Podcasts about regulatory

SUMMARY: Brian, Brandon, and Aaron focus on AI watermarking, driven largely by EU transparency requirements, and discuss how approaches like token-selection patterns can be detected but were reportedly cracked quickly with tools that strip watermarks. Brandon and Brian debate whether watermarking is useful long-term, suggesting most people care more about whether content is helpful than whether AI was involved, and questioning the added cost and real-world impact of such regulation. They also explore implications for education policies that ban AI use, changing assessment methods to curb cheating, and potential enterprise and government procurement issues where “no AI” requirements could trigger disputes and lawsuits, while AI review may also level the playing field in contract understanding.SHOW: 1058SHOW TRANSCRIPT: The Enterprise AI Show #1058 TranscriptSHOW VIDEO: https://youtu.be/6zlN_oIR5XcSHOW LINKS:Anthropic WatermarkingClaude Support on WatermarkingSHOW SPONSORS:Nasuni - Activate your data for AI and request a demoTopic: Anthropic recently started invisibly watermarking all Claude-generated text and files (Aug 11), joining Google (SynthID) and ~190 companies that signed the EU's AI Act Transparency Code. Article 50 became enforceable August 2, with fines up to €15M or 3% of global turnover for non-compliance. Within 24 hours of Anthropic's announcement, a free tool to strip Claude's watermark showed up on GitHub.Core question: Is watermarking building durable AI provenance infrastructure, or is it a regulatory checkbox that breaks the moment someone runs a paraphraser?Discussion angles:The cat-and-mouse problem: Watermarks degrade with editing/paraphrasing/translation by design; light edits survive, heavy rewrites don't. Is a signal that vanishes under normal use actually useful, or just plausible deniability for labs?Regulatory arbitrage: EU forces the mandate, but xAI hasn't signed the voluntary Code. What happens to companies operating in the gap, and does the EU rule become a de facto global standard the way GDPR did?What it's actually good for: Not a lie detector, a provenance/tamper flag. Useful for enterprise content authenticity and platform moderation pipelines, much less useful for catching a student or a bad actor who just runs one rewrite pass.FEEDBACK?Email: show @ the enterprise ai show dot comBluesky: @TheEntAIShow.bsky.socialTwitter/X: @TheEntAIShowInstagram: @TheEntAIShow

There is a strange thing happening in rental housing across the United States.If you looked only at national statistics, you might conclude that the business of owning an apartment is largely unchanged. Since January 2025, more than forty states have passed, published, or court-decided something that touches deposits, notices, fees, or evictions. Each individual change can look small.Taken together, they represent something much larger.---------**Real Estate Espresso Podcast:** Spotify: [The Real Estate Espresso Podcast](https://open.spotify.com/show/3GvtwRmTq4r3es8cbw8jW0?si=c75ea506a6694ef1)   iTunes: [The Real Estate Espresso Podcast](https://podcasts.apple.com/ca/podcast/the-real-estate-espresso-podcast/id1340482613)   Website: [www.victorjm.com](http://www.victorjm.com)   LinkedIn: [Victor Menasce](http://www.linkedin.com/in/vmenasce)   YouTube: [The Real Estate Espresso Podcast](http://www.youtube.com/@victorjmenasce6734)   Facebook: [www.facebook.com/realestateespresso](http://www.facebook.com/realestateespresso)   Email: [podcast@victorjm.com](mailto:podcast@victorjm.com)  **Y Street Capital:** Website: [www.ystreetcapital.com](http://www.ystreetcapital.com)   Facebook: [www.facebook.com/YStreetCapital](https://www.facebook.com/YStreetCapital)   Instagram: [@ystreetcapital](http://www.instagram.com/ystreetcapital)  

In this episode, Holly Buckley, Chair of Healthcare at McGuireWoods, discusses the latest healthcare private equity trends, including transaction volume, physician practice investments, AI adoption, state regulations and the outlook for deals and exits. Overview – McGuireWoods Healthcare Growth & Operations Conference 2026. Online registration by Cvent

Global prediction markets are booming. Trading volumes reached a record US$24 billion in April this year, heavily driven by excitement over the FIFA World Cup and sports betting. But with that expansive growth come risks. Recent high-profile cases alleging insider trading related to the markets have alarmed businesses over the fear employees could exploit their nonpublic information for personal gain. Regulators have taken notice, and enforcement is on the rise. How can businesses protect themselves from insiders who might use the prediction markets for ill gain? How significant is the enforcement and regulatory impact on companies? And what's on the horizon as the prediction markets continue to captivate the public? Join The Sidley Podcast host and Sidley partner, Sam Gandhi, as he speaks with two of the firm's thought leaders on these issues — Ian McGinley, a partner in Sidley's Securities Enforcement and Regulatory and White Collar Defense and Investigations practices and a former Commodity Futures Trading Commission director of enforcement, and Matthew Podolsky, also a partner in Sidley's Securities Enforcement and Regulatory and White Collar Defense and Investigations practices. Matt is a former acting United States attorney for the Southern District of New York and former chief of their Securities and Commodities Fraud Task Force. Together, they discuss the exponential growth of the prediction markets, what is driving that growth, and the real-world risks of insider trading prosecutions related to engaging with those markets. Executive Producer: John Metaxas, WallStreetNorth Communications, Inc.

The Independent Communications Authority of South Africa (ICASA) says it has identified regulatory failure in satellite spectrum licensing following an inquiry. The Authority says this has led to it drafting amendments to the Radio Frequency Spectrum Regulations of 2015, and the Radio Frequency Spectrum Fees Regulations of 2010. The Ammendments aim to enable direct-to-device satellite connectivity for all South Africans, including underserved communities. This means that connectivity will no longer just rely on terrestrial networks, but also satellites. This came out of the virtual public hearings on the Draft Amendment to the Radio Frequency Spectrum Regulations of 2015, and the Draft Amendment to the Radio Frequency Spectrum Fees Regulationso of 2010. Nothando Magudulela reports...

Yahoo Finance reported that Nvidia is in talks with South Korean AI chip startup Rebellions about a potential deal, with no terms disclosed. Nvidia, led by CEO Jensen Huang, seeks to extend its platform reach as startups look for distribution, software compatibility, and market access. A partnership could take the form of a minority investment, joint development, or distribution, with developer tooling and CUDA integration central to adoption. Supply considerations and local support in South Korea could influence delivery timelines and procurement. Competitive pressure from AMD, Intel, cloud providers' custom silicon, and local players like FuriosaAI provides context. Regulatory reviews, shaped by precedents such as Mellanox's approval and Arm's failed sale, may affect scope and timing. Founders should prepare for heterogeneous AI fleets, multi-chip support, and co-selling requirements in enterprise sales.Learn more on this news by visiting us at: https://greyjournal.net/news/ Hosted on Acast. See acast.com/privacy for more information.

The dominant structural shift explored is the erosion of document-based differentiation for MSPs and IT service providers, driven by advances in generative AI, regulatory mandates, and automation of AI detection and content creation processes. Regulatory requirements such as the EU AI Act are compelling vendors like Anthropic and Google to introduce invisible watermarks on machine-generated content, while vendors including OpenAI have yet to standardize this practice. At the same time, third-party entities such as BlazeHive are automating the production and humanization of AI-generated output, raising concerns about the long-term viability of artifacts as proof of human oversight or competency. Evidence cited includes Anthropic's implementation of invisible watermarks on content produced by its Claude model, fulfilling regulatory obligations and planning to release detection tools to third parties. The durability of these watermarks is limited: "light editing probably won't strip the mark, but a complete rewrite... will" according to Anthropic's own guidance. Market analysis by Ramp shows a ceiling on enterprise spend for premium AI models like Anthropic's Fable 5, with adoption of high-end models remaining restricted in practice, and cost pressures pushing organizations towards locally-run, unmetered models such as Alibaba's recent release. Additional developments reinforce the structural gap in process and talent. Channel Dive and Information Week report that IT providers face increasing difficulty deploying the AI tools they sell, not because the tools are unavailable, but due to a lack of engineering skill and process clarity. Gartner's research, as reported by Information Week, identifies that failures in deploying AI agents stem from breakdowns in business process definition, not deficiencies in the technology. These trends illustrate that service providers' core asset is not tooling but an explicit, transparent process with clear review and accountability—something that automation and documentation alone cannot supply. For MSPs and IT service providers, these trends create risks around vendor substitution, diminished artifact value, and increased client scrutiny. The implication is a need to codify review standards and accountability practices for deliverables, as automated AI output can no longer serve as a market differentiator, and clients now have both the suspicion and means to probe the origins of documents. Differentiation will shift toward the ability to transparently describe, defend, and consistently execute meaningful human review and oversight—not merely the ability to generate professional-looking outputs. Providers who cannot articulate and document their review process may find themselves commoditized or excluded from competitive evaluations. 00:00 The Mark Arrives Everywhere  03:11 A Test That Can't Come Back No 06:38 Nobody Can Answer With the File 09:24 Why Do We Care?    Supported by:  OpenText Guardz 

In this episode, we explore Finland's upcoming regulated gambling market, focusing on the recent overturning of the absurd slot tax proposal by the Supreme Court, and discuss the implications for market regulation, channelisation, and industry adaptation.Key TopicsFinland's slot tax proposal and its overturning by the Supreme CourtImplications of the tax ruling on Finland's gambling marketThe role of the Supreme Administrative Court in gambling regulationChannelisation challenges and offshore competition in FinlandLessons from Swedish and Dutch gambling regulation modelsThe importance of stakeholder trust and collaboration in regulationPotential market adaptations and regulatory flexibilityImpact of regulation on black market and player protectionHost: Charlie HornerGuests: Joe Streeter & Ted Orme-ClayeProducer: Anaya McDonaldEditor: Anaya McDonaldLearn how Optimove's Positionless Marketing is changing how iGaming teams operate. Discover how operators are using Optimove's Positionless Marketing Platform to launch personalised CRM campaigns, dynamically change casino lobbies and bet slips, and create engaging gamified experiences. Learn more at optimove.com.Finally, remember to check out Optimove at https://hubs.la/Q02gLC5L0 or go to Optimove.com/sbc to get your first month free when buying the industry's leading customer-loyalty service. 

Peter Warren forklarer hva et hedgefond egentlig er, etter at Leopold Aschenbrenners fond kollapset, hvorfor shortlisten på Oslo Børs ikke betyr det folk tror den betyr. Resten går til strømregningen: norgesprisen, konsesjonskraften og hva en kilowattime faktisk koster deg.Kapitler(00:00) Intro og Skygard(00:52) Strømprisen: hva du faktisk betaler(03:55) Ukens marked: halvledere, Korea og Oslo Børs(05:07) Moonshot, H100 og bitcoin-rabatten(09:48) Krypto, gull og 30-åringen på 5,22(14:51) Borr Drilling: shortlisten som ikke handler om shorting(21:34) Hva er egentlig et hedgefond(35:41) Regnestykket bak norgesprisen(44:08) Parkering, overvåking og elsykkelen(53:23) Regulatory capture og AI-modellene(59:26) Boligmarkedet i Oslo må ned Hosted on Acast. See acast.com/privacy for more information.

Brian Dombrowski, Wyatt Larew, and Jay Maguire are our guest this week to discuss Hemp & Cannabis policy on Blazed Weekly News Podcast this week. A number of lawsuits have been filed as many of you know, also the 30 day extension was given on the federal side that could help industry members. Voting out bad Texas policies and politicians are discussed as well as corruption. Leave your thoughts below. 

Regulatory and compliance costs are taking a bite out of salad bowl producers in Monterey County.  It could ultimately affect food shoppers.  And a conversation with Farm Employers Labor Service to help farmers protect employees from heat and to stay compliant with heat illness regulations. The fines are costly.  

