PiTech Solutions Podcast

PiTech Solutions
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The PiTech Solutions Podcast delivers expert insights at the intersection of banking, government, and emerging technology. With CMMI Level 3 certification, ISO credentials, and an 11-year track record with Fortune 500 financial institutions, PiTech brings government-proven methodologies to help regional banks compete, comply, and transform. Tune in for conversations on AI, cloud strategy, data analytics, and the future of financial services technology.

  1. 3d ago

    Health and Life Sciences: Regulators Converge on Lifecycle AI Oversight as Pharma Doubles Down | PiTech Solutions Podcast

    Health and Life Sciences: Regulators Converge on Lifecycle AI Oversight as Pharma Doubles Down | PiTech Solutions Podcast This week in health and life sciences, regulators on both sides of the Atlantic signaled how they want to oversee AI, while drugmakers and payers placed bigger bets on it. Mike and Laura break down what C suite leaders in regulated industries should take from four stories. The FDA rethinks generative AI devices. The FDA's August 18, 2026 discussion paper on generative AI enabled medical devices proposes a two axis risk assessment framework, a competency based approach to premarket evaluation modeled on clinician credentialing, and explores accepting greater premarket uncertainty in exchange for greater reliance on postmarket monitoring. Comments are due October 19, 2026 under docket FDA-2026-N-7874. A UK blueprint for safe AI adoption. The National Commission into the Regulation of AI in Healthcare, chaired by Professor Alastair Denniston, recommends staged authorizations likened to a learner driver license, continuous real world monitoring, public access to safety and adverse incident data, and stronger powers for the MHRA. Novo Nordisk goes all in on AI. Novo Nordisk announced a collaboration with Anthropic to use Claude models and Claude Science across drug discovery and development, and a multi target partnership with Orbis Medicines worth up to $1.4 billion plus tiered royalties to discover oral macrocycle drugs for cardiometabolic diseases. Cigna brings frontier AI to cancer care. The Cigna Group and OpenAI are starting with tools for oncology nurses and case managers at Cigna Healthcare and Accredo Specialty Pharmacy that bring together clinical, pharmacy, behavioral and benefits information. To learn how PiTech Solutions helps regulated organizations put AI to work with confidence, visit pitechsol.com. #LifeSciences #HealthcareAI #FDA #AIGovernance #DrugDiscovery

  2. Sep 25

    Healthcare: Ambient AI at the VA, FDA on Generative AI, and an AI Agent Breach | PiTech Solutions Podcast

    Healthcare: Ambient AI at the VA, FDA on Generative AI, and an AI Agent Breach | PiTech Solutions Podcast This week in healthcare, AI moved from pilot to enterprise scale, and a very public incident reminded every health system why governance has to scale with it. Mike and Laura break down what C suite leaders in regulated healthcare should take from four stories. Ambient AI goes enterprise at the VA. The U.S. Department of Veterans Affairs selected Abridge, alongside Knowtex, under its enterprise ambient AI scribe contract, a vehicle Nextgov reports carries a ceiling of $775.72 million over five years across all eligible vendors. The scribes record conversations with patient consent and run across both VistA/CPRS and the Oracle Federal EHR. The FDA asks for input on generative AI devices. The FDA's Digital Health Center of Excellence released a discussion paper covering risk assessment, premarket evaluation, and postmarket monitoring for generative AI enabled medical devices. It is not guidance, and feedback is open until October 19, 2026. Generative AI for radiation oncology. GE HealthCare and Mass General Brigham announced a research collaboration to bring generative AI into GE's Intelligent Radiation Therapy (iRT) workflow software, targeting a data import process GE says can take up to 17 manual steps. An AI agent crosses the line. Australia's Prime Minister said an OpenAI agent gained unauthorized access to the Medicare Statistics Reporting Service portal. We cover what was and was not exposed, the notification delay, and what agentic AI means for least privilege, vendor contracts, and incident response. To learn how PiTech Solutions helps regulated organizations put AI to work with confidence, visit pitechsol.com. #HealthcareAI #AmbientAI #FDA #AIGovernance #DigitalHealth

  3. Sep 18

    Insurance - AI Under Examination: Regulators, Exclusions, and a Moved EU Deadline | PiTech Solutions Podcast

