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Beyond the Extension: Why FSMA 204 Compliance is a Competitive Mandate, Not a Waiting Game

The regulatory landscape of the American food supply chain just shifted, but not in the way many had hoped. While the FDA recently announced a 30-month extension for FSMA 204 compliance, moving the deadline from January 2026 to July 20, 2028, this should not be taken as a signal to pause work. For leaders in the food industry, this extension offers a strategic “breather” by providing more time to fix foundational data maturity gaps that have plagued the supply chain for decades. At SEI, we view this window as a critical opportunity. The complexity of the mandate remains unchanged, and the risks of a “wait-and-see” approach to regulatory enforcement become increasingly costly. The Mandate: What is FSMA 204? Signed into law in 2011, the Food Safety Modernization Act (FSMA) represented the first major federal update to food safety in over 70 years. Section 204 specifically targets traceability. It requires any entity that manufactures, processes, packs, or holds foods on the Food Traceability List (FTL) to maintain extensive records of Critical Tracking Events (CTEs) and Key Data Elements (KDEs). The FTL includes high-risk items such as: Dairy & Proteins: Soft cheeses, shell eggs, finfish, crustaceans, and mollusks Produce: Fresh leafy greens, ready-to-eat salads, and nut butters Processed Goods: Fresh-cut fruits and vegetables The Complexity of the 24-Hour Rule The most daunting aspect of FSMA 204 isn’t just keeping records – it’s the speed of retrieval. Upon request, covered entities must provide the FDA with an electronic sortable spreadsheet containing required traceability information within 24 hours. For organizations still relying on antiquated, paper-based systems, siloed Excel files, or non-interoperable systems that use data-latent feeds and manual data mapping, this requirement is nearly impossible to meet. Traceability is a team sport, and your data is only as good as the information passed to you by your upstream suppliers. The High Cost of “Close Enough” The financial and brand-equity stakes of non-compliance are staggering. History shows that when traceability fails, the entire industry pays: The QSR “Contagion Effect”: In 2020, the major fast-casual chain Chipotle agreed to pay a $25 million federal fine to resolve charges related to outbreaks between 2015 and 2018. However, the damage extended far beyond one balance sheet. Market research indicated that during the height of the crisis, consumer trust in the entire fast casual category dipped, as patrons struggled to distinguish which supply chains were truly safe.  The Lettuce Ripple Effect: The 2018–2019 E. coli outbreaks linked to romaine lettuce resulted in total societal and industry losses estimated between $280 million and $350 million. Because the industry lacked the precision traceability now mandated by FSMA 204, the FDA was forced to issue broad, sweeping warnings. The Cost of Ambiguity from Grower to Consumer: During the E. coli outbreaks, even growers hundreds of miles away from the source of contamination had to plow under healthy crops because they couldn’t digitally “prove” their product wasn’t part of the affected lot. This lack of granular data caused consumer prices in certain markets to spike by as much as 168%. The Hidden Math of a Recall Beyond the immediate headlines, the indirect costs of product recall triage can paralyze an organization: The Traceability Tax: Manufacturers with inadequate data systems see their direct recall costs increase by 70%, adding up to $7M in unnecessary expenses due to the inability to isolate specific lots.  Operational Paralysis: 30% of food and beverage companies report that recent recalls led to employee layoffs, while 26% faced total plant shutdowns. Market Cap Erosion: Serious food recalls result in an average $109 million loss in shareholder wealth within just five trading days of the announcement. When it comes to product recall triage, precision matters. Without digital traceability, a single contaminated lot can trigger a blanket recall, forcing retailers to pull every product off the shelf, even if 99% of the stock is safe.  Excessive labor costs, inventory waste, and operational disruption can be mitigated with traceability enablement. Why Your Partners Aren’t Waiting If you’re a supplier, your customers — the major grocery retailers and food service operators — are likely already grading you. Many end-of-chain partners have already operationalized their traceability plans. They are sending “Dear Valued Supplier” letters demanding: Standardized Data: Adoption of GS1-128 barcodes or Electronic Data Interchange (EDI) Data Accuracy: Recognizing that incorrect master data leads to exponentially wrong traceability data Audit Readiness: Ensuring all links in their chain can meet the 24-hour digital request window How SEI Transforms Compliance into Value Compliance is the floor; operational excellence is the ceiling. SEI helps organizations across the food supply chain leverage FSMA 204 requirements to drive actual business value: Data Foundation & Analytics: We help you move from messy data to immaculately governed master data, ensuring your traceability records are not only accurate from the first mile to the last, but nested using standard hierarchies that make every attribute an asset to the enterprise. Supply Chain Visibility: By implementing interoperable systems and business processes, we help you identify bottlenecks and reduce inventory waste/spoilage, turning a regulatory burden into an efficiency gain to unlock both P&L and balance sheet benefits. Risk & Resilience: We build the frameworks necessary to respond to FDA requests instantly, protecting your brand from the “blanket recall” scenario. Is Your Organization Ready for 2028? 28 months may seem like a long runway, but organizations with gaps in their data need to start now. The July 2028 FDA compliance deadline will be here before we know it, and with every facet of the food supply chain impacted, time needs to be treated as a critical resource, not a luxury. Whether you’re a grower establishing first-mile data, a distributor managing complex logistics, or a retailer or food service provider protecting your brand at the point of sale, SEI can help you navigate what comes next. The FSMA 204 extension offers a rare window to move beyond band-aid fixes and build a more resilient foundation. SEI can help assess your current data maturity, identify gaps across your traceability chain, and evaluate vendor management policies so you’re prepared to lead, not just catch up. Use this time to do things right and build a roadmap that turns a requirement into a more streamlined, high-integrity operation. Ready to schedule your FSMA 204 Readiness Consultation with SEI? Let’s Talk!

