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A tartalmat a SCCE biztosítja. Az összes podcast-tartalmat, beleértve az epizódokat, grafikákat és podcast-leírásokat, közvetlenül a SCCE vagy a podcast platform partnere tölti fel és biztosítja. Ha úgy gondolja, hogy valaki az Ön engedélye nélkül használja fel a szerzői joggal védett művét, kövesse az itt leírt folyamatot https://hu.player.fm/legal.
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Compliance Perspectives
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A tartalmat a SCCE biztosítja. Az összes podcast-tartalmat, beleértve az epizódokat, grafikákat és podcast-leírásokat, közvetlenül a SCCE vagy a podcast platform partnere tölti fel és biztosítja. Ha úgy gondolja, hogy valaki az Ön engedélye nélkül használja fel a szerzői joggal védett művét, kövesse az itt leírt folyamatot https://hu.player.fm/legal.
An SCCE Podcast
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101 epizódok
Mind megjelölése nem lejátszottként
Manage series 2837193
A tartalmat a SCCE biztosítja. Az összes podcast-tartalmat, beleértve az epizódokat, grafikákat és podcast-leírásokat, közvetlenül a SCCE vagy a podcast platform partnere tölti fel és biztosítja. Ha úgy gondolja, hogy valaki az Ön engedélye nélkül használja fel a szerzői joggal védett művét, kövesse az itt leírt folyamatot https://hu.player.fm/legal.
An SCCE Podcast
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101 epizódok
Minden epizód
×By Adam Turteltaub When we last spoke with Tyler Shultz back in 2020, he discussed his experience at Theranos as both an employee and a whistleblower. Four years later, the case is in the rearview mirror, the former CEO is in prison, he founded two startups of his own, and he now speaks to corporations about cultivating courageous work cultures With the benefit of some time and distance, he shares in this podcast his experiences and what he has learned, particularly about corporate culture. The behaviors he saw at Theranos provided for him a lesson in what not to do. There, he felt the dysfunctional culture was created intentionally. Management, he believed, wanted employees to fear them and reinforced that through locked doors, barricades and firing people who disagreed with leadership. here were even NDAs that restricted the ability of employees to speak with each other. To create a good culture, he argues, companies need to do the opposite of what he saw at Theranos. First, start by defining what the core values of the organization are to give employees a common language with which to discuss potential issues. Next, create a culture that reinforces those values. That includes: Ensuring that the policies match the values Not having overly restrictive NDAs Preventing the formation of silos Encouraging collaboration Watching out for high levels of turnover Being transparent with regulators and investors Listen in to learn more about how to create the right culture and avoid becoming the next Theranos. Listen now…
By Adam Turteltaub Few things hold more promise, or cause more stress for compliance professionals, than AI. What is it? How does it work? And does anyone know how to keep it from showing so much bias? David Silva, Chief Compliance Officer at Collaborative Imaging, will be addressing the topic of “Healthcare, Artificial Intelligence, and Compliance” at the 2025 HCCA Compliance Institute, which will takes place April 28-May 1 in Las Vegas. To get some of his insights now, we sat down for this podcast. David explains that part of the challenge is that AI is so fast changing that it’s hard to keep up. We don’t yet know what we don’t know about it. At the same time, though, the technology is showing great promise in healthcare in areas such as coding, simple reports and helping with third-party vetting. Compliance teams have an important role to play in the implementation of AI in healthcare, he explains. Ideally, they should be a part of the AI governance team, working with a broad range of departments and helping to ensure that programs are monitored to avoid issues with privacy or the False Claims Act, for example. So how should compliance professionals become a valued and effective part of AI efforts? He advocates for staying engaged and pushing to be invited to meetings. When there, keep your ear to the ground, learn more about operational workflows, and try to make sure that AI does what it is supposed to do, without crossing legal and regulatory lines. Listen in to learn more, then join us for even more at the 2025 HCCA Compliance Institute. Listen now…
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1 Madhavi Perumpalath and Alka Kumar on Auditing Physician Documentation and Billing [Podcast] 14:18
By Adam Turteltaub Chart auditing may not be the sexiest part of healthcare compliance, but it plays an important role in discouraging Medicare fraud and catching problems early. Madhavi Perumpalath, Director-Physician Practice Compliance at Northeast Georgia Health System and Alka Kumar, Compliance Director and Privacy Officer at Resolve Pain Solutions, explain that CMS provides good guidance to healthcare providers, such as diagnosis and procedure codes that are appropriate to bill for. Take advantage of it. Embrace proactive auditing, they advise, to help identify issues and ensure the quality of the claim before it goes out the door. It can also prevent both over and under billing. How frequently should you audit? It depends on several factors, including the size of your organization, regulatory requirements, resources available and the overall risk environment. And, remember, you can’t audit everything. Instead, they recommend developing an annual audit plan focusing on the high-risk areas, but also doing some random samples of other areas as well. This dual approach maximizes efficiency and minimizes overlooked issues. Listen in to learn more about how to conduct the audits and what to look for. Listen now…
