Anne Kanyusik Yoakum

I’m asked quite often about the promises and potential of AI. My answer is still the same…AI can be a powerful tool when used correctly but is far from replacing the need for human correction and oversight. AI cannot write a scientific or technical paper accurately. Below is a great example of why. Sadly, I have seen many (yes, too many) examples of professionals who should know better trying to take this shortcut. AI cannot run your company. I have also seen far too many executives turn to AI for important documents or even strategy input. The output I have seen has always been 99.9% off. Using AI to “fake it until you make it” is a sure fire way to accelerate your professional failure. AI cannot diagnose your health care problem. Sadly, shortcomings of the health care system can also result in missed diagnoses as well as long and unnecessarily complicated health care journeys. Get a second opinion. Put in the time to see a highly-trained specialist with a focus in the disease area. This might mean travel to a specialty center. Diagnosing, and worse yet, trying to treat based on AI can be dangerous. Understand the shortcomings of AI and use it wisely. Do the work to verify the output. If you cannot distinguish, find someone who can help you. Let’s work together to advance the use of #AI to accelerate and not harm. #firstdonoharm

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What FDA partners do in February (and March, and April...and May...)? My law school Dean — a former U.S. Senator — once said we should never think of law as a business. Wow, have times changed! For today’s food & drug regulatory partners and aspiring partners, client development isn’t optional — it’s part of the professional skill set. So, what does effective client development actually look like? Let me suggest something my candidates have schooled me on that seems to work exceptionally well in regulatory practices: 👉 Become a trusted, practical problem-solver before you become “the lawyer.” Awhile back, Jim Ries of Offit Kurman offered a deceptively powerful reminder: "Be interested, not just interesting." That idea immediately made me think of a coaching client of mine. He was unexpectedly offered a General Counsel role by a company whose regulatory matters he had never formally handled. But there was no client pitch...he didn't "chase" the work. But because, over time: ✔️ He stayed genuinely curious about their products and business model ✔️ He shared observations on regulatory risk and strategy ✔️ He offered practical insights when issues surfaced ✔️ He demonstrated commercial awareness — not just legal knowledge ✔️ He added value without keeping score Not "salesy" No pressure. Just consistent, thoughtful engagement. In regulatory law, trust is the currency. And trust is built through: --Reliability --Practical guidance --Proven judgment Two closing thoughts for 2026 for food & drug regulatory attorneys: 🔹 Clients remember who helps them think clearly about risk 🔹 Business development often looks like education, not selling 🔹 Consistency beats intensity Because here’s the reality: Most regulatory client relationships develop gradually… …but can also pay off disproportionately. It’s already mid-February. What will you do this year to strengthen your client development approach?

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A viable med‑mal case has to clear three bars. And the economics must be real. Here’s what to look for (and not to look for): 1 - Serious, life‑altering harm. The wrong medication that did not cause long term problems or havind to spend an extra hour in the ER are usually insufficient. 2 - Medically clear failure. From a medical standpoint it should be pretty obvious, think a blown diagnosis or a cascade that shouldn’t have happened. 3 - Damages that justify costs. Getting from first meeting to day one of trial costson average $100,000 in hard expenses (experts, depos, filings, records), before my time or staff. Here are some aspects to consider as well: 1 - Minor or transient harm that won’t support six‑figure case costs. 2 - Ambiguity on standard of care or causation, if it isn’t medically clear, it’s unlikely to hold up at trial. 3 - Damages that can’t carry the required spend to reach trial an the intrusion into my clients’ lives. Early in my career, I thought proving a missed diagnosis or an obvious mistake was enough. What I learned, especially through my work on the Pennsylvania Patient Safety Authority and certification in Patient Safety & Quality Care, is that most preventable harm stems from systemic breakdowns. It is estimated that roughly 80-something percent of preventable medical error is systemic. The surgeon holding the scalpel is usually the last stop in a chain of failures, not the sole cause. When harm is serious, the medicine is clear, and the damages justify the cost, accountability is possible. When those pieces aren’t there, it isn’t.

