Podcasts about compliance programs

Preflight: Sponsor: This episode is sponsored by The Law Offices of Robert M. Strumor, LLC – you can find them at https://www.strumorlaw.com/ The Law Offices of Robert M. Strumor, LLC, handles various aviation matters, including FAA safety investigations and pilot medical certifications. You can find them on the web at https://www.strumorlaw.com/ Cruise Flight: Talking Points: … Continue reading SMAC341 FAA's Compliance Program The post SMAC341 FAA's Compliance Program appeared first on Stuck Mic AvCast.

What if one missing note in your chart could cost you your license—or even your freedom? That's not a scare tactic—it's exactly what happened to today's guest, Dr. Roy Shelburne. A respected dentist turned federal inmate, Roy learned the hard way that poor documentation and billing practices can destroy even the most well-intentioned practice. Now, he's using his story to help others protect what they've built—and to ensure no one else has to go through what he did. If you're running a dental practice and think documentation is just a formality, think again. This episode is a must-listen. I'm joined by Dr. Roy Shelburne—a dentist, speaker, and compliance expert with a story that'll stop you in your tracks. After being sentenced to federal prison for documentation-related issues, Roy has made it his mission to help other dentists avoid the same fate. In this conversation, Roy opens up about what happened, what he wishes he had known, and the simple (but often overlooked) systems that can protect your practice, your license, and your peace of mind. We also talk about why clear documentation isn't just about legal protection—it's the key to smoother insurance reimbursements, fewer patient disputes, and stronger clinical care. Here are some of the interesting things we talked about in this episode: If it's not in your chart, it didn't happen—legally or clinically. Why blind disregard can be interpreted as intent to defraud. The real reason so many dentists struggle with insurance claims. How to build a 7-step compliance program that protects your entire team. Why moving to ICD-10 may be on the horizon (and how to get ahead of it). How better records actually lead to better patient care. This episode is packed with wisdom every dental professional should hear. Don't wait until it's too late—learn from someone who's lived it. — Key Takeaways 00:42 Introduction and Event Announcement 03:04 Roy Shelburne's Journey: From Prison to Advocacy 10:24 The Importance of Clinical Record Keeping 16:57 Documentation: Key to Efficient Reimbursement 26:02 Implementing a Compliance Program 32:15 Final Thoughts and Lightning Round — Connect with Dr Roy

In this episode of 1st Talk Compliance, Kevin Chmura is joined by Rachel Rose, JD, MBA, as they discuss the False Claims Act in detail. The FCA, one of five federal laws built to combat fraud, waste, and abuse, is the government's primary fraud fighting tool, with the healthcare industry paying the largest contributor in recoveries for over a decade. Learn not only about how to avoid running afoul of this law, but also some details of cases in which it was violated, and the repercussions those who did so faced. In addition, find out how a proper compliance program can protect your practice in various ways, including staying up to date on cybersecurity training. Kevin Chmura Rachel, welcome to the podcast. Thanks for joining us.   Rachel V. Rose Thank you, Kevin, for having me back for another round of a very major healthcare compliance topic.   Kevin Chmura It very much is, yeah. This one generates some revenue for the government. So this is one that I think especially in today's environment, people should be paying a lot of attention to. So as I said in the intro, we're here to talk about the False Claims Act. It's one of the most important fraud, waste and abuse laws that applies to physicians and health care practitioners of all kinds. The healthcare industry has consistently been one of the, if not the highest contributor to funds received under the False Claims Act. And it's essential to be familiar with the law and maintain compliance programs to mitigate that risk. Rachel, I know you spend a fair amount of time in your practice in and around the False Claims Act defending and representing customers and providers. So you're perfect to cover this topic for us. Wondering, though, if you could give us a brief synopsis of the False Claims Act and why is it unique?   Rachel V. Rose Absolutely. So as you mentioned, my practice focuses a lot on the False Claims Act, and I am fortunate to do a lot of compliance work not only around the False Claims Act, but HHS. OIG has identified five important federal fraud, waste and abuse laws. The False Claims Act, the Anti-Kickback Statute, the Stark Law, the Exclusion Authorities, and the Civil Monetary Penalties. And Kevin, as you mentioned, the False Claims Act is really the federal government's primary fraud fighting tool. And in 2024, there were more than $2.9 billion in recoveries and, moreso healthcare represented over two thirds of that amount. That healthcare trend, as you mentioned, being the largest contributor, has gone on for at least the last decade. And what the False Claims Act does that makes it unique are really, I would say, five main things. But first, the False Claims Act goes back to 1863, and it is also known as the Lincoln Law. Its primary purpose, even back during the Civil War, was to root out fraud that was being perpetrated on the government. So how would that be done? Congress thought about it and said, well, the government could do it on its own if they caught wind of something, or they could insert a provision which gave an individual known as a relator, also known as a whistleblower, the potential to bring fraud to the government's attention and receive a portion of the recovery. It's very important to note that a relator and I represented several relators successfully, sometimes with co-counsel, sometimes with not, so I get to see the False Claims Act from the whistleblower standpoint as well. But this notion of being able to represent a whistleblower is the first distinguishing factor. And that's because most other civil cases, a person can represent themselves on a pro say basis, meaning they don't need a lawyer. There was a provision in the False Claims Act which in fact requires an individual to be represented by a lawyer. So unless the relator is a lawyer, then the individual needs to obtain counsel in order to file a False Claims Act case. That's the first thing. Secondly,

Andrew Mahler, Vice President of Privacy and Compliance Services, Clearwater, speaks with Kathleen Healy, Partner, Robinson Cole, and Robert Martin, Senior Legal Counsel, Mass General Brigham, about how health care compliance teams can build effective governance models, monitor legal risks, and prepare for enforcement activity related to artificial intelligence (AI). They discuss how to build an effective AI oversight framework and assess AI systems for bias and transparency, compliance considerations related to the Health Insurance Portability and Accountability Act and the 21st Century Cures Act, what federal agencies are signaling in terms of their AI priorities, and future trends shaping AI compliance in health care. Kate and Robert spoke about this topic at AHLA's 2025 Complexities of AI in Health Care conference in Orlando, FL. Sponsored by Clearwater. AHLA's Health Law Daily Podcast Is Here! AHLA's popular Health Law Daily email newsletter is now a daily podcast, exclusively for AHLA Premium members. Get all your health law news from the major media outlets on this new podcast! To subscribe and add this private podcast feed to your podcast app, go to americanhealthlaw.org/dailypodcast.

The Labor Department is making major cuts to a watchdog office that ensures federal contractors aren't discriminating against their employees. The Office of Federal Contract Compliance Programs laid off about 90% of its staff last week, leaving only about 50 employees nationwide. OFCCP was created in 1965 to protect American workers from race and gender discrimination by federal contractors. Employees who got RIF notices will separate from the agency on June 6.See Privacy Policy at https://art19.com/privacy and California Privacy Notice at https://art19.com/privacy#do-not-sell-my-info.

Are you running a compliance program that's making a real impact—or just checking the boxes? In this episode, Michael Volkov dives into LRN's 2025 Program Effectiveness Report, an annual benchmark that separates the truly impactful compliance programs from those that are merely operational. Based on insights from 1,500 global ethics and compliance professionals, this year's report draws a clear line between high-impact and medium-impact programs—and what it takes to bridge the gap. The conversation highlights urgent risks, cultural disconnects, and the strategic value of automation, data, and leadership alignment in shaping tomorrow's compliance functions.You'll hear him discuss:How high-impact programs are defined by their strategic use of automation, data analytics, and benchmarking tools to drive measurable compliance outcomesWhy third-party risk management—including due diligence and supply chain oversight—is a defining trait of the most effective programs todayThe growing trust gap between Gen Z employees and middle managers, and why this generational shift poses a cultural red flagThe continued dominance of outdated internal systems, regulatory complexity, and budget pressure as top operational challenges facing compliance leadersHow high-impact programs are integrating AI into both their codes of conduct and employee training, preparing teams for emerging tech risksWhat medium-impact programs can do to evolve: focus on training, automation, and peer collaboration to elevate impact and resilienceResourcesMichael Volkov on LinkedIn | TwitterThe Volkov Law Group

One does not simply start a trade compliance program...  In this week's episode of Simply Trade, we're joined by Ellen Smith, CEO and founder of Amalie Trade Compliance Consulting LLC. Ellen shares her personal journey into the world of international trade and offers practical insights on:  ✅ What trade compliance programs are  ✅ Why companies need them  ✅ How to build and maintain a successful compliance strategy Whether you're new to trade or a seasoned professional, this episode is packed with tips that can help you avoid costly mistakes and create systems that actually work. 

