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Great Women in Compliance

Great Women in Compliance: GWIC Roundtable on Putting AI to Use in Compliance

🎙 📣 🎙 It’s #GWIC Roundtable Wednesday, and Lisa Fine & Ellen Hunt are talking with two experts, Diana Kelley and Gwen Hassan, about putting AI to Use for Ethics & Compliance Teams.

Tune in to learn about:

  • How Ethics & Compliance Teams streamline their workload and amplify their impact with AI solutions
  • What frameworks and safeguards should you utilize to protect against hallucinations and unintended consequences?
  • What disclosures or opt-out features should you consider to alert users that the interactions are AI-based?
  • The state of current and future AI regulation

Listen now at Corporate Compliance Insights at https://lnkd.in/d9VGcfw or wherever you hear podcasts.

If you are using AI in your Ethics & Compliance function in a way we didn’t mention, please tell us in the comments.

#GWIC is proud to announce that it has been nominated for the #WomenInPodcastAwards. This is a people’s choice award, and whether you vote for #GWIC or other nominees, we ask that you send the elevator back down by voting. Voting opens August 1, 2024, and details can be found on the #GWIC LinkedIn page at http://www.linkedin.com/groups/12156164

#EthicalLeadership #AI #Ethics #Compliance #WomenLeaders #WomenPodcasts

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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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31 Days to More Effective Compliance Programs

31 Days to a More Effective Compliance Program: Day 29 – Strategic Considerations for Implementing AI in Compliance

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 Ethico and a free White Paper on top compliance issues in 2024, click here.

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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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Blog

AI and Emerging Technologies Enhancing Regulatory Intelligence and Compliance

Regulatory intelligence plays a crucial role in today’s business landscape, where regulatory requirements are constantly evolving. Staying ahead of these changes is not only essential for compliance but also offers a competitive advantage. I recently had the opportunity to visit with Caroline Shliefer, founder and CEO of RegAsk, on the topic of AI and emerging technologies enhancing regulatory intelligence and compliance. RegAsk has a tagline that states, “Empowering Smarter Regulatory Decisions Curated Regulatory Intelligence Augmented by AI.” It is certainly that and much more.
Caroline Shliefer is a seasoned professional with a rich background in healthcare, law, and regulatory affairs, boasting a PharmD PhD and a health law degree. Her perspective on emerging technologies enhancing regulatory intelligence and compliance is shaped by her extensive experience in the EU, US, and Asia and her role as the founder of RegAsk, which leverages technology to address compliance challenges. She believes that technologies such as AI, machine learning, blockchain, and data analytics are revolutionizing regulatory monitoring, enabling faster and more accurate interpretation of regulatory information, and fostering a more proactive approach to compliance. Her goal with RegAsk is to digitize and streamline the regulatory intelligence process, reducing the risk of non-compliance and fostering innovation.
Regulatory intelligence involves the systematic collection, analysis, and dissemination of information about regulatory requirements, policies, and guidelines that impact product development, manufacturing, and distribution. Traditionally, this process has been manual and challenging, requiring businesses to collect information from various sources and analyze it accurately. However, emerging technologies such as artificial intelligence (AI), machine learning, blockchain, and advanced data analytics are revolutionizing regulatory monitoring and compliance.
AI and machine learning are transforming regulatory monitoring by enabling swift and accurate interpretation and analysis of regulatory information. These technologies can track regulations across different jurisdictions and provide predictive analytics, reducing manual workload and mitigating human errors. By leveraging AI, businesses can anticipate regulatory changes and define various scenarios, allowing them to be prepared and gain a competitive advantage. As Caroline Shliefer, the guest on the podcast, highlighted, being proactive and understanding the small signals that can lead to new regulations is crucial for success.
Blockchain technology ensures secure record-keeping and smooth audits. It brings a level of security and transparency, helping businesses keep records securely and conduct audits more efficiently. This technology is particularly relevant in industries where traceability and accountability are essential, such as supply chain management.
Advanced data analytics allows for anomaly detection and informed decision-making. By analyzing compliance data, businesses can gain deeper insights and intelligence, enabling them to detect anomalies and make strategic decisions faster. These insights help companies understand the impact of regulatory changes on their operations and take proactive actions to ensure compliance.
The integration and automation of these emerging technologies synchronize and streamline the compliance process, resulting in fewer errors and efficient adaptation to new regulatory changes. Compliance managers and decision-makers are empowered and augmented by these technologies, allowing them to focus on strategic aspects while routine and tedious tasks are handled by technology.
Regulatory intelligence is not limited to a single business area. It extends to various sectors, including life sciences and consumer goods. Within consumer goods, regulations related to environmental sustainability and packaging are particularly important. Monitoring and complying with these regulations is crucial for businesses operating in these sectors.
Looking ahead, the future of automated regulatory intelligence is promising. The integration of AI and machine learning will continue to enhance regulatory tracking, enabling businesses to autonomously monitor, analyze, and report compliance requirements across various jurisdictions. Predictive analytics will allow companies to forecast future regulatory shifts and trends, enabling proactive strategy adjustments. This proactive approach ensures consistent compliance and helps businesses stay ahead in the ever-evolving regulatory landscape.
Regulatory intelligence providers, like RegAsk, are true market differentiators. They not only catalog regulatory changes but also anticipate them. By leveraging emerging technologies, they can advise clients on potential regulatory changes before they occur, allowing businesses to be prepared and ready to adapt. This proactive approach to regulatory intelligence and compliance is a game-changer, offering businesses a competitive edge.
In conclusion, emerging technologies are enhancing regulatory intelligence and compliance by revolutionizing the way businesses monitor and interpret regulatory information. AI, machine learning, blockchain, and advanced data analytics empower compliance managers and decision-makers, enabling them to stay ahead of regulatory changes and make informed decisions. By embracing these technologies, businesses can foster a proactive and resilient approach to regulatory compliance, ensuring compliance and gaining a competitive advantage in the market.

Resources

Caroline Shliefer on LinkedIn

RegAsk