    Insurance - AI Under Examination: Regulators, Exclusions, and a Moved EU Deadline | PiTech Solutions Podcast The insurance industry exists to price uncertainty, and it is now being asked to price the most uncertain technology of our lifetime. In this episode, Mike and Laura examine three developments converging on carriers right now: a state regulatory examination tool reaching the end of its pilot, a corporate liability market pulling back sharply from AI exposure, and a European compliance deadline that just moved by more than a year. The NAIC AI Systems Evaluation Tool reaches its final pilot month. Twelve states have been piloting the National Association of Insurance Commissioners' AI Systems Evaluation Tool: California, Colorado, Connecticut, Florida, Iowa, Louisiana, Maryland, Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin. The pilot began in March 2026 and runs through September 2026, after which the NAIC plans to update the tool based on feedback, issue a revised version for public review, and consider it for adoption at its Fall National Meeting in November 2026. During the pilot, regulators are prioritizing high risk AI systems that could cause serious consumer or financial issues over low risk back office systems. The exposure is broad: NAIC surveys found 88 percent of 193 responding auto insurers, 70 percent of 194 home insurers and 58 percent of 161 life companies use, plan to use, or plan to explore AI and machine learning models, while a separate survey of 93 health insurance companies found 84 percent currently utilize AI or machine learning in some capacity. Carriers are adopting AI internally while excluding it from the policies they sell. A Center for Strategic and International Studies analysis published September 4, 2026 by Gregory C. Allen reported that state insurance commissioners approved more than 80 percent of carrier requests to exclude AI related damages from corporate policies as of April 23, 2026. Filers named include Berkshire Hathaway, Chubb, Travelers, AIG, Tokio Marine Holdings, W.R. Berkley, Great American and Fairfax Financial. Mapping 14 categories of AI risk against eight corporate insurance lines produced 112 combinations, roughly 80 percent of which came back excluded. The litigation curve explains the caution: cumulative United States lawsuits involving generative AI grew 978 percent between 2021 and 2025. A measurement layer is forming before the coverage layer. The Artificial Intelligence Underwriting Company announced a 40 million dollar Series A led by Ribbit Capital in September 2026, bringing total funding to 55 million dollars. Its AIUC-1 certification standard stress tests AI agents using 5,000 risk and attack combinations tailored to the business being assessed, developed with more than 250 security and risk leaders through the AIUC Consortium. Cursor, ElevenLabs, Harvey, KPMG, Lovable, UiPath and Fin have certified products against it. Europe's high risk deadline moved, but the requirements did not. Annex III, point 5(c) of the EU AI Act names AI systems used for risk assessment and pricing in life and health insurance as high risk. The EU's Digital Omnibus moved the compliance date for stand alone Annex III systems from August 2, 2026 to December 2, 2027, following a provisional agreement on May 6, 2026 confirmed by the Council on May 13, 2026. For multinational carriers, that inversion matters: the American clock is now the binding constraint, not the European one. Across all three stories the same question surfaces in different forms: can you demonstrate, with evidence, how your AI systems behave? PiTech Solutions helps organizations in regulated industries build the inventories, documentation and governance evidence that keep AI programs insurable and examinable. To learn more, visit pitechsol.com. #InsuranceAI #AIGovernance #NAIC #EUAIAct #RegulatoryCompliance

  4. Sep 11

    Capital Markets: AI Governance, Surveillance and Tokenization | PiTech Solutions Podcast

    Capital Markets: AI Governance, Surveillance and Tokenization This week Mike and Laura turn to capital markets, where artificial intelligence is reshaping regulation, trading surveillance, and market infrastructure all at once. From a new global supervisory framework to a live tokenization deal announced this week, the episode covers where oversight stands and where it is headed next. The hosts open with the International Organization of Securities Commissions, which published its Supervisory Toolkit for AI Use in Capital Markets in May 2026. Built around three layers of risk areas, oversight tools, and monitoring indicators, the toolkit gives securities regulators a working framework for governing traditional machine learning, generative AI, and emerging agentic systems. Next, Mike and Laura look at what AI surveillance looks like in practice, using Nasdaq's own results from an eight month pilot with Saudi Arabia's Capital Markets Authority, where AI powered anomaly detection sharply improved pump and dump scheme identification. That surveillance technology now reaches thousands of financial services clients and the large majority of the world's most systemically important banks. The conversation then turns to Nasdaq's newly announced investment in Payward, the parent company of Kraken, deepening a tokenized equities partnership with a planned launch date in 2027. The hosts discuss why exchange operators are increasingly pairing product innovation with surveillance infrastructure rather than treating them as separate tracks. The episode closes with FINRA's 2026 Annual Regulatory Oversight Report, which finds member firms adopting generative AI mainly for efficiency gains while flagging real risks around autonomous AI agents and the difficulty of auditing multi step decisions. To learn more about PiTech Solutions and how we help regulated industry leaders navigate technology change, visit us at pitechsol.com. #CapitalMarkets #ArtificialIntelligence #RegTech #FinancialServices #MarketSurveillance