How do you take a model that works in process development and get it accepted for use in GMP manufacturing? That question stalls most bioprocess modeling projects before they start. Ignasi Bofarull-Manzano, Senior Data Scientist and CMC Consultant at Körber Pharma, pushes back on the premise: the process you run today is already governed by a mathematical model, fitted once at small scale during process characterization and then left untouched for years, even as the process shifts.Part 1 separated digital models from digital shadows and digital twins, and made the case for starting with the decision rather than the data. Part 2 goes into the plant: what regulators actually require, what the numbers looked like on a real biologics process, and where a team should start on Monday morning.Topics covered:Core differences—and surprising similarities—between modeling in development versus manufacturing (02:35)Regulatory requirements: credibility assessments, model risk, and validation steps for digital twins (05:07)Real-world example: How deploying an end-to-end process model led to 35% yield increase for Takeda, and considerations for ROI in manufacturing (08:34)Advice for startup leaders on when to invest in modeling and how to scale efforts case-by-case (11:42)Steps for scientists new to modeling: identifying bottlenecks, starting simple, and proving value offline before scaling up (12:26)The importance of understanding basic statistics before relying on AI-generated models (15:22)A stepwise summary for deploying digital modeling effectively in biotech (16:01)Smart insight: The digital twin is the last step, not the first. Identify the bottleneck, build the simplest model that supports the decision, and concatenate it end to end so you can see how a parameter moves final drug substance quality rather than one unit operation's output. Prove the value offline. Only then connect interfaces, because that is where the cost and the validation burden live. Teams that lead with the twin arrive at the C-level with a proof of concept and no evidence. Teams that lead with the offline model arrive with a number.Before a digital twin can earn its keep, you need connected data, the right model, and a clear decision for it to support. These four episodes cover that ground — data silos, hybrid and mechanistic modeling, and twins built to survive regulatory scrutiny.Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya BurkovEpisodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovEpisodes 17 - 18: How Extracting Gold From Your Data Accelerates Process Development with Ioscani Jiménez del ValEpisodes 263 - 264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David HardyConnect with Ignasi Bofarull-Manzano:LinkedIn: www.linkedin.com/in/ignasi-bofarullKörber Pharma website: www.koerber-pharma.comSupport the show

Most companies bring in regulatory expertise when they're ready to file. Leland Keyt, VP of Regulatory Affairs and Quality Assurance at Apreo Health, makes the case that by then you've already absorbed costs you didn't need to, and explains what early regulatory partnership actually looks like in practice.Leland and Nick get into why risk tolerance is the thing that catches scaling companies, the hidden costs of rework beyond timeline, how regulatory input changes product decisions across geographies, and what regulators are scrutinizing more closely now.A few of Leland's key takeaways:Early means concept phase, not pre-submission. Even your IP narrative can matter years later in a submissionCompanies often run more testing than they need. Efficiency means answering the right questions with the least dataRisk tolerance is what gets companies in trouble. What's acceptable in development isn't acceptable at PMAPost-market obligations happen underneath the water, and they're a resourcing problem more than a regulatory oneRework isn't just timeline, it's product cost and a supply chain issueBiocompatibility interpretation varies by geography and can change what you develop and whenAI, usability, and management review are all getting closer regulatory attentionBuild a scalable QMS. It's the bedrock, and it isn't an afterthoughtAbout Leland KeytLeland Keyt is VP of Regulatory Affairs and Quality Assurance at Apreo Health, which is running a US pivotal study for an implantable airway scaffold for severe emphysema. She has over 20 years in medical devices across startups, mid-size companies, and multinationals, previously serving as Chief Product Officer at Biorithm and Senior Director of RA/QA at Pulmonx, where she navigated FDA's Breakthrough Device Program to a 178-day PMA approval.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

Rae McMahan joins Over the Counter to discuss recent regulatory action involving CVS Caremark and the Federal Trade Commission, exploring what the collection of PBM reform efforts means for the greater pharmacy industry moving forward.

The Financial Times reported that some Anthropic investors are targeting a $2 trillion valuation in a record-setting IPO. Anthropic, led by CEO Dario Amodei and president Daniela Amodei, builds the Claude family of language models and emphasizes safety. Amazon announced a commitment of up to $4 billion in 2023 and Google invested in 2023, including a reported $2 billion convertible note, providing distribution and compute through their clouds. A $2 trillion debut would surpass Saudi Aramco's roughly $1.7 trillion listing by valuation and would test investor appetite for long-duration AI growth. The valuation case depends on revenue growth outpacing training and inference costs and on chip and cloud contract terms. Regulatory inquiries into big tech AI investments and ongoing copyright litigation could influence costs and market structure. Founders should watch cloud pricing, co-selling options, and procurement strategies as capital concentrates in AI.Learn more on this news by visiting us at: https://greyjournal.net/news/ Hosted on Acast. See acast.com/privacy for more information.

This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.volts.wtf/subscribeLast year I did a pod on Montana's surprising burst of bipartisan housing legislation. Turns out Idaho was watching. This year its legislature passed six housing bills of its own (two others failed). Republican state Sen. Ben Toews and Democratic state Rep. Megan Egbert join me to walk through what passed, what didn't, and what they gave away to get it done — plus the property tax cap that quietly works against all of it, and why duplexes turned out to be the red line.Chapters:00:00 – Introduction and the Idaho housing package02:43 – How each guest came to the housing issue06:39 – Inside the interim housing study committee09:05 – SB 1354, ADUs by right, and Dillon's Rule12:52 – The 5,000 to 10,000 compromise, and HOAs15:03 – SB 1352 starter homes, manufactured homes, lot splits16:28 – HB 706 and single-stair buildings18:11 – The permitting shot clock and the 6-day rule19:48 – Living with the compromises, and why counties were left out22:54 – The two bills that died: duplexes and YIGBY28:41 – HB 389, the property tax cap, and the growth undertow34:41 – What the public understands about growth37:23 – Regulatory reform on supply side vs. incentives for housing43:59 – The February deadline and city resistance48:52 – Horizontal vs. vertical density56:03 – What comes next for the committee & Idaho housing

Having an ISO 13485 Quality Management System in place does not automatically mean that your quality processes are effective.A strong QMS should help an organization identify problems, evaluate their significance, capture information from the market, investigate systemic issues, and continuously improve.In this Easy Medical Device podcast collection, we examine several situations that can reveal whether a QMS is truly functioning—or simply looks good on paper.Understanding NC vs CAPAOne of the most misunderstood areas of quality management is determining when to open a Nonconformity and when to escalate an issue into a CAPA.Not every isolated problem requires a complete CAPA investigation. However, when an issue becomes recurring, systemic, significant, or potentially high-risk, a deeper investigation may be necessary.The objective isn't to create as many CAPAs as possible. It's to recognize the problems that genuinely require root cause investigation and corrective action.Why “We've Never Had a Complaint” Can Be DangerousZero complaints may sound like excellent news, but it can also raise an important question:Is your organization effectively capturing all sources of customer and post-market feedback?Potential complaints may appear through distributor communications, service reports, customer emails, returned products, training feedback, or other customer-facing channels.If this information isn't properly evaluated, the organization may miss important product performance or safety signals.The Fake QMS ProblemA Quality Management System can look excellent on paper.Procedures exist. Forms are available. CAPA processes are defined. Risk management documentation is complete.But if employees don't follow those processes in daily operations, the QMS can become disconnected from reality.That's the core of the “fake QMS” problem: the documented system and the way the company actually operates become two different systems.During an audit, this gap can quickly become visible.Building a QMS That Actually WorksAn effective QMS should be integrated into everyday operations rather than maintained only for certification or audits.Problems should be identified and evaluated appropriately. Customer feedback should feed into complaint handling and post-market activities. Significant and recurring issues should trigger investigation, and lessons learned should contribute to continuous improvement.Ultimately, the goal isn't to create a perfect-looking Quality Management System.The goal is to create a QMS that helps your organization consistently identify problems, manage risk, improve processes, and support the delivery of safe and effective medical devices.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

On this episode of Chit Chat Stocks, Brett and Ryan speak with Alex Morris from TSOH Investing Research on the state of the media sector. We discuss: (00:00) Introduction (02:09) Major changes in the media sector over recent years (08:12) Disney's current position (12:51) The challenges and opportunities in sports (22:40) Impacts of social media platforms on media consumption (34:38) The influence of platforms like YouTube, TikTok, and Reels (44:24) Netflix's content strategy, gaming, and future directions (47:37) Netflix stock performance and valuation concerns (55:41) Regulatory and competitive landscape in media mergers TSOH Investing Research: ⁠https://thescienceofhitting.com/⁠ ***************************************************** Subscribe to our newsletter, Emerging Moats: ⁠emergingmoats.com⁠  ********************************************************************* Chit Chat Stocks is presented by Interactive Brokers. Get professional pricing, global access, and premier technology with the best brokerage for investors today:  ⁠https://www.interactivebrokers.com/⁠  Interactive Brokers is a member of SIPC.  ********************************************************************* Fiscal.ai is building the future of financial data. With custom charts, AI-generated research reports, and endless analytical tools, you can get up to speed on any stock around the globe. All for a reasonable price.  Use our LINK and get 15% off any premium plan: ⁠⁠https://fiscal.ai/chitchat⁠  ********************************************************************* Disclosure: Chit Chat Stocks hosts and guests are not financial advisors, and nothing they say on this show is formal advice or a recommendation. Learn more about your ad choices. Visit megaphone.fm/adchoices

The episode identifies an acute shift in liability and accountability across the software and AI supply chain, where risk increasingly moves from vendors to service providers and operators. This dynamic is illustrated through incomplete vendor patches, AI tool output, and changing regulatory structures. Companies like N-able experienced authentication bypass flaws in widely used remote monitoring platforms, while industry-standard software licenses continue to disclaim warranties and cap or exclude liability, leaving providers responsible for the consequences. A key development is N-able's N-central authentication flaw, wherein a patch issued for an earlier vulnerability proved incomplete according to the Federal Vulnerability Database, enabling attackers to exploit the same vector. The finalized fix arrived days after exploitation began, but all previous builds — including those labeled patched — remained exposed. Simultaneously, research from Anthropic and disclosures by OpenAI revealed AI models acting outside intended boundaries, with incident response often lagging behind real-world impact. Notably, neither affected vendor assumed material liability, and disclosure of the incidents was voluntary, not compelled by contract or regulation. Meanwhile, IBM's annual cost of data breach report found AI-driven attacks up 56% with average breach costs nearing $6M, further emphasizing financial exposure. These incidents exemplify a structural trend: vendors disclaim output, while client agreements with IT providers warrant monitoring, maintenance, and remediation, resulting in providers accepting risk not assumed upstream. Regulatory responses differ by geography — in the U.S., CISA's only binding obligation was for operators to remediate vulnerabilities by a set deadline, not for vendors to prevent or report them. The EU's forthcoming Cyber Resilience Act will require reporting of exploited vulnerabilities within 24 hours and is expanding product liability to software, but these rules benefit consumers and regulators rather than business buyers and still stop short of assigning financial obligations to vendors. The operational effect for MSPs and IT service providers is increased contract risk, as provider promises to clients typically outpace the limited, warranty-free commitments of vendors. The rate and scope of vulnerabilities, amplified by AI-driven development and remediation, add volume and complexity without increasing the rate of effective outcomes. Providers are advised to reconcile their own service agreements with the actual commitments of software suppliers, clarify for clients where their true responsibilities lie, and prepare for a procurement environment where scrutiny of vendor warranties becomes the norm rather than the exception. 00:00 The Ones Who Patched Got Hit 04:16 Sold As Is, All The Way Down 08:02 The Only Enforceable Promise 11:47 Why Do We Care?  Supported by:  Pax8 LogMeIn

The recent $14.1 million False Claims Act settlement against Complete Health Partners Holdings, a management services organization operating provider groups in Florida, Alabama, and Colorado, brings to light the role coders can play in False Claims Act cases.In this instance, it was alleged that Complete Health Partners Holdings directed physicians to add high-value, risk-adjusting codes for Drug and Alcohol Dependence and Major Depressive, Bipolar, and Paranoid Disorders to the medical records of Medicare Advantage patients when those codes were not indicated.So, listen and learn when special guest Liz Soltan, counsel for Whistleblower Partners, will discuss the role of coders in these cases.The popular weekly Internet broadcast will also feature these additional instantly recognizable panelists, who will report more news during their segments:• POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of California-Davis Medical Center, will share her point of view during the broadcast.• CDI Report: Cheryl Ericson will provide an update on all things clinical documentation integrity (CDI).• SDoH Report: Tiffany Ferguson will report on news happening at the intersection of compliance and medical record coding.• The Coding Report: Christine Geiger will report on the latest coding news.• Talk Ten Tuesday News Desk: Timothy Powell, will deliver the latest news from the Talk Ten Tuesday News Desk.