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Stop Reinventing Jury Instructions - GenAI Use Case Every trial judge knows the moment. It is late in the day, counsel are debating language, and someone hands up a proposed charge pulled from a case you vaguely recognize. Another lawyer insists the pattern instruction is outdated. A clerk is searching through old files while you edit in real time and a jury waits down the hall. At some point, most judges have the same thought. There has to be a better way to run this part of a trial. There is, but it requires us to stop treating jury instructions as disposable documents and start treating them as institutional knowledge. Over the course of a career, every trial judge builds a quiet collection of charges. The ones that worked. The ones that survived appellate scrutiny. The ones you refined after watching jurors wrestle with language that should have been clearer the first time they heard it. Yet too often those improvements live in scattered folders, aging hard drives, or the memory of a former law clerk. We solve the same problem repeatedly, not because it is unsolvable, but because we have never captured the solution in a durable way. Trial judges should be building a living knowledge base of jury instructions. Pattern instructions are the obvious foundation, but they should not be the ceiling. Gather the language you trust. Preserve the charges that held up on appeal. Borrow great phrasing from respected colleagues. Keep the versions that worked exactly the way you intended in front of a live jury. What begins as a personal library gradually becomes judicial memory that improves rather than resets with each trial. This is where GenAI becomes useful long before a jury is ever sworn. Instead of assembling instructions during a charge conference, judges can use these tools ahead of time to organize and maintain their library so it is searchable, structured, and ready when needed. The law remains yours. The judgment remains yours. What disappears is the unnecessary assembly work. Once that library exists, the dynamic inside the courtroom changes. You are no longer drafting under pressure. You retrieve, tailor, and refine. The time savings matter, but the real benefit is cognitive. When you are not expending energy assembling familiar instructions at the edge of exhaustion, you preserve mental bandwidth for the decisions that actually require judicial judgment. Here is what that looks like in practice. Assume you just tried a murder case with an added firearm charge. In a modern GenAI workflow, you would upload the indictment and give a simple instruction. Draft the jury charges using my standard instructions as the default. Build the set that corresponds to the counts in this indictment and format it the way I typically deliver it in court. Then you add the only thing that changes from case to case. If self-defense is at ... Read the full article here: https://lnkd.in/gx_64H2G

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It’s not over in Minnesota, medtech lawyer Ryan Johnson of Fredrikson & Byron, P.A. says as he warns other device industry hubs and his law firm advises clients of their rights in case ICE shows up. “Lots of our clients are used to having the FDA stop by or CMS, but not necessarily armed agents looking to grab their employees," he said in a Medical Design & Outsourcing interview that you can read in the comments below.

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𝗦𝗰𝗶𝗲𝗻𝗰𝗲 𝗼𝗻 𝗧𝗿𝗶𝗮𝗹: 𝗧𝗵𝗲 𝗠𝗡 𝗦𝘂𝗽𝗿𝗲𝗺𝗲 𝗖𝗼𝘂𝗿𝘁 𝗥𝗲𝗰𝗼𝗻𝘀𝗶𝗱𝗲𝗿𝘀 𝗙𝗼𝗿𝗲𝗻𝘀𝗶𝗰 𝗚𝗮𝘁𝗲𝗸𝗲𝗲𝗽𝗶𝗻𝗴 The Minnesota Supreme Court is reconsidering whether breath alcohol testing should remain subject to a court-created burden-shifting framework or instead be evaluated under the same foundational reliability standards that govern all scientific evidence under Minn. R. Evid. 702 and 403. At the Court’s invitation, our firm filed the supplemental amicus brief on behalf of the National College for DUI Defense. This case presents a structural question: will courts continue to carve out special evidentiary treatment for one category of forensic proof, or reaffirm that scientific reliability standards apply uniformly? The Court’s answer will influence how trial courts conduct Rule 702 hearings, allocate burdens of proof, and evaluate foundational reliability challenges statewide. It may also serve as a doctrinal reference point for future scientific-evidence litigation beyond the DWI context. This firm's Daniel Koewler led the strategic design and drafting of the brief. Dan has represented appellants or served as primary author in well over 100 appellate matters, including dozens before the Minnesota Supreme Court, and he has prevailed before the United States Supreme Court. When doctrinal architecture is under review, seasoned appellate judgment matters. Caleb Anthony contributed substantially to research and analytical development. He continues to demonstrate the rigor and forensic fluency required for complex evidentiary litigation. High-level appellate advocacy depends on precision. The firm's paralegals were instrumental in producing the final product. Kim Rodrigue, Shelley Arndt, and Jane Nowacki ensured meticulous citation support, record accuracy, and full compliance with the Court’s technical requirements. Appellate credibility rests in the details. We view appellate advocacy not as episodic litigation but as a sustained engagement in the development of evidentiary doctrine. We welcome the opportunity to help shape the standards that govern scientific proof in Minnesota courts.