By Adam Turteltaub With value-based care growing, what role does compliance play? To find out we spoke with Carolyn Barton, Vice President, West Regional Compliance Officer at Kaiser Permanente. She explains that at Kaiser they define value-based care as a healthcare delivery and financing model that improves health outcome and increases access to affordable care in the community through evidence-based care, a commitment to equity and simplicity and aligned incentives. Doctors and health plans, she reports, work in an integrated system focused on the patient and delivering the right care at the right time and place. To make that work their electronic health record (EHR) system is the foundation not just for collecting patient data but also for sharing protocols for treating patients. By implementing systematic, evidence-based approaches through these protocols, they help mitigate racial and ethnic inequities. The results she shares are impressive. Kaiser patients are 20% less likely to die prematurely from cancer compared with others in their community, and they are 33% less likely to have a premature death from heart disease. The compliance team plays a key role by helping, for example, physicians identify the scope of their practice risk such as ensuring that, as patients are moved to a lower level of care, there is proper staffing in place to treat them. To ensure your compliance team succeeds in the values-based care world, she recommends being agile, supporting the organization’s efforts at risk mitigation, building trust, making yourself accessible when there are questions, and thinking creatively. Listen in to learn more about how your compliance team can thrive in this environment, and also what mistakes to avoid. Listen now…
By Adam Turteltaub No one would dispute that stress and compliance go hand in hand, but Scot Eibel (LinkedIn), a former chief compliance officer and currently leading Eibel Coaching and Compliance Consulting, warns that doesn’t mean it has to get out of control. There are steps we can all take to manage our stress levels. One stressor to watch for is over vigilance. While we all need to be vigilant, assessing risk and watching out for threats, it needs to be tempered. Resist the temptation, he warns, to engage in worst case scenario thinking, which increases stress and makes it difficult to focus on any positives. Catastrophic thinking isn’t healthy for you or for the organization. Another stressor for compliance professionals can be feelings of isolation. In some ways it is inherent to the job, but that doesn’t mean it needs to be absolute. Look to others in the compliance community for connections and build cohesiveness on your compliance team. Stress is much more manageable when you have support. When it comes to those problems that seem too difficult to solve, take a breath, he recommends, and focus on what you can do. Don’t seek perfection but seek progress and remember that excellence doesn’t happen overnight. Finally, don’t be afraid to set limits. Compliance professionals can be, as he put it, “sacrificial people” who are willing to put others and the organization first. It’s noble, but sometimes you need to to say “no” or “no” and offer some advice. Listen in to learn more about how better to manage your stress. Listen now…
By Adam Turteltaub Benjamin Christenson, Trial Attorney and Special Assistant to the Director for Criminal Enforcement at the US Department of Justice Antitrust Division, joins us for this podcast in which he sheds light on the their document, Evaluation of Corporate Compliance Programs in Criminal Antitrust Investigations (ECCP). First issued in 2019, the ECCP was updated in 2024 to reflect changes in business, the law and technology, as well as what the Antitrust Division had learned over the last five years. He shares that there are three significant areas of focus in the ECCP worth particular study: AI and Emerging Technology. As companies deploy AI, it’s essential that compliance teams have visibility into what is being done, understand it and monitor antitrust issues such as using the technology to fix prices. NDAs and Whistleblowers. Like others in enforcement, the DOJ is concerned when a non-disclosure agreement may have a chilling effect on potential whistleblowers who are considering reporting an issue to the US government. In addition, whistleblowers need to know that they are protected by Federal law. Third party communication platforms. As employees increasingly move out of email and use texts or tools such as WhatsApp, organizations need to train their workers of the need to preserve the documents Overall the ECCP is very similar to the Criminal Division’s document on evaluating compliance programs, but the latest Antitrust Division ECCP is worth spending time with on its own right, especially if you have risk in this area. Listen in to learn more. Listen now…
By Adam Turteltaub Want to improve your code of conduct? Don’t miss the session: Cornering the Code: A Multi-Disciplinary Approach Toward a Better Code of Ethics at the 2025 SCCE European Compliance & Ethics Institute. In this podcast Matej Drascek, Head of Internal Audit at LON d.d. and Ursula Schmidt of Schmidt Advisory recommend starting with the right language. Research has shown, they explain, that people react more strongly to words like “we” and “our”, which can convey a stronger sense of shared responsibility than words like “you”, “I” or “it”. Also, words like “must” or “have to” carry more weight than “may” or “should”. Of course, just using “we” and “must” won’t do it all. The code, they tell us, should have a service character that gives guidance to people and gives employees a sense of purpose. It should also be dynamic and work as a bit of a safety valve. It should provide reassurance that it protects them from making mistakes and helps them feel safer when addressing issues. For the code of conduct to be valuable in a crisis, it must have first been written clearly and avoid ambiguity. It should fit the organization’s culture, be practical, and able to be applied in a reasonable manner. Listen in to learn more. Then don’t miss their session at the 2025 SCCE European Compliance & Ethics Institute. Listen now…