In this episode of Unsecurity, Megan, Brad, Nathan, and Eric unpack the recent 60-day pause on CMMC Phase 2 requirements and what it really means for contractors and subcontractors.The conversation goes beyond the headline to explore the ongoing importance of self-attestation, the risks of false claims, and why compliance is still very much on the clock.The team also breaks down the real costs of becoming assessment-ready, from initial scoping and technical debt to policy work, evidence collection, and third-party assessments.Along the way, they explain why shortcuts and “easy button” solutions can create bigger problems later, and why due diligence matters when choosing a compliance partner.If your organization is weighing whether CMMC is worth the investment, this episode offers a grounded look at the business, security, and operational tradeoffs involved.Be sure to like, subscribe, and hit the notification bell for more insightful episodes.#UnsecurityPodcast #Cybersecurity #FRSecure #MyTech #CMMC #DoWWe want to hear from you!Reach out at unsecurity@frsecure.com and follow us for more:LinkedIn: https://www.linkedin.com/company/frsecure/Instagram: https://www.instagram.com/frsecureofficial/Facebook: https://www.facebook.com/frsecure/BlueSky: https://bsky.app/profile/frsecure.bsky.socialAbout FRSecure:https://frsecure.com/FRSecure is a mission-driven information security consultancy headquartered in Minneapolis, MN. Our team of experts is constantly developing solutions and training to assist clients in improving the measurable fundamentals of their information security programs. These fundamentals are lacking in our industry, and while progress is being made, we can't do it alone. Whether you're wondering where to start or looking for a team of experts to collaborate with you, we are ready to serve.

In this episode, I talk with Ning Leng, Ph.D., Director II, Data and AI Acceleration Group, Data & Statistical Sciences at AbbVie, about the growing role of the R Consortium in the pharmaceutical industry. Ning brings extensive experience in statistics, computational genomics, open-source technology, and the adoption of R across the pharmaceutical industry. Before joining AbbVie, she spent 10 years at Roche Genentech, where she helped drive the adoption of R, cloud technologies, Git, and Shiny. We discuss how the R Consortium creates a platform for statisticians, programmers, pharmaceutical companies, and regulators to collaborate on practical challenges—and how that collaboration is changing the way we approach regulatory submissions.

Good morning from Pharma Daily: the podcast that brings you the most important developments in the pharmaceutical and biotech world. Today, we're diving into a landscape marked by remarkable scientific breakthroughs, strategic alliances, and regulatory milestones that are shaping the future of healthcare. Novo Nordisk is making waves with its new partnership with Amazon Web Services, utilizing artificial intelligence to accelerate drug discovery for chronic diseases. By integrating cloud computing and machine learning models, this collaboration highlights the increasing role of digital transformation in drug development. Novo Nordisk's commitment to innovation is further underscored by the launch of a new London Innovation Hub, enhancing research capabilities in the UK and demonstrating how technology can streamline the development of novel therapeutics. In clinical trial news, Silence Therapeutics has achieved a significant milestone with its investigational therapy Divesiran. This small interfering RNA therapeutic met primary endpoints in a Phase 2 trial for polycythemia vera, highlighting the potential of RNA-based therapies in treating complex blood disorders. Meanwhile, AbCellera's monoclonal antibody therapy ABCL635 has shown promising Phase 2 data for alleviating menopause-related hot flashes, surpassing existing treatments and underscoring the potential of targeted biologics in women's health. Regulatory achievements are further advancing personalized medicine. LabCorp received FDA approval for its PGDx elio tissue complete CDx companion diagnostic for BRAF-mutant advanced melanoma. This tool is pivotal for identifying patients who could benefit from targeted therapies, enhancing precision medicine approaches in cancer treatment. Similarly, AstraZeneca's Calquence and Enhertu have received notable endorsements, reinforcing the critical role of regulatory bodies in facilitating access to innovative treatments. The industry's business landscape is vibrant with strategic partnerships and acquisitions aimed at advancing therapeutic pipelines. Sobi's $580 million deal with Innate Pharma to advance lacutamab through Phase III lymphoma trials underscores how combining expertise can accelerate drug development and commercialization efforts. Financially, companies like Denali Therapeutics are surpassing revenue expectations with products like their enzyme replacement therapy Avlayah for Hunter syndrome, while fundraising activities are empowering biopharmaceutical companies to drive forward pain and oncology initiatives. Despite these advances, challenges persist. Sionna Therapeutics' recent clinical setback in cystic fibrosis reinforces Vertex Pharmaceuticals' dominance in CFTR modulator therapies. Additionally, Tenax Therapeutics encountered disappointment with TNX-103 failing to meet primary endpoints in a Phase 3 trial for pulmonary hypertension associated with heart failure. Manufacturing capabilities are also a focal point as Bristol Myers Squibb plans a substantial investment in Houston, reflecting an industry trend towards expanding infrastructure to meet demand and ensure supply chain resilience. However, compliance remains critical, as seen with Scholar Rock's decision to drop Novo Nordisk's Catalent facility following an FDA inspection. In contrast to setbacks, some companies are achieving breakthroughs. Jazz Pharmaceuticals' acquisition of Actio Biosciences aims to enhance their epilepsy treatment portfolio by integrating clinical-stage assets into its pipeline—a strategic move reflecting ongoing consolidation within the industry. The promise of genetic-targeted therapies is vividly illustrated by Biogen's ALS treatment Qalsody, marking a major scientific breakthrough as the first FDA-approved drug targeting a genetic cause of ALS. Patients have reported symptom stabilization and improvement—a significant advancement given ALS's progressive nature. Meanwhile, psychedelics are emerging as transformative agents in psychiatric medicine. As traditional medications often fall short, psychedelics offer hope for innovative mental health therapies supported by growing clinical and policy backing. However, navigating regulatory landscapes remains challenging. The FDA's recent actions illustrate ongoing struggles to balance innovation with oversight amidst leadership transitions. Real-world evidence is increasingly influencing regulatory decisions—reshaping how companies approach market access strategies by integrating patient experiences into evidence-based decision-making. In oncology, Replimune's melanoma drug has finally earned FDA approval after previous setbacks—a testament to persistence and the potential impact of innovative cancer therapies on patient outcomes. These developments underscore a dynamic pharmaceutical and biotech industry where breakthrough technologies like genetic-targeted therapies and psychedelics promise transformative impacts on patient care. Yet, they also highlight the complexities of bringing these innovations to market amidst stringent regulatory standards and competitive pressures. As we continue to track these stories, one thing is clear: the relentless pursuit of novel treatments remains at the forefront of advancing global healthcare.Support the show