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 explore a subject more fully. Are you looking for some hard-hitting insights on compliance? Look no further than Compliance into the Weeds! In this Compliance into the Weeds episode, Tom Fox and Matt Kelly take a deep dive into the critical yet often overlooked aspects of data analytics. They discuss Matt's recent blog post on the ‘Unsexy Keys to Data Analytics,' emphasizing the importance of foundational infrastructure over flashy visualizations. The conversation covers the need for robust data validation, the cooperation between compliance, business units, and IT departments, and the challenges faced by compliance officers in smaller companies. Highlights include real-world examples, the role of data governance, and how to align compliance risk management with corporate objectives amid ever-changing business landscapes. Key highlights: The Importance of Data Infrastructure Compliance vs. Enterprise Data Analytics Collaboration Across Departments Data Governance and Change Management Aligning Compliance with Corporate Risk Management Resources: Matt in Radical Compliance Tom Instagram Facebook YouTube Twitter LinkedIn Compliance into the Weeds was recently honored as one of the Top 25 Regulatory Compliance Podcast. Learn more about your ad choices. Visit megaphone.fm/adchoices

Where does creativity fit into compliance? In more places than you think. Problem-solving, accountability, communication, and connection—they all take creativity. Join Tom Fox and Ronnie Feldman on Creativity and Compliance, part of the award-winning Compliance Podcast Network. Ronnie's company, Learnings and Entertainment, utilizes the entertainment devices people use to consume information in their everyday, non-work lives and apply it to important topics around compliance and ethics. It is not only about being funny. It is about changing the tone of your compliance communications and messaging to make your compliance program, policies, and resources more accessible. In this episode of Creativity and Compliance, Tom Fox and Ronnie Feldman take up the challenge of adding spice to your compliance program and discuss the importance of adding creativity and ‘spice' to corporate compliance programs. They explore how standard compliance elements like policies, training, and communications often fail to engage employees effectively. By integrating playful, positive, and humorous elements, companies can make their compliance programs more digestible and engaging, leading to better adherence and fewer issues. Examples include short videos, infographics, and interactive games to convey important messages. They emphasize the need for regular, engaging content that employees will look forward to, transforming the compliance department into a trusted, supportive resource. Key highlights: The Epiphany: Ingredients for Compliance Adding Spice to Compliance Programs Different Ways to Spice Up Compliance Creative Approaches to Compliance Training Engaging and Fun Compliance Strategies Resources: Ronnie Ronnie Feldman (LinkedIn) Learnings & Entertainments (LinkedIn)  Ronnie Feldman (Twitter) Learnings & Entertainments (Website) Compliance Confessions – inspired by “Mean Tweets,” these 90-second commercials address misconceptions and excuses to promote speak-up culture and the E&C team as positive and helpful. E&C Training Jams – a soulful singer banters with ethics & compliance, explaining policies, sharing examples, and debunking excuses.  Tales from the Hotline – Real speak-up-themed stories about workplace behavior gone wrong. Workplace Tonight Show! – E&C meets SNL Weekend Update, explaining corporate risk topics and why employees should care. 60-Second Communication & Awareness Shorts – A variety of short, customizable music and multimedia, quick-hitter “commercials” promoting integrity, compliance, speaking up, and the E&C team as helpful advisors and coaches. Custom Live & Digital Programing – Custom creative programming that balances the seriousness of the subject matter with a more engaging delivery. After all, you can't bore people into learning. Tom Instagram Facebook YouTube Twitter LinkedIn Creativity and Compliance was recently honored as one of the Top 35 Podcasts on Creativity by Feedspot. Learn more about your ad choices. Visit megaphone.fm/adchoices

In this episode of The Ethics Experts, Nick and Gio welcome Andrew McBride. Andrew McBride is the CEO of Integrity Bridge LLC, a consulting practice offering strategic & operational compliance support for companies. Andrew has over 25 years of compliance experience, at an international law firm and several multinational companies in the Americas, Europe and Australasia. In his most recent role as Chief Risk & Compliance Officer at Albemarle Corporation, he built a new ethics and compliance program, and recruited a new team, against the backdrop of an FCPA investigation. The investigation was resolved by way of a Non-Prosecution Agreement with the U.S. Department of Justice and Cease & Desist Order with the U.S. Securities and Exchange Commission. As part of the resolution, Albemarle secured a 45% reduction in penalty due to its co-operation with the investigation and the compliance program that was built, the largest FCPA % penalty reduction to date. In recognition of these efforts Albemarle was awarded Compliance Program of the Year by Compliance Week in May 2024. In parallel to the FCPA investigation and business ethics efforts, Andrew played a key role supporting Albemarle's commitment to sustainability including UN Global Compact membership, management of the company's human rights framework and support for the company's successful efforts to achieve certification against the Initiative of Responsible Mining Assurance (IRMA)'s Mining Standard. Prior to Albemarle, Andrew was Associate General Counsel Compliance at BHP, Senior Antitrust Counsel at BP and Managing Associate at Linklaters. Andrew is admitted to practice law in England, Western Australia & California. He is also a Certified Fraud Examiner.

Welcome to the award-winning FCPA Compliance Report, the longest-running podcast on compliance. In this episode, Tom welcomes Jag Lamba, CEO of Certa.AI, the podcast's sponsor. We look at the recent events involving economic and trade sanctions levied on Colombia (now withdrawn) and the announcement of DeepSeek as a cost-effective competitor to ChatGPT in the AI space to discuss how quickly your risks can change. We overlay this discussion through the lens of the DOJ's 2024 Update on the Evaluation of Corporate Compliance Programs (2024 ECCP). Jag provides insights on how compliance officers can proactively manage risk amidst rapidly changing global landscapes by ensuring their programs are well-designed, adequately resourced, and effective. Key takeaways include the importance of data, controls, and technology in building robust compliance frameworks and using business impact and ROI to secure necessary resources. Key highlights: Current Events Impacting Compliance 2024 ECCP-Designing a Well-Structured Compliance Program 2024 ECCP-Adequate Resourcing for Compliance Programs 2024 ECCP: Effectiveness of Compliance Programs in Practice Proactive Risk Management Strategies Export Controls and Compliance Challenges Resources: Jag Lamba on LinkedIn Certa.ai Learn more about your ad choices. Visit megaphone.fm/adchoices

Join CJ Wolf as he sits down with Clint Narver, a former DOJ prosecutor and healthcare compliance expert, to explore best practices, emerging trends, and real-world strategies for avoiding legal pitfalls. Highlights: - Learn how to safeguard your organization against research fraud. - Insights into the DOJ's perspective on compliance programs. - Real-life examples of compliance missteps and how to avoid them. - The role of training, monitoring, and proactive measures in compliance success. Ready to strengthen your compliance program? Listen to the full episode and gain the tools to navigate the complexities of healthcare compliance.