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I’m sure that it’s only a matter of time before problems like this routinely show up in regulatory submissions for medical devices prepared by regulatory consultants using AI to support efficient preparation of those submissions. I’ve already heard concerns that FDA review staff are using FDA’s AI tool, Elsa, which could make similar mistakes when distilling and summarizing lengthy submissions. Thanks for sharing, David Allen Larson.

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🌎 𝐀𝐜𝐫𝐨𝐬𝐬 𝐭𝐡𝐞 𝐀𝐭𝐥𝐚𝐧𝐭𝐢𝐜 𝐍𝐞𝐰𝐬 - 𝐀𝐮𝐠𝐮𝐬𝐭 𝟮𝟬𝟮𝟱 🇺🇸 𝐌𝐢𝐧𝐧𝐞𝐬𝐨𝐭𝐚 𝐯𝐬. 𝐓𝐢𝐤𝐓𝐨𝐤 Minnesota’s AG is suing #TikTok, alleging addictive features (infinite scroll, push alerts, filters, LIVE) harm kids and that the platform misleads users about safety and parental controls. 🇺🇸 𝐈𝐧𝐬𝐭𝐚𝐠𝐫𝐚𝐦 𝐋𝐨𝐜𝐚𝐭𝐢𝐨𝐧-𝐒𝐡𝐚𝐫𝐢𝐧𝐠 𝐒𝐜𝐫𝐮𝐭𝐢𝐧𝐢𝐳𝐞𝐝 South Dakota’s AG — backed by 36 other states + Illinois — urged #Meta to tighten Instagram’s new location-sharing tool, citing risks for minors & domestic violence survivors. 🇺🇸 𝐓𝐞𝐱𝐚𝐬 𝐈𝐧𝐯𝐞𝐬𝐭𝐢𝐠𝐚𝐭𝐞𝐬 𝐀𝐈 “𝐓𝐡𝐞𝐫𝐚𝐩𝐢𝐬𝐭𝐬” Texas AG is probing Meta AI Studio & Character.AI for marketing AI chatbots as mental health tools without oversight, potentially impersonating licensed professionals & mishandling data. 🇺🇸 𝐅𝐓𝐂 𝐃𝐚𝐭𝐚 𝐒𝐞𝐜𝐮𝐫𝐢𝐭𝐲 𝐖𝐚𝐫𝐧𝐢𝐧𝐠 The #FTC reminded tech giants — including Alphabet, Amazon, Apple, Cloudflare, Discord, Meta, Microsoft, Signal, Slack, and X (formerly Twitter) — that foreign compliance (e.g., UK Online Safety Act, EU DSA) does not exempt them from U.S. privacy obligations. 🇺🇸 𝐥𝐥𝐢𝐧𝐨𝐢𝐬 𝐑𝐞𝐬𝐭𝐫𝐢𝐜𝐭𝐬 𝐀𝐈 𝐢𝐧 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 Licensed professionals in Illinois cannot use AI to assist therapy or psychotherapy if sessions are recorded or transcribed, unless patients (or their legal representatives) are informed in writing about the AI’s use and purpose, and give written consent — fines up to $10,000 per violation. 🇧🇷 𝐁𝐫𝐚𝐳𝐢𝐥 𝐓𝐚𝐫𝐠𝐞𝐭𝐬 𝐇𝐚𝐫𝐦𝐟𝐮𝐥 𝐂𝐡𝐚𝐭𝐛𝐨𝐭𝐬 Brazil’s AGU gave Meta 72 hours to remove of all AI chatbots that simulate children and engage in sexually charged conversations with users, as a lack of effective moderation mechanisms was a concrete risk to the psychological integrity of minors. Summer might have been laid-back, but regulators didn’t take a vacation — August came in hot with enforcement.🍹Curious what else summer stirred up?