Welcome to RIMScast. Your host is Justin Smulison, Business Content Manager at RIMS, the Risk and Insurance Management Society.   In this episode, Justin interviews RIMS SERMC Member Eric Lobser about his career path at Spire Inc. They discuss his start in Budget Analysis at Laclede Gas, which eventually became Spire Inc. He moved into Operations, Treasury, and then Strategic Planning, including Acquisitions. He continued his career as VP of Enterprise Risk Management. Eric shares how he grew into that position, using knowledge he had gained from all the departments he had worked with. He tells about his early presentations to the Board. Eric explains what ERM means to him, and how ERM helps companies manage risks, including reputation, engage in opportunities, and make the resource allocation decisions that lead to success and mitigate failures.   Listen for Eric's idea to improve the ERM acronym.   Key Takeaways: [:01] About RIMS and RIMScast. [:16] About this episode of RIMScast. Our guest is Eric Lobser. He was a practitioner in the natural gas sector for 35 years. We're going to get his ERM philosophies today. But first… [:42] RIMS-CRMP Workshop. We are delighted to announce that on August 27th and 28th, RIMS President Manny Padilla will be leading the two-day in-person workshop at St. John's University at 101 Astor Place in New York City. A link to the registration is in this episode's show notes. [1:02] RIMS-CRMP Virtual Workshops. RIMS will partner with PARIMA for the RIMS-CRMP Exam Prep on September 1st and 2nd. Registration links are in this episode's show notes. [1:13] Also on the webinars page, you will see a two-part series hosted by the RIMS Membership Department. The "Classroom to Career" webinar series highlights how RIMS equips students with the knowledge, skills, and connections needed to thrive in risk management careers. [1:28] Participants will gain insights into industry trends, career pathways, and practical tools that help them confidently step into the evolving world of risk management after graduation. These sessions will be hosted on September 1st and 9th. [1:41] These sessions are member exclusives and are complimentary for RIMS members, of course. So, if you are interested in becoming a member, this would be the time. Visit RIMS.org/membership. [1:51] RIMS is back on YouTube. Our handle is @RIMSOfficialChannel. We've got plenty of videos there, including RIMScast, RIMScast Canada video podcasts, and other informative and entertaining content from RIMS. Subscribe to the channel today! [2:10] On with the Show! We will take a deep dive into Enterprise Risk Management with Eric Lobser. Eric recently retired from a 35-year career in the natural gas sector. He remained with one company that eventually became Spire Energy. [2:26] Eric is also a member of the RIMS Strategic and Enterprise Risk Management Council. [2:32] We will discuss his career journey, how one role led to the next before settling on Enterprise Risk Management, and his philosophies on what makes ERM truly valuable and why the acronym could use an upgrade. Let's get to it! [2:52] Interview! Eric Lobser, Welcome to RIMScast! [3:17] Justin and Eric met last year during a webinar. Eric has a fascinating career. His entire career was at Spire. Originally, it was Laclede Gas Company. Then it became The Laclede Group, and then Spire. Eric's career was 35 years and some months long. [3:53] Justin says that shows our audience that you can have a risk career at one company. You don't need to jump around. If you're doing well, if you're comfortable, if the company's treating you right, and you're doing a good job. [4:10] Eric says the risk career came later in his life. It was the culmination of a lot of other things he did. He had a varied set of positions at Spire. Over time, it was multiple types of companies. As you go through CEOs, things change. [4:31] Eric says he was there for about five CEOs and got to see many different sides of how business operates. [4:49] Eric says he graduated from Boston College in 1990. It was a tough job market. He wanted a job on the East Coast, but it was an expensive place not to have a job. He went back home. [5:08] His stepfather had a contact at the Laclede Gas Company. He interviewed, and they offered him a position, which he took. Within two weeks, he thought he would be crazy to stay at that company more than a couple of years. He thought it was odd they had a few computers. [5:29] Eric came from a school with a library full of computers. You had to sign up to use them. It taught him to use his mind, and it instilled patience. Those elements have been valuable to Eric's career. [6:06] Eric started as a budget analyst and did that for about a year and a half, in the corporate office in downtown St. Louis. [6:33] Then he was fortunate to move to Operations to do the same sort of work with all the department heads to help them with their budgeting, to translate things from Operations into financial terms and get better relationships with the people who ran the business. [6:53] Eric says he got to understand the business better from the view of the boots on the street. [7:04] Justin asks if risk management and ERM came onto Eric's radar in August 2001, when he became the Managing Director for Strategic Planning and Corporate Development. [7:18] Eric says that he had also worked with property insurance in Treasury. There's a big commodity risk at a natural gas company. There are also market risks and credit risks. [7:33] Eric says Strategic Planning was new to The Laclede Group, taking the budget period and extending it out three years, rolling in strategy and planning. [7:49] Eric helped them to develop software for business planning, custom-made from Access, to help support the Balance Scorecard they rolled out. It included something for Initiatives for making improvements, which were tied to Metrics.  [8:11] There were Action Items. There was a section where you laid out your different risks and what you were doing to mitigate them. The Action Items often required support from other areas. The software would put that into their business plan so they could see it and collaborate. [8:33] Eric says risk management and collaboration are hand-in-hand. [9:09] Eric speaks of a change in leadership, where they went from mostly looking at operational excellence and continual improvement to a more external look at other businesses, at ways to diversify within the gas industry: storage, pipeline, E&P, and more. [9:40] That was the beginning of the thought processes Eric would go through, looking at different businesses; what can go right with them, and what can go wrong. [9:57] Part of modeling acquisitions is taking a look at those scenarios and looking for the probability of a downside, what that downside looks like, and what will drive it. What has to go right to have the best case? What does the base case look like? What are those probabilities? [10:20] Eric says that was the beginning of understanding how risk and business go hand-in-hand. They can't have opportunity without risk. There's no reward without risk. Understanding that was an element of that job. [10:39] Eric was fortunate to have a tremendous boss during that time who helped him gain critical thinking about how things operate. [10:58] Eric says when they were looking at how other companies operate, they were companies within the gas industry, to stay within their knowledge base, and simplify their business, within the natural gas value chain, from wellhead to burner tip. [11:30] They were looking at exploration & production, gathering & processing, pipelines, underground storage, down to uses for it, including compressed natural gas for vehicles and local distribution utilities.  [11:58] Justin suggests that the 13-year period when Eric was in Strategic Planning and Corporate Development, holding several positions, was a key time in his career. Eric says yes, and it was his favorite period. He had gone to school for investment banking and acquisitions. [12:42] Eric says, at the same time, it was a tremendous amount of work. He thought maybe it wasn't the best place to spend his lifetime because of the level of work and stress involved. [13:04] Eric was married and raising a family, and that had to come into play, as well. He says while his wife was extremely patient with him during all those times, sometimes working around the clock, he felt it wasn't the right long-term opportunity for him. [13:20] Eric says one of the things he learned when he was doing acquisitions was developing models for how utilities make money. Eric worked with people who did rate cases at the company, to understand what drove cash flow. [13:47] In doing that, Eric learned how regulations work and how tariffs work. That led to asking himself, if this isn't the right career for me, taking a look at something next to it, which was regulatory and government affairs. [14:27] Eric had already started to learn about it. Once he was in charge, he based it on Missouri regulations. The first acquisition was a company in Kansas City, Missouri. [15:05] The second acquisition was Alagasco in Alabama, and that was a completely different type of ratemaking approach that was annual. They had a formal department. Eric was asked to develop something more formal for the entire company. [15:21] Eric says then they acquired Energy South, which brought them into Mobile and also Mississippi, a third rate jurisdiction. There was a mountain of information to climb. His drive and thirst for knowledge helped him up the curve pretty quickly. [15:53] Eric says relationships and the stuff between the lines are just as important as what you can read about and study. [16:12] Eric says, pulling from his enterprise risk career, one of the impacts is not just financial, but reputation. Reputation is a huge element of rate setting. Your reputation precedes you to the commission that oversees rate case litigation and the parties to the case. [16:47] The parties that are involved include industrials, AARP, low-income groups, an energy efficiency group, and other parties. [17:01] Understanding where they're coming from, and what they're trying to achieve, and working towards something that gives all parties some of what they want, is a key element. [17:18] If you were a bad operator; if you had a significant incident that showed you weren't a safe operator, or you weren't treating your customers well, then going into the rate case, people had their minds set that they wanted to give you not a rate increase but a rate reduction. [17:40] The value of the relationships and the reputation, the stuff that is gray and in between the lines, is not just about what the numbers are but who you are as a business. [17:56] A Quick Break! Many fantastic RIMS events are coming up in 2026. The 11th Annual Chicagoland Risk Forum will return to the Old Post Office on Thursday, September 24th, 2026. Visit ChicagolandRiskForum.org for more information. [18:12] The RIMS Western Regional Conference will be held from October 4th through the 7th in Seattle, Washington. The agenda is live, and registration is open. Visit RIMSWesternRegional.com and the link in this episode's show notes for more information. [18:29] Save the dates: October 18th through the 21st. We will be in Quebec City to celebrate the 50th Live RIMS Canada Conference. Booth sales are open, and sponsorship opportunities are still available. Advance registration is open now. [18:45] Visit RIMSCanadaConference.ca for more information. Also, remember to check out RIMS.org/Canada for our spinoff show, RIMScast Canada, hosted by National Conference Committee Chair, Aaron Lukoni. [19:00] The RIMS ERM Conference 2026 will be held on November 19th and 20th in Columbus, Ohio. Registration is now open. [19:10] Through August 21st, you can nominate a program for the RIMS ERM Global Award of Distinction. If you know of an ERM Program that is award-worthy, we want to hear about it. A link to the nomination form is in this episode's show notes. Visit RIMS.org/ERM2026. [19:29] We're already looking to RISKWORLD 2027, which will be held over four days in New Orleans, Louisiana, from April 18th through the 21st! The call for session proposals is now live and will stay active through August 21st. [19:44] RIMS members can exclusively register by September 4th for the best rate. And get first access to the hotel block. Hotel reservations open on October 28th, ahead of public registration. Sitting this out is the real risk! The link to registration is in this episode's show notes. [20:04] Let's Return to Our Interview with Eric Lobser! [20:31] Justin asks about compliance at a natural gas company. Eric says his career at a critical infrastructure utility delivering a relatively volatile product to people's homes was very safety-oriented with a lot of rules, regulations, and areas of compliance. [21:04] The whole industry faced a need to replace some of its aging infrastructure. That started when Eric was in Treasury and trying to think about how they would afford all the replacements they were going through. [21:22] It came again when Eric was in Regulatory, trying to understand the balance between safety and rates and what's best for the business and what's best for the customer. [21:53] Compliance is not something you can decide to do a little bit or a lot. You have to meet at least the minimum standards. Spire was always at that point but also found the benefit of going beyond that, to deal with it a little bit more strategically. [22:14] Spire was generally a group that looked at opportunities to do replacement in a way that overall was more cost-effective, exceeding requirements on their compliance. Compliance was an enterprise risk. [22:34] Eric says it was not just making sure they were in compliance, but also what the cost of compliance is and what if people change their minds and all of a sudden want us to do this or that? [22:53] Being a regulated utility, your rates are dependent on somebody deciding you deserve to have this. [23:02] Compliance was more often not physical replacement but putting in another pipe beside the old pipe and terminating the old cast iron pipe that had degraded and become a safety issue. [23:26] Spire always paid attention to where they were getting leaks or water potentially getting into the system and areas of geography that had similar types of risk. [23:39] Spire took a strategic approach to look at the information they were getting and figure out where to go and do wholesale changes rather than responding to risks as they popped up. [23:54] Eric says that was the approach where they took compliance and said if we do more, it probably can be better for us and better for the customer to take a better strategic approach. [24:19] Eric says it's inconvenient and sometimes problematic for people when there are workers in the street. Part of Eric's career was dealing with claims and issues that can happen with construction. The construction was necessary to make sure the system was safe. [24:53] Eric says the most prevalent claims were when they were doing excavation and hit something unmapped, like an underground dog fence or sprinkler system. To be cost-effective, they used reliable outside partners to replace these. [26:44] Eric says that every year, when he was in Strategic Planning, he would help put on a two-day conference for the Board to review company strategy and present new ideas. [27:01] Any time they found an acquisition opportunity that met the muster of the executives, they presented that to the Board. [27:!3] Eric says the Board is extremely interested in rate cases, which are the heart and soul of a utility's business. [27:28] Something Eric found helpful later in his career, doing regulatory work, was to pull together parties without overlapping interests, such as the Board and the Public Service Commission, to help them find agreement on why something was beneficial for the customers. [28:58] Eric says, for the first time or two, presenting to the Board was frightening. He was fortunate enough not to be leading the presentations. He reported to officers who helped develop the business planning and strategy. They helped Eric work his way into bigger roles. [29:32] Eric says when he became more involved in doing the modeling, one time he was called by the CEO to speak to the Board while he was on a family vacation. His wife reminds him of this. The Board was very interested in the upside case and downside case of a model scenario. [30:31] Eric says in that phone call he had to give the Board a rigorous view of why they should spend $1.1 billion on this acquisition. While exciting, Eric says presenting to the Board was a very stressful part of the job. They're relying on things that he's saying to them. [31:12] Eric says acquisitions have their own timeline and they develop however they want to. It's not like going to the grocery store to pick up something. When something pops, it pops, and it's all hands on deck. You don't stop until the job is done. [31:35] One more Quick Break! RIMS, The Foundation for Risk ManagementTM, is dedicated to shaping the future of the profession. By making a contribution, you are strengthening the global risk management community and investing in the future of the industry. [31:55] The Foundation also supports the Spencer Educational Foundation but has a different mission. The Foundation focuses on providing opportunities for those professionals who have already decided to enter risk management and are just getting started. [32:09] You can learn more about the Foundation by visiting www.RIMS.org/FRM.  While you're there, be sure to check out information about the Susan Meltzer Scholarship Fund, which was established to honor Ms. Meltzer, who was RIMS President in 1999 and 2000. [32:28] Susan Meltzer was a cherished RIMS President and contributed so much to RIMS and the greater risk community. Learn more at RIMS.org/FRM.  [32:36] Let's Return to Our Interview with Eric Lobser! [32:52] Eric says that it seems to him that if people viewed Enterprise Risk Management more as Enterprise Value Management, they would better understand that it's more about what you need to do to improve the value of your company. [33:19] In Eric's Strategic Planning days in Corporate Acquisitions, he learned that Expected Value is about changing probabilities, not just the impact of those probabilities. [33:32] Eric says Enterprise Risk Management does a great job of addressing both the likelihood and the impact of things going wrong and things going right. What you're building with ERM is value. You're adding to the value of the company. [33:46] Eric thinks more people would engage. It would resonate with a lot of the corporate cultures to look at ERM as a way to build value for the company. [34:08] Justin says that for almost eight years, Eric was the Spire VP of ERM. Justin asks if Eric was able to hit the ground running, going from Regulatory and Government Affairs into ERM. [34:32] Eric says the position started with Insurance, and then Commodity Risk Management, other elements of the business that helped him up the learning curve. From Acquisitions, Regulatory, Operations, and Customer Service, Eric understood a lot about the business. [34:55] Eric says having a couple of years when he was in charge of Spire's Insurance program, including Captive Management, where you retain risk instead of transferring it, was a great transition to eventually getting Enterprise Risk. [35:31] Eric says he read every book he could get his hands on in the time he had. He noticed some of the things they were doing were based on ISO 31000. Eric read through ISO and COSO. COSO felt very intricate and detailed. [36:10] Eric asked himself what the potential was that we were going to adopt something. The culture of the business manages the risk. ERM oversees how the business manages risk. Eric wanted to pick a framework that fit more with Spire's corporate culture. [36:39] Eric says ISO 31000 is adjustable. He felt like it was a good fit. It was more about strategy and enterprise than Spire's focus had been. It was not just about what could go wrong and what they should be concerned about happening, but what must go right. [37:22] Eric says that looped in what he learned in Strategy, what they have to do to be successful, and what could derail them from that. Spire transitioned a little bit less away from risks and more to strategic imperatives and what they had to do to achieve their strategic vision. [38:02] Justin asks about ERM conferences and what makes a great ERM session. Eric says it's a practitioner who has lived through it with real-world experience on what works, what doesn't work, and why it didn't work. [38:18] Eric says everything's specific to the company, so what works for one may not work for another. An experienced practitioner brings a level of credibility that is important. Eric wants a presenter who focuses on what helps a company be more successful in executing its strategy. [38:41] Eric says a lot of presentations go into risk registers and software, but in the end, risk management is change management, with very complex systems. The presenter should speak to engaging the business, getting different areas to collaborate, and making better decisions. [39:31] Eric says those decisions are about how you allocate resources. Resources are limited. You can't do everything, so you prioritize. [39:41] ERM helps you to prioritize better, using a process of identification and assessment, to help you understand how important a risk is in relation to other risks, how soon it needs to be dealt with, and what level of mitigation and controls you already have in place. [40:13] Eric says, ERM helps you determine if this risk is extremely well-managed and there are resources you can take away from it to put toward a risk that's less well-mitigated. [40:22] Eric says a good ERM session presenter talks about how ERM helps a corporation make better decisions and effectuate those resource allocations that then help that company to be more successful. That's what ERM is about, and when somebody talks about that, it resonates. [41:02] Eric says when he hears a concept that really resonates with him, he tries to pull those concepts together. He has used principles from the Enterprise Risk Oversight Committee. [41:44] Justin says the Global ERM Award of Distinction call for submissions is open. You can send in those nominations now. RIMS Global ERM Award of Distinction nominations are open through Aug. 21! [41:57] Justin asks Eric what makes an Enterprise Risk Management program award-worthy. Eric says some of it is going to be based on the eye of the beholder. Enterprise Risk should be customized to the culture. People are going to view what makes a great program differently. [42:28] Eric says that the SERMC is looking for, with the diverse perspectives of the members, a program that is well-integrated into Strategic Planning, helps the business make decisions, and most importantly, helps it be more successful, with fewer downturns, than their competitors. [43:09] Eric says the business manages risk. ERM can help oversee what they're looking at and turn its attention to important things, and help determine the best ways to mitigate or treat risk, or support what they are doing, so the strategy prevents threats from derailing the company. [43:33] Eric says, in the end, a company that is consistently successful is probably the mark of a good Enterprise Risk Management program. [43:51] Justin says, we're going to see you again on November 19th and 20th in Columbus, Ohio at the RIMS ERM Conference. You can get your nominations in now for the RIMS Global ERM Award of Distinction. We'll have a special awards ceremony, like we do every year. [44:07] Eric, it has been such a pleasure to have you on RIMScast! I look forward to seeing you in Columbus. [44:19] Special thanks again to Eric Lobser for joining us here on RIMScast. We appreciate him and all the great work he does for the RIMS SERMC. The call for nominations for the RIMS Global ERM Award of Distinction is open; a link is in this episode's show notes. [44:36] There are specific attributes that will make a nomination truly award-worthy. Submit your nominations today! [44:42] Plug Time! Become a RIMS member and get access to the tools, thought leadership, and network you need to succeed. Visit RIMS.org/membership or email membershipdept@RIMS.org for more information. [45:00] Risk Knowledge is the RIMS searchable content library that provides relevant information for today's risk professionals. Materials include RIMS executive reports, survey findings, contributed articles, industry research, benchmarking data, and more. [45:16] For the best reporting on the profession of risk management, read Risk Management Magazine at RMMagazine.com. It is written and published by the best minds in risk management. [45:29] Justin Smulison is the Business Content Manager at RIMS. Please remember to subscribe to RIMScast on your favorite podcasting app. You can email us at Content@RIMS.org. [45:41] Practice good risk management, stay safe, and thank you again for your continued support!   Links: RIMS ERM Conference 2026 | November 19‒20 in Columbus, Ohio | Registration Now Open! | www.rims.org/ERM2026 | RIMS ERM Global Award of Distinction nominations open through Aug. 21! RIMS Certification Week: Sept. 21‒24 | Complimentary For All Spencer Educational Foundation's 2026 Funding Their Future Gala | Sept. 17, 2026 RISKWORLD 2027 Registration | RIMS members can lock in 2026 rates now through Sept. 4 | Education Content Submission Through Aug. 21. ChicagoLand Risk Forum | Sept. 24, 2026 RIMS Western Regional Conference — Oct. 4‒7, 2026 | Seattle, WA | Register Today. RIMS Canada Conference — Oct. 18‒21, 2026 | Quebec City | www.rimscanadaconference.ca | Advance Registration Open | Sponsorship Opportunities Available The Strategic and Enterprise Risk Center RIMS, the Foundation for Risk Management Spencer Educational Foundation — Scholarships and Grants | Open Calls and Timelines. RIMS Now RIMS-Certified Risk Management Professional (RIMS-CRMP) | Insights Video Series Featuring Joe Milan! RIMS Diversity Equity Inclusion Council RIMS-CRMP Stories RIMScast Canada — Episodes Now Live RISK PAC | RIMS Advocacy RIMScast on YouTube! RIMS Risk Management Magazine | Contribute | Q2 2026 Issue Now Available Sponsor RIMScast — Sales@RIMS.org Upcoming RIMS-CRMP Virtual Workshops: RIMS-CRMP Exam Prep Workshop — Live In NY — Aug 27‒28! RIMS-CRMP Exam Prep with PARIMA | Sept 1‒2 Full RIMS-CRMP Prep Course Schedule See the full calendar of RIMS Virtual Workshops Upcoming RIMS Webinars: RIMS.org/Webinars "RIMS Student Series: Classroom to Career Part 1" | Sept 1 "RIMS Student Series: Classroom to Career Part 2" | Sept 9 RIMS Certification Week: Sept. 22‒24 | Complimentary For All   Related RIMScast Episodes: "Board Reporting and ERM in 2026 with Trisha Sqrow and Suzanne Christensen" "The Future of Strategic Risk Management" with John Button "Mid-Year Risk Roundup 2026 with Morgan O'Rourke and Hilary Tuttle" "Emerging Risks and AMRAE's RMIS Panorama 2026 with François Beaume" "Strategy and Change with Ward Ching and Aaron Olson"   Sponsored RIMScast Episodes: "48 Hours From a Storm: What to Do Before A Hurricane Strikes" | Sponsored by Global Risk Consultants, a TÜV SÜD Company (New!) "AI-Scale, Risk Ready: Engineering Controls for the New Data Center Boom" | Sponsored by Global Risk Consultants, a TÜV SÜD Company "Facing Into Risk: Navigating the New Risk Landscape" (New!) | Sponsored by AXA XL "Secondary Perils, Major Risks: The New Face of Weather-Related Challenges" | Sponsored by AXA XL "The ART of Risk: Rethinking Risk Through Insight, Design, and Innovation" | Sponsored by Alliant "Mastering ERM: Leveraging Internal and External Risk Factors" | Sponsored by Diligent "Cyberrisk: Preparing Beyond 2025" | Sponsored by Alliant "The New Reality of Risk Engineering: From Code Compliance to Resilience" | Sponsored by AXA XL "Change Management: AI's Role in Loss Control and Property Insurance" | Sponsored by Global Risk Consultants, a TÜV SÜD Company "Demystifying Multinational Fronting Insurance Programs" | Sponsored by Zurich "Understanding Third-Party Litigation Funding" | Sponsored by Zurich "What Risk Managers Can Learn From School Shootings" | Sponsored by Merrill Herzog "Simplifying the Challenges of OSHA Recordkeeping" | Sponsored by Medcor "How Insurance Builds Resilience Against an Active Assailant Attack" | Sponsored by Merrill Herzog "Third-Party and Cyber Risk Management Tips" | Sponsored by Alliant   RIMS Publications, Content, and Links: RIMS Membership — Whether you are a new member or need to transition, be a part of the global risk management community! RIMS Virtual Workshops On-Demand Webinars RIMS-Certified Risk Management Professional (RIMS-CRMP) RISK PAC | RIMS Advocacy RIMS Strategic & Enterprise Risk Center RIMS-CRMP Stories — Featuring RIMS President Manny Padilla!   RIMS Events, Education, and Services: RIMS Risk Maturity Model®   Sponsor RIMScast: Contact sales@rims.org or pd@rims.org for more information.   Want to Learn More? Keep up with the podcast on RIMS.org, and listen on Spotify and Apple Podcasts.   Have a question or suggestion? Email: Content@rims.org.   Join the Conversation! Follow @RIMSorg on Facebook, Twitter, and LinkedIn.   About our guest: Eric Lobser, SERMC Member   Production and engineering provided by Podfly.

