Podcasts about chief regulatory officer

We love to hear from our listeners. Send us a message.Dr. Bambi Grilley is Professor of Pediatrics and the Director of Clinical Research and Early Product Development for the Center of Cell and Gene Therapy (CAGT) at Baylor College of Medicine AND she is Chief Regulatory Officer at ISCT. Dr. Grilley talks to us about her role as CRO at ISCT and the global regulatory landscape for cell and gene therapies. She takes a deep dive into the pediatric patient journey, and she shares her expectations for ISCT 2024 Vancouver.

Welcome to the award-winning FCPA Compliance Report, the longest-running podcast in compliance. In this episode, Tom Fox welcomes John Gebauer, Chief Regulatory Officer at COMPLY, and John Van Der Wal, Senior Director, Compliance Advisory at COMPLY. John Gebauer and John Van Der Wal are seasoned professionals in the financial industry, each with over three decades of experience and a focus on regulatory changes and compliance challenges. Gebauer believes that there is a need for stricter controls and requirements in the ESG space. He emphasizes the importance of firms having the necessary documents and procedures to back up their claims of being ESG advisors. Van Der Wal shares a similar perspective. He stresses the need for more controls and requirements in ESG advising, the importance of vendor due diligence, and the potential of AI and machine learning technologies in preventing inappropriate activity. Both Gebauer and Van Der Wal highlight the importance of staying up-to-date with changing rules and regulations in the financial industry. Join Tom Fox, John Gebauer, and John Van Der Wal on this episode of the FCPA Compliance Report to delve deeper into these insights. Key Highlight: Compliance Consulting Expert: John Gebauer Private Fund Reform Rule: Addressing Industry Concerns and Improving Practices Comprehensive Approach for Rule Implementation Cybersecurity Measures to Prevent Insider Trading The Impact of Cybersecurity Regulations on Finance Resources: John Gebauer on LinkedIn COMPLY Tom Fox Instagram Facebook YouTube Twitter LinkedIn Learn more about your ad choices. Visit megaphone.fm/adchoices

The volume of data integrity violations cited in FDA warning letters has risen alarmingly over the last decade. Several examples of poor data integrity practises have demonstrated the consequences it can have on a biotech's future, particularly when is occurs at an early stage of development.In episode 11 of Let's Talk Quality, I was joined by Brian Furmanski, Chief Regulatory Officer for Kriya Therapeutics. Brian has a large remit, covering regulatory, quality and clinical, and is passionate about all things data. He speaks about his background with the FDA, his journey to Kriya, and how he is implementing a culture of data integrity in his current role. We discuss the following:The importance of data integrity in pharma and biotech.What does good data integrity look like? How Brian drives a culture of data integrity in his current role.Data integrity gone wrong - real life examples.The consequences of poor data integrity practises. When biotech's should be thinking about developing more robust quality systems.How to start building better data integrity practises into your business.The challenges of overseeing multiple functions in a start-up biotech.Huge thanks to Brian for joining us on the show and sharing some best practises for implementing great data integrity practises. For a biotech leader, especially if you're in preclinical studies, ensuring you are implementing and embedding a culture that drives data integrity excellence is paramount to your future success. I hope you enjoy the show!

Digital payments have made lives easy, right? Even the transactions rose from 10.2 billion in 2017 to 87.3 billion in 2022. But, this has also led to an increase in fraud. According to a report by the Reserve Bank of India, digital payments fraud amounted to ₹82.76 crore in 2021-22, up from ₹55.28 crore in the previous year. And phishing accounted for 40% of all the reported cases. Recently, Safexpay, a Thane-based payment gateway was in the news for losing around ₹25 crore to fraud attacks. So, are digital payments really making lives easy? Listen to Host Anupriya Nair on the latest episode of The Morning Brief podcast as she along with ET's fintech expert Pratik Bhakta gets into a conversation with Rahul Jain, CFO at NTT DATA Payment Services, and Bharat Panchal, Chief Regulatory Officer at Discover Financial Services. Tune in!   If you like this topic, here are some recommendations from TMB: Kremlin & Crude: India's oil bill lower but fuel bills still running high, Lithium: India's Quest for White Gold, The Uncertain Fate Of Asia's Largest Refinery, India plays bad cop to developed world at COP27, E-20 Explained: The blender's pride or bane? and more! You can follow Pratik Bhakta on his social media: Twitter and Linkedin  Catch the latest episode of ‘The Morning Brief' on ET Play, The Economic Times Online, Spotify, Apple Podcasts, JioSaavn, Amazon Music and Google Podcasts. See omnystudio.com/listener for privacy information.