By Adam Turteltaub I want to write enough about this podcast to get you to listen to it, but not too much because then you might decide that reading this was enough. I’m conflicted, and conflicts of interest are the topic of this podcast with Kasturi Venkatesh, who spoke on the topic “Ethics in Action: A Fun Guide to Tackling Personal Conflicts of Interest” at the 2024 SCCE Compliance & Ethics Institute. When it comes to managing the issue, she explains, the primary goal for compliance teams is to help the workforce identify and bring forward potential conflicts. The challenge is that they often hesitate to bring these issues to management or the compliance team out of fear and a lack of understanding. Training is helpful, but it can’t demonstrate all the potential issues, nor can it always overcome the anxiety. That takes a personal touch of reassurance. In this podcast, Kasturi makes the case for a gentle hand a nuanced eye. The compliance team needs to be aware of the sensitivities of workers and also that, in some geographies, for example, with limited talent pools, there are likely to be many potential conflicts of interest. The nuanced eye needs to understand that challenge as well as see subtle issues, such as two connected workers who are “safely” in different departments, but there may still be some interaction between the two that could prove problematic. Listen in to learn more. Listen now…
By Adam Turteltaub On November 6, 2024, the U.K.'s Home Office issued Economic Crime and Corporate Transparency Act 2023: Guidance to organisations on the offence of failure to prevent fraud (the Guidance). It comes out of the Economic Crime and Corporate Transparency Act (ECCTA), which establishes that a corporation can be held criminally liable for failing to prevent fraud committed by any “associated person” for the benefit of the company. This “associated person” can be an employee or even a third party. There is a defense, explains James Tillen, member at Miller & Chevalier, for organizations that had reasonable prevention procedures at the time of the offence. What constitutes reasonable? There are six principles: Top level commitment A risk assessment Proportionate risk-based prevention procedures Due diligence Communication and training Monitoring and review Sound familiar? It is, since it builds off the guidance for the UK Bribery Act and is very similar to the US approach. It’s not identical, though, since, unlike the US criteria for evaluating compliance programs, this guidance is fraud-specific, with details designed to address the risks posed by the fraud triangle of motive, opportunity and rationalization. Listen in to learn more about the guidance and the particular attention it pays to monitoring the mental well-being of employees. Listen now…
By Adam Turteltaub Auditing and monitoring of the compliance program is pretty standard these days. Entain’s Karen Nightingale, Group Director of Ethics & Compliance and Jonathan Fox, Group Head of Ethics & Compliance Programmes, make the case in this podcast for going to the next level and actively testing your program. The two will also be addressing the topic at the 2025 SCCE European Compliance & Ethics Institute, which will take place in Lisbon, 10-12 March. Doing so, they suggest, can turn a reactive compliance program into a proactive one by actively searching for points of weakness, identifying red flags in advance and addressing them early. In practice, testing is more like an audit. It should be done periodically and provide an in-depth look at whether processes and controls are working as intended. By going deeper, it can uncover where there may be a weakness in what may appear to be a strong process as a whole. To determine what controls to test, there are several factors. First is recognizing that your organization likely has limited resources: don’t plan a test that you don’t have the resources to carry out. Second, identify the taxonomy of risks and which fall within the compliance team’s remit. Next, prioritize the risks: identify the highest risks and start there. As you do this work, ask for help from other parts of the organization. HR, legal, internal audit and others may all be great help. Listen in to learn more, and then plan on attending their session at the 2025 SCCE European Compliance & Ethics Institute. Listen now…