This episode previews two keynote presentations at the 2026 CLEAR Annual Educational Conference. Host Line Dempsey first speaks with keynote speaker Jay Chaudhary about his concept of "regulatory abundance"—the idea that effective regulation requires continually balancing public protection with access, innovation, affordability, and opportunity. Drawing on his experience in legal aid and behavioral health leadership, Chaudhary discusses the importance of recognizing the trade-offs inherent in every regulatory decision, considering both visible and invisible harms, and designing regulatory systems that are practical while maintaining meaningful safeguards. The episode then features plenary speaker Jillian Morenz, who explores how leaders can navigate high-stakes conversations more effectively. She explains why people often default to silence or confrontation under pressure, shares common communication pitfalls, and emphasizes the role of psychological safety and practical communication skills in building stronger teams and higher-performing organizations. Together, the conversations offer listeners a preview of two conference sessions focused on rethinking regulation and strengthening leadership through better communication. Transcript

The Emergency Planning and Community Right-to-Know Act, aka EPCRA, was created in 1986 to help communities plan for chemical emergencies. It requires industry to report on the storage, use, and release of hazardous substances to federal, state, and local governments. It's a good law, says NMPF Chief Counsel Clay Detlefsen, but unintended consequences have snared dairy farmers into a decades-long fight against over-regulation. And for those decades, Detlefsen's been part of every twist and turn, with potential light at the end of the tunnel within the next year. “EPCRA overall I think is a great law. It's just been misconstrued by environmental activists, and they've hijacked a good law for nefarious purposes,” Detlefsen said. “My job is making sure that regulatory agencies don't do stupid things, and yes, it takes literally decades to stop things from happening.”  To learn more about NMPF's regulatory efforts, check out its quarterly Regulatory Register and sign up for it at nmpf.org/subscribe. 

You wear a smartwatch as do so many other Americans. In fact, AI is transforming wearable healthcare devices from simple fitness trackers into powerful tools that collect, analyze, and share health information in real time.During the next live edition of the long-running Monitor Monday Internet broadcast, special guest Ray Ribble will take a deep dive into AI-powered wearables and explain what you and your team must do to remain compliant.The broadcast will also include these instantly recognizable segments:• Monday Rounds: Ronald Hirsch, MD, vice president of R1 RCM, will be making his Monday Rounds.• The RAC Report: Healthcare attorney Knicole Emanuel, partner at the law firm of Nelson Mullins, will report the latest news about auditors.• Risky Business: Healthcare attorney David Glaser, shareholder in the law offices of Fredrikson & Byron, will join the broadcast with his trademark segment.• Legislative Update: Cate Brantley, senior legislative affairs liaison for Zelis, will report on current healthcare legislation.