Rural hospitals have traditionally had less access to independent system review solutions than their urban counterparts. Dr. Pahuja and his team are changing that by offering affordable clinical advisory services geared toward rural hospitals. Our guests for this episode are Dr. Deepak Pahuja, Chief Medical Officer, and Dr. John Hall, Chief Regulatory Officer, at Aerolib Healthcare Solutions. They will discuss the future trends of rural healthcare and how the community can positively impact the viability of a hospital. “The survivability of rural hospitals depends upon the survivability of their communities.” -Dr. John Hall  “It's a combination of what your community needs, what your system can afford, the quality of the service being provided, and the back end.” -Dr. Deepak Pahuja In addition to being the Chief Regulatory Officer at Aerolib, Dr. Hall joined the Executive Team at Knox Community Hospital as the Chief Medical Officer in September 2021. Before joining Knox Community Hospital, Dr. Hall served in a wide range of hospital and university executive physician roles as well as general counsel for a compliance firm, Chief Clinical Officer for a nationally recognized compliance and revenue cycle firm, and CEO of a state medical board. In his role as Chief Medical Officer, Dr. Hall oversees the activities of the medical staff office, anesthesia services, and hospitalist services.   Dr. Hall received his medical degree from the University of Cincinnati, business degrees from Texas Tech University and the University of Texas Rio Grande Valley, and a law degree from Concord Law School. He is certified in anesthesiology, pediatric anesthesiology, legal medicine, and medical management. He is a member of the American College of Legal Medicine, the American Health Law Association, and the California Bar. Dr. Deepak Pahuja is the Chief Medical Officer of Aerolib Healthcare Solutions LLC. He is Board certified in Internal Medicine and has a Master of Business Administration in Healthcare Management from the University of Massachusetts-Amherst-Isenberg School of Management. Dr. Pahuja specializes in innovations in healthcare and serves as the Founder of the Empowering Physician Advisor Show https://physicianonline.org. Dr. Pahuja is a Fellow of the American College of Physicians and the Society of Hospital Medicine.  His company Aerolib Healthcare Solutions is a Physician owned physician-led consulting firm providing Physician Advisor Gap Coverage for hospitals, Clinical and Regulatory Education for providers, Healthcare Analytics, and Artificial Intelligence for healthcare organizations.  To learn more about Aerolib Healthcare Solutions visit their website: Aerolib Healthcare Solutions – Home

In this Space Café Radio - SpaceWatch.Global publisher Torsten Kriening spoke with Ann Vandenbroucke, Chief Regulatory Officer at Rivada Space Networks, about the excitement of working at a constellation start-up, ITU challenges, and space sustainability from the angle of an operator. They also addressed European autonomy for space communication and the issue of frequency scarcity. Space Café Radio brings you talks, interviews, and reports from the team of SpaceWatchers while out on the road. Each episode has a specific topic, unique content, and a personal touch. Enjoy the show and let us know your thoughts at radio@spacewatch.global!Please visit us at SpaceWatch.Global, subscribe to our newsletters. Follow us on LinkedIn and Twitter!