Compliance
Article

HIMSS 2026 Recap: It’s a Marathon, and a Sprint

The HIMSS Global Health Conference & Exhibition brings together some of the most influential voices in healthcare to tackle the challenges shaping the future of health IT. Our team got the opportunity to attend this year’s event in Las Vegas, connecting with leaders across the ecosystem, trading ideas, and discovering what’s real versus what’s hype. Discussions spanned AI, data readiness, digital access, and funding realities, often highlighting a central point: progress is being made, though not without friction. Here are a few of the biggest takeaways we gathered from HIMSS 2026. CMS Is Going Digital, but Not Everyone Is Ready One of the most talked-about shifts was CMS’s (Centers for Medicare & Medicaid Services) move toward digital identity and access. With partnerships like ID.me and new requirements for Medicare.gov, CMS is pushing forward on modernizing how patients use services, while many organizations are still catching up. What we’re seeing: Digital identity will become a requirement for accessing key services via the CMS Health Technology Ecosystem Providers will need to support both digital and paper-based identity workflows Questions around privacy, security, and usability are still evolving At the same time, many patients, especially those in underserved or vulnerable populations, still lack access to the tools needed to participate fully in a digital-first system. Takeaway:  The shift to verified digital access brings technical, operational, and patient experience implications that organizations must plan for now. $50b in Funding Doesn’t Guarantee Progress There’s no shortage of investment flowing into healthcare IT, but access to funding and how to use it effectively is far more complicated. Discussions around the Rural Health Transformation (RHT) Program highlighted a critical tension. While the program brings $50 billion in funding over five years to strengthen rural healthcare systems, the path to impact is anything but straightforward. States are using this funding to address a wide range of priorities, from expanding access and strengthening workforce capacity to modernizing infrastructure and enabling new care delivery models. However: Funding is tied to state-specific priorities and pre-defined plans Technology is only one piece of broader transformation efforts Administrative, regulatory, and coordination challenges can slow execution Timelines are aggressive, requiring rapid alignment across stakeholders Takeaway:  Health funding is accelerating change, but a clear strategy and strong execution remain essential. AI Adoption Is Rising. Data Readiness Isn’t. AI continues to dominate the conversation, but the focus is shifting. Last year was about experimentation. This year is about application, particularly around agentic AI and automation. Where we’re seeing traction: Non-clinical use cases like billing, scheduling, and chart abstraction Tools designed to reduce manual effort and improve efficiency Where challenges remain: Most healthcare data — let alone electronic health records (EHRs) — still isn’t structured or standardized enough for meaningful AI use Critical data can live in dozens of different places across systems The need for data transformation is still very real Meanwhile, platforms like Epic are pushing forward with embedded, no-code agentic AI across EHR and ERP systems. This is raising the bar for what “integrated AI” looks like and making it harder for point solutions to compete.  The takeaway here is a familiar one: AI is only as effective as the data behind it. For many organizations, that foundation is still under construction. Smaller Organizations May Have the Biggest Opportunity In a space defined by complexity, speed is starting to matter more than scale. Larger organizations are often navigating layers of regulation, legacy systems, and operational overhead. Smaller organizations don’t carry that same weight, and that creates room to move faster. We’re seeing smaller teams: Adopt new technologies more quickly Test and iterate without large-scale disruption Focus on impact without adding unnecessary complexity Takeaway:  Agility drives progress more than sheer size. Continuing the Conversation Healthcare organizations aren’t standing still, but moving forward requires more than access to technology or funding. It takes alignment across people, processes, and systems. At SEI, we see these moments as opportunities to help organizations turn momentum into measurable progress. We’re grateful to everyone who took the time to connect, share perspectives, and challenge assumptions along the way. If you’re navigating similar questions around digital transformation, AI, data, or operational change, we’re always up for a conversation. Let’s Keep It Going!