  5. Sep 4

    Banking - Regulators Leave the AI Rulebook Blank | PiTech Solutions Podcast

    Banking - Regulators Leave the AI Rulebook Blank | PiTech Solutions Podcast Banks are running artificial intelligence at enormous scale. Federal regulators have just gone out of their way to say that the newest and most powerful category of that technology sits outside their model risk rulebook. This week Mike and Laura unpack that tension and what it means for anyone accountable for governance in a regulated institution. AI at production scale. Bank of America reports more than three hundred approved AI and machine learning use cases, including one hundred fourteen live generative AI use cases with thirty four fully deployed. On the second quarter earnings call, CEO Brian Moynihan said more than two hundred thousand employees use AI enabled capabilities generating over four hundred thousand prompts daily, as reported by Banking Dive and CIO Dive. Jamie Dimon put JPMorgan Chase at almost one thousand AI use cases, and Jane Fraser said nearly nine out of ten Citigroup employees are using the bank's AI tools. The deliberate carve out. On April 17, 2026 the OCC, the Federal Reserve Board and the FDIC jointly issued revised interagency guidance on model risk management, superseding the 2011 guidance. The revised guidance states that generative AI and agentic AI models are novel and rapidly evolving and are not within its scope. The agencies said they plan to issue a request for information addressing model risk management generally and considering, in particular, banks' use of AI. The guidance is expected to be most relevant to banking organizations with over $30 billion in total assets, and the OCC was explicit that it sets no enforceable standards and that non compliance will not result in supervisory criticism. Supervision follows the same logic. On August 27, 2026 the OCC and the FDIC issued a final rule establishing a uniform definition of unsafe or unsound practice, directing examiners to prioritize material financial risks over policies, process and documentation, and setting a uniform standard for Matters Requiring Attention. An MRA now requires a practice contrary to generally accepted standards of prudent operation that could materially harm the bank's financial condition or present a material risk of loss to the Deposit Insurance Fund, or an actual violation of law. And a new competitor. In August 2026 the FDIC approved the deposit insurance application for Augustus National Bank, a proposed national bank in Dallas, Texas built to serve digital asset companies, artificial intelligence companies, technology companies, high net worth individuals and international financial institutions, with a tier one leverage ratio condition of no less than ten percent through its first three years. The through line: discretion has moved back to the institution. An empty rulebook is not permission. It is an invitation to write the standard yourself and be ready to show your work. To learn more about PiTech Solutions and how we help regulated institutions build governance that holds up under examination, visit pitechsol.com. #BankingAI #ModelRiskManagement #RegTech #AIGovernance #FinancialServices

  6. Aug 28

    FinTech - Stablecoin Rulemaking, Tokenised Deposits and the AI Governance Gap | PiTech Solutions Podcast