 Julian Hashim, Chief Regulatory Officer, Bursa Malaysia

The Inflation Reduction Act is a new law designed to hasten the United States' energy transition (and do nothing about inflation). In the last episode before the midterm election, learn about the energy path the Democratic Party has plotted for us and learn how this new law can possibly save you tens of thousands of dollars. Please Support Congressional Dish – Quick Links Contribute monthly or a lump sum via PayPal Support Congressional Dish via Patreon (donations per episode) Send Zelle payments to: Donation@congressionaldish.com Send Venmo payments to: @Jennifer-Briney Send Cash App payments to: $CongressionalDish or Donation@congressionaldish.com Use your bank's online bill pay function to mail contributions to: 5753 Hwy 85 North, Number 4576, Crestview, FL 32536. Please make checks payable to Congressional Dish Thank you for supporting truly independent media! View the show notes on our website at https://congressionaldish.com/cd261-inflation-reduction-act Jen Podcast Appearances EP 63 Honest Government Analyst Jennifer Briney talks Privilege, White House & Hotels. The Living Numbers Podcast with Tony Rambles. Disaster - Jennifer Briney. A Word with Tom Merritt. Background Sources Recommended Congressional Dish Episodes CD259: CHIPS: A State Subsidization of Industry CD250: Congress Saves the Postal Service CD246: BIF: Appalachian Chemical Storage CD240: BIF The Infrastructure BILL CD218: Minerals are the New Oil CD205: Nuclear Waste Storage CD146: Repeal & Replace CD048: The Affordable Care Act (Obamacare) Tax Credits and Refunds Home Energy Efficiency Tax Credits “Tax Credits for Energy Efficient Home Improvements.” eFile. Rocky Mengle. Sept 16, 2022. “Save More on Green Home Improvements Under the Inflation Reduction Act.” Kiplinger. “Federal Income Tax Credits and Other Incentives for Energy Efficiency.” Updated Aug 18, 2022. Energy Star. Electric Appliance Rebates “Quick Facts: United States.” U.S. Census Bureau. Electric Car Tax Credit 26 U.S. Code § 30D - Clean vehicle credit. Cornell Law School Legal Information Institute. Alternative Fuels Data Center. “Electric Vehicles with Final Assembly in North America.” U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy. Kelley R. Taylor. Oct 18, 2022. “EV Tax Credits Are Changing: What's Ahead.” Kiplinger. Greg Iacurci. Oct 15, 2022. “The 'bummer' of the $7,500 electric vehicle tax credit: Its full value may be hard to get.” CNBC. John Bozzella. Aug 5, 2022. “What If No EVs Qualify for the EV Tax Credit? It Could Happen.” Alliance for Automotive Innovation. John Bogna. Jun 22, 2022. “Hydrogen-Powered Cars: Fuel Cell Electric Vehicles Explained.” PCMag. U.S. Geological Survey. “Mineral Commodity Summaries 2021.” U.S. Department of the Interior. “OFAC Sanctioned Countries.” Princeton University Research & Project Administration. Alternative Fuel vehicle refueling property credit Kelley R. Taylor. Sept 14, 2022. “The Federal Tax Credit for Electric Vehicle Chargers is Back.” Kiplinger. 26 U.S. Code § 30C - Alternative fuel vehicle refueling property credit. Cornell Law School Legal Information Institute. Hydrogen Catherine Clifford. Sep 8, 2022. “The clean hydrogen energy economy was a dream. The climate bill could make it a reality this decade.” CNBC. Emma Ochu et al. Jun 17, 2021. “Hydrogen Fact Sheet: Production of Low-Carbon Hydrogen.” Columbia University School of International and Public Affairs, Center on Global Energy Policy. “Lisa Murkowski.” Open Secrets. Jay Bartlett and Alan Krupnick. December 2020. “Decarbonized Hydrogen in the US Power and Industrial Sectors: Identifying and Incentivizing Opportunities to Lower Emissions.” Resources for the Future. 24/7 Wall St. Feb 16, 2020. “How Many Gas Stations Are In U.S.? How Many Will There Be In 10 Years?” Market Watch. Health Care “The Inflation Reduction Act Lowers Health Care Costs for Millions of Americans.” Oct 5, 2022. Centers for Medicare & Medicaid Services. “Inflation Reduction Act: CMS Implementation Timeline.” 2022. Centers for Medicare & Medicaid Services. Carbon Capture Angela C. Jones and Ashley J. Lawson. Oct 5, 2022. “Carbon Capture and Sequestration (CCS) in the United States.” Congressional Research Service. Emily Pontecorvo. Aug 22, 2022. “Will the Inflation Reduction Act jumpstart carbon capture?” Grist. “Global Status of CCS 2021.” 2021. Global CCS Institute. “Carbon capture and storage could also impact air pollution.” Nov 17, 2011. European Environment Agency. Offshore Wind Leases Abby Husselbee and Hannah Oakes. Aug 25, 2022. “The IRA Offshore Energy Leasing Provisions' Potential Impacts.” Harvard University Environmental & Energy Law Program. “Memorandum on the Withdrawal of Certain Areas of the United States Outer Continental Shelf from Leasing Disposition.” Sept 8, 2020. The White House. Fossil Fuels David Jordan. Oct 6, 2022. “Interior moves forward with oil and gas drill site leasing.” Roll Call. “Inflation Reduction Act Fossil Fuel Provisions.” Aug 18, 2022. Enersection. 30 U.S. Code § 226 - Lease of oil and gas lands. Cornell Law School Legal Information Institute. The Associated Press. Apr 16, 2022. “Biden increases oil royalty rate and scales back lease sales on federal lands.” NPR. Taxes Kelley R. Taylor. Oct 10, 2022. “The Inflation Reduction Act and Taxes: What You Should Know.” Kiplinger. “Inflation Reduction Act includes 15% corporate minimum tax on book income.” August 16, 2022. EY. Jacob Bogage. Aug 12, 2022. “The new Wall Street tax key to Democrats' Inflation Reduction Act.” The Washington Post. Peter Warren. Aug 11, 2022. “‘Inflation Reduction Act' Holds the SALT.” Empire Center. “Lobbying: Intuit Inc.” Open Secrets. “CBO Cost Estimate: H.R. 1 - the Tax Cuts and Jobs Act.” November 13, 2017. Congressional Budget Office. The Law H.R.5376 - Inflation Reduction Act of 2022 “Summary: Estimated Budgetary Effects of H.R. 5376, the Inflation Reduction Act of 2022.” Revised August 5, 2022. Congressional Budget Office. Audio Sources Full Committee Hearing On Opportunities and Challenges in Deploying Innovative Battery and Non-Battery Technologies for Energy Storage September 22, 2022 Senate Committee on Energy and Natural Resources Witnesses: Tim Hemstreet, Managing Director for Renewable Energy Development, PacifiCorp Spencer Nelson, Managing Director, Research and New Initiatives, ClearPath Ted Wiley, President and Chief Operating Officer, Form Energy 19:19 Sen. Joe Manchin (D-WV): When it comes to storage, there has rightly been a focus on the supply chain, particularly for lithium ion batteries that power electric vehicles and phones in our pockets and many other modern technologies. While we have benefited from the use of this important battery chemistry, the fact that China is responsible for 75% of global lithium ion battery production, including 60% of the world's cathode production and 80% of the world's anode production, should give everyone pause. That is why I was proud to champion Inflation Reduction Act which incentivized the onshoring of the entire battery supply chain, from the production and processing of raw materials, to the battery pack assembly and everything in between. Full Committee Hearing On Domestic Critical Mineral Supply Chains March 31, 2022 Senate Committee on Energy and Natural Resources Witnesses: Dr. Steve Fortier, Director, USGS National Minerals Information Center, U.S. Department of the Interior Scott Melbye, President, Uranium Producers of America Julie Padilla, Chief Regulatory Officer, Twin Metals Minnesota Abigail Wulf, Vice President, Critical Minerals Strategy and Director of the Center for Critical Minerals Strategy, Securing America's Future Energy Dr. Paul Ziemkiewicz, Director, West Virginia Water Research Institute, West Virginia University 24:14 Sen. Joe Manchin (D-WV): It makes no sense to remain beholden to bad actors when we have abundant resources in manufacturing know-how