The U.S. Department of Justice Antitrust Division recently updated its guidance regarding the division's “Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations.” What are the key changes? In this episode, Alicia Downey and Anora Wang talk to Emma Burnham, Antitrust Division Director of Criminal Enforcement, about how prosecutors assess the effectiveness of corporate antitrust compliance programs against the backdrop of the increasing utilization of artificial intelligence and ephemeral messaging technology. Private practitioner Tee St. Matthew-Daniel of Paul Weiss joins the conversation with her insights on the elements of the updated guidance that companies and their antitrust counsel need to consider, as well as a preview of the Section's biannual Women's Antitrust Roundtable. With special guests: Emma Burnham, Director, Antitrust Division, Department of Justice and Tee St. Matthew-Daniel, Partner, Paul, Weiss, Rifkind, Wharton & Garrison LLP Related Links: U.S. Department of Justice Antitrust Division, Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (Nov. 13, 2024) Antitrust Magazine Interview with Emma Burnham, Director, Antitrust Division, Department of Justice, Antitrust, Vol. 39, Issue 1, Fall 2024 (Dec. 13, 2024)  Hosted by: Alicia Downey, Downey Law LLC and Anora Wang, Arnold & Porter Kaye Scholer LLP

On this Astonishing Healthcare podcast episode, return guests Heidi McKinnon, PharmD, CHC (Head of Compliance at Capital Rx), and Symara Schmidt, PharmD, PMP, CHC, BCGP (Director, Compliance Programs), join host Justin Venneri in the studio for another Pharmacy Benefits 101 discussion about Pharmacy Audits, including how pharmacy benefit managers (PBMs) and pharmacies can work together to avoid issues and improve compliance - it is possible!They explain everything from common audit triggers and types of audits to how the audits work and resources pharmacies can leverage to improve compliance and reduce friction/errors. Why are compliance executives at a PBM explaining all this? Well, it's an important topic, and there are misperceptions about pharmacy audits. There can be positive outcomes, and reducing fraud, waste, and abuse in the pharmacy supply chain is always a good thing.Related ContentAH023 - Compliance Matters, with Heidi McKinnon, PharmD, CHCAH025 - Empowering Pharmacists, with NASPA's Krystalyn Weaver, PharmD, JDReference MaterialsThe Capital Rx Pharmacy Provider ManualPHARMACY AUDITS, An Important Tool for Fighting Fraud, Waste, and Abuse and Protecting PatientsPAAS National - Home PagePlease visit Capital Rx Insights for more information, including this episode's transcript!

Schellman, founded in 2002 as SAS 70 Solutions, was originally focused on just one audit standard; the SAS 70 (subsequently replaced by SOC 2). As the client base grew so did the request to perform other audits outside of the SAS 70. Schellman grew its offerings over the past 20+ years by identifying client needs and then determining if we have the skillset and expertise to deliver high quality work. We have always stayed true to our core strengths and expertise, which is why Schellman is the only Top 100 CPA firm that specializes in IT Audit and Cybersecurity.Schellman provides full-spectrum cybersecurity third-party audits, assessments, and certifications. In a marketplace with growing cybersecurity compliance needs, organizations are struggling to incorporate additional framework and regulations in an efficient and effective way. At Schellman we harnesses our expertise and deep knowledge across the compliance standards to roadmap audits throughout the year that promotes the highest return on evidence collection and subject matter expert time.By performing specific assessments in a staggered or parallel fashion, Schellman is able to collect once and test many; both in terms of information from subject matters experts and evidence from business stakeholders. The broad range of our compliance offerings, along with our combined audit approach and depth of expertise sets Schellman apart. Schellman's approach was built to provide expertise and quality work while valuing and respecting the time and stress assessments/audits place on an organization.Learn more about Schellman: https://itspm.ag/schellman9a6vNote: This story contains promotional content. Learn more.Guests:Michael Parisi, Head of Client Acquisition, Schellman [@Schellman]On LinkedIn | https://www.linkedin.com/in/michael-parisi-4009b2261/Ryan Meehan, Director, Schellman [@Schellman]On LinkedIn | https://www.linkedin.com/in/ryan-meehan-cisa-cissp-ccsfp-iso-lead-cipp-71a5939ResourcesLearn more and catch more stories from Schellman: https://www.itspmagazine.com/directory/schellmanLearn more about 7 Minutes on ITSPmagazine Short Brand Story Podcasts: https://www.itspmagazine.com/purchase-programsNewsletter Archive: https://www.linkedin.com/newsletters/tune-into-the-latest-podcasts-7109347022809309184/Business Newsletter Signup: https://www.itspmagazine.com/itspmagazine-business-updates-sign-upAre you interested in telling your story?https://www.itspmagazine.com/telling-your-story

Schellman, founded in 2002 as SAS 70 Solutions, was originally focused on just one audit standard; the SAS 70 (subsequently replaced by SOC 2). As the client base grew so did the request to perform other audits outside of the SAS 70. Schellman grew its offerings over the past 20+ years by identifying client needs and then determining if we have the skillset and expertise to deliver high quality work. We have always stayed true to our core strengths and expertise, which is why Schellman is the only Top 100 CPA firm that specializes in IT Audit and Cybersecurity.Schellman provides full-spectrum cybersecurity third-party audits, assessments, and certifications. In a marketplace with growing cybersecurity compliance needs, organizations are struggling to incorporate additional framework and regulations in an efficient and effective way. At Schellman we harnesses our expertise and deep knowledge across the compliance standards to roadmap audits throughout the year that promotes the highest return on evidence collection and subject matter expert time.By performing specific assessments in a staggered or parallel fashion, Schellman is able to collect once and test many; both in terms of information from subject matters experts and evidence from business stakeholders. The broad range of our compliance offerings, along with our combined audit approach and depth of expertise sets Schellman apart. Schellman's approach was built to provide expertise and quality work while valuing and respecting the time and stress assessments/audits place on an organization.Learn more about Schellman: https://itspm.ag/schellman9a6vNote: This story contains promotional content. Learn more.Guests:Michael Parisi, Head of Client Acquisition, Schellman [@Schellman]On LinkedIn | https://www.linkedin.com/in/michael-parisi-4009b2261/Ryan Meehan, Director, Schellman [@Schellman]On LinkedIn | https://www.linkedin.com/in/ryan-meehan-cisa-cissp-ccsfp-iso-lead-cipp-71a5939ResourcesLearn more and catch more stories from Schellman: https://www.itspmagazine.com/directory/schellmanLearn more about 7 Minutes on ITSPmagazine Short Brand Story Podcasts: https://www.itspmagazine.com/purchase-programsNewsletter Archive: https://www.linkedin.com/newsletters/tune-into-the-latest-podcasts-7109347022809309184/Business Newsletter Signup: https://www.itspmagazine.com/itspmagazine-business-updates-sign-upAre you interested in telling your story?https://www.itspmagazine.com/telling-your-story

Welcome to the award-winning FCPA Compliance Report, the longest running podcast in compliance. In this edition of the FCPA Compliance Report, Tom Fox welcomes back Vince Walden, founder of KonaAI. Vince reports on the 2024 Update to the Evaluation of Corporate Compliance Programs. (Today's episode is a cross-posting from Data Driven Compliance.) Walden, a distinguished expert in compliance data analytics, actively participates in industry forums such as the Society of Corporate Compliance and Ethics annual summit in Grapevine, Texas. He advocates for compliance professionals to have ample access to relevant data sources, enabling them to monitor and test policies, controls, and transactions effectively. Walden stresses the importance of AI developers being vigilant about potential biases and public harm, aligning with the Department of Justice's stance on accountability. He advises compliance practitioners to collaborate with internal audit and finance teams to ensure they have the necessary transactional data for comprehensive risk assessments, highlighting successful, cost-effective implementations like those at Albemarle as models for gradual, data-driven compliance program adoption. Highlights in this Episode Data-Driven Compliance for Cost Savings Enhancing Compliance through Advanced Data Analysis Identifying High-Risk Areas for Data Analytics Proactive Risk Mitigation through Real-Time Monitoring ROI-driven Compliance Programs with Data Analytics   Resources: Vince Walden on LinkedIn KonaAI Tom Fox Instagram Facebook YouTube Twitter LinkedIn For more information on the Ethico Toolkit for Middle Managers, available at no charge by clicking here. Learn more about your ad choices. Visit megaphone.fm/adchoices

Rob Black is the Founder of Fractional CISO and has guided numerous companies in enhancing their security postures. With extensive experience in product and corporate security roles at prominent companies like PTC, Axeda, and RSA Security, Rob is recognized as a trusted authority in risk management and cybersecurity innovation. In this episode… As companies face increasing pressure to meet security and compliance demands, many are turning to AI to enhance their governance, risk, and compliance programs. Tools like ChatGPT and Claude can streamline processes such as summarizing reports and generating responses to security questionnaires. While these tools can improve efficiency, they can also produce inaccuracies, underscoring the importance of human oversight. How can companies use AI responsibly to enhance these programs? AI tools can save security teams a ton of time, but they're not reliable enough to replace human oversight. This means that companies need to establish clear guidelines and governance frameworks on AI usage to protect sensitive information and mitigate risks. By integrating these strategies, companies can build more resilient and compliant programs.  In this episode of She Said Privacy/He Said Security, Jodi and Justin Daniels talk with Rob Black, the Founder of Fractional CISO, about integrating AI into governance, risk, and compliance programs. Rob explores the benefits and risks of utilizing AI in these programs, emphasizing the need to blend AI with human oversight. He also emphasizes the need for companies to have a security-first mindset when implementing AI tools to reduce risk and ensure long-term success.

