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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
Resource

Data Strategy: The Foundation for GenAI Success

Data and a well-defined Data Strategy are crucial to successful GenAI Adoption. At SEI, we believe great AI starts with great data. As organizations accelerate toward a future shaped by GenAI, one truth becomes clear: AI is only as powerful as the data that fuels it.  While many are eager to harness the speed and scale of GenAI to transform how they operate, far fewer have laid the groundwork to do so successfully. The challenge? Most companies are still early in their data maturity journey. Without a strong, trusted data foundation, even the most promising AI initiatives can stall — delivering poor outputs, eroding trust, and putting long-term ROI at risk. Organizations must treat data as a strategic asset to unlock AI’s full potential. That means modernizing legacy systems, improving governance, integrating platforms, and embedding data literacy across every level of the business. It also means aligning AI efforts with core business objectives and building the infrastructure and practices to support scale, security, and sustainability. This case study explores the core data principles and strategic steps organizations must take to move from experimentation to enterprise-grade GenAI. When it comes to AI, good data isn’t just important — it’s everything. Is your Data an Enabler or a Deterrent? We are at an exciting crossroads with AI and GenAI a top priority for organizations across all industries. Here are some key fundamental reasons that make maturing their Data Capabilities crucial. GenAI is Only as Good as the Data It Consumes GenAI models rely heavily on high-quality, relevant, and structured data to generate accurate, valuable, and context-aware outputs. If the input data is fragmented, biased, outdated, or lacks depth, GenAI outputs will reflect those flaws, resulting in poor decisions, hallucinations, or reputational risk. Data Strategy Aligns AI with Business Goals A clear data strategy, with the right Data Governance Framework ensures that GenAI efforts are targeted at high-impact use cases, aligned with organizational priorities. It defines what data matters, who owns it, and how it will be governed, enabling scalable and responsible AI use. Governance and Compliance Are Built on Data Foundations GenAI introduces new risks related to data privacy, security, copyright, and explainability. A mature data strategy embeds governance frameworks to ensure regulatory compliance, ethical AI use, and trustworthy outputs, particularly critical in healthcare, finance, and regulated sectors. Metadata, Context, and Semantics Matter GenAI needs metadata, taxonomies, and knowledge graphs to understand the business context and produce domain-specific results. A strong data strategy helps define and manage this semantic layer, enabling more precise and useful generation. This is critical to ensure trust. Operationalization Depends on Data Infrastructure Deploying GenAI into production requires clean pipelines, data catalogs, feature stores, and APIs. A modern data architecture, enabled by a well thought out data strategy, ensures that GenAI is not just a prototype, but a repeatable, secure, and governed solution. Feedback Loops Require Data to Improve Continuous learning, fine-tuning, and reinforcement mechanisms need labeled data and user feedback. A data strategy ensures the organization has the systems to capture this feedback, close the loop, and refine the GenAI models over time. A deep dive into GenAI… Why is a deliberate Data Strategy an imperative for GenAI success? A Data Strategy should be a precursor to your Gen AI solutions before they are deployed in Production. Failing to do that, may cause challenges that erode trust, cost more and run the risk of getting defunded. Core Data Principles for LLM Performance Optimization Data QualityA well-structured dataset will always yield better results than excessive model tuning. Contextual RelevanceEnsure that the data provided to the LLM is domain-specific and relevant to the business problem. Consistency & StandardizationEstablish data normalization practices to remove inconsistencies across sources. Real-Time Data AccessibilityIf the use case requires dynamic responses, ensure access to fresh and updated data. Bias & Ethical ConsiderationsConduct bias audits and ensure fairness in AI-generated outputs. Making Data Usable, Valuable, and Error-Free Data Ingestion & Processing Identify relevant data sources (structured, semi-structured, and unstructured). Implement ETL (Extract, Transform, Load) pipelines to cleanse and transform data. Use schema-on-read approaches to handle evolving data formats. Data Storage & Management Store unstructured data (text, documents) in vector databases for efficient retrieval. Maintain structured data in a modern data warehouse (e.g., Snowflake, databricks). Enable real-time access via streaming pipelines (Kafka, Apache Pulsar). Data Labeling & Annotation Use human-in-the-loop (HITL) techniques to validate training datasets. Implement automatic entity recognition (NER) for structured metadata extraction. Leverage active learning models to continuously improve data annotations. Fine-Tuning & Retrieval Optimization Fine-tune the model with domain-specific datasets if necessary. Use Retrieval Augmented Generation (RAG) with a vector database to reduce hallucinations. Implement hybrid search (BM25 + dense vector search) to improve query relevance Model Testing & Validation Implement LLM evaluation frameworks (HELLO-SWE, OpenAI’s Evals). Validate model outputs using ground-truth datasets. Track performance metrics (BLEU score, perplexity, retrieval precision). Governance, Security & Compliance Establish LLM usage policies and data governance frameworks. Implement data access controls to prevent leakage of sensitive information. Monitor prompt injections and adversarial attacks for security. Challenges Facing D&A Leaders Today’s leaders are faced with the challenge of delivering AI innovation without clear direction, skilled employees and in-depth understanding of the resources needed to make AI successful. Data is an enabler for AI solutions. Enablement requires: Data strategies to increase data maturity across the organization Data platforms that support scalability, flexibility and acceleration of new solutions Organizational governance and literacy of data supporting business initiatives Pressure to Accelerate D&A leaders are under pressure to deliver results faster, even if the company doesn’t have a clear plan in place. Upskilling Employees Training employees to work with data is difficult due to partial support and data maturity across the organization. AI Knowledge Leaders want to use AI, but there is a gap in understanding what is needed to make it work, including skills, budgets and resources. Evolving Role AI is changing what D&A leaders do. They need to adjust their strategies and ways of working to keep up with growing demands. Data Technologies, Platforms & Frameworks Want easy access to share this case study? Download the PDF here

AI
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!

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