here in the United States. And make no mistake, we are beholden, particularly when it comes to many of the minerals that go into clean energy technologies. That is why I've sounded the alarm about going down the path of EVs alone and advocated for equal treatment for hydrogen 45:08 Abigail Wulf: As things stand, without some significant course corrections on America's critical minerals enterprise, the leading automobile power won't be the United States. It will be China. Not because of superior design or technology, but because of their massive head start and established market power, if not utter dominance, in all aspects of the supply chain that powers these [electric] vehicles. But simply mining alone does not begin to address the fundamentals of America's mineral supply chain challenge. Where we are most lacking and where China is most dominant is in that crucial but largely hidden processing phase and midstream component production. We simply can't dig up a rock and stick it in a Tesla. You have to crush it, smelt it, and refine it into precursor material that has been sold to somebody else to turn it into battery guts, namely cathodes, anodes and electrolytes. Today, the United States has less than 4% of all minerals processing capacity and makes 0% of the world's cathodes and anodes. By contrast, China is the world's largest processor of copper, nickel, cobalt, lithium and rare earth elements, and they control 60% of anode production and 40% of global cathode production. Consider that in 2019, about 70% of the world's cobalt supply was mined in the Democratic Republic of Congo, but more than 70% of that cobalt was refined in or controlled by China. Full Committee Hearing On Clean Hydrogen February 2, 2022 Senate Committee on Energy and Natural Resources Witnesses Dr. Sunita Satyapal, Director, Hydrogen and Fuel Cell Technologies Office, Hydrogen Program Coordinator, U.S. Department of Energy Dr. Glen Richard Murrell, Executive Director, Wyoming Energy Authority Jonathan Lewis, Senior Counsel and Director of Transportation Decarbonization, Clean Air Task Force Michael J. Graff, Chairman & Chief Executive Officer, American Air Liquide Holdings, Inc. Brian Hlavinka, Vice President, New Energy Ventures, Corporate Strategic Development, Williams 21:07 Sen. Joe Manchin (D-WV): However, we have some challenges to tackle in order to build a clean hydrogen economy. Producing hydrogen without emissions is two to six times the cost of current production methods. Also, retrofitting end-use applications to use hydrogen as a feedstock, from chemical plants to cars and trucks, will take huge investments from both public and private sectors. This is the demand that we need to develop hydrogen markets that can sustain themselves. The other big challenge is the safe and efficient transport and storage of large volumes of hydrogen, given its physical properties. There's a lot of promising work being done in this space and will allow us to leverage our vast natural gas pipeline network to transport hydrogen to market. 22:00 Sen. Joe Manchin (D-WV): That is why I made research, development, and demonstration of these technologies a central part of the Energy Infrastructure Act, which this committee reported with bipartisan support last year, and which was subsequently included in the recently enacted Bipartisan Infrastructure Law. In that bill, we fund $9.5 billion in research, development and demonstration of clean hydrogen, and we tasked the Department of Energy to develop a national strategy and a roadmap to get us to a clean hydrogen economy. 27:25 Sen. James Lankford (R-OK): I'm concerned that the conversation around green versus blue hydrogen will pit technologies against each other rather than working together to establish a robust hydrogen marketplace. The simple truth right now is that 95% of hydrogen produced in the United States is made from natural gas. 1:42:00 Sen. Lisa Murkowski (R-AK): Can you share what the administration's policy is with regards to converting natural gas to hydrogen? We recognize that there are some within the [Biden] administration, certainly some groups that may have influence on the administration, who are very firm about not using fuel sources like natural gas. So the question is, is there a role for conversion to play? And what might we anticipate with regards to support and funding that might come with it? Dr. Sunita Satyapal: Thank you again for the question. And as mentioned, with hydrogen shot, we're really looking at all of the pathways. It's really about clean hydrogen. So whether it's natural gas, carbon feedstocks, nuclear renewables, you know, any pathway to get to the low carbon intensity, we're really pivoting away from the colors. There's a lot of complexity: green, blue, purple, turquoise….Pyrolysis is another approach. In fact, our loan program office just announced financing of $1 billion solid carbon, which is another value added product, no need for the CCS portion. So definitely an all-of-the-above strategy needed to meet all of our goals. Full Committee Hearing to Examine Development and Deployment of Large-Scale Carbon Dioxide Management Technologies July 28, 2020 Senate Committee on Energy and Natural Resources Witnesses: Steven Winberg, (Former) Assistant Secretary for Fossil Energy at the US Department of Energy Shannon Angielski, Executive Director of the Carbon Utilization Research Council Dr. Julio Friedmann, Center on Global Energy Policy, Columbia University 25:06 Dr. Julio Friedmann: Net zero means that any residual emissions must be balanced by removal, as Secretary Moniz said. It means that reduction of co2 emissions and removal of co2 emissions are complementary but distinct actions and that both are necessary. The National Academies and the IPCC find that this must be done at enormous scale exceeding the size of the global oil and gas industry today. We are not where we need to be to make this real. 48:35 Shannon Angielski: In addition, the International Energy Agency modelled the contributions of different technologies to meet that mid-century 2 degree scenario. And it shows that CCUS accounts for approximately 100 Giga tons of needed global co2 emissions reductions by 2060. To put this into perspective, this would be achieved by the operation of 1100 carbon capture systems on the equivalent of 500 megawatt coal fired units, or 3200 natural gas combined cycle units, which would need to be operating for the next 30 years. 1:59:00 Steven Winberg: The rest of the world is going to continue using fossil energy, whether it's coal or oil or natural gas. And that's why we have moved forward quickly on the coal first program, because it offers the opportunity for what I think of as 21st century coal. Right now the Chinese own the space in power generation — coal fired power generation. We have an opportunity to take technology and springboard over what the Chinese are building, which is basically 1970s vintage technology that we built, and they now have improved slightly, but they're selling it around the world, to countries that have coal under their feet, and they're going to continue using that coal. But with the coal first program, we can move into power generation, and we can move into hydrogen production, because these countries also, as they build out their transport sector, may not do it the same way that developed countries, they may move more swiftly into hydrogen. And so there's an opportunity there to take our technology using their natural resources that are under their feet, and produce zero emitting power generation and zero emitting hydrogen and perhaps even net negative hydrogen and net negative electricity and they can use that hydrogen in the transportation sector as well as the industrial sector. Cover Art Design by Only Child Imaginations Music Presented in This Episode Intro & Exit: Tired of Being Lied To by David Ippolito (found on Music Alley by mevio)