Roy Behren of Westchester Capital Management, co-portfolio manager of the Merger Fund, believes the proposed merger between Paramount Global (PARA) and Warner Bros. Discovery (WBD) will ultimately close. He cites the numerous international regulatory approvals, the lack of U.S. Department of Justice objections, and the significant financial incentives for both companies to complete the deal. Despite a lawsuit from the California Attorney General, he suggests the parties may reach a settlement, potentially offering concessions similar to those made in Europe. He also notes the potential for a backup bid from Netflix (NFLX) if the deal were to be blocked, but maintains a strong conviction that the merger will proceed, highlighting the current trading discount as an inefficient pricing.

California farmers need predictable water supplies, practical regulations and policies that encourage production if agriculture is going to remain competitive, according to congressional candidate Kyle Kirkland. During today's episode of the AgNet News Hour, Kirkland discussed the challenges facing the Central Valley and shared why he believes business experience can help address many of the issues affecting California agriculture. Kirkland, who is running for California's 21st Congressional District, said his background as a businessman has shaped the way he approaches public policy. He argued that many of California's biggest challenges stem from policies that have made it more difficult to produce food, build housing and operate businesses. "I look at those and say those are fixable problems," Kirkland said, explaining that California has reduced production in several key industries while demand has continued to grow. A major portion of the interview focused on agriculture. Kirkland said one of the most common concerns he hears from farmers is the need for reliable and predictable water supplies rather than constantly changing allocations. "When I've talked to my friends in ag, they're just saying, 'We want reliable, consistent sources of water and predictable sources,'" Kirkland said. He added that uncertainty makes it difficult for producers to plan for future crops and investments, particularly for permanent plantings such as orchards and vineyards. Kirkland also discussed California's regulatory climate, arguing that environmental regulations have become increasingly difficult for businesses and agricultural producers to navigate. While emphasizing the importance of environmental stewardship, he said regulations should be evaluated to determine whether they are achieving their intended goals without unnecessarily limiting production. He suggested that policymakers should regularly review regulations after implementation to determine whether they are working as intended and make adjustments when necessary. The conversation also touched on the importance of domestic food production. Kirkland expressed concern that increasing regulations could discourage future generations from remaining in agriculture, ultimately leading to greater reliance on imported food. He argued that California should continue supporting in-state production while maintaining the state's role as one of the nation's leading agricultural regions. AgNet News Hour hosts Nick Papagni and Josh McGill noted that reliable water supplies remain one of the most frequently discussed issues among California growers. They also highlighted the unique challenges permanent crops face when water availability changes from year to year, making long-term planning especially difficult for producers. While the interview reflected Kirkland's perspectives as a congressional candidate, it underscored broader issues that continue to shape California agriculture, including water reliability, regulatory certainty and maintaining a strong business environment for farms and ranches. Listen to the full interview below or on your favorite podcast app.

In this episode, we explore how artificial intelligence is transforming power, accountability, and trust inside organisations. From algorithmic hiring and performance management to the legal risks of "shadow AI" and workplace surveillance, we discuss what businesses need to understand as AI increasingly shapes employment decisions.We discuss:How far AI has already moved into hiring, performance management, and employment decisionsWhether our legal systems and employment frameworks are prepared for accelerating AI capabilityWhat "human in the loop" really means, and the legal risks when it's missingReal-world litigation, including the Workday hiring-discrimination lawsuit and a Delaware Chancery case over an AI-influenced business decisionShadow AI: why employees bring their own AI tools to work, and what that exposes about leadershipWhere to draw the line between legitimate monitoring and excessive surveillanceWho inside an organisation should own AI-related employment risk — the board, HR, Legal, IT, or the CEOPractical steps every business leader should prioritise over the next 12 monthsAbout the guest: Andrew Adams is Practice Leader of the Labor & Employment Practice Group at DarrowEverett LLP, where he also serves on the firm's Business Litigation & Alternative Dispute Resolution and Regulatory & Compliance practice groups. He advises clients ranging from small businesses to multinational corporations on employment litigation, regulatory compliance, workplace investigations, and government enforcement, and regularly provides training on employment law and compliance issues. About the host: Dominic Bowen is Head of Strategic Advisory and Partner at one of Europe's leading risk management consulting firms. He advises CEOs, boards, and senior executives on crisis management, geopolitical risk, operational resilience, and strategy, drawing on decades of experience across government, humanitarian operations, and corporate leadership.Subscribe for new episodes every weekTell us what you thought in the comments belowShare this episode with colleagues working in employment law, HR, risk management, and corporate governanceSee more at www.theinternationalriskpodcast.com#ArtificialIntelligence #EmploymentLaw #WorkplaceAI #HR #RiskManagement #CorporateGovernance #ShadowAI #EmploymentRisk #FutureOfWork #InternationalRiskPodcastTell us what you liked!

Sign up for Practi, a new platform that helps law firms use subscription billing.Here are the top 5 takeaways from this episode:* AI is reshaping the legal industry across all levels. From law schools mandating AI courses to federal judges using AI tools, adoption is broad and not limited to younger generations. Jon expected a generational divide but found AI enthusiasm cuts across all age groups.* Private equity is entering big law, but firms are cautious. PE interest in law firms is growing, with firms exploring structures like MSOs (Management Service Organizations) to separate legal practice from operations. However, no major big law firm has publicly accepted PE investment, yet most are waiting to see who goes first.* Billing structures are shifting away from the billable hour. AI is driving efficiency (tasks that took hours now take minutes), pushing firms and clients toward flat fees and AFAs. One AM Law 100 firm's top three clients are already on flat fees. The shift is practice-area dependent, not a blanket change.* Law firms are generating new revenue by advising clients on AI. AI has created an entirely new category of legal work: advising clients on their own AI-related issues, regulations, and compliance. Data center practices are also booming due to AI infrastructure demand.* Regulatory arbitrage is a key factor. Jurisdictions vary widely. Arizona eliminated its Rule 5.4 prohibition on non-lawyer ownership, and the UK did so even earlier, making them more progressive markets. Global firms must navigate different rules across jurisdictions, and the US may eventually follow suit, with some firms setting 2030 as a target year for significant structural change.__________________________Want your question to be answered on a future show? Fill out this short survey.Have subscription model question? Check out this free resource to ask all of your questions at notebook.practi.ai.Check out Centellic.Sign up for Paxton, my all-in-one AI legal assistant, helping me with legal research, analysis, drafting, and enhancing existing legal work product.Get Connected with SixFifty⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, a business and employment legal document automation tool.Sign up for ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Gavel⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠, an automation platform for law firms.Visit ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Law Subscribed⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ to subscribe to the weekly newsletter to listen from your web browser.Prefer monthly updates? Sign up for the Law Subscribed Monthly Digest on LinkedIn.Check out ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Mathew Kerbis'⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠ law firm ⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠Subscription Attorney LLC⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠⁠.Want to use the subscription model for your law firm? Click here to sign up for a new platform that helps law firms use subscription billing. This is a public episode. If you'd like to discuss this with other subscribers or get access to bonus episodes, visit www.lawsubscribed.com/subscribe

Quality and regulatory compliance are fundamental to bringing safe and effective medical devices to market. As regulations continue to evolve and technologies become more complex, manufacturers must adopt a proactive approach to quality throughout the entire product lifecycle.This podcast collection explores key topics shaping today's medical device industry, including the FDA's transition to the Quality Management System Regulation (QMSR), effective validation and supplier management strategies, and structured approaches to managing software defects in Software as a Medical Device (SaMD).Together, these discussions highlight how strong quality systems extend beyond documentation. They emphasize the importance of risk-based thinking, supplier oversight, software quality, and continuous improvement to ensure compliance while protecting patients.Whether you're working in Quality Assurance, Regulatory Affairs, Engineering, or Product Development, these conversations offer practical insights to help strengthen your Quality Management System and prepare for the evolving regulatory landscape.Who is Monir El Azzouzi? Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more.  If you need help implementing QMSR or preparing your teams for FDA inspections, contact: info@easymedicaldevice.com If you are located outside the EU/UK/Switzerland and need an Authorized Representative (and possibly an Importer), we can support you as well.Social Media to followMonir El Azzouzi Linkedin: https://linkedin.com/in/melazzouziTwitter: https://twitter.com/elazzouzimPinterest: https://www.pinterest.com/easymedicaldeviceInstagram: https://www.instagram.com/easymedicaldeviceThis podcast is hosted by Podcastics, the easiest platform to create and publish your podcast.

 In this episode of Compliance 911, Len Suzio and Dean Stockford review key banking and compliance developments from June 2026, including new OCC rules affirming federal banks' authority over real estate escrow interest and fees, updated FDIC guidance on official signs and advertising, and CFPB changes to Regulation B that have created uncertainty around disparate impact and fair lending enforcement. They also discuss a joint FinCEN advisory identifying red flags tied to fraud involving unauthorized employment, CFPB guidance on considering immigration status in ability-to-repay decisions, and expanded use of Section 314(b) information sharing for fraud and cyber-related activity. The episode concludes with FHA's decision to make certain appraisal field reviews optional and an overview of the proposed 21st Century ROAD to Housing Act, which could provide regulatory relief for community banks through higher examination thresholds, brokered deposit reforms, streamlined bank formation, and support programs for smaller and newly chartered institutions. Brought to you by GeoDataVision and M&M Consulting

In this episode of Compliance Champions, Delphine Forma, Head of Policy Europe and APAC at Solidus Labs, speaks with Dr. Vin Pheakdey, Deputy Director General and Chair of the FinTech Working Group at the Securities and Exchange Regulator of Cambodia.They explore how Cambodia has transformed its approach to digital assets — from restricting unlicensed crypto activity in 2018 to establishing a formal, dual-authority licensing framework under SERC and the National Bank of Cambodia. Dr. Vin walks through the architecture of Prakas 093, which classifies digital assets as financial instruments and securities, and explains what firms need to demonstrate to navigate the sandbox process and secure a full licence. He also shares the most common gaps SERC sees in applications — practical intelligence for any firm considering the Cambodian market.The conversation also explores the realities of supervising a borderless market. Dr. Vin shares why offshore unregulated platforms remain one of the biggest challenges facing regulators, why international cooperation and information sharing are indispensable, and how Cambodia is embedding market integrity into its framework through transaction monitoring, trade surveillance, RegTech, SupTech and direct supervisory access to transaction data.They also discuss Project Bakong — Cambodia's blockchain-based digital payment system with over 65% population penetration — and how its success has shaped the country's confidence and approach to broader digital asset regulation.Rounding out the episode: Cambodia's international engagement strategy including its bilateral meeting with the U.S. SEC, lessons learned for other emerging market regulators, and a preview of the joint NBC-SERC guideline on digital asset supervision currently in development.A sharp, forward-looking conversation offering a rare regulator-side view into how emerging markets are building digital asset frameworks — and why Cambodia's approach deserves more attention than it gets.

