts of data, AI can identify patterns and anomalies, allowing organizations to address potential issues proactively.

This predictive capability is precious in the life sciences industry, where the stakes are high. Ensuring the highest quality products can directly impact patient safety and regulatory compliance. Leveraging AI to predict and prevent quality issues represents a transformative shift in managing compliance.

When implementing AI in compliance, you should take a risk-based approach. This involves starting with low-risk AI applications to gain confidence in the technology before moving on to more critical areas. For instance, generating training exams is a low-risk application that can still deliver significant benefits. As organizations become more comfortable with AI, they can explore its use in more complex and higher-risk areas.

This cautious approach aligns with the principles of compliance, where assessing and managing risk is a fundamental aspect of the profession. By gradually incorporating AI, organizations can mitigate potential risks while harnessing the technology’s power to enhance compliance processes.

While AI offers tremendous potential, we both stressed the importance of the “Human in the Loop” approach. AI can provide valuable insights and automate processes, but human oversight remains crucial. This is particularly important in life sciences, where the consequences of errors can be severe. Ensuring that humans review and validate AI-generated outputs helps maintain the accuracy and reliability of compliance efforts. This “Human in the Loop” reflects a balanced approach to AI integration. By combining the strengths of AI with human expertise, organizations can achieve a more robust and effective compliance framework.

Lowe shared his vision for the future of AI in compliance. He envisions a world where AI becomes integral to software applications, transforming how professionals interact with technology. Instead of navigating complex interfaces, users will engage with AI-driven chatbots that provide instant answers and guidance. This shift will enable compliance professionals to access the information they need more efficiently and effectively. AI has the potential to identify gaps in compliance frameworks and suggest appropriate controls. This capability can significantly enhance the effectiveness of compliance programs by ensuring that organizations are always prepared for audits and regulatory scrutiny.

As AI continues to evolve, collaboration within the industry will be essential. Lowe mentioned initiatives like the Convention for Healthcare AI, where industry players and regulators discuss the ethical implications and best practices for AI use. Such collaborations are vital to ensure that AI is leveraged responsibly and ethically, particularly in industries like life sciences, where the impact on human health is significant.

AI has transformative potential for compliance. By automating routine tasks, shifting from reactive to predictive compliance, and adopting a risk-based approach, AI can significantly enhance the efficiency and effectiveness of compliance programs. However, the human element remains crucial to ensure accuracy and reliability. As the industry continues to explore and embrace AI, collaboration and ethical considerations will play a vital role in shaping the future of compliance. By harnessing the power of AI, organizations can stay ahead of regulatory requirements, improve product quality, and ultimately protect patient safety. The journey towards AI-driven compliance is just beginning, and the possibilities are exciting and profound.

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Trekking Through Compliance

Trekking Through Compliance: Episode 8 – Risk Management Lessons from Miri

In this episode of Trekking Through Compliance, we consider the episode Miri, which aired on October 27, 1966, with a Star Date of 2713.5.

Episode Summary

A disfigured man attacks a landing party who dies after Kirk strikes him. They discover a preadolescent, Miri, who ran away from them because “grups” kill and maim children before dying. She and her friends are “onlies,” the only ones left. The distress call is traced to an automated signal. The landing party, except for Spock, notices purple lesions on their bodies; Miri tells them that these are the first signs of the disease, and they will soon become like the other adults. When the disease begins, its victims have seven days to live. Although Spock is immune, he considers himself a carrier who could infect the Enterprise if he returns.

Back on the Enterprise, after vaccinating everyone and leaving the children in the care of a medical team, Kirk sends for teachers and advisers to help the children improve their lives.

Commentary

In this episode of Trekking Through Compliance, host Tom Fox explores the Star Trek original series episode ‘Miri.’ Responding to a distress signal, the Enterprise crew discovers a planet that is a duplicate of Earth, inhabited only by children due to a disease that kills anyone who has reached puberty. The episode delves into themes of disaster preparedness, environmental and public health compliance, data governance, supply chain management, and employee welfare. The episode offers crucial compliance and risk management lessons relevant to modern organizations through these themes.

Key Highlights

  • Plot Summary of ‘Miri’
  • Behind the Scenes and Fun Facts
  • Risk Management Lessons from ‘Miri’

Resources

Excruciatingly Detailed Plot Summary by Eric W. Weisstein

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Trekking Through Compliance

Trekking Through Compliance – Episode 7 – Compliance Lessons from What are Little Girls Made of?

In this episode of Trekking Through Compliance, we consider the episode What Are Little Girls Made of?, which aired on October 20, 1966, Star Date 2712.4.