The telecommunications, media, and technology sectors are exciting fields, but if you work in public policy, one must constantly adapt. Anisa Green shares with Joe how she built her career and how to find a team that values your presence at work. Anisa Green Anisa Green is Director of  Federal Regulatory at AT&T, where she also serves as Chief of Staff for the Executive Vice President and Chief Regulatory Officer in AT&T's DC office. Anisa has over 24 years of expertise in regulatory, legal and advocacy work. She is currently working on universal service regulatory issues, with a focus on consumer broadband affordability, digital equity, and rural healthcare matters.  In addition to serving as a Trustee of the Federal Communications Bar Association Foundation, Anisa champions various organizations focused on empowering, encouraging and educating youth, women, and marginalized communities. Hailing from Brooklyn, NY, with roots in the West Indies, Anisa holds a BA in Philosophy and Communication from the George Washington University, is a certified paralegal, and has taken numerous continuing legal education credits to further her knowledge. When she is not running after her children and caring for her family, she takes advantage of a few stolen moments by shopping, reading a book, catching a movie, or taking a long walk or ride.  Resources Anisa on LinkedIn FCBA – The Tech Bar

This week on the podcast, our USA Country Lead, Oliver Kerr is joined by Jon Wellinghoff, Former Chairman of the Federal Energy Regulatory Commission (FERC) and current Chief Regulatory Officer at Voltus, the world's leading platform for Distributed Energy Resources (DERs). With a distinguished career in the US energy sector, Jon was the longest serving Chairman of FERC during the Obama administration after he was appointed first as a commissioner by George W Bush in 2006. Jon and Oliver discuss: • The role of FERC and the Federal Government more broadly in the energy transition • The potential of demand-side response which remains a relatively small part of energy mix in US and the reason why haven't we seen more progress • Whether it is possible to reach Net Zero with renewables, efficiency and demand-side response, or do we also need supply-side investment in other low carbon generation like nuclear, CCS, hydrogen, long-duration storage

If you're taking a candidate into clinical trials that will be monitored by multiple international regulatory bodies, this episode is an absolute must-listen. Dr. Daniela Drago , Chief Regulatory Officer at Aurion Biotech, shares her encyclopedic knowledge of the dynamic regulatory harmonization landscape. Along the way, she offers concrete advice on creating multijurisdictional regulatory efficiencies that will smooth your journey through the clinic and beyond. Don't miss this one. 

Tune in as Jeff Alberts, Partner at IIB Gold APM, Pryor Cashman, guest hosts an episode with Rebecca Rettig, General Counsel of Aave, Jai Ramaswamy, Chief Regulatory Officer at Andreessen Horowitz, and Jason Allegrante, Head Regulatory Counsel and Chief Compliance Officer at Fireblocks to talk about the recent OFAC sanctions compliance guidance for virtual currency industry and what it might mean for FBOs.