By Adam Turteltaub Note: This podcast was recorded on December 17, 2024. Any changes made after this date will be addressed at the Compliance Institute. At the 2025 HCCA Compliance Institute in Las Vegas, Adam Greene (LinkedIn), partner at Davis Wright Tremaine LLP will be leading the session “New Developments in Health information Privacy.” In this podcast he provides an overview of what he sees as notable privacy compliance challenges and what compliance teams need to be doing. Starting with the HIPAA Privacy Rule, reproductive information is the top of the list. There was a December 23, 2024 deadline for covered entities and business associates to have implemented a prohibition of using any personal health information (PHI) for the purposes of imposing liability or investigating reproductive health care that is lawful under state or federal law. That information, per the rule, should not even be provided to law enforcement or courts that seek to punish an individual for providing or facilitating that care. Relatedly, there is an attestation requirement in instances of judicial or law enforcement information requests that the requester is not seeking the PHI for this prohibited purpose. That is causing a great deal of confusion and challenge for compliance officers. Adding to the confusion is the possibility that the new Administration may reverse the policy. For now, though, he shares, it’s prudent to follow the rule until such time that changes are made by the government. Listen in to learn more about the complexities of this issue, the Confidentiality of Substance use Disorder Patient Record Rule, his insights on website disclosures of user information, and more. Then plan to join his session at the 2025 HCCA Compliance Institute in Las Vegas, taking place April 28-May 1. Listen now…
By Adam Turteltaub Well, it turns out that you can be in two places at once, if you are a surgeon. Even better, you can bill the government under the Medicare program for being at both of them. It’s not quite as strange as it sounds, explains Sara Brinkmann, Partner, and Lauren Gennett, Counsel, of King & Spalding, and, of course, there are rules. Overlapping surgeries occur when one attending surgeon is responsible for procedures that overlap in time. The attending may perform the critical part of the procedure in both, assuming they are not supposed to happen at the exact same time. Non-critical portions of the procedure, such as closing the patient, are left to a resident. There must also be a backup surgeon in case something goes awry. Payment for both surgeries is possible so long as there are the requisite safeguards in place and the various other CMS rules are followed. There may also be state requirements to be mindful of as well. If those rules aren’t followed, there is substantial risk. As they explain, overlapping surgeries have been the subject of intense scrutiny and enforcement actions. Listen in to learn more, and, for the record, overlapping podcast listening is not approved. Listen now…
By Adam Turteltaub On November 22, 2024, Principal Deputy Assistant Attorney General Nicole Argentieri recapped the changes made during the Biden Administration in enforcement policies and announced a few new ones. To better understand what this all means, we spoke with Daniel Kahn (LinkedIn) , partner at Davis Polk, and himself a veteran of the DOJ. There were a number of meaningful changes during the last few years, he noted. Most notably the voluntary disclosure program was significantly expanded, with companies with aggravating circumstances now able to still have the possibility of a declination. There is a catch, though, the bar for cooperation has been raised. The organization must have disclosed promptly, engaged in extraordinary cooperation and remediation and have had an effective compliance program at the time of the incident. A new change, just announced, is the addition of what we referred to in the podcast as “clawforwards” in addition to clawbacks. Organizations are expected to not pay bonuses to employees involved in suspected wrongdoing. Perhaps the greatest change just announced is a difference in how the DOJ handles self-disclosures. In the past companies that did not have a perfect self-disclosure might find themselves a bit stranded. Now the DOJ is recognizing good faith efforts even when the voluntary disclosure may not have been as timely as it could have been. Listen in to learn more and to hear what he says companies should do with an upcoming change in administration. Listen now…
By Adam Turteltaub Once again it is time to sit down with Matt Kelly (LinkedIn), Editor and CEO at Radical Compliance and discuss what happened last year and where the compliance profession is going in the new one. In this podcast we looked back at 2024 and explored five key topics. Changes from the DOJ The DOJ recently issued a recap of its key activities over the last year or so, and Matt notes that a key change has been an increased willingness to give credit to companies that work with the Department of Justice. In the past, the DOJ had only given full credit to companies that had self-disclosed, but now there is greater leniency for organizations who have demonstrated that they are willing to cooperate with the government and make serious remediation efforts. Lessons from Recent Dispositions Matt pointed to the TD Bank case and noted that, as he saw it, the company laid the seeds for its scandal by having a zero expense growth strategy across its business. That led to compliance spending shrinking, rather than growing, as the business rapidly expanded. The key lesson there: recognize the compliance risks of your business strategy. Looking at Boeing’s continued woes he notes that the court has now made quality a central part of the company’s compliance metrics. The definition of compliance and scope of compliance programs could well be growing, with the recognition that having a speak up culture and effective controls isn’t just valuable for legal and regulatory compliance. From the RTX case he finds a lesson for companies in the importance of thorough due diligence and taking the time to understand the risks fully prior to acquisition. Compliance Team Struggles Compliance teams still need to earn their place fully as a trusted advisor for issues outside of the traditional compliance lane, such as AI and supply chain risk, which is often divided up among several departments. Compliance Program Progress The vast majority of CEOs now see compliance as much more than a check the box exercise. They also recognize that having an ethical workforce is an asset. Matt also notes great progress in anticorruption due diligence and an opportunity to show that the same tools that help vet third parties in this risk area can be useful in many others. Listen in to learn more about his thoughts about 2024 and to prepare for a successful 2025. Listen now…