Episode Summary

After the Enterprise travels to the planet Exo III to investigate Roger Corby’s fate, two security guards, Matthews and Rayburn, are killed after beaming down. It turns out that Corby, known as the Pasteur of archeological medicine, has discovered the remains of an ancient culture. They were using machinery he had found, which creates androids.

Corby begins implementing his plan by creating an android of Kirk to be taken to Minas 5, where he will start spreading androids throughout the galaxy. However, Corby kills his robot servant, Rok, who has remembered the equation “existence, survival must cancel out programming.” This equation made Rok realize that the clash between humans and androids that led to his civilization’s demise centuries ago was becoming inevitable again and caused him to attempt to kill Corby. Corby then reveals he is an android. Corby destroys the remaining android and himself, ridding the universe of Exo III androids for all times.

Commentary

In this episode of Trekking Through Compliance, Tom Fox delves into the Star Trek episode ‘What Are Little Girls Made Of?’ to uncover its relevance for compliance professionals. The storyline involves the Enterprise crew investigating Dr. Roger Corby, who has created androids capable of impersonating humans. This raises critical issues around transparency, data privacy, ethical considerations, risk assessment, and regulatory compliance. Fox connects these sci-fi narratives to real-world compliance challenges with insights from the episode and additional fun facts.

Highlights

  • Plot Summary: What Are Little Girls Made Of?
  • Fun Facts and Behind the Scenes
  • Exploring Compliance Lessons

Resources

Excruciatingly Detailed Plot Summary by Eric W. Weisstein

MissionLogPodcast.com

Memory Alpha

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Trekking Through Compliance

Trekking Through Compliance – Episode 5 – Compliance Lessons from The Enemy Within

In this episode of Trekking Through Compliance, we consider The Enemy Within, which aired on October 6, 1966, Star Date 1672.1.

While gathering specimens on planet Alpha 177 (whose night temperature reaches -120 degrees), the transporter malfunctions, stranding the remaining 4-man landing party (including Sulu) on the planet; Kirk beams up. Kirk is split into two alter-egos, the evil one (hostility, lust, violence), which arrives unnoticed a few minutes after the good Kirk (compassion, love, tenderness) after the crew has left the transporter room.

The evil Kirk enters Yeoman Janice Rand’s quarters and lies in wait for her. She scratches him when he attacks her. She fights him off, and soon after that, the good Kirk shows signs of losing both his decisiveness and ability to command. This leads to a gut-wrenching scene where Spock and McCoy interview Rand about the attack.

Spock and Scotty rig the transporter to run off the impulse engines and successfully fix the transporter. He is overpowered when the good Kirk tries to bring the evil Kirk to the transporter. The evil Kirk goes to the bridge and orders the Enterprise to leave orbit, but the good Kirk follows him there. Kirk eventually returns to normal when the transporter is modified and used to fuse his two parts. The landing party is also beamed back up, suffering from frostbite, but nothing worse.

Commentary

This episode explores the duality of Captain Kirk’s personality after a transporter malfunction splits him into two alter egos. The podcast discusses the episode’s themes and their relevance to modern compliance lessons, such as the duality of human nature, the importance of a unified identity, effective leadership in crisis, monitoring and internal controls, addressing ethical dilemmas, and fostering psychological safety. It also touches upon the cultural changes highlighted by the Me Too movement compared to the 1960s portrayal of gender issues. The episode strongly encourages viewers to rewatch with a contemporary lens and apply its lessons to real-world compliance challenges, underlining the importance of this application.

Key Highlights

  • Plot Summary: The Enemy Within
  • Me Too Lessons and Ethical Reflections
  • Compliance Lessons from The Enemy Within

Resources

Excruciatingly Detailed Plot Summary by Eric W. Weisstein

MissionLogPodcast.com

Memory Alpha

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Compliance Tip of the Day

Compliance Tip of the Day: Compliance Lessons from The Gunvor FCPA Enforcement Action

Welcome to “Compliance Tip of the Day,” the podcast where we bring you daily insights and practical advice on navigating the ever-evolving landscape of compliance and regulatory requirements.

Whether you’re a seasoned compliance professional or just starting your journey, our aim is to provide you with bite-sized, actionable tips to help you stay on top of your compliance game.

Join us as we explore the latest industry trends, share best practices, and demystify complex compliance issues to keep your organization on the right side of the law.

Tune in daily for your dose of compliance wisdom, and let’s make compliance a little less daunting, one tip at a time.

In today’s episode, we consider Gunvor FCPA’s enforcement action, which  presents numerous lessons learned. Today we unpack the key compliance takeaways.

For more information on the Ethico ROI Calculator and a free White Paper on the ROI of Compliance, click here.