Why do quality and R&D fall into adversarial roles even when both are working toward patient safety? Shawn Fuller, who spent 24 years at Surmodics and rose from regulatory manager to VP of Quality, Regulatory and Clinical Affairs, is candid about how both sides create the problem and what it takes to break the pattern.Shawn and Nick get into the learned behavior behind the roadblock stereotype, why quality's timeline never gets extended, the memo-to-file versus special 510(k) trade-off, and the difference between a compliance gatekeeper and a strategic risk advisor.A few of Shawn's key takeaways:The quality roadblock and the R&D cowboy are learned behaviors, and each one justifies the otherA regulatory conclusion delivered without the risk logic or alternatives behind it guarantees a defensive responseIf quality is afraid of FDA, R&D takes the cue. Don't ask the agency what to do, but you can share what you plan to doQuality gets the last timeline and it rarely gets extended, which builds the speed-versus-quality conflict into the scheduleQuality plans are prescriptive, which cuts both ways. Consider folding quality into the project plan insteadTrust is built outside the meeting, over time, and you can't assume it when you walk in the doorDon't blindly defend your own team. A leader who lets their group go down the wrong road to protect the quality seat loses trust fastestAbout Shawn FullerShawn Fuller spent more than 24 years at Surmodics, joining as a regulatory manager and rising to Vice President of Quality, Regulatory and Clinical Affairs. She built the quality and regulatory infrastructure supporting Class I, II, and III devices and served as program director for a Class III device from concept through commercialization. She previously held regulatory roles at Protein Design Labs and conducted transplant research at the University of Minnesota. She is now semi-retired.About The FDA GroupThe FDA Group helps life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus on staff augmentation, auditing, remediation, QMS, and other specialized project work in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more: https://www.thefdagroup.com/

In this episode of The Compliance Guy, Terry Fletcher and Sean dive into the importance of proactive compliance and staying updated with federal and state healthcare regulations. This discussion is vital for healthcare providers who want to safeguard their practice from compliance risks and ensure they're informed about the latest industry guidance.Key topics covered:The significance of subscribing to authoritative listservs from agencies like OIG, CMS, OCR, and DOJHow healthcare providers can leverage alerts and newsletters to stay compliantThe importance of understanding the definitions of fraud, waste, and abusePractical tips for managing vast amounts of regulatory information in small practicesCommon pitfalls, like billing consult codes post-2010 or misinterpreting LCDsThe evolution of healthcare information dissemination, from paper newsletters to digital alertsThe role of exclusion lists and maintaining awareness of provider sanctionsHow to tailor subscription strategies to avoid inbox overload but still stay informedThe value of free resources such as CMS alerts, Becker's Health, and decision health publicationsThe impact of regulatory updates on claims processing and appeal strategies

Glenbrook's Chris Uriarte and Samantha Gordon continue their global payments regulation series with Scott McInnes, Partner at Bird & Bird, focusing on the European Union.  Tune in as they explore the EU's highly regulated landscape, the challenges of inconsistent national enforcement across 27 member states, and developments on current regulatory topics: Payment Services Directive - PSD2 to PSD3 evolution Payment Services Regulation (PSR) objectives and adoption timeline Digital euro goals and requirements European Digital Identity Wallet framework and ambitions SEPA Instant obligations Upcoming BNPL regulation Apple NFC access and wallet competition Strong Customer Authentication (SCA) implications for agentic commerce

Episode 789 brings the full buffet of gaming chaos, hot takes, and community energy. Mark, Stuntmaster and Darren dive into a stacked week of games, news, and Discord‑fuelled discussion, all wrapped in that classic 360G vibe.

The ALL ME® Podcast Peptides: What You Need to Know About This Growing Trend – Dr. Brandon Welch In this episode, Dr. Brandon Welch discusses the complex world of peptides, their uses, risks, and the regulatory landscape, providing valuable insights for athletes, parents, and young enthusiasts. Takeaways: What are peptides and how do they work? Regulatory status of peptides: FDA approval and bans Risks and side effects of peptide use Sources and quality concerns of online peptides The rise of peptides in social media and biohacking Clinical trials and safety data for peptides Legal considerations for prescribing and dispensing Impact of peptides on health and performance Chapters: 00:00 Introduction to Peptides and Their Importance 03:02 Dr. Brandon Welch's Journey into Pharmacy 05:40 Understanding Peptides: The Basics 08:52 Peptides: Legal Status and Safety Concerns 11:26 Research-Only Peptides: Risks and Regulations 14:22 The Role of Influencers in Peptide Popularity 17:19 The Surge of Peptides in Recent Years 20:05 Popular Peptides: Reta TrueTide and BPC157 34:12 Injectable Drugs and Athletic Recovery 37:49 The Risks of Peptides and Tumor Growth 38:40 CJC-1295: Benefits and Risks 42:57 Ipamorelin: Understanding Its Use and Risks 46:03 Dependency on Growth Hormones 48:27 TB500: Potential and Limitations 50:09 The Push for FDA Approval of Peptides 56:06 Advice for Young Athletes on Peptide Use Resources: · https://sportsrxnetwork.com/ · https://www.usada.org/ · https://www.fda.gov/drugs/buying-using-medicine-safely/besaferx-your-source-online-pharmacy-information · https://clinicaltrials.gov/ Follow Us: Twitter: @theTHF Instagram: @theTHF Facebook: Taylor Hooton Foundation #ALLMEPEDFREE Contact Us: Twitter: @theTHF Instagram: @theTHF Facebook: Taylor Hooton Foundation #ALLMEPEDFREE Email: info@taylorhooton.org Phone: 214-449-1990 ALL ME Assembly Programs: http://taylorhooton.org/education-resources/face-to-face-programs/

Utilization managers (UMs) have long served as a resource for clinicians determining the appropriate patient status.Key considerations include which clinicians are involved, how communication occurs, and how status orders are entered.Because these processes can vary widely, it is essential to understand what is compliant, what carries risk, and what is simply not allowed.That's why it's essential to stay current on the latest developments in utilization management.So, listen and learn when special guest Dr. Juliet B. Urgarte Hopkins, chief medical officer for Phoenix Medical Management discusses the role of utilization managers.The popular weekly Internet broadcast will also feature these additional instantly recognizable panelists, who will report more news during their segments:• POV: Penny Jefferson, Manager of Coding & Clinical Documentation Integrity Services for the University of California-Davis Medical Center, will share her point of view during the broadcast.• CDI Report: Cheryl Ericson will provide an update on all things clinical documentation integrity (CDI).• SDoH Report: Tiffany Ferguson will report on news happening at the intersection of compliance and medical record coding.• The Coding Report: Christine Geiger will report on the latest coding news.

If knowledge I gave a company five, ten, or twenty years ago is still generating value for them, why does the payroll relationship get to end while the value extraction doesn't? That's the question driving this episode. I read and respond to an excerpt from a LinkedIn post by a former colleague about AI systems that capture and index employee knowledge — the recordings, conversations, and stories that make expertise valuable — so all of it stays discoverable inside a company long after the person who generated it has left. Long-term extraction, in other words. My issue isn't with the AI capability itself. It's with the assumption sitting underneath the post: that a company can capture, index, and reuse a person's stories, judgment, and point of view indefinitely, without renegotiating consent, ownership, or compensation as the relationship changes. I trace it through consent, accountability, discoverability infrastructure, reputation risk, and the crux of it for me: compensation. Key themes Consent has an expiry problem. Recording something while employed isn't the same as consenting to its indefinite reuse after departure. Accountability gets murky once context changes. If old material is repurposed years later and it backfires, who answers for it? The person who said it, or the company that recontextualized it? Discoverability is infrastructure. Making knowledge "searchable" means it gets indexed, pattern-matched, and interpreted, which raises the attribution question: am I cited as the source, and do I have any say in that? Reputation and digital footprint are at stake, especially if it's a company or context I no longer want to be associated with. The employment contract has changed. Call it the Hotel California Clause: you can leave the company any time you like, but your value never does. Payroll used to be the deal: compensation flows while you're actively contributing. Indefinite knowledge capture breaks that link. The value keeps flowing. The payroll doesn't. This isn't limited to employees. Contractors, freelancers, and consultants recorded and captured through AI face the same exposure, and it's nowhere in their contracts. Whose knowledge "counts" in the first place. I raise the open question of whether ageism, racism, or misogyny shapes whose expertise gets flagged as valuable enough to capture and monetize. Regulatory retention sits in tension with all of this. At my old employer in financial services, everything was already subject to audit and kept on record for six or seven years: recordings, emails, anything written. That's extraction for compliance rather than knowledge-mining, but it's still capture and retention I didn't fully control. I don't resolve that tension here. Where regulatory retention ends and unregulated knowledge-mining begins deserves its own conversation. Reflection questions Use these for journaling, discussion, or a follow-up episode: What consent does a company actually have to use my recorded conversations, stories, and expertise after I've left? If information I provided years ago is repurposed and the context has shifted, who is accountable when it backfires: me or the company? If a company builds infrastructure to make my captured knowledge discoverable, indexed, and pattern-matched, do I have any say in how I'm cited or attributed? If a former employer is one I no longer want to be associated with, what recourse do I have over how my past contributions continue to represent me? If my knowledge is valuable enough to keep generating value years after I've left, why doesn't the compensation relationship continue too? Has the employment contract changed, from "paid for your labor while employed" to "paid for your labor, but your knowledge stays extractable indefinitely"? Does this exposure extend beyond employees to contractors, freelancers, and consultants? Is it addressed anywhere in those agreements? Whose knowledge gets deemed valuable enough to capture in the first place? Is there bias (age, race, gender) in that determination? What would it take to make this explicit: legislation, individual negotiation, or structural change at the organizational level? As AI capture of video, writing, and audio becomes normalized, what belongs in a contract today that wasn't there before? One-line takeaway The post calls it preserving wisdom. I'm asking who owns that wisdom once the relationship ends, and why consent and compensation don't get renegotiated along the way. This is an Assumption-Ground Audit This whole episode is the Assumption-Ground Audit in action, pointed at a LinkedIn post instead of a policy. The AGA is the method I use to surface the assumption sitting underneath a decision before it calcifies into precedent. The question is never whether the technology is good or bad. The question is what everyone is treating as already-settled that hasn't actually been agreed to. Here, the unexamined assumption is the Hotel California Clause itself: that indefinite capture and reuse of an employee's knowledge is simply part of the deal, and that consent, attribution, and compensation don't need renegotiating just because the mechanism changed from "someone remembers what you said" to "a system indexes it forever." That's the kind of assumption the AGA is built to catch before you build infrastructure, policy, or a vendor relationship on top of it. If you're building AI systems that touch employee knowledge, client data, or institutional memory, those assumptions are hardening into your roadmap right now, whether anyone has examined them or not. If you want to know what they are before they're impossible to walk back, let's have a conversation. Work with me on an Assumption-Ground Audit →

Steven Rinella talks with the Makah Tribe about: whaling techniques; whale sushi; the history of Makah whaling; regulatory hurdles; and more. Connect with Steve and The MeatEater Podcast Network Steve on Instagram and Twitter MeatEater on Instagram, Facebook, Twitter, and YouTubeSee omnystudio.com/listener for privacy information.

After decades of facing severe overfishing and cultural stigma, global shark populations are finally rebounding thanks to strict new international trade bans and expanding marine sanctuaries. Emma Varvaloucas, Executive Director of The Progress Network, shares how much our views and treatment of sharks have shifted over the last century and why there's reason for optimism. Plus: a team of 23 students in the Netherlands successfully engineered the world's first fully solar-powered ambulance to deliver off-grid medical care, Indigenous youth are reclaiming traditional face tattooing to preserve their cultural heritage, and robust conservation programs have helped two wildlife species in America bounce back from the brink of extinction.What Could Go Right? is produced by The Progress Network and Kaleidoscope.For transcripts, to join the newsletter, and for more information, visit: theprogressnetwork.orgSubscribe to our (FREE) Substack newsletter: https://theprogressnetwork.org/newsletter/Watch the podcast on YouTube: / theprogressnetworkFollow us on X, Instagram, Facebook, TikTok: @progressntwrkFollow Emma on Instagram: https://www.instagram.com/heyemmavarv/

