PiTech Solutions Podcast

PiTech Solutions

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. 2h ago

    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

  2. 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

  3. Aug 7

    Insurance - AI Governance Becomes Examinable, and Claims Delivers the Return | PiTech Solutions Podcast

    Insurance - AI Governance Becomes Examinable, and Claims Delivers the Return Insurance has crossed a line this year. The question is no longer whether AI works in a carrier environment. It is whether your organization can operate it responsibly, prove that it did, and rebuild the process around it. Mike and Laura unpack the week's most consequential developments for insurance executives and explain why the carriers separating themselves are not the ones with the most advanced models. The pilot to production gap is now visible in the financials. Organizations that have fully integrated AI into operational workflows are nearly four times more likely to report revenue growth than those still piloting, at fifty eight percent versus fifteen percent. Yet seventy nine percent of organizations report adoption challenges, a double digit increase over the prior year. The tooling improved. Legacy infrastructure, fragmented data, and organizational readiness did not. Claims is where the measurable return lives. AI powered claims automation is delivering thirty to forty percent cost reductions per claim, and BCG research shows AI enabled carriers cutting claim resolution time by seventy five percent, from thirty days to seven and a half. Laura argues the cycle time number matters more than the cost number, because a claim that closes in seven days does not become a complaint, does not attract an attorney, and does not sit on the books accruing reserve uncertainty. Governance stopped being aspirational. At least twenty four states plus the District of Columbia have now adopted the NAIC Model Bulletin or substantially similar guidance. The development that changes the character of the obligation is the NAIC AI Systems Evaluation Tool, which gives examiners a standardized approach to reviewing insurer AI governance. Principles based guidance with an exam methodology behind it is a compliance regime. The European deadline has arrived. Annex three of the EU AI Act classifies risk assessment and pricing systems for life and health insurance as high risk, with obligations applying from August second of twenty twenty six and penalties reaching thirty five million euro or seven percent of global turnover. Mike and Laura explain why the NAIC and European frameworks, structurally different as they are, demand largely the same evidence, and why carriers should build one governance capability rather than two compliance projects. Modernization and AI are the same program. With realistic core system replacement running eighteen to thirty six months, the episode closes on why phased migration that unlocks a real AI capability at each stage beats deferring all the value to a distant end state. To learn more about how PiTech Solutions helps carriers and regulated enterprises turn AI ambition into governed, production grade capability, visit pitechsol.com. #InsuranceAI #AIGovernance #ClaimsAutomation #NAIC #InsurTech

  4. Jul 31

    Capital Markets - Tokenization Goes Live, Agentic AI Reaches Production, and the T+1 Clock Starts Ticking | PiTech Solutions Podcast

    Capital Markets: Tokenization Goes Live, Agentic AI Reaches Production, and the T+1 Clock Starts Ticking Two clocks are running in capital markets right now. One is the innovation clock, moving faster than almost anyone predicted. The other is the readiness clock, and that is where most firms are quietly falling behind. In this episode, Mike and Laura unpack four developments reshaping the sector and explain what each one demands of leadership teams in regulated industries. Tokenized securities move from theory to production. The Depository Trust and Clearing Corporation moved tokenized securities into live trading in July 2026, processing real production trades in tokenized stocks, exchange traded funds, and U.S. Treasurys. The limited production rollout expands to full service integration in October 2026. The eligible asset set is deliberately conservative, covering Russell 1000 equities, major index funds, and Treasury bills, and the industry working group behind it spans more than fifty firms including Goldman Sachs, J.P. Morgan, BlackRock, Circle, and Ondo Finance. The broader tokenized real world asset market now sits near $33.8 billion, with BlackRock's tokenized Treasury fund alone above $2 billion. The regulatory picture gets clearer. On January 28, 2026, SEC staff issued a joint statement establishing that tokenization does not change the legal character of an asset. If it was a security before it went on chain, it remains one. Chair Paul Atkins has since set an agenda covering crypto capital raising, digital asset custody, and on chain trading of tokenized securities, with a proposal known as Regulation Crypto in circulation. Full rulemaking across the SEC and CFTC may take up to eighteen months, which is precisely why waiting for final rules is the riskiest option available. Agentic AI crosses from pilot to production. Broadridge put agentic AI into live production across capital markets and wealth management workflows in May 2026, with new clients told to expect up to 30% day one operational cost reduction. Seventy seven percent of the largest global asset managers now run organization wide generative AI deployments, and algo wheel adoption has climbed to 42%. But 63% of buy side firms still lack unified data across front, middle, and back offices, and that fragmentation, not model quality, is the binding constraint on autonomous operations. The crowding paradox. Research covered by Bloomberg on July 1, 2026 suggests a profitable trading signal may now lose half its excess return in roughly eighteen months, down from five to seven years before AI became widespread. New York University researchers studying nearly one million institutional fund holdings found portfolios growing measurably more similar as AI adoption spreads, most sharply among the heaviest users. Mike and Laura discuss what that means for where competitive advantage actually lives, and why AI governance is now a risk control rather than a compliance checkbox. T+1 arrives in the UK and Europe. Go live is October 11, 2027, but the date executives should have circled is December 31, 2026, when trade allocations and confirmations between buy side firms and executing brokers must complete on trade date. That interim deadline effectively ends next day confirmation as an operating practice, and ESMA has been specific about what it requires: enhanced automation, extended CSD operating hours, improved trade confirmation processes, and coordination across a still fragmented European infrastructure. The connecting thread across all four stories is that automation is no longer optional and the deadlines are now external. Firms no longer set their own pace on modernization. To learn more about how PiTech Solutions helps organizations in regulated industries build the data foundations and automation capabilities these shifts demand, visit pitechsol.com. #CapitalMarkets #Tokenization #AgenticAI #T1Settlement #FinancialServices