Our guest is Esther Abels, Chief Clinical Officer and Chief Regulatory Officer at Visiopharm, as well as the president-elect of the Digital Pathology Association. Esther also leads the regulatory and standards task force at the DPA with a focus on FDA collaborations to drive regulatory and standard classifications for interoperability and computational pathology in the field of digital pathology. We're going to be talking about standardization in digital pathology - not only in preanalytical factors such as fixation and staining - but also in the interpretive or analytic component, as well which is becoming increasingly important to ensure optimal diagnostic results for patients and incorporation of digital pathology data into diagnostic and drug discovery programs. We discuss regulation. What are some misconceptions about regulation how can we use regulation as a tool to protect patients and better develop and provide products and services? And how can we partner with regulators to help advance the science. What is the DPA working on now and what is their long-term vision for the future of the field? The annual meeting of the Digital Pathology Association, Pathology Visions is going to be held this October in Las Vegas.

Former Federal Energy Regulatory Commission Chairman and current Chief Regulatory Officer of Voltus Jon Wellinghoff told us about how when he led FERC, he helped establish the regulatory and legal foundation, through technical conferences, rulemakings, and ultimately in a case at the US Supreme Court, for how smart grid and its associated technologies, these days called distributed energy resources (DERs), would be introduced into markets. He helped us see the history and the very bright future he is working with Voltus to help create and this is one interview not to miss.

Host Tom Foley talks to Dr. Chris Elliott FREng, Chief Regulatory Officer, Leman Micro Devices discussing the advances of medical devices coupled with AI and how that advances consumer empowerment. This show is sponsored by HP and Intel. HP Engage long lifecycle products provide the stability, safety and security you need plus flexibility and performance designed for today and tomorrow. Intel would like you to know, they are going above and beyond together with new standards for business, with the latest intel VPro processors, delivering what IT needs for performance, security, remote manageability and stability. To stream our Station live 24/7 visit www.HealthcareNOWRadio.com or ask your Smart Device to “….Play HealthcareNOW Radio”. Find all of our network podcasts on your favorite podcast platforms and be sure to subscribe and like us. Learn more at www.healthcarenowradio.com/listen/

One of the hallmarks of practicing medicine in the 21st century is the creation and maintenance of electronic health data.  Although much of the discussion around data is about ransomware, breaches, and EHR systems, that discussion is expanding.  The Office of Civil Rights is in the midst of a right of access initiative to help patients get their medical records.   The CURES Act addresses information blocking.  This marks a change of focus from rules surrounding the protection of medical data to the use and accessibility of that data. In this episode of SoundPractice, Mike Sacopulos interviews Deven McGraw, Chief Regulatory Officer for Ciitizen and former Deputy Director for Health Information Privacy at The Office of Civil Rights. Ms. McGraw will walk us through the rules for and status of Information Blocking. She will also cover the recent Office of Civil Rights' Right of Access Initiative policies surrounding the “Designated Records Set.”  Since HIPAA went into effect in 1996, healthcare providers have been endeavoring to safeguard patient data. After 25 years, prepare to shift your thinking. Join us for a look at healthcare data, patient privacy, and the law. Deven McGraw Co-Founder & Chief Regulatory Officer, Ciitizen.   deven@ciitizen.com Learn more about the American Association for Physician Leadership at www.physicianleaders.org  

One of the hallmarks of practicing medicine in the 21st century is the creation and maintenance of electronic health data.  Although much of the discussion around data is about ransomware, breaches, and EHR systems, that discussion is expanding.  The Office of Civil Rights is in the midst of a right of access initiative to help patients get their medical records.   The CURES Act addresses information blocking.  This marks a change of focus from rules surrounding the protection of medical data to the use and accessibility of that data. In this episode of SoundPractice, Mike Sacopulos interviews Deven McGraw, Chief Regulatory Officer for Ciitizen and former Deputy Director for Health Information Privacy at The Office of Civil Rights. Ms. McGraw will walk us through the rules for and status of Information Blocking. She will also cover the recent Office of Civil Rights' Right of Access Initiative policies surrounding the “Designated Records Set.”  Since HIPAA went into effect in 1996, healthcare providers have been endeavoring to safeguard patient data. After 25 years, prepare to shift your thinking. Join us for a look at healthcare data, patient privacy, and the law. Deven McGrawCo-Founder & Chief Regulatory Officer, Ciitizen.  deven@ciitizen.comLearn more about the American Association for Physician Leadership at www.physicianleaders.org  