By Adam Turteltaub Retaliation is the bane of every compliance program, with the potential of destroying employee confidence in reporting systems, not to mention embarrassing and expensive lawsuits. It is also complex and can be subtle, explains Keith Read, a former chief ethics and compliance officer and author of the book The Unconventional Compliance Officer: Doing Things Differently. There is overt retaliation, such as firing an employee for blowing the whistle. But there is also softer, more subtle retaliation, such as not including the whistleblower in meetings or on projects. He advises compliance teams to be sensitive to all of the many forms of retaliation and to treat it as a risk area. That means look at where and how retaliation can occur, and then take the time to determine if is occurring. Track how the careers of whistleblowers go and see if the trajectory has changed for the worse. Also, look to patterns in management. He found that retaliation followed certain managers around the organization. With this data in hand, you are better able to both support the whistleblower and foster a stronger culture of compliance. Listen in to learn more about how to prevent retaliation from undercutting your compliance program. Listen now…
By Adam Turteltaub How do you know your compliance program is working, both for your peace of mind or if the government comes knocking? It’s a tough question, and many wonder either how to start measuring or if they’re measuring the right thing. Andrew McBride, Founder & Chief Executive Officer at Integrity Bridge, has a great deal of experience in this area from his time serving as Chief Compliance Officer at Albemarle. In the wake of an FCPA scandal, the company had to be able to demonstrate the strength and effectiveness of its efforts. In this podcast he advises you remember three key questions from the US Department of Justice’s compliance program evaluation criteria: Is the program well designed? Is it applied earnestly and in good faith? Is it working? At the same time, though, he cautions not to just seek simple metrics alone. It’s important to also track why you are measuring what you are measuring. Compliance teams need to take the time to build out the supporting narratives that explain why and how their choices were made and have a fully written out risk assessment. These documents help guide what is measured and establish why those measurements are worth taking. Having the narrative in place also helps the program keep its focus. Over time people change and memories fade as to why a given compliance path was taken. With strong documentation of the original thinking, the compliance team can better assess if the program is delivering what it needs to or if it needs adjustment. When it comes to who does the analysis of the data, he highly recommends hiring a data analyst. These individuals have the capacity to turn the numbers into meaningful dashboards and graphics that everyone can understand. They can also be adept at finding data where you might not think to look. Listen in to learn more about how to effectively measure the effectiveness of your measurement efforts. Listen now…
By Adam Turteltaub Oh, come on, we all know it: sometimes the business people get tired of all those compliance requirements. That’s okay and to be expected. But, how do you know when it has progressed beyond the usual (and maybe healthy) resistance to full-blown exhaustion? Cecilia Fellouse, General Manager of Compliance for Good, warns that, ironically, when the business team stops pushing back, it can be a sign of compliance fatigue. They may just be going behind your back to get what they want. Another troubling sign to watch out for is systematic escalation. Instead of addressing issues to you, they’re taking the issue straight to higher-level management. So, what can cause compliance fatigue and these bad behaviors? She cites several factors and ways to avoid them. Saying “no” too often and being perceived as operating from an ivory tower. Constantly denying requests without providing constructive feedback can make the compliance team seem out of touch. Lack of engagement with frontline teams. Take the time to talk with them and learn their needs Limited or lack of support from top management. Without their support, the job is all but impossible An isolated compliance team. Without interaction with others, including members of the compliance community, it’s easy for the compliance team to get burned out. You need to make the effort get out there and connect. She also strongly advocates for taking the time to truly understand the business, not just as a whole but also on a more granular basis, down to what is done day to day. Listen in to learn more, including some signs to watch for in the compliance team that suggests that it, too, may be suffering from compliance fatigue. Listen now…