  5. Jul 24

    Banking - Agentic AI Reaches Production While Stablecoins and New Model Risk Rules Reshape the Sector | PiTech Solutions Podcast

    Banking - Agentic AI Reaches Production While Stablecoins and New Model Risk Rules Reshape the Sector | PiTech Solutions Podcast This week on the PiTech Solutions Podcast, Mike and Laura unpack the forces converging on banking in 2026, a year when artificial intelligence stopped being an experiment and became a core operating priority. From autonomous agents on the front line to a redrawn regulatory map covering AI, stablecoins, and open banking, this is the strategic briefing that C suite leaders in regulated industries need. Agentic AI moves from pilot to production. With 82% of U.S. banks planning to increase their AI budgets, institutions like BNY, TD Bank, and Commonwealth Bank of Australia are deploying autonomous agents and even naming chief AI officers. The early returns are concentrated in fraud and compliance, where detection agents cut false positives by 60% or more and automation reduces AML and KYC workloads by 30 to 50 percent. The model risk rulebook gets rewritten. The Federal Reserve, OCC, and FDIC issued SR 26-2 in April, superseding the decade old SR 11-7 framework. Notably, it leaves generative and agentic AI outside its formal scope, placing the governance burden squarely on boards and executives. Stablecoins, tokenized deposits, and open banking. The GENIUS Act has made stablecoin strategy operationally unavoidable, with real implications for deposits and lending capacity. Tokenized deposits are emerging as banks' preferred path to modernize payments without losing the customer relationship, while Section 1033 keeps open banking in regulatory limbo. The through line is clear: technology and customer expectations are outpacing regulation, and the winners are building governance and infrastructure now. To learn more about PiTech Solutions, visit pitechsol.com. #Banking #AgenticAI #FinTech #Stablecoins #RegTech

  6. Jul 17

    FinTech - Programmable Money Goes Mainstream: Open USD, Circle's Trust Bank, and Agentic Commerce | PiTech Solutions Podcast

    FinTech - Programmable Money Goes Mainstream: Open USD, Circle's Trust Bank, and Agentic Commerce This week Mike and Laura turn their attention to FinTech, where one of the busiest stretches of the year is redrawing the map of digital finance. From a consortium stablecoin backed by the biggest names in payments to AI agents completing real transactions on live rails, the infrastructure of money is being rebuilt in software, and executives in regulated industries need a point of view. The Open USD launch. A new independent venture called Open Standard has unveiled Open USD, a stablecoin backed by more than 140 companies including Visa, Mastercard, BlackRock, Coinbase, Google, IBM, Standard Chartered, US Bank, American Express, BBVA, BNY, and Stripe. Mike and Laura unpack its shared governance model, its fee free mint and redeem economics that invert the traditional issuer keeps the float model, and why the announcement moved Circle's stock within hours. Circle's regulatory counterpunch. Circle secured final approval from the Office of the Comptroller of the Currency to form a national trust bank housing USDC custody, giving the digital dollar a federally supervised path and changing the risk calculus for banks and insurers that have stayed on the sidelines. Agentic commerce goes live. CaixaBank and Visa completed a real world agentic card transaction, Visa announced a suite of AI, stablecoin, and token innovations for programmable commerce, Stripe is enabling AI agent payments with AWS, and Malaysia's Boost is already handling the bulk of customer enquiries with an agentic banking platform. The hosts explore the liability, authentication, and fraud questions this raises for chief risk officers. Adoption meets regulation. With 62 percent of financial services firms deploying AI agents and 93 percent of those granting them autonomy, regulators are responding: the FCA is adapting its framework for AI enabled financial systems and Colorado's AI lending disclosure rules are now in effect. Mike and Laura close with three questions every leadership team should ask about programmable finance. To learn more about how PiTech Solutions helps organizations in regulated industries navigate digital transformation, visit pitechsol.com. #FinTech #Stablecoins #AgenticAI #DigitalPayments #RegTech

  7. Jul 10

    Health and Life Sciences - Big AI Enters Drug Discovery as Regulators Align | PiTech Solutions Podcast