HIMSSCast welcomes healthcare privacy expert Deven McGraw, currently Chief Regulatory Officer for Ciitizen who previously served as Deputy Director, Health Information Privacy at OCR, as well as Acting Chief Privacy Officer at ONC, to discuss the forthcoming information blocking rules, upcoming HIPAA overhaul, and more with host Jonah Comstock and Healthcare IT News Executive Editor Mike Miliard. Talking points:Challenges of complying with the new info blocking rulesHow the new rules flip the script on data sharingInfo blocking rules vs CMS rules on APIsPatient right of access and form and format requirementsMarket opportunities created by the new rulesWhat could happen next with national privacy legislation?Defining health data for legislative purposesLooking at the upcoming updated HIPAA rulesPrivacy implications of vaccine credentialingMisconceptions about when HIPAA appliesWhat Ciitizen is working on these daysDeven’s parting advice on the info blocking rulesMore about this episode: Privacy protections to encourage use of health-relevant digital data in a learning health system (Deven's paper with Ken Mandel)Ciitizen's websiteHHS publishes final regs on info blocking, interoperabilityHIMSSCast: How providers and payers should be preparing for new info blocking and patient access rulesONC officials offer update on information blocking rules complianceInfo blocking compliance date nears: Legal experts offer toolkit to helpCOVID-19 highlights the importance of ONC info blocking rules, says RuckerHealthcare industry groups react to extended info blocking compliance timelineHHS floats major changes to HIPAA Privacy RuleHIMSSCast: HIPAA Privacy Rule proposed changes - What they mean and what to expectOffice of Civil Rights extends comment period on changes to HIPAA privacy ruleThree ways providers get HIPAA right of access wrongHow to solve the 'Goldilocks' dilemma of health data sharing?Apple requires COVID-19 vaccine passport developers to work with public health authorities

Carlos Peña, PhD, MS, is Chief Regulatory Officer, leading the newly established Office of Regulatory Services at the Jacobs Institute. Prior to the JI, Carlos served as the Director of the Office of Neurological and Physical Medicine Devices, at the Center for Devices and Radiological Health (CDRH), at the U.S. Food and Drug Administration (FDA). He was also the Assistant Director of Emerging Technologies in the Executive Office of President Barack Obama (2012-2014). He joins us to discuss the FDA's medical device approval process, how the JI's newly established Office of Regulatory Affairs will benefit the Buffalo-Niagara region, and more.    'Can the FDA Keep Up?' is the chapter in the Jacobs Institute’s Future of Medicine report that challenges whether the agency can keep pace with medical innovation.   Visit our Future of Medicine web page. Learn more about the Jacobs Institute. To help further the future of medicine, please consider supporting us today.

Questions always arise over what is fair remuneration for directors and what should it be based on. Is there a sweet spot? We speak to Foo Lee Mei, Chief Regulatory Officer at the Securities Commission Malaysia, for her views. We also ask about the recent findings of their Corporate Governance Monitor 2020 report. Image Credit: Shutterstock

In our second episode, Shannon Yavorsky sits down with Deven McGraw, Co-Founder and Chief Regulatory Officer, Ciitizen Corporation, and former Deputy Director for Health Information Privacy at the Office for Civil Rights of the U.S. Department of Health and Human Services.

Deven McGraw , JD, MPH, LLM is the Chief Regulatory Officer at Ciitizen (and former official at OCR and ONC). Vince Kuraitis, JD/MBA is an independent healthcare strategy consultant with over 30 years’ experience across 150+ healthcare organizations. He blogs at e-CareManagement.com. Together, they have written a fantastic series called the Health Data Goldilocks Dilemma which sheds light on the many complex issues related to our ever-increasing demand for health data and privacy law. https://thehealthcareblog.com/the-health-data-dilemma-sharing-privacy-both/ Ciitizen Website: https://www.ciitizen.com/ Deven McGraw’s Medium: https://medium.com/@ciitizen Vince’s website: http://e-caremanagement.com/ Vince’s 143 Healthcare ICO list, last updated Oct. 2018: https://docs.google.com/spreadsheets/d/1TANOZmuYtVhyn1C9PV6YLsOBlQNOEOBExB7u2_Kkork Show Notes •Introduction of Deven's and Vince's background •Journey into healthcare law, privacy standards, and current positions •Healthcare industry expectations during COVID19 pandemic •When did you first hear about blockchain? •Deven - Responsibilities at Ciitizen Health as Chief Regulatory Officer and vision as a company •Vince - Principal, blogger, and consulting work at Better Health Technologies •What is the government doing well to address the serious pandemic situation? •Contact tracing - Apple and Google Exposure notification API platform for public health organizations •Data privacy - Realistic technology expectations - HIPAA •Data Goldilocks concept •Unique privacy and security attributes of DLT •Deven- Ciitizen Scorecard? •What advice would you give larger EMR companies like Epic and Cerner? •Advice to healthcare regulators? •Deven - Ciitizen's investors include Andreessen Horowitz, Verily, and Intermountain healthcare •What do you disagree on? •Recommended resources -https://medium.com/@tomaspueyo/coronavirus-the-hammer-and-the-dance-be9337092b56 •Wrap-up and Final Takeaways News Corner https://finance.yahoo.com/news/hashcashs-post-pandemic-plans-streamline-070000831.html In May, HashCash Consultants announces a plan to streamline the medical supply chain by forming a consortium of medical equipment suppliers, pharmaceuticals and medical goods manufacturers, distributors and other key players. Health Unchained Links Website: https://healthunchained.org Telegram: t.me/healthunchained Twitter: twitter.com/Healthunchaind Disclaimer: Remember, the Health Unchained podcast is for informational and entertainment purposes only and we are not providing any sort of legal, financial, or medical advice. Please do your own research and due diligence before making any important decisions related to these matters.