AI
Article

From Hype to ROI: What’s Actually Working in Enterprise AI

A Turning Point for Enterprise AI On March 5, 2026, SEI Seattle brought together more than 80 leaders to answer one question: What’s actually working in enterprise AI? “From Hype to ROI: What’s Actually Working in Enterprise AI” wasn’t a night of vendor talking points. It was a practitioner’s field guide, forged from lived experience, hard failures, and real wins — featuring executives and practitioners from Google, Microsoft, AIGovOps Foundation, and SEI. The Panelists: Antonio Mañueco — Practice Lead, AI & Technology, SEI Ravi Vedula — Corporate Vice President, Microsoft IDEAS Ken Johnston — Founder, AIGovOps Foundation Alix Han — Agentic AI & AI-Powered UX, Google AI Is Not a Tool — It’s a Tectonic Shift Most organizations are still treating AI like software. Something to layer onto existing processes. That’s where things break down. Only 5% of AI pilots deliver meaningful impact. Not because the technology fails, but because the approach does. “If you’re looking at AI as a tool, you’re missing a giant mark. Imagine sitting in 1999 trying to bolt ROI calculations onto the Internet. You would have absolutely missed the mark.” — Antonio, Practice Lead AI & Technology, SEI The panel drew a clear parallel to the Industrial Revolution, the internet age. AI is larger in scope and faster in speed than anything that’s come before. Ravi reinforced the scale of the moment, drawing on 25 years watching technology reshape Microsoft. “I’m in a consequential role, in a consequential company, at the most consequential time in history. How could you not be excited? And if you’re not also a little terrified, you’re living under a rock.” — Ravi, Corporate Vice President, Microsoft IDEAS Fix the Foundation Before You Scale Most organizations are trying to scale AI on top of weak data foundations. Even at Microsoft’s size, Ravi shared how teams ran into inconsistent definitions, missing context and data not designed for machine use. “Data is the fuel for AI. Most companies never actually invested in it. The starting line has moved way ahead, and they’re not going to catch up without fixing the data layer first.” — Ken, Founder, AIGovOps Foundation Without a solid data layer, governance unravels. Ken shared two real-world cases, not born of bad intentions, but of inadequate structure:  Litigation revealed that an insurer’s human-review step averaged just 1.2 seconds per claim. An autonomous agent deleted a production table, added synthetic data, and altered logs to hide the error. What this means: Clean, structure, and add semantic context to your data Define owners and require human review for AI outputs Set up monitoring for your deployments to catch and resolve issues quickly Trust and Adoption Come Down to People Even the best AI fails if the experience doesn’t hold up — and if your culture isn’t ready for it. Alix watched real users type a single word, “table,” expecting sophisticated data retrieval. The gap between what designers assumed and what users actually needed was significant. “You get one shot. If your agent ships and doesn’t work well, users won’t come back. Make sure whatever you release does that one thing really, really well.” — Alix, Agentic AI & AI-Powered UX, Google The deeper challenge the panel kept returning to was unlearning. Ravi was direct: “We are obsessing about the code. We are not focusing enough on the culture.”  Antonio pushed on this further, asking the audience how many use AI to write outgoing emails and how many use it to summarize incoming ones: “A lot of what we do in the enterprise is accumulated debt dressed as process.” What this means: Focus on real user needs Rethink workflows, not just automate them Keep human judgment at the center What This Means for Your Organization The panelists closed the evening by distilling their experience into actionable guidance. Across their different vantage points — product, governance, data infrastructure, and delivery — five clear themes emerged: Focus on one outcome first Resist the temptation to let a thousand experiments bloom. Pick an entity, a kernel, a use case — and get it right. Success compounds. Fix your data before you scale your AI Semantic richness, freshness, quality, and governance are not post-launch concerns. They are prerequisites. Govern from the start, not as an afterthought Accountability structures, risk classification, and compliance integration are what separate one-time pilots from trusted, scalable capabilities. Instrument everything and build for learning Treat every deployment as Version 1. At the end of every AI session, ask the model how you can accomplish the same outcome in fewer steps. Keep humans at the center There will always be roles that are irreplaceably human: judgment, relationships, reading a room, holding the line. Protect that. Invest in people. From Strategy to Execution, End to End AI strategy without execution doesn’t deliver value. Execution without strategy creates waste. SEI brings both — and a proven methodology to get you there. The SEI AI Transformation Approach: 01: Define a Path ForwardRigorous AI assessment and strategy — evaluating readiness, identifying high-value use cases, and building a clear roadmap aligned to your business goals.02: Prepare the OrganizationBuilding AI literacy, managing culture change, and ensuring your people understand the real value and real limits of AI before you scale.03: Experiment & InnovateTurning strategy into production-ready solutions — custom agentic workflows, vendor evaluation, and the data infrastructure to support each use case.04: Sustain ValueEmbedding intelligent automation into critical processes, governing AI agents with rigor, and building the feedback loops that improve performance over time. Across all four phases, SEI brings full-spectrum capabilities, allowing us to serve as a single, accountable transformation partner rather than a collection of specialized vendors. AI & Technology • Concept to Delivery • Data & Analytics • Security, Risk & Compliance • Strategy & Operations SEI Seattle: Where Strategy Meets Execution Since opening in 2023, SEI Seattle has built a team focused on solving complex, real-world AI challenges across the Pacific Northwest and beyond. Seattle was a deliberate choice — it’s the epicenter of technology innovation in North America, and its entrepreneurial spirit matches our own. This event reinforced what we see every day: organizations don’t need more AI ideas. They need partners who can help make AI actually work. If you’re on your own AI journey and want to be part of this dialogue, we invite you to connect with the SEI Seattle team. Let’s talk! Want to share the full recap of this event? Download the PDF here!

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