    Health and Life Sciences - Big AI Enters Drug Discovery as Regulators Align | PiTech Solutions Podcast This week Mike and Laura turn to health and life sciences, a sector experiencing one of its most consequential stretches in years. Frontier AI labs are moving directly into drug discovery, AI designed drug candidates are heading into pivotal trials, and regulators on both sides of the Atlantic are finally moving in lockstep. Here is what C suite leaders in regulated industries need to know. First, the headline story: on June 30, 2026, Anthropic launched Claude Science, a research platform built for scientific laboratories and pharmaceutical research operations, and announced an internal drug discovery program focused on neglected diseases. The move places Anthropic alongside Google DeepMind and OpenAI in the race to bring frontier AI into pharma, and the market reaction was immediate, with established computational drug discovery firms seeing shares fall on the news. Second, 2026 is the year AI drug discovery meets clinical reality. Industry estimates suggest 15 to 20 AI programs may enter pivotal Phase three trials this year, backed by enormous capital including Isomorphic Labs raising 2.1 billion dollars and Eli Lilly committing 2.75 billion dollars to expand its Insilico Medicine partnership. Yet no AI designed drug has received FDA approval to date, making the coming trial readouts the true test of the technology. Third, the FDA is moving on two fronts at once: warning against overreliance on AI in pharmaceutical manufacturing while embracing AI innovation in clinical trials through its real time clinical trials initiative and a proposed pilot program for AI enabled early phase trials. Combined with the joint EMA and FDA common principles for responsible AI in medicine development published in January, global compliance teams now have a clearer path to building one AI governance framework across jurisdictions. Finally, the hosts examine the operational transformation underway, with research showing 75 to 85 percent of pharma workflows contain tasks that agentic AI could enhance, potentially freeing 25 to 40 percent of organizational capacity, alongside surging investment across cell and gene therapies and the broader AI in life sciences market. To learn more about how PiTech Solutions helps organizations in regulated industries navigate digital transformation, visit pitechsol.com. #HealthAndLifeSciences #AIinPharma #DrugDiscovery #ClinicalTrials #DigitalTransformation

  8. Jul 3

    Healthcare - FDA's New AI Rules, Billion Dollar AI Savings, Ambient Documentation, and Cyber Resilience | PiTech Solutions Podcast

    Healthcare - FDA's New AI Rules, Billion Dollar AI Savings, Ambient Documentation, and Cyber Resilience | PiTech Solutions Podcast Healthcare has reached a genuine inflection point in twenty twenty six, and this week Mike and Laura break down the four forces reshaping the industry for C suite leaders: a regulator loosening its grip on low risk AI while raising the bar on governance, health systems banking hundreds of millions in AI driven savings, an ambient documentation revolution measurably reducing clinician burnout, and a cybersecurity mandate that has moved from the server room to the boardroom. The FDA's landmark shift on AI oversight. In January the FDA published guidance that pulls many low risk AI enabled clinical decision support tools and consumer wearables outside of medical device regulation, provided clinicians can independently review recommendations. High risk diagnostic and treatment tools remain fully regulated, and new human oversight requirements are coming to combat automation bias. The net effect: faster paths to market, with the governance burden shifting squarely onto health systems themselves. AI at industrial scale. UnitedHealth Group projects nearly one billion dollars in AI savings this year, and HCA Healthcare expects roughly four hundred million, driven heavily by revenue cycle automation. With more than eighty percent of UnitedHealth's twenty two thousand engineers now building with AI, the era of pilots is over. Yet a trust gap persists: over half of clinicians want clinical AI built by trusted medical resources, and shadow AI remains a top compliance concern. Ambient documentation goes mainstream. Johns Hopkins, Mayo Clinic, Emory, Corewell Health and others have deployed ambient AI scribes, and Emory's study showed clinician burnout falling from about fifty two percent to thirty nine percent within thirty days. With accessible per clinician pricing and rollouts of three to nine months, documentation has become the proving ground where health systems build AI governance muscle. The cyber resilience mandate. With data extortion attacks rising, supply chain risk climbing, and over seven million connected medical devices expected in smart hospitals this year, regulators are responding. An updated HIPAA Security Rule is expected in twenty twenty six, including an anticipated seventy two hour requirement to restore critical EHR functions after an incident. Eighty four percent of health system CIOs plan to increase security funding. The winners in healthcare's AI era will be the organizations with the strongest governance, the clearest ROI discipline, and the most resilient foundations. To learn more about how PiTech Solutions helps leaders in regulated industries navigate digital transformation, visit pitechsol.com. #HealthcareAI #DigitalHealth #FDARegulation #ClinicianBurnout #CyberResilience

See All (34)

About

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.

Information

  • Creator
    PiTech Solutions
  • Years Active
    2026
  • Episodes
    34
  • Rating
    Clean
  • Copyright
    © 2026 PiTech Solutions Podcast
  • Show Website
    PiTech Solutions Podcast