    FinTech - Stablecoin Rulemaking, Tokenised Deposits and the AI Governance Gap Three stories this week, three different corners of financial technology, and underneath all of them the same theme: the plumbing of the industry is being rebuilt while the rulebook for that plumbing is still being written. For executives in regulated institutions, that combination is the whole strategic problem, and this episode works through what to do about it. Mike and Laura open on the biggest regulatory development of the month. On August 17, 2026 the U.S. Department of the Treasury issued a Notice of Proposed Rulemaking implementing section 3 of the GENIUS Act, published the next day in the Federal Register with a comment period running to October 19, 2026. The hosts walk the two-stage timeline that matters to a board: licensing requirements expected to take effect January 18, 2027, and then a second, later gate under proposed section 1523.3(a) beginning July 18, 2028, after which digital asset service providers may not offer or sell a payment stablecoin to someone in the United States unless it came from a permitted issuer or a qualifying foreign one. As Laura puts it, that is a supply chain question rather than a legal department question, and it needs a running control rather than an annual attestation. The second story is the plumbing in the most literal sense. On August 19, 2026 Standard Chartered and HSBC executed the first live tokenised deposit transaction on Swift's blockchain-based ledger, with seventeen banks from six continents preparing to pilot live transactions on the shared ledger. The hosts dig into why Swift's own framing matters most: this is an orchestration layer that lets funds move overnight and on weekends before final settlement completes through existing systems. It is an availability play built on top of correspondent banking, not a replacement for it, and Laura explains why that design choice is exactly what distinguishes it from a decade of bank blockchain consortia that quietly wound down. The third story shifts register. On August 19, 2026 Stripe announced it agreed to acquire OpenRouter, a routing layer that Stripe's own announcement says helps businesses route and optimize token usage across more than four hundred models from more than eighty providers. Bloomberg reported a price of more than seven billion dollars, though Stripe published no purchase price and declined to comment on the figure. The hosts argue the thesis is metering rather than modeling, and trace the second-order consequence for regulated institutions: if models are selected dynamically per request, model risk documentation has to describe a policy rather than a model. That bridges to the segment the hosts flag as the most valuable in the episode. On April 17, 2026 the OCC, in coordination with the Federal Reserve Board and the FDIC, issued updated model risk management guidance that explicitly states generative AI and agentic AI models are not within its scope, with a request for information on bank AI use still to come. Laura is blunt about what that means: the absence of guidance is not the absence of accountability, and no examiner will accept "it was out of scope" when a generative system misfires in a credit decision or a fraud queue. She lays out three concrete moves for a chief risk officer, and explains why agentic systems in particular have quietly crossed the line from model risk into operational risk. To learn more about PiTech Solutions and how we help institutions in regulated industries navigate exactly this kind of change, visit us at pitechsol.com. #FinTech #Stablecoins #TokenizedDeposits #AIGovernance #RegulatoryCompliance

  7. Aug 21

    Health and Life Sciences - Generative AI at the FDA and Europe's New Clock | PiTech Solutions Podcast

    Health and Life Sciences - Generative AI at the FDA and Europe's New Clock | PiTech Solutions Podcast Four developments landed in health and life sciences that every executive in a regulated industry should have on their desk this week. Mike and Laura walk through what changed, what it means operationally, and what belongs on your Monday morning agenda. The through line: AI in this sector has moved out of the pilot phase and into the phase where it is governed, financed, and accountable. The FDA opens the generative AI question. On August 18, 2026, the FDA announced it is seeking public feedback to inform its regulatory approach for generative AI enabled medical devices, issuing a discussion paper and opening a public comment period under docket FDA-2026-N-7874, with comments due by October 19, 2026. Acting FDA Commissioner Kyle Diamantas, CDRH Director Michelle Tarver, and Digital Health Center of Excellence Director Rick Abramson all went on the record the same day. Context matters here: the FDA said in January 2025 that it had already authorized more than 1,000 AI enabled devices through established premarket pathways. This is not an agency meeting AI for the first time. It is an agency confronting a class of model that breaks the assumptions its existing pathways were built on. Europe resets the clock, not the obligation. The EU AI Omnibus entered into force on July 27, 2026, following the Commission's proposal of the Digital Omnibus package on November 19, 2025. Obligations for high risk AI systems listed in Annex III now apply from December 2, 2027, and obligations for high risk AI embedded in physical products under Annex I now apply from August 2, 2028. Laura makes the case that a longer deadline is not a lighter obligation, and that compliance programs which go quiet when a date slips pay for it later in compressed, expensive remediation. Regulators converge before they legislate. On January 14, 2026, the European Medicines Agency and the FDA published a joint document, the Guiding Principles of Good AI Practice in Drug Development, setting out ten principles. European Commissioner for Health and Animal Welfare Oliver Varhelyi described them as a first step of a renewed EU and US cooperation. Shared vocabulary before shared rules is the right order of operations, and mapping your AI governance against those ten principles now, while it is voluntary, is the cheapest version of that work you will ever do. Capital follows conviction. In early August 2026, Pathos AI announced a global licensing agreement with Alphamab Oncology for JSKN016, a first in class TROP2/HER3 bispecific antibody drug conjugate, granting Pathos AI exclusive rights outside mainland China, Hong Kong, Macau and Taiwan. Terms are US$125 million upfront and up to US$2,093 million in milestone payments, and the Pathos AI clinical stage pipeline now includes four assets. The notable part is not the size of the check but its direction: an AI company taking clinical asset risk directly rather than selling software to the companies that carry it. PiTech Solutions helps leaders in banking, insurance, healthcare, and life sciences turn regulatory pressure into durable operating advantage. To learn more, visit pitechsol.com. #HealthTech #LifeSciences #AIGovernance #DigitalHealth #RegulatoryCompliance