Recorded via video conference under the Florida shelter-in-place order during the COVID 19 pandemic.Virtually safeguard your business and employees with FBMC’s Chief Regulatory Officer, Patrick Flemming Esq. Find out about what kind of cyber threats can affect your business and ways to protect yourself and your employees against them.

It's been a while, but we're glad to be back with a brand new episode of Quality Content. Last week, Canada 2020 hosted its 5th Annual Health Innovation Summit which looked the state and sustainability of the Canadian health care system. On this episode, our host Alex Paterson sits down with some Canada's leading health experts for in-depth conversations around the future of innovation in health care. Here's who you can expect from this episode of Quality Content: Bill Charnetski, Executive Vice Presiden, PointClickCare Elizabeth Toller, Executive Director, Regulatory Innovation, Health Canada David Lee, Chief Regulatory Officer, Health Canada Jodi Butts, Independent Board Member, Aphria

Last week, Canada 2020 hosted it's 5th Annual Health Innovation Summit, bringing together key representatives from across the health system to expose how advancements in technology and investments in innovation help improve health outcomes and reduce costs. Here's what you can expect from Part 2 of this episode of 2020 live: Presentation: Stepping into the Future of Treatment & Care in CanadaElizabeth Toller, Executive Director, Regulatory Innovation, Health CanadaDavid Lee, Chief Regulatory Officer, Health Canada In ConversationThe Hon. Mary NG, Minister of Small Business, Export Promotion and International Trade In Conversation: Adopting Innovation on the Front LinesAlex Munter, President & CEO, CHEOJodi Butts, Independent Board Member

Tim Byun, the Chief Regulatory Officer of OKCOIN, stepped Inside the ICE House to offer his thoughts on where crypto is headed and forecast the regulatory and compliance hurdles arising as the market grows. Today, there are nearly 200 cryptocoin exchanges located around the world and over 4,500 types of cryptocoin. Initial Coin Offerings (ICOs) are seeing a dramatic hike: over $2 billion in new ICOs, in March 2018, compared to just $19.5 million in March 2017, according to CoinDesk. Tim Byun helps us understand where the trends are headed. Inside the ICE House: https://www.theice.com/podcast/inside-the-ice-house

Compliance, so often followed by the rulebook, also needs a playbook: one that gets everyone on board, from the C-suite to the front-line employees who deal with customers. What are the five key ingredients that help organizations create a culture that improves compliance and bolsters the bottom line? Pam Perdue, the Executive Vice President and Chief Regulatory Officer at Continuity, lays down the blueprint for getting compliance out of silos and into the lifeblood of financial institutions.

Option Block 133: One Thing Sebastian Won't Do Trading Block: With Greek deadline looming, will we get a vol pop or further vol implosion? CBOE is being investigated by the SEC, and its Chief Regulatory Officer put "on leave." TVIX is starting to couple back again, and volume in UVXY has helped alleviate that of TVIX. The new iPad is not exactly setting the market on fire or the hottest thing since sliced bread? Where is Apple vol in the wake of this announcement? Odd Block: Usual activity in Starbucks Corp. (SBUX), D.R. Horton, Inc. (DHI), and Carnival Corp. (CCL). Xpress Block: Tim Navabi discusses advice for working with your broker, and the process that goes into a broker override. Around the Block: Non-farms is the big event tomorrow that everyone will be watching. Keeping an eye on Greece.

Power Down The Rev. Canon Sally G. Bingham, President, The Regeneration Project Chris King, Chief Regulatory Officer, eMeter Gregory Walton, Assistant Professor of Psychology, Stanford University Energy underpins our civilization. It’s hardly surprising that convincing people to use less of something so tied to their comfort and survival is challenging. Smart policy has given California a head start, but it’s not enough. We need to dig deeper to reap energy savings, say these three experts convened by Climate One. “I think there’s a downside in focusing too narrowly on money,” says Gregory Walton, Assistant Professor of Psychology, Stanford University. Instead, Walton and his team focus on creating the sense that saving energy is a community movement. We need to reach a point where saving energy becomes the social norm, he says, as is the case with wearing seat belts and recycling. “There’s a psychological transformation that happens,” Walton says. “It’s the same behavior, the same experience, but it comes to feel very different by virtue of its social need.” There are still other levers to pull. “I have a bit of an advantage, in that most religions can use guilt,” jokes Rev. Sally G. Bingham, President and Founder, California Interfaith Power & Light. “Sometimes it works. But mostly our congregations that are cutting their energy use are doing it for the right reasons,” she says. “Fairly often a congregation will begin this process for money saving reasons, but also because they feel they are doing the right thing” Chris King, Chief Regulatory Officer, eMeter, says customers need better information. “There’s this strong desire for more information and ability to do something,” he says. “What they really want to know: How much energy does each of my appliances use?” It’s helpful to know that electricity consumption spiked when I plugged in my toaster, he says, but without comparing it to the total, the bigger picture is lost. A better solution is to give customers a monthly breakdown for electricity use by all appliances, which he says can be done with up to 90% accuracy using a combination of the smart meter and algorithms. This program was recorded in front of a live audience at the Commonwealth Club of California, San Francisco on July 22nd, 2011