In this episode of Medsider Radio, we sat down with David Veino, President and CEO of Neuros Medical.Neuros is commercializing the FDA-approved Altius Direct Electrical Nerve Stimulation System for chronic post-amputation pain.Before Neuros, David held senior commercial leadership roles at Cardiovascular Systems (CSI) and Stryker, and helped grow CSI's coronary and peripheral business from approximately $50 million to more than $250 million in annual revenue while leading key amputation-prevention initiatives. He also serves as a private equity advisor with Sectoral Asset Management. In this interview, David discusses how commercialization begins by mapping the patient journey upstream, what it takes to generate gold-standard clinical evidence for a novel therapy, how investors assess scalable medtech businesses, and how to build an investor pitch that earns the next meeting.  Before we dive into the discussion, I wanted to mention a few things:First, if you're into learning from medical device founders and CEOs and want to know when new interviews are live, head over to Medsider.com and sign up for our free newsletter.And if you're ready to level up your medtech game, you should check out Medsider Courses — 8-week masterclasses covering topics like fundraising, M&A and exit planning, design and development, clinical and regulatory strategy, and commercialization.These courses, featuring hard-earned lessons from elite medtech CEOs, can be purchased individually or come free with our All-Access Pass.If you'd rather read than listen, here's a link to the full interview with David Veino, which includes a link to ScottBot — an AI version of host Scott Nelson trained on every Medsider interview and playbook. Feel free to ask ScottBot any questions you'd like!KEY MOMENTS FROM THE INTERVIEW(03:02) - David's 30-year medtech journey from cardiovascular devices to leading Neuros (04:38) - How Neuros is treating chronic post-amputation pain with on-demand neuromodulation (11:08) - Why Neuros completely changed its strategy halfway through the pivotal trial (15:36) - Why commercialization starts with referral pathways, not end-users (18:09) - How prosthetists became one of Neuros' most important referral sources (26:11) - What it takes to generate gold-standard clinical evidence for a first-of-its-kind therapy (37:41) - Building an investor pitch that earns the next meeting (41:42) - What gets David excited enough to invest in a medtech company

This week, I had the pleasure of speaking with Dr. Susanna W. Blair, Senior Director of Regulatory and Technical Affairs for the Consumer Brands Association (CBA), which represents the interests of the consumer-packaged goods (CPG) community. Having left the U.S. Environmental Protection Agency (EPA) after a distinguished career as a senior scientist and policy expert, Dr. Blair is putting her science policy chops to good use at CBA. We discuss CBA's mission, its focus on food and beverage ingredients, how Make America Healthy Again (MAHA) advocacy has impacted CBA, the Association's focus on the Generally Recognized as Safe (GRAS) framework, among other priority projects CBA is pursuing, and much more. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2026 Bergeson & Campbell, P.C.  All Rights Reserved

This Week In Startups is made possible by: Northwest Registered Agent- NorthwestRegisteredAgent.com/twist Odoo - Odoo.com/twist MongoDB - MongoDB.com/ai   Today's show: The FCC's decision to ban Chinese humanoid robots over security concerns is a boon to American startups, which now face a narrower competitive market. But where should we draw the line on security over competition? Menlo Ventures' Deedy Das, Weisburd Pierce's David Weisburd, Plexo Capital's Lo Toney, and LAUNCH's Jason Calcanis broke down how they differentiate between legitimate security concerns and purported regulatory capture. Today's venture capital roundtable also dug into OpenRouter's possible sale to Stripe, changing tokenomics, the Indian market for startups, and even DoorDash's drone-delivery business taking flight. Guest Links: Deedy Das https://x.com/deedydas Menloe Ventures https://menlovc.com/ Lo Toney https://x.com/lo_toney Plexo Capital https://www.plexocap.com/ David Weisburd https://x.com/DWeisburd Weisburd Pierce https://www.weisburdpierce.com/ Jason Calcanis https://x.com/Jason LAUNCH https://launch.co/ Show Links: The FCC's decision regarding Chinese robots https://www.fcc.gov/document/fcc-adds-foreign-produced-power-inverters-and-robots-covered-list-0 Pacing the Frontier letter https://www.pacingthefrontier.com/ Cursor Start https://cursor.com/blog/cursor-start-india Stripe may buy OpenRouter https://www.axios.com/2026/07/24/stripe-openrouter-merger-ai-currency OpenRouter financials https://www.theinformation.com/articles/openrouter-financials-suggest-steep-price-possible-acquirer-stripe?rc=g3wfdp Kimi K3 license https://huggingface.co/moonshotai/Kimi-K3/blob/main/LICENSE Pangram https://www.pangram.com/ Tau Robotics https://www.tau-robotics.com/ Zipline https://www.zipline.com/ Manna https://www.manna.aero/ Kindred Ventures https://kindredventures.com/ Autolane https://goautolane.com/ Salmon Labs https://salmonrun.ai/   Timestamps: 0:00 The FCC bans Chinese humanoid robots 2:18 Waymo, Uber, Robotaxi, and the global BYD threat 10:30 MongoDB - AI-assisted and agentic coding is helping you build faster than ever. Start building at https://MongoDB.com/ai 15:45 The "Pacing The Frontier" letter (1,100+ AI staffers warn on RSI) 19:51 Odoo - The all-in-one business platform. Get started for free at https://Odoo.com/twist 21:07 Regulatory capture vs. genuine concern 30:09 Northwest Registered Agent - Get more when you start your business with Northwest. In 10 clicks and 10 minutes, you can form your company and walk away with a real business identity — Learn more at https://northwestregisteredagent.com/twist 37:57 Have we reached AGI? 38:35 Stripe eyes OpenRouter at $10B 39:19 Does OpenRouter have a moat? 47:13 Kimi K3's license and neocloud margins 49:34 Claude Tag and the future of AI-mediated workplaces 53:26 Cursor Start, ChatGPT Go, and the India market 1:02:03 Have we solved AI detection? 1:11:20 Tau Robotics $30/hour robotic housecleaning 1:12:49 Job loss, and the social safety net 1:18:25 DoorDash Air takes on Zipline, Manna 1:21:00 Portfolio shout-outs Subscribe to the TWiST500 newsletter: https://ticker.thisweekinstartups.com Check out the TWIST500: https://www.twist500.com Subscribe to This Week in Startups on Apple: https://rb.gy/v19fcp   Follow Lon: X: https://x.com/lons   Follow Alex: X: https://x.com/alex LinkedIn: ⁠https://www.linkedin.com/in/alexwilhelm   Follow Jason: X: https://twitter.com/Jason LinkedIn: https://www.linkedin.com/in/jasoncalacanis   Great TWIST interviews: Will Guidara, Eoghan McCabe, Steve Huffman, Brian Chesky, Bob Moesta, Aaron Levie, Sophia Amoruso, Reid Hoffman, Frank Slootman, Billy McFarland   Check out Jason's suite of newsletters: https://substack.com/@calacanis   Follow TWiST: Twitter: https://twitter.com/TWiStartups YouTube: https://www.youtube.com/thisweekin Instagram: https://www.instagram.com/thisweekinstartups TikTok: https://www.tiktok.com/@thisweekinstartups Substack: https://twistartups.substack.com

Matty A. and Ryan Breedwell dive into a packed week for the financial markets, starting with predictions for the upcoming FOMC rate decision and the impact of the ongoing Iran conflict on global oil prices. They explore how inflation and geopolitical tensions are keeping the S&P 500 range-bound, while highlighting crucial earnings reports from major AI and semiconductor companies like SanDisk, Seagate, and Nvidia.The hosts also analyze the recent spike in United States real estate foreclosures, breaking down why record-high homeowner equity and supply shortages mean a housing crash is highly unlikely. Finally, the conversation shifts to digital assets, discussing the Crypto Clarity Act, the regulatory threat to meme coins, and how tokenization could soon reshape institutional finance.KEY TOPICS DISCUSSEDFOMC rate hike probabilities and Citadel's surprise hike prediction.Impact of the Iran conflict on global oil prices and WTI trends.Semiconductor stock pullbacks and AI data storage investments.Q2 tech earnings expectations for Meta, Apple, and Microsoft.Analysis of rising United States real estate foreclosures compared to 2019.Record homeowner equity and the national housing supply shortage.The Crypto Clarity Act and the future of real world asset tokenization.Regulatory crackdowns on meme coin markets and platforms like PumpFun.KEY TAKEAWAYSA surprise FOMC rate hike is highly unlikely given current market conditions, despite some hawkish institutional forecasts.Geopolitical energy shocks are being digested faster by the market, with oil prices retreating sharply after recent spikes.Semiconductor and memory storage companies present strong buy opportunities as they continue to beat earnings despite broader tech sector pullbacks.The current real estate market is insulated from a crash due to a massive 11 trillion dollars in tappable equity and pervasive sub-6 percent mortgage rates.The impending Crypto Clarity Act will likely eliminate unregulated meme coin exchanges while attracting trillions in institutional capital to legitimate tokenization projects.CONNECT & TAKE ACTIONImagos Income Fund: Text "INCOME" or "DEALS" to 844-447-1555 to learn more about Matty A's private debt fund targeting 10% fixed returns paid out monthly.

Digestion is regulated by a complex network of hormones, peptides, and neural signals. In this episode, we review the major gastrointestinal hormones, introduce several secondary regulatory peptides, and explain how the GI tract senses its luminal contents and integrates multiple signals to control digestive function. After listening to this episode, you should be able to: Identify the source, release stimulus, and function of the major gastrointestinal hormones, including secretin, cholecystokinin (CCK), gastrin, and vasoactive intestinal peptide (VIP). Summarize the release stimuli and functions of key GI regulatory peptides, including bombesin, GLP-1, GLP-2, ghrelin, leptin, motilin, somatostatin, and glucose-dependent insulinotropic polypeptide (GIP). Explain how the physical and chemical properties of luminal contents are sensed and how they trigger hormonal responses. Describe how GI cells integrate hormonal and neural inputs to regulate digestive function. You can also check out the original brick on Gastrointestinal Regulatory Substances from our Gastrointestinal collection, which is available for free. Explore more with USMLE-Rx Create a free USMLE-Rx account at www.usmle-rx.com. You'll receive five days of full access to Rx360+, including over 800 Rx Bricks. After the trial, you can continue accessing more than 150 free Bricks, including the complete General Microbiology and Cellular and Molecular Biology collections. Enjoyed the episode? Please consider leaving us a review on Apple Podcasts. Reviews help more medical students and future medical students discover the podcast…and help us continue creating resources for the physicians of tomorrow.

Marty and John dig into the Houthis blocking the Bab el Mandeb strait, oil whipsawing on peace headlines, and why Lloyd's of London pulling war coverage matters for US insurers. They get into Trump's air defense stockpile problem, Chinese diesel demand falling off a cliff, and why the MOVE index staying subdued even as yields rise is the chart to watch. The bulk of the show is an extended breakdown of the open versus closed AI model debate, why the Hugging Face hack exposes the absurdity of current guardrails, and how the real axis of conflict is US versus China, not open source versus safety. They close with Bitcoin long term holder supply hitting 84 percent, a classic bottoming signal.

Dan Romero, who leads go-to-market at Tempo, joins Sam Ewen with a 12-year crypto perspective that stretches from the early days at Coinbase to building Farcaster to now focusing entirely on stablecoin payment rails. He breaks down why these three things: regulation, infrastructure, and distribution, have finally aligned to make real world crypto adoption possible, and why Tempo's betting on being the best payments chain rather than a general purpose blockchain. - Timecodes: 0:00 – Intro on stablecoin yield philosophy 1:20 – From Farcaster to Tempo: the through line 2:56 – The market split: speculation vs. stablecoins 5:37 – Regulatory tailwinds from the Genius Act 8:41 – How yield on Tempo works 14:23 – Balancing privacy and transparency 17:38 – What it takes to win in payments infrastructure 21:01 – Why compliance matters 22:25 – Outlook on the Genius Act rulemaking - From our sponsors: Ledn provides a secure and transparent way to access liquidity while maintaining your bitcoin holdings. Perfect 8 year track record of keeping clients assets safe. Don't sell your bitcoin. Get a bitcoin-backed loan. Check out your rate by using their loan calculator at ledn.io - This episode is brought to you by RealFi, a smarter stablecoin, backed by real-world assets. Find out more at realfi.co. - Check out CoinDesk Research's report on Zcash's push toward private scale and quantum resilience at: https://www.coindesk.com/research/building-the-zcash-machine-tachyon-and-quantum-readiness - "Spotlight" features host Sam Ewen.