By Adam Turteltaub Do you ever ask yourself, “What kind of compliance officer am I?” Netherlands-based Susan du Becker, Director, Risk & Compliance at Microsoft, thinks we all should. To her experience, there are two answers to that question. One is a regulatory compliance officer: someone who is focused on the requirements of regulators, potential fines and legal consequence. The other is a business compliance officer, who is focused on what the business needs and how to ensure it achieves its goals while staying within the multitude of white lines the laws and regulations have painted. She envisions herself as the latter, balancing business and regulatory requirements. She recognizes that the business unit will test the limits, and that she is there to make sure there are always two feet solidly on the ground. To keep the business team focused on their legal and regulatory obligations, she advocates for making it clear what lines absolutely may not be crossed, taking the time to meet with them regularly and being prepared to have some difficult conversations if necessary. She also believes that compliance teams are most effective when not positioning themselves as just a gate keeper. Listen in to learn more about the approach, the role of governance and how to ensure the business understand this it owns compliance. Listen now…
By Adam Turteltaub Rob Tull (LinkedIn), Managing Director at Effective Compliance LLC wants every compliance officer to be both competent and able to demonstrate it. He advocates for the development of four sequential, underlying skills: Communication The ability to be aware of risks Adaptability, and Decision-making/judgement Underlying all of them is knowledge, and together they form a framework for effective compliance programs. The single most important competency area, he argues, is communication. The ability to translate complex laws and regulations into simple language that helps the business make good decisions is paramount. So, too, is the ability to tailor your message to the audience: management and the board likely need to hear something different than line managers. Listen in to learn more about what makes for competency for compliance professionals. Listen now…
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Compliance Perspectives
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By Adam Turteltaub Who are you talking to? When you think about all the employees in your organization, who do you see in your mind? You probably, and should, think of several people: the person in the plant, the R&D people, the sales team. They all have different needs, maybe even different cultures. Adam Balfour, Carsten Tams and Karen Moore (LinkedIn), each of whom is a veteran compliance professional, explain in this podcast why it’s so important to truly know who the people are in your organization and the risks they interact with. They explain that you have to take the time to get in their heads to understand what their needs are and how best to communicate with them. One technique they advocate for is developing personas: Create fictional, yet realistic descriptions of the types of people in your organization. That will help you better flesh out who they are, their goals and their skills. This process also helps you stand in their shoes and understand not what you want to say but how they are likely to interpret and use that information. Listen in to learn more about how to bring your workforce to life in front of you and have a real impact on their behavior. Listen now…
By Adam Turteltaub It’s a complex world, we all know, and we all try to simplify it and our lives, at least from time to time. Nitish Upadhyaya, Director-Behavioral Insights at Ropes & Gray’s R&G Insights Lab and podcaster, wants compliance teams to appreciate complexity and, if not embrace it, at least understand how to work with it. For him this journey started many years ago with the recognition that disincentives don’t always work. He wanted to understand why. This led him to an understanding of complexity, which explores the connections between people and systems and how nonlinear and unpredictable things can be. Appreciating that knot of connections is important for compliance teams, he argues, since the nature of the job involves affecting individual behavior and culture. He outlines several principles that compliance teams should follow: Move away from the idea that you can map everything. Context matters. Understand the human dynamics and stories. The only real rule in a complex system is it will have unintended consequences. When dealing with a complex system, think of the direction you want, not just the end point. It's about managing energy in the system and following natural contours Anomalies are helpful. Outliers can be your next risk or innovation. Map constraints, the things that connect or limit people, such as fear of retaliation or cultural issues, And when it comes to a root cause analysis, dig until you find not just the root, but the several roots that likely underlie it. Listen in to learn more about approaching and harnessing complexity. Listen now…
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Compliance Perspectives
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1 Kelly Willenberg on the Latest Edition of the Research Compliance Professional’s Handbook [Podcast] 9:44
By Adam Turteltaub The Health Care Compliance Association just published the 4th edition of the Research Compliance Professional’s Handbook, and to see what’s new in it we sat down with the editor, Kelly Willenberg (LinkedIn) of Kelly Willenberg & Associates. The Handbook, she explains is there to help both those who attend the HCCA Healthcare Research Compliance Academy and anyone looking for a desktop reference that addresses the fundamentals of research compliance. It addresses topics such as safety, privacy, monitoring, and biosecurity. For this edition each chapter was reviewed thoroughly with any and all necessary updates made, including to the chapter on FDA regulations. In addition, a new chapter was written to address AI. It defines what AI is and why compliance teams need to look at it from a risk management perspective. The chapter also addresses the integration of AI and how therapies are changing. One admonition that she provides for compliance teams is to watch Europe. As with privacy, Europe has taken the lead in AI regulation. Be sure to listen in and then take a look into buying your own copy of Research Compliance Professional’s Handbook, 4th Edition. Listen now…