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations. Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them. Chapters: 00:56 Understanding FDA Compliance Programs 02:33 Types of FDA Inspections 03:04 Mock Audits and Process Validation 03:45 Combination Product Manufacturer Definition 04:38 Inspection Guides and Compliance 06:47 Supplier Controls and Responsibilities 09:20 Challenges in Mock Pre-Approval Inspections 16:32 Supplier Management and Quality Agreements 24:19 Contract Manufacturers and Design Control 25:03 Conclusion Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.

In this episode of CyberIntel, Brian Odian discusses the importance of integrating standards when creating a compliance program. If you have any questions you want answered on CyberIntel, email us at cyberintel@vikingcloud.com and our experts will be in touch - we may even make it the subject of a future episode! CyberIntel provides a deep dive into the world of cybersecurity and compliance. Hosted by Brian Odian, VikingCloud's Director of Managed Compliance Services APAC, amongst other cybersecurity and compliance expert advisors, we explore the nuances of various compliance standards and the latest in cybersecurity news, trends and threats. New episodes every two weeks! CyberIntel is presented by VikingCloud. VikingCloud is leading the Predict-to-Prevent cybersecurity and compliance company, offering businesses a single, integrated solution to make informed, predictive, and cost-effective risk mitigation decisions - faster. VikingCloud is the one-stop partner trusted by 4+ million customers every day to provide the predictive intelligence and competitive edge they need to stay one step ahead of cybersecurity and compliance disruption to their business. 

Is your HR department rolling their eyes at compliance? Does your company have a non-retaliation policy? The report, based on over 1,000 global responses, reveals growing maturity in compliance programs but notable gaps, such as only 61% having a hotline and 55% having a non-retaliation policy. Join us on this week's Corruption Crime and Compliance to learn how cross-functional relationships are strong with data privacy and risk but weak with HR and finance. Michael Volkow highlights NavX's report, showing compliance's high engagement in processes like reputational harm and data breaches but often being involved late in mergers and acquisitions. Learn that common compliance issues include privacy, cybersecurity, and regulatory demands. The report also covers ESG programs and the need for better third-party risk management - tune in to hear more!You'll hear him talk about:How compliance is often brought in late during mergers and acquisitions, with 20% of respondents noting no engagement in these processes.Notable gaps that include only 61% of organizations having a hotline or whistleblower internal reporting channel and only 55% having a non-retaliation policy.How the report shows progress in the maturity of compliance programs, with half of the respondents rating their programs in the top two tiers of maturity.Compliance having strong relationships with data privacy and risk functions, but experiencing significant resistance from HR and finance departments.Half of the organizations experiencing at least one compliance issue in the past three years, with privacy and cybersecurity being the most common issues.Two-thirds of boards receiving periodic compliance reports, but one-third do not, highlighting a need for improved board engagement in compliance matters.Resources:Michael Volkov on LinkedIn | TwitterThe Volkov Law GroupNavex State of Risk and Compliance Report

The False Claims Act—alongside the Anti-Kickback Statute and Stark Law—represents one of the five core fraud, waste, and abuse laws identified by the HHS Office of the Inspector General. Out of the billions of dollars reclaimed through False Claims Act recoveries in 2023, the majority was attributed to the healthcare industry. This concerning trend highlights the importance of maintaining robust compliance programs and prioritizing education surrounding these regulations. In this episode of 1st Talk Compliance, Rachel Rose, JD, MBA discusses recent key developments in the False Claims Act landscape and shares tips on how healthcare providers can enhance their compliance strategies and mitigate regulatory risks. Tune in to gain a comprehensive understanding of the False Claims Act and its role in the healthcare sector, hear updates on several recent significant fraud, waste, and abuse cases, and receive actionable insights into bolstering your organization's compliance initiatives.

In this episode of School Safety Today by Raptor Technologies Michelle Dawn Mooney sat down with special guest, Carrie Mockler, the Vice President of Operations at PublicSchoolWORKS, a Raptor Technologies company. PublicSchoolWORKSis a fully automated, all-in-one learning management system for online training for school staff and a comprehensive risk management program.Key Takeaways:• Why having a Safety and Compliance Program is important.• How to create a sustainable solution in an ever-changing landscape.• How to get buy-in from staff who are already overwhelmed with initiatives.In her 15 years at PSW, Carrie Mockler has transformed it into the K-12 safety and wellness trailblazer it is today. Carrie has been described as a people-centric leader and the heartbeat of the organization, and in her time there, she has built an infrastructure that ensures long-term positive outcomes for teachers, staff, and students.

Compliance gets a dust off with the new General Compliance Program Guidance released by the federal Office of the Inspector General (OIG) in November 2023. While there is a lot to digest, Husch Blackwell's Josi Wergin and Natasha Sumner join host Meg Pekarske to break it down highlighting important differences from past guidance and key implementation considerations. They also read the tea leaves on what to expect in forthcoming hospice specific compliance guidance. An important listen for everyone in hospice!

Max talks with Mark Kolber, an aviation lawyer and CFI, about the FAA's compliance program. Mark explains that the program, launched in 2015, shifted from a punitive approach to a more rehabilitative one, encouraging pilots to report mistakes and undergo retraining rather than facing severe penalties. He highlights the benefits of being proactive and transparent with the FAA to resolve issues through remedial training. Mark discusses the importance of filing a NASA form for protections if a case goes to formal enforcement and advises seeking professional guidance when contacted by the FAA. He clarifies that while the compliance program handles minor infractions, serious violations like fraud or repeated offenses still lead to formal enforcement actions. The conversation includes practical advice for pilots who receive a Brasher warning, suggesting they contact the tower with brief, factual information without making admissions. Mark emphasizes that modern technology like ADS-B makes evading detection impossible, advocating for cooperation and transparency as the best approaches. If you're getting value from this show, please support the show via PayPal, Venmo, Zelle or Patreon. Support the Show by buying a Lightspeed ANR Headsets Max has been using only Lightspeed headsets for nearly 25 years! I love their tradeup program that let's you trade in an older Lightspeed headset for a newer model. Start with one of the links below, and Lightspeed will pay a referral fee to support Aviation News Talk. Lightspeed Delta Zulu Headset $1199 Lightspeed Zulu 3 Headset $899Lightspeed Sierra Headset $699 My Review on the Lightspeed Delta Zulu Send us your feedback or comments via email If you have a question you'd like answered on the show, let listeners hear you ask the question, by recording your listener question using your phone. News Stories William Anders, Apollo 8 astronaut, killed in San Juan Islands plane crash Distractions, multitasking, miscommunication led to near-collision at JFK Loose iPad Jams Pilot's Trim Wheel, Leading To An Emergency Landing Flight to drop candy ends in crash No certificated pilot aboard plane in deadly Alaska crash Martin Mars ‘Experiences' Offered Stearman pilot admits to lying to NTSB about 2022 crash, pleads guilty YouTuber Faces Federal Charges For Alleged Helicopter Stunt FL helicopter pilot charged after landing on shorebird nesting site Oakland pilot allegedly flew marijuana cross-country in his Cessna FAA certification means electric air taxis could start flights to SFO in 2025 Mentioned on the Show Buy Max Trescott's G1000 Book Call 800-247-6553 Buy Max Trescott's G3000 Book Call 800-247-6553 Mark Kolber's articles in IFR Pilot Magazine Free Index to the first 282 episodes of Aviation New Talk So You Want To Learn to Fly or Buy a Cirrus seminars Online Version of the Seminar Coming Soon – Register for Notification Check out our recommended ADS-B receivers, and order one for yourself. Yes, we'll make a couple of dollars if you do. Get the Free Aviation News Talk app for iOS or Android. Check out Max's Online Courses: G1000 VFR, G1000 IFR, and Flying WAAS & GPS Approaches. Find them all at: https://www.pilotlearning.com/ Social Media Like Aviation News Talk podcast on Facebook Follow Max on Instagram Follow Max on Twitter Listen to all Aviation News Talk podcasts on YouTube or YouTube Premium "Go Around" song used by permission of Ken Dravis; you can buy his music at kendravis.com If you purchase a product through a link on our site, we may receive compensation.