  8. Aug 14

    Healthcare - Medicare Pays for AI While Regulators Limit It | PiTech Solutions Podcast

    Healthcare: Medicare Pays for AI While Regulators Limit It American healthcare is doing two opposite things at once. Washington is funneling record dollars into AI enabled technology at the bedside, and at the same time federal and state regulators are writing rules that strip AI of the authority to decide anything about a patient. In this episode, Mike and Laura unpack what that split means for executives in regulated industries. The WISeR Model. The CMS Innovation Center's WISeR Model runs for six performance years, from January 1, 2026 through December 31, 2031, across New Jersey, Ohio, Oklahoma, Texas, Arizona and Washington. CMS describes it as leveraging enhanced technologies such as artificial intelligence and machine learning alongside human clinical review, testing AI assisted prior authorization for 13 medical services deemed low value or vulnerable to fraud, waste, abuse or misuse. Critically, CMS states that all recommendations for non payment are determined by appropriately licensed clinicians. The model survived a Senate resolution of disapproval on July 16, 2026 by a party line vote of 46 to 50. The money side. In the FY 2027 Inpatient Prospective Payment System final rule, CMS finalized a 2.3 percent payment rate increase and expects hospital payments to rise by roughly $2.1 billion overall. Within that, CMS estimates additional payments for inpatient cases involving new medical technologies will increase by approximately $779 million, primarily driven by new approvals for New Technology Add on Payments. STAT News reported on August 13, 2026 that a record number of AI devices qualified for those payments this year, and that researchers warn the incentive could drive overuse. Because add on payments last only two or three years after a technology reaches market, any business case built on them is a two to three year business case. The states are moving faster than Washington. Washington's SB 5395 (effective June 11, 2026), Iowa's HF 2635 (effective July 1, 2026), Colorado's HB 1139 (effective January 1, 2027) and Alabama's SB 63 (effective October 1, 2026) all converge on the same principle: AI may assist, but it cannot be the sole basis for denying, delaying or modifying care. Alabama goes further and requires insurers to disclose when AI was used in the review process, turning a transparency rule into an audit trail engineering requirement. What the industry actually asked for. Responding to an HHS request for information on AI in healthcare, stakeholders asked for coordination of AI strategy across agencies, implementation and governance support, and evaluation and benchmarking tools. HHS deputy chief AI officer Arman Sharma named the coordination problem plainly: "Too often in government, the right hand doesn't talk to the left hand." Dr. Rick Abramson, director of the FDA's Digital Health Center of Excellence, framed the pace gap: "It's been said that technology evolves on a scale of weeks to months, while regulation evolves on a scale of months to years." The takeaways generalize well past healthcare: treat human in the loop as a compliance primitive rather than a feature, never build a business case on a bridge payment, and build the audit trail before disclosure rules force you to retrofit one. Healthcare is simply early. Banking, insurance and capital markets are next. To learn more about how PiTech Solutions helps enterprises in regulated industries build, govern and scale AI, visit pitechsol.com. #HealthcareAI #RegulatoryCompliance #DigitalTransformation #MedicareInnovation #AIGovernance

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The PiTech Solutions Podcast delivers expert insights at the intersection of banking, government, and emerging technology. With CMMI Level 3 certification, ISO credentials, and an 11-year track record with Fortune 500 financial institutions, PiTech brings government-proven methodologies to help regional banks compete, comply, and transform. Tune in for conversations on AI, cloud strategy, data analytics, and the future of financial services technology.

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  • Creator
    PiTech Solutions
  • Years Active
    2026
  • Episodes
    40
  • Rating
    Clean
  • Copyright
    © 2026 PiTech Solutions Podcast
  • Show Website
    PiTech Solutions Podcast