By Adam Turteltaub It’s one thing if a company wants to protect its trade secrets. But, what if it wants to keep its dirty little secrets from getting out? Then, the SEC may want to step in. Stephen Cohen (LinkedIn), partner at Sidley Austin, and a former senior leader in the Enforcement Division at the SEC, explain in this podcast that, to understand the issue, we need to look back to the Dodd-Frank Act. The law led to the SEC whistleblower program and included anti-retaliation authority. The SEC believed it had implicit authority to punish efforts that impeded direct communication by whistleblowers with the Commission and its staff. Both the SEC and CFTC have created similar rules prohibiting organization and individuals from taking any action that inhibits someone communicating directly with the SEC about a possible securities law violation. The SEC has interpreted that to mean that language in non-disclosure and severance agreements, codes of conduct, policies and elsewhere that either require employees to report issues internally rather than to the government, or require non-disclosure to the government as a condition of severance, are illegal. Several companies have since run afoul of the SEC on this issue, with cases going back to 2015. So what should companies do? For one, make sure that they are properly balancing the need to protect confidentiality without interfering with whistleblowing. Watch for language prohibiting disclosure of information to third parties that doesn’t provide an exception for the government. Be on the lookout, too, for policies requiring departing employees to attest that they did not disclose information to the government. Look, too, at what your employment agreements say. Likewise, watch what language you include in agreements with your third parties. The SEC looks askance, there, too, to language that it perceives would inhibit reporting of wrongdoing. Listen in to learn more about this evolving issue and its many pitfalls. Listen now…
By Adam Turteltaub Greg Walters is an attorney in the Cyber Risk and Governance Branch at the SEC. But in this podcast he’s not speaking as an enforcer but as someone who has seen a lot of compliance training during his career as a government attorney across numerous agencies. He warns that while an organization may boast of 100% completion rates for their training, that doesn’t mean 100% of the employees got the message. That’s especially true of online training, where, unlike live training, it’s hard to tell if people are truly following along and then adjust the learning. The goal, he argues, is not to just give knowledge but to affect behavior. So, to see what impact the training has had, look to changes in the number of types and questions you receive, as well as incidents that do or don’t occur. Also, take the time to understand your audience and make sure that the training is relevant to them and reflects the culture of the organization. Listen in to learn more tips for improving the effectiveness of your compliance training program. Listen now…
By Adam Turteltaub There is an expectation in many, if not most people, that at some point they will, or should be, promoted. But how do you know if you are ready? And, once you are promoted, what does it take to succeed in your new role? To find the answers we spoke with compliance veteran, Debbie Hennelly, Founder & President of Resiliti. The first piece of advice she shares is that not everyone needs or wants to be a manager. For many it’s okay to say that they love being a subject matter expert and advisor, and they aren’t ready, or maybe never will be ready, to be something else. If you are looking to move up, how do you know you are ready? She reports that you don’t until you are actually in the job. That’s especially true for compliance people, since we who often don’t benefit from the leadership and management training that is given to other parts of the organization. Once in the role, let the team know that you value them. If there was someone else on it that you beat out for the role, acknowledge the situation and let the person know you recognize the sensitivities and hope to earn their trust. If you are new to the organization, know that it’s okay and better to spend the first 90 days doing a lot more listening than talking. Resist the urge to make changes until you have a better understanding of the organization’s culture. Also, take the time to introduce yourself to peers and leaders. Ask them about their roles and how you can support them. Listen in to learn more about how to step up successfully. Listen now…
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Compliance Perspectives