The RSA Conference in San Francisco is renowned for being a hub of cutting-edge discussions around everything related to cybersecurity, and this year, one of the spotlight was on and AI governance. In this conversation featuring industry experts from LogicGate, the focus was on unraveling the challenges organizations face in adapting to the rapidly evolving landscape of AI implementation.Unveiling the ExpertsModerated by Sean Martin, the discussion kicked off with a warm welcome to the LogicGate team, setting the stage for a deep dive into the complexity of AI governance. Matt Kunkel, the CEO of LogicGate, shared insights from his extensive consulting background in building GRC solutions for a diverse range of organizations. His vast experience culminated in the creation of the Risk Cloud Platform, a versatile tool that aids organizations in automating risk management processes tailored to their specific needs.The CISO PerspectiveNick Kathmann, the Chief Information Security Officer at LogicGate, brought to the table over two decades of experience in cybersecurity. His journey through managing security compliance for major players like Virtustream and RSA highlighted the intricate web of challenges posed by evolving technologies like AI. Nick emphasized the critical importance of aligning internal governance with external regulations to ensure a robust security posture.Demystifying AI GovernanceAs the conversation continues Sean Martin steered the discussion towards demystifying AI governance and its impact on organizational frameworks. The panel shed light on the dual challenges organizations face – the risk of embracing AI too recklessly and stifling innovation versus the risk of over-regulating and impeding progress. The consensus was clear – a balanced approach that marries speed and security is imperative for a successful AI governance strategy.The LogicGate SolutionMatt and Nick unraveled the intricacies of the AI governance solution developed by LogicGate, designed to provide organizations with a holistic framework for managing AI risks. By integrating AI governance with existing risk management protocols, LogicGate's platform offers a transformative approach that streamlines processes, enhances visibility, and ensures compliance with emerging standards.Looking Towards the FutureThe conversation concluded with a forward-looking approach, underscoring the rapidly evolving nature of AI technologies and the indispensable need for agile governance frameworks. The consensus was that staying ahead of the curve demands continuous assessment, adaptation, and alignment of AI governance with overarching business objectives.In ClosingThis episode of On Location Coverage at the RSA Conference 2024 offered a glimpse into the complexities and opportunities that AI governance presents for organizations worldwide. With LogicGate leading the charge in innovative solutions, the future of AI governance looks promising, anchored in a foundation of collaboration, foresight, and strategic alignment.As organizations navigate the uncharted waters of AI implementation, partnering with pioneers like LogicGate is poised to be the key to unlocking the full potential of this transformative technology. Stay tuned for more insights and developments on AI governance as we journey towards a future powered by innovation and resilience.Learn more about LogicGate: https://itspm.ag/logicgate-92d6bcNote: This story contains promotional content. Learn more.Guests: Matt Kunkel, CEO at LogicGate [@LogicGate]On LinkedIn | https://www.linkedin.com/in/matt-kunkel-91056143/Nick Kathmann, Chief Information Security Officer at LogicGate [@LogicGate]On LinkedIn | https://www.linkedin.com/in/nicholaskathmann/ResourcesLearn more and catch more stories from LogicGate: https://www.itspmagazine.com/directory/logicgateView all of our RSA Conference Coverage: https://www.itspmagazine.com/rsa-conference-usa-2024-rsac-san-francisco-usa-cybersecurity-event-infosec-conference-coverageAre you interested in telling your story?https://www.itspmagazine.com/telling-your-story

By Adam Turteltaub What makes for an effective compliance program, not just from a legal perspective but from a practical one? Getting that answer, and sharing it is the focus of the LRN 2024 Ethics & Compliance Program Effectiveness Report To learn what it contains we sat down with Meredith Hunt (LinkedIn), Ethics and Compliance Specialist at LRN. In this podcast she shared that more effective programs are focused on values rather than rules, and underscore the importance of ethical culture. They are also taking a risk-based approach. Their research also revealed the importance of adapting to the current business environment. With employees working remotely has come a change in how they gather information. The code of conduct, policies and procedures have to be accessible wherever workers are. Within the compliance program's internal operations, effective programs, they report, are focusing more on data and metrics, looking for the data that show where the program is and isn't working, and enabling continuous improvement. Listen in to learn more about how to create a more effective compliance program in your organization.

The US Department of Justice Criminal Division has been increasingly vocal about what makes organizations' ethics and compliance programs effective. This input on program effectiveness takes the form of guidance to prosecutors about what questions to ask when companies negotiate to resolve DOJ investigations into corporate wrongdoing on favorable terms. What does this guidance on program effectiveness mean in practice for E&C professionals? In this episode of LRN's Principled Podcast, host Susan Divers speaks with John Michelich, who retired last November after 35 years as a federal prosecutor with the Department of Justice's Criminal Division. Listen in as they explore how the DOJ evaluates E&C programs, as well as best practices for companies settling misconduct investigations.  For a full transcript of this podcast, visit the episode page at LRN.com Explore our blog collection for additional resources on Program Effectiveness.

"Compliance always needs to be improving.” - Noah  In this episode Ian Andrews (CMO, Chainalysis) speaks to Noah Perlman (Chief Compliance Officer, Binance), whose exchange was very focused on trading and users in the early days and now turning the  page to building out a robust Compliance program. Noah shares his journey from being a prosecutor at the US Attorney's Office, working at Morgan Stanley, to his current role at Binance.  He discusses the challenges and opportunities of working in compliance in the crypto industry, the importance of trust and transparency and the steps Binance is taking to improve its compliance program. Noah also talks about the collaboration between Binance and law enforcement agencies, the regulatory landscape in different countries, and his excitement for innovation and the future of centralized exchanges vs decentralized platforms.  Minute-by-minute episode breakdown 2 | Noah's transition from a prosecutor to Chief Compliance Officer at Binance  6 | Experience and cultural differences between TradFi and Crypto  9 | Importance of rebuilding trust in the crypto market and industry  12 | Impact of the settlement with the US government on Binance and Chief Compliance Officer role  15 | Collaboration with law enforcement and focus on rooting out bad actors  19 | Discussion on the future of crypto and the role of centralized exchanges 21 | Debate on the US government's approach to crypto regulation  25 | Excitement about innovating in compliance through technology and killer crypto use cases  Related resources Check out more resources provided by Chainalysis that perfectly complement this episode of the Public Key. Website: Binance: 188,487,264 Users Trust Us! Blog: Binance FZE Receives a VASP Licence from Dubai's Virtual Assets Regulatory Authority Blog: Binance's Proof-of-Reserves System: A Year of Upgrading User Assets Transparency Press Release: Statement Regarding Tigran Gambaryan Registration: Digital premiere of Links 2024 (NYC Main Stage Content and more - Register Now!) Blog: London's Metropolitan Police Lead Disruption of Phishing-as-a-Service Provider LabHost YouTube: Chainalysis YouTube page Twitter: Chainalysis Twitter: Building trust in blockchain Tik Tok: Building trust in #blockchains among people, businesses, and governments. Telegram: Chainalysis on Telegram  Speakers on today's episode Ian Andrews * Host * (Chief Marketing Officer, Chainalysis)  Noah Perlman (Chief Compliance Officer, Binance) This website may contain links to third-party sites that are not under the control of Chainalysis, Inc. or its affiliates (collectively “Chainalysis”). Access to such information does not imply association with, endorsement of, approval of, or recommendation by Chainalysis of the site or its operators, and Chainalysis is not responsible for the products, services, or other content hosted therein. Our podcasts are for informational purposes only, and are not intended to provide legal, tax, financial, or investment advice. Listeners should consult their own advisors before making these types of decisions. Chainalysis has no responsibility or liability for any decision made or any other acts or omissions in connection with your use of this material. Chainalysis does not guarantee or warrant the accuracy, completeness, timeliness, suitability or validity of the information in any particular podcast and will not be responsible for any claim attributable to errors, omissions, or other inaccuracies of any part of such material.  Unless stated otherwise, reference to any specific product or entity does not constitute an endorsement or recommendation by Chainalysis. The views expressed by guests are their own and their appearance on the program does not imply an endorsement of them or any entity they represent. Views and opinions expressed by Chainalysis employees are those of the employees and do not necessarily reflect the views of the company.

Only have time to listen in bite-sized chunks? Skip straight to the parts of the podcast most relevant to you:How to update risk monitoring systems. (6:03)Why is the FCPA and compliance monitoring and analytics under scrutiny? (10:40)How can AI and other technologies help with risk monitoring and detection. (12:31)Tips on implementing the DOJ's guidance on incentive compensation structures. (14:46)Tips on implementing the DOJ's and the FTC's guidance on messaging apps and collaboration tools guidance. (20:19)The U.S. Department of Justice (DOJ) has upped the ante on compliance program effectiveness with a wave of guidance issued since 2022. Legal and compliance leaders would benefit from assessing and improving three key priorities outlined by the DOJ:Update risk monitoring systemsIncorporate incentives into compensation structures to foster compliance culture and establish clawback policiesEstablish policies and procedures to preserve communications and data from messaging and collaboration tools and personal devices that are used for business purposesIn this installment of the Strategic GC Podcast, Gartner analyst Lauren Kornutick and host Alissa Lugo discuss how leaders can improve compliance program effectiveness based on DOJ guidance. It includes three areas to prioritize, how to assess compliance program effectiveness, as well as case studies from QBE, AbbVie and Intel on progressive risk assessment and monitoring practices.Gartner analyst Lauren Kornutick advises general counsel and other C-suite leaders on AI risk and governance, as well as compliance technology. She has more than 15 years of experience in compliance risk management, including setting up compliance, privacy, risk management, and ESG-related programs, and compliance risk management technology applications. Before Gartner, Lauren was responsible for product marketing of a risk and compliance product and advised senior leaders at private and public companies on deploying compliance risk technology.

Only have time to listen in bite-sized chunks? Skip straight to the parts of the podcast most relevant to you:How to update risk monitoring systems. (6:03)Why is the FCPA and compliance monitoring and analytics under scrutiny? (10:40)How can AI and other technologies help with risk monitoring and detection. (12:31)Tips on implementing the DOJ's guidance on incentive compensation structures. (14:46)Tips on implementing the DOJ's and the FTC's guidance on messaging apps and collaboration tools guidance. (20:19)The U.S. Department of Justice (DOJ) has upped the ante on compliance program effectiveness with a wave of guidance issued since 2022. Legal and compliance leaders would benefit from assessing and improving three key priorities outlined by the DOJ:Update risk monitoring systemsIncorporate incentives into compensation structures to foster compliance culture and establish clawback policiesEstablish policies and procedures to preserve communications and data from messaging and collaboration tools and personal devices that are used for business purposesIn this installment of the Strategic GC Podcast, Gartner analyst Lauren Kornutick and host Alissa Lugo discuss how leaders can improve compliance program effectiveness based on DOJ guidance. It includes three areas to prioritize, how to assess compliance program effectiveness, as well as case studies from QBE, AbbVie and Intel on progressive risk assessment and monitoring practices.

By Adam Turteltaub In late 2023, The Office of Inspector General (OIG) at the Department of Health and Human Services issued its new General Compliance Program Guidance. In this podcast, David Schumacher, Partner and Co-Chair of the Fraud & Abuse Practice at Hooper Lundy & Bookman explains that this document is both evolutionary and revolutionary. For years the OIG's office had been offering guidance through the Federal Register. To make that information more accessible it moved it online, consolidated the information, added interactive features and created a much richer resource which makes it both easier for compliance teams to understand the OIG's expectations and more difficult for some to claim that they were unaware of the rules. The changes, though, are more than just the media used to communicate OIG expectations. The document demonstrates both the ongoing expectations by OIG for robust compliance programs and communicates changes in focus. For one, it reveals an enhanced emphasis on quality issues in healthcare and patient safety. It also reflects the OIG's efforts to ensure effective compliance program in new entrants into healthcare, such as private equity and technology firms. Both may well discover that practices that are permissible elsewhere are not in healthcare. The guidance also encourages incentivizing compliance. Another gem in the guidance is the clear message to carefully scrutinize arrangements with third parties. Due diligence at the outset is important, but it is also necessary on an ongoing basis to determine if the relationship is necessary and the price tag is fair market value. Listen in to learn more, and be sure to check out the General Compliance Program Guidance.

Andrew Ruskin, Partner, K&L Gates LLP, speaks with Mary Edmondson, Chief Compliance Officer, Inova Health, about the aftermath of last year's Supreme Court decision in the SuperValu case and how health care organizations can prepare for potential investigations. They discuss how to ensure that stakeholders in an organization feel comfortable raising questions with compliance, how to evaluate whether a current practice is lawful, lessons learned from the Christiana case, and how to demonstrate reasonable steps related to compliance with the 60-day repayment rule.To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.

By Adam Turteltaub When it comes to compliance technology, there are two challenges. First is finding the right solutions to increase your programs effectiveness. Second is securing the resources to acquire and deploy the technology. Parth Chanda, Founder and CEO of Lextegrity, covers both topics in this podcast. When it comes to tech, he explains, you want tools that give you the confidence that your program is effective in practice and not just on paper. You also need to prioritize based on risk, and your organization's own experience with technology. If the history is short or non-existent, start with something relatively simple such as training or policy management.  Tools that can make it easier for employees to report wrongdoing are also invaluable. To secure the resources you need, he advises making the business case by focusing on the ROI, for example, by showing that investigations can be completed in less time and with less staff. But, as you look at technology, be realistic and recognize that technology will not remove human judgement. It can expose gaps and gray areas, but then the compliance team will need to step in to understand the nuances and the appropriate solution.

In this week's episode, Katherine Forrest and Anna Gressel share their thoughts on compliance programs for AI and highlight some key regulatory concerns.   ## Learn More About Paul, Weiss's Artificial Intelligence Practice: https://www.paulweiss.com/practices/litigation/artificial-intelligence

Welcome to the Great Women in Compliance Podcast. In this episode, Lisa visits with Alejandra Montenegro Almonte, who is a member at Miller & Chevalier, and is the Chair of their International Practice, and Practice Co-Lead, Workplace Culture. Prior to joining Miller & Chevalier, she was General Counsel for the North American and Latin American Division at Gategroup and an associate at Weil, Gotshal & Manges.  Alejandra has won awards and recognition from Chambers, Best Lawyers in America and Latin America, among others.  In this episode, Alejandra discusses her experience in global ethics and compliance programs, from advising on best practices to workplace investigations.  Alejandra has leveraged her experience in-house and in law firms to provide practical advice and explains her approach in advising clients.  Alejandra also provides insight on her experiences with monitorships, as she has advised clients in monitorships and acted as a monitor.  She talks about the importance of a proactive relationship between the monitor and the organization as well as some thoughts about best practices for communications and meetings. She applies a similar set of principles to all of her work, focusing on learning about a business including their market dynamics and risks as a part of building the best program for that organization.  She uses that as a foundation for her work on program enhancements and on how to conduct workplace investigations. As this is Women's History Month, Alejandra provides some ideas in how we can best support women – and diversity – in our workplaces. Key Highlights ·      Building Global Ethics & Compliance Programs ·      Experience in Monitorships as an Advisor and a Monitor ·      Providing Practical Advice on Compliance Risks  ·      Cultural Nuances in Global Workplace Dynamics ·      Insights During Women's History Month Resources Join the Great Women in Compliance community on LinkedIn here. 

In this episode Terry and Sean take on the updated Compliance Program Guidance from the OIG and more specifically the section dealing with quality and substandard care leading to prosecution. Don't miss this one!

By Adam Turteltaub Behavioral health shares many of the same compliance challenges as the rest of healthcare, but it also has several of its own. To understand the risks, we sat down with Community Counseling Solutions' Executive Director Kimberly Lindsay and Compliance & Privacy Officer Tim Timmons. They will be leading the session “Developing an Ethics and Compliance Program in Behavioral Health” at the HCCA 28th Annual Compliance Institute, which will be in Nashville, April 14-17 and also offered in a virtual format. In this podcast they identify several typical compliance challenges in the behavioral health setting: Managers and supervisors who are well intentioned but busy, not holding staff accountable and not reporting in a timely manner. Incidents after hours when a patient is in crisis. This is a very difficult situation.  The team is eager to help the patient get better, but with lots of adrenaline flowing in a difficult situation, they may find themselves sharing more information about the patient than they should. Sharing PHI improperly when working with community partners. Mishandling of subpoenas and court ordered requests for records which may not comport with 42 CFR. Coding and dual diagnosis treatment Treatment plans that are not updated before providing services Overly verbose documentation Listen in as they outline these issues and ways to address them. Then, plan on joining us in Nashville for the 28th Annual Compliance Institute.