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By Adam Turteltaub What if you had a compliance program and nobody noticed? It’s not likely. But what if you had a compliance program, and nobody understood what it did? That, sadly, is more than a bit of an ongoing problem. To take on that challenge we spoke with Carolina Santos de Silva, Head of Ethics & Compliance EMEA for Bridgestone EMEA and Pauline Blondet, Co-Owner and Chief Operating Officer of Upright Solutions. The two recently published the article “How to Sell Ethics and Compliance to your Organization” in the October issue of Ethikos. They persuasively argue in this podcast for compliance teams to think about their product, brand and having a robust message. Start with your product. Is it ethics, ethics and compliance, integrity? Think through which best defines what you are offering. Your brand is the image the compliance team communicates within the organization and what differentiates you from other departments. It needs to reflect the department’s message. From the brand will come a pitch, or your department’s elevator speech. It should introduce yourself, present your why or purpose, explain what it is that the organization is facing as a challenge and introduce the solution you are providing, and include a call to action. Some other pieces of advice they offer are: Define who your target audiences are, including an assessment of where they are when it comes to compliance, what you expect from them and what the gaps are. To gain leadership support, help them understand the broader compliance context in which the organization operates. Don’t assume leadership understands its role within a compliance program. Show them and then thank them when they help. Seek out as many touchpoints with the workforce as possible. Remember that who sends the message can be just as important as the message itself. Listen in to learn more about strategic and innovative ways to sell your compliance program internally. Listen now…
By Adam Turteltaub With the explosion of sanctions regimes globally, and particularly in the US, most any company that exports just about anything now has to have a trade compliance effort. To understand what that entails we spoke with Julia Komarovskaya, Export Compliance Manager at MathWorks. It’s a complex challenge, she explains, with the Bureau of Industry and Security (BIS), International Traffic in Arms Regulations (ITAR), and Office of Foreign Assets Control (OFAC) all having a say, and often with overlapping jurisdictions. Organizations need to watch what goods they export, to where and to whom. Knowing your customer has never been more important. To navigate this minefield, she recommends first recognizing that the rules don’t apply only to goods. Services can be covered as well. Also recognize that exporting something as innocuous as a pencil could be prohibited, if sent to the wrong person. Developing an export control program right takes understanding what you are exporting now, working closely with the business team as early in the process as possible, and planning for the long term since regulations are guaranteed to grow more complicated over time. Listen in to learn more about the basics of the complex world of trade compliance. Listen now…
By Adam Turteltaub Reports are that there over 50 million people in the world living in modern slavery conditions, and, of those, 60% work in forced labor in the private economy. Ensuring that your organization isn’t sourcing from suppliers who victimize labor is both a moral and a legal obligation, with more and more jurisdictions enacting legislation in this area. Vera Belazelkoska, Managing Director at Ulula urges organizations to look to balancing this risk with a mixture of boots on the ground and technology. Both, she notes, have their virtues and limitations. While having someone visit a factory provides an eyewitness account, it’s expensive, and unscrupulous manufacturers may hide the truth from investigators. Technology solutions are less expensive, but they are not necessarily as precise as they could be, often providing country data, but not the granularity needed. Only with a prudent mixture of the two can an organization gain a better understanding of its supply chain and the presence, or absence, of modern slavery in it. Listen now…
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Compliance Perspectives
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By Adam Turteltaub There are hundreds of Compliance Perspectives podcasts, and this is the first one that is a podcast about podcasts. More specifically, the podcasts created by the compliance team at John Deere. The compliance team there had long looked to a wide range of tools for reaching the workforce including a monthly email newsletter, channel on internal social media, an intranet site and even digital signs on TV screens at their facilities. Yet, despite all this effort, they knew they could do more. As Wendy Davies-Popelka, the Associate Director, Global Ethics & Compliance, explains, the compliance team was listening to and hooked on several podcasts, and it occurred to them that they should try and create one of their own. So, they did. The podcasts are generally 5-10 minutes long and are based on actual cases that occurred at the company. Investigators, business people and others are interviewed to tell the story, from initial allegation through dispensation. The series has been very successful with a growing audience. Importantly, it has demystified the compliance program. To learn more about the podcasts and how easy they can be to create, be sure to listen to this podcast about John Deere’s podcasts. Listen now…
By Adam Turteltaub Psychological safety is a term we hear a lot in business and elsewhere. It’s also a concept that Jen Mason, Vice President, Enterprise Compliance & Ethics at McKesson, thinks we in compliance should embrace. It means creating an environment where employees can feel comfortable expressing their thoughts, ideas and concerns without facing negative consequences. It’s not about being nice. It’s about listening, following through on what you say you will do, being respectful of the workloads of others and showing empathy. It’s also about not punishing mistakes, pushing people until they burnout and talking more than you listen. It’s also about having policies that are flexible but consistent. Listen in to learn more about how to create psychological safety, including at those difficult times when there may be a conflict. Listen now…
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