From our sister show the China Business Law Podcast: Boon Kim Fam talks with Shirley Zhang, Global Compliance Director at Dover Fueling Solutions. On running a global compliance program out of Shanghai for a multinational company. On the challenges of “work-life integration” and time management during COVID-19. And how Shirley and her team manage to stay on top of an ever increasing number of data privacy and other compliance regulations around the world.

On this, the final segment of our conversation with Jackson Wood of Descartes, we discuss the need for a collaborative, cross-functional approach to effectively manage global trade compliance and supply chain risks. Representatives from procurement, logistics, and compliance must work together using the right tools and data to gain strategic insights. New technologies can help streamline processes and empower teams to focus on analysis rather than transactional tasks. Main Points - The importance of bringing together procurement, logistics, and compliance teams to holistically evaluate supply chain options and risks - How assessing the current supply chain baseline is critical before conducting "what if" scenario planning for geopolitical disruptions - Leveraging trade data and tools in a collaborative workflow to identify alternative sourcing options and evaluate regulatory, cost, and resiliency factors - Examples of how automation can reduce operational burdens for compliance teams and allow them to spend more time on strategic issues and education - Tips for international companies on strengthening global supply chain resilience through accurate risk exposure mapping and continuous monitoring of changing trade conditions - The role of strategic sourcing in preparing for potential supply chain disruptions from geopolitical tensions and considering "what if" scenarios - Advice on taking initial steps to evaluate needs and opportunities before investing in trade management technology solutions Enjoy the show! Host: Andy Shiles: https://www.linkedin.com/in/andyshiles/  Host/Producer: Lalo Solorzano: https://www.linkedin.com/in/lalosolorzano/  Co-Producer: Mara Marquez: https://www.linkedin.com/in/mara-marquez-a00a111a8/ Show references: Global Training Center - www.GlobalTrainingCenter.com Simply Trade Podcast - twitter.com/SimplyTradePod  Jackson Wood - https://www.linkedin.com/in/jacksondavidwood/   Contact SimplyTrade@GlobalTrainingCenter.com or message @SimplyTradePod for: Advertising and sponsoring on Simply Trade Requests to be on the show as guest Suggest any topics you would like to hear about Simply Trade is not a law firm or an advisor. The topics and discussions conducted by Simply Trade hosts and guests should not be considered and is not intended to substitute legal advice. You should seek appropriate counsel for your own situation. These conversations and information are directed towards listeners in the United States for informational, educational, and entertainment purposes only and should not be In substitute for legal advice. No listener or viewer of this podcast should act or refrain from acting on the basis of information on this podcast without first seeking legal advice from counsel. Information on this podcast may not be up to date depending on the time of publishing and the time of viewership. The content of this posting is provided as is, no representations are made that the content is error free. The views expressed in or through this podcast are those are the individual speakers not those of their respective employers or Global Training Center as a whole. All liability with respect to actions taken or not taken based on the contents of this podcast are hereby expressly disclaimed.

Welcome to the Great Women in Compliance Podcast. Today Hemma visits with Hayley Tozeski on her career in compliance. Hayley Tozeski is a seasoned professional in strategic compliance and risk management in business conduct, with a rich background in big law and financial crime enforcement. Hayley's perspective on the subject is that it is vital to prioritize and allocate resources effectively, advising companies on strategic investment of money, time, and resources in managing risks. She believes that a clear strategy is essential for the company and its stakeholders to understand the timeline and pace of development in managing ethics and compliance risks. Additionally, Hayley emphasizes the importance of addressing underlying business processes and building a solid foundation before implementing an ethics and compliance program, viewing strategy as the key to connecting different pieces of the program and ensuring that they are aligned and effective. Join Hemma Lomax and Hayley Tozeski on this episode of Great Women in Compliance to delve deeper into these insights. Key Highlights ·      Strategic Resource Allocation in Compliance Management ·      Building Strong Ethics and Compliance Programs ·      Effective Risk Management through Data Analytics ·      Strategic Risk Management for Ethical Business Conduct ·      Driving integrity through values, leaders, and champions ·      Supporting Youth Transitioning from Foster Care ·      Connecting and Learning Through Mentoring Resources Join the Great Women in Compliance community on LinkedIn here. 

In this week's episode of Corruption, Crime, and Compliance, we usher in the New Year with a deep dive into something that happened in November of last year. As we begin 2024, it's crucial to reflect on the substantial shifts in the healthcare industry's compliance framework. The HHS Office of Inspector General's Comprehensive Compliance Guidance, released late last year, has set a new standard for healthcare companies, reinforcing the importance of an independent compliance function and outlining a robust framework for effective compliance programs. Michael Volkov meticulously dissects the seven key elements of this groundbreaking guidance, emphasizing its relevance not just in healthcare, but across the spectrum of compliance practices. You'll hear Micheal discuss:The HHS Office of Inspector General issued the Comprehensive Compliance Guidance (GCPG) in November 2023, a significant document for the healthcare industry, emphasizing the need for independent and robust compliance programs.The guidance is structured around seven core elements: written policies and procedures, effective compliance leadership, training, open lines of communication, enforcing standards, risk assessment, and responsive corrective action for detected offenses.The role of a Chief Compliance Officer is critical, and they should:Report directly to the CEO or have independent access to the board,Have sufficient stature within the entity equal to other leaders,Demonstrate unimpeachable integrity, judgment, assertiveness and approachable demeanor, andHave sufficient funding, resources and staff to operate the program. Emphasizing the separation of legal and compliance functions, the GCPG recommends that compliance officers focus solely on compliance, avoiding roles in legal or financial departments.The GCPG advises the establishment of a compliance committee, meeting quarterly, with responsibilities spanning legal regulation analysis, policy review, training effectiveness, and annual risk assessment.The CEO should include a signed introduction in the code of conduct. The board should include a signed endorsement or similar written statement to support the compliance commitment, and entities should review their codes when a new CEO is hired.Clear communication and board oversight is crucial, and they should be well-informed about compliance programs, and ensure that the compliance officer has sufficient access to them.How compliance officers and boards should respond when compliance concerns are reported or discovered, and focus on the root causes of the misconduct to prevent recurrence.ResourcesMichael Volkov on LinkedIn | TwitterThe Volkov Law Group

By Adam Turteltaub We are starting a new year of Compliance Perspectives podcasts by going back to basics with an episode designed for those who are charged with starting a compliance program. While the conversation is directed to this audience, there are some good reminders even for established programs. Providing guidance are Pam Cleveland, Compliance Officer – Medicare Advantage for UCLA Health FPG and Megan Grifa, Senior Director, Compliance at Sidecar Health. So, if you are charged with launching a program, where do you begin? They advise starting by taking the time to develop a work plan that outlines your compliance program elements. Look to see what the regulatory requirements are for the business you are in and make a catalog of them. That, in turn, will help you set the objectives of your program. Next, take the time to tailor those requirements to the unique aspects of your organization. To do so, first spend time with operations to understand their level of knowledge, processes, resources and documentation. That will help you prioritize what needs to be done. Take the time also to gain the support of leadership. They may need education in everything from what a compliance program is to the specific requirements of your situation. One very effective technique is bringing them examples of non-compliance in your industry and the consequences of it. On an ongoing basis, follow the seven elements of a compliance program and make sure that you prepare your colleagues for the fact that changes happen. Law and regulations evolve, and the compliance program must do the same. It will help things go a bit smoother when you have to institute a new direction. Listen in to learn more about the essential steps for starting a compliance program.

By Adam Turteltaub When compliance professionals discuss AI most of the conversation tends to focus on the risk.  Frank Orlowski (LinkedIn), Founder and President of Ation Advisory Group, though, is far from all gloom and doom on the topic. In fact, he believes AI can be an asset to compliance programs. AI, he explains, can be of great value for compliance any place where there are large amounts of transactions that need to be monitored and checked. Two notable examples are travel & entertainment and accounts payable/vendors. AI is very useful for identifying outlier transactions that could be a sign of trouble. In manufacturing, it can be very helpful in monitoring materials being used. AI can also be helpful, he believes, in ESG efforts. But, there are limits. AI is not ready for handling contracts, he argues. It is also chronically deficient when it comes to addressing the gray areas of ethics and fairness. There it's important for compliance teams to work with the business unit closely to ensure decisions are adequately documented and AI does not make decisions that would be regrettable from an ethics perspective. Listen in to learn more about how AI could help your compliance efforts.

Be careful what you put in writing. In this special episode, Captain Integrity Bob Wade discusses the recent General Compliance Program Guidance (GCPG) issued by the OIG (Office of Inspector General) with Alex Krouse, Associate General Counsel - Provider Arrangements at Parkview Health. This is Part 2 of a 2-part episode, originally recorded as a webinar for the American Association of Provider Compensation Professionals (AAPCP) on November 16, 2023. Hear the questions and issues the OIG has offered, when Fair Market Value (FMV) becomes irrelevant, why emails are evil, the manner in which remuneration is determined, and why you need to be careful with deals with family members of physicians. Email Bob to get the slides and learn more at CaptainIntegrity.com

In this episode of the CodeCast Podcast, Terry Fletcher discusses the seven elements of an effective compliance program. Last month, HHS-OIG outlined and updated this guidance. With a broad spectrum of healthcare entities, staff, and providers playing a role in healthcare delivery today, this information can be generally applied across the entire healthcare industry or […] The post 7 Elements of a Successful Compliance Program via OIG appeared first on Terry Fletcher Consulting, Inc..

In November, the Department of Health and Human Services' Office of the Inspector General (OIG) issued new compliance program guidance that affirms OIG's long-standing focus on the seven elements of an effective compliance program, first published in 2003. In this episode of Connected With Latham, partner Chris Schott and associate Danny Machado are joined by guest Lynn Robson of United Therapeutics. They discuss how the OIG's compliance framework is relevant to drug manufacturers, how past enforcement actions can inform implementation of a compliance program, and how an effective compliance program can be beneficial in the enforcement context.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York's Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York's Disciplinary Rules to Latham & Watkins LLP, 1271 Avenue of the Americas, New York, NY 10020, Phone: 1.212.906.1200

Is your company's compliance program truly effective, or is it just ticking boxes? In this episode of Corruption, Crime, and Compliance, Michael Volkov dives deep into LRN's PEI survey with Susan Divers. Susan sheds light on the global nature of ethics and compliance programs, challenging the misconception that they are solely US-centric. They discuss the power of values, the shift from a cop to a coach approach, and the revolutionary trends in employee-centric training, especially in the age of remote work. Susan Divers is the Director of Thought, Leadership, and Best Practices at LRN. She has a wealth of experience as a former Chief Compliance Officer, and her emphasis on values over rules in compliance programs has made her a trailblazer in the industry. You'll hear Michael and Susan discuss:The LRN PEI survey challenges the perception that ethics and compliance are US-centric; many programs worldwide share common features such as codes of conduct, training policies, and audits.Examining a decade of data, the report delves into how ethics and compliance programs responded to the disruptions caused by the pandemic.LRN's data reinforces the idea that ethics and compliance programs relying on values and ethical cultures are more effective than those solely based on rules. Shifting from a cop approach to a coach approach enhances program effectiveness.Ethical companies experience lower employee misconduct rates, higher employee satisfaction and productivity, and achieve greater sustainable financial performance.The pandemic prompted a shift in focus from content-driven training to employee-centric, relevant, and mobile-friendly modules. Shorter modules, just-in-time training, and tailored approaches are emerging as best practices.Ensuring accessibility through web-based policies and procedures, coupled with interactive capabilities and data analytics, becomes crucial in bridging the gap between remote workers and compliance initiatives.Gathering data on employee interactions provides insights into the effectiveness of compliance programs. Metrics such as completion times, pass rates, and group performance allow for targeted efforts to enhance the program's impact.Michael emphasizes the challenge for compliance officers in handling the plethora of available data. Choosing the right metrics, setting standards, and ensuring the usability of metrics over time are crucial considerations.The report highlights that high-performing ethics and compliance programs are integral to the decision-making processes of companies. 70% of respondents reported modifying or abandoning a business initiative due to an ethics and compliance risk assessment.Susan introduces the concept of embedding a short Ethical Culture survey at the end of training courses. This real-time survey, known as the Ethical Pulse Culture survey, serves as a powerful tool to gauge and improve the ethical culture within organizations.The Ethical Pulse Culture survey becomes a game-changer, operationalizing compliance by offering a moving average of data insights. This survey, incorporated into scorecards, provides business managers with valuable insights into their business unit's ethical culture over time.ResourcesSusan Divers on LinkedIn | EmailLRN

CEOs play a pivotal role in shaping an organization's commitment to ethical practices. Involving CEOs in compliance training, having them share their experiences, and demonstrating a personal commitment to compliance initiatives sets a strong tone from the top. This engagement fosters a culture of ethics and compliance throughout the organization, reinforcing the importance of ethical conduct at all levels.Mary Shirley is a highly regarded authority in the field of ethics, compliance, and corporate governance. She is widely recognized for her expertise in helping organizations navigate the complex landscape of compliance, mitigate risks, and promote ethical practices. With a wealth of experience and insights, Mary Shirley has become a sought-after thought leader, speaker, and author. Her book, Living Your Best Compliance Life: 65 Hacks and Cheat Codes to Level Up Your Ethics and Compliance Program, has earned acclaim for bridging gaps in existing literature on compliance programs.You'll hear Michael and Mary discuss:Organizations can promote ethics and compliance by recognizing and rewarding individuals or teams who exhibit ethical behaviors. This creates a positive atmosphere throughout the company, as employees are more likely to behave ethically if they see that it is valued and rewarded. Additionally, recognizing and rewarding ethical behavior can help to set a good example for other employees and encourage them to behave ethically as well.Engaging leaders from different regions and departments in compliance training programs ensures diverse perspectives and reinforces the importance of compliance at all levels. Leaders from different regions and departments will have different experiences and understanding of compliance issues. By engaging them in training programs, organizations can gain a more holistic view of compliance risks and how to mitigate them. Practical solutions and problem-solving are essential for compliance initiatives. For example, shortening documentation requirements or providing training for HR on investigation best practices can be effective solutions. These solutions can help to reduce the burden of compliance on employees and make it easier for businesses to comply with regulations.One of the critical elements Mary discusses is the significance of building strong relationships within the company. Collaboration and idea implementation are key to success in the compliance world.Collaboration between legal, compliance, and HR teams, along with training for HR on investigation best practices, helps streamline compliance efforts.CEOs play a critical role in setting the tone for compliance within an organization. They are the ones who set the example for their employees, and their actions and words can have a significant impact on whether or not employees comply with regulations. When CEOs are involved in compliance training, it demonstrates that they are committed to ethical practices and that they take compliance seriously.Mary recommends forming task forces to validate compliance ideas at an early stage, fostering a culture of innovation and problem-solving.Encouraging employees to share personal anecdotes related to compliance principles humanizes the process and fosters a culture of ethical work. When employees feel like they can share their own experiences with compliance, it helps them to understand the principles on a deeper level. It also helps to create a sense of community and belonging, as employees see that they are not alone in their commitment to ethical behavior. KEY QUOTE“One of the things that I learned way later that I wish I had was that when you involve people in the conceptualizing aspect [of] building a compliance initiative… and they feel [like they are] part of it… you're in a much better position to get buy-in when you [implement].” - Mary ShirleyResourcesMary Shirley on LinkedIn Order Mary's new book: Living Your Best Compliance Life

This week, our guests are Cinthia Motley and Sean Buckley from Dykema, who are discussing cybersecurity law and compliance with data collection. Ben has the story of a Federal Judge blocking an Arkansas law limiting minors' access to social media. Dave's got the story of court-ordered blocking of websites at the Domain Name Service (DNS) level. While this show covers legal topics, and Ben is a lawyer, the views expressed do not constitute legal advice. For official legal advice on any of the topics we cover, please contact your attorney.  Links to stories: Quad9 Founders on the Dangers of Global DNS Blocks by Rights Holders Judge blocks Arkansas law requiring parental approval for minors to create social media accounts Got a question you'd like us to answer on our show? You can send your audio file to caveat@thecyberwire.com. Hope to hear from you. Learn more about your ad choices. Visit megaphone.fm/adchoices