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When was the last time a frontier model admitted it hallucinated? I had a "Matrix" moment today while stress-testing Gemini on Indiana Medicaid law. I gave it a standard fact pattern: A husband and wife jointly own their home (titled as "husband and wife"). The wife enters a nursing home paid for by Medicaid. After she passes, can the state of Indiana file a claim against the home? The AI insisted the home was at risk. As an estate planning and elder law attorney practicing in Indiana, I knew the answer was a hard NO. Under Indiana laws, the state cannot file a claim against the estate of a recipient's surviving spouse. If the home passes by operation of law to the husband, there is zero estate recovery. I had to push back three times. I cited the specific mechanics of Indiana law. And I refused to accept the "hallucination" of a risk that doesn't legally exist. To my surprise, the model finally broke. It admitted it was wrong and had "hallucinated" a risk that doesn't exist under Indiana statutes. The TLDR Takeaways: 1.       Trust your expertise: LLMs are built on general (and sometimes stale) logic. They often fail at the specific nuances of state-level law. 2.       Persistence is a prompt: If you know the law, don't let the confidence of an AI shake you. Push back. 3.       The Human Element: Right now, you shouldn't fully trust an AI for legal advice. If you’re an expert, trust yourself. When an LLM is wrong, it’s wrong. And sometimes, you have to be the one to school the machine. #LegalTech #AI #LegalEngineering #MedicaidPlanning #AIdrivenlawfirm

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The FDA was never good at responding to FOIA requests. Now it’s worse. For companies operating in highly regulated spaces, access to government records isn’t a luxury, it’s how you protect yourself. But lately, I’m seeing serious breakdowns in the system. • FOIA functions have been gutted and consolidated, and many of the people who knew how to handle requests are gone • Delays are no longer occasional, they’re systemic • When transparency breaks down, enforcement becomes harder to challenge If you rely on FOIA for insight, defense, or strategy, don’t assume the system is working. Plan for silence, not speed. And if you want results, you might need to sue the government. Want the full breakdown? I talk about it here: https://lnkd.in/eDYmXcGK #FDA #FOIA #RegulatoryStrategy #GovernmentTransparency #ComplianceRisk #CBP #RegulatoryAffairs

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The FDA made a game-changing move last week: it will now publish CRLs in *real-time* as part of Commissioner Makary's "radical transparency" initiative. [For non-life sciences folks: Complete Response Letters (CRLs) are FDA's formal letters explaining why a drug application was rejected and what needs to be fixed before approval. For various reasons, a sponsor (the company seeking approval) won't always see a path forward.] This builds on the July release of 200 CRLs for drugs that were ultimately approved. Last week’s batch of 89 goes further, including CRLs for non-approved drugs. On its face, this sounds like a big win for transparency. Here’s the threshold problem I see with publishing CRLs: they only tell half the story. When FDA publishes a CRL, the public only sees the agency’s conclusions and concerns. CRLs are a one-sided narrative of what's often a complex, nuanced regulatory conversation. What they don’t see? The sponsor's scientific pushback, the heated discussions about study design, the disagreements over endpoints, or the ongoing negotiations that happen behind the scenes. What’s being published does not include the sponsor’s response, commitment, or any rebuttal. But that's just the beginning. This shift also raises thorny challenges: ▪️ SEC Disclosure and Litigation – SEC pressures, securities suits, investor questions about “failures” taken out of context ▪️ Trade Secret Concerns – Who decides what’s confidential and gets redacted? (Probably AI.) Does the sponsor get a say? What happens if mistakes are made?  ▪️ Litigation Ammunition – Partial stories create risk when later cited in disputes. Don't get me wrong, I’m not opposed to transparency. But regulatory science and drug approvals are messy, iterative, nuanced, and collaborative. The general public isn’t likely aware of this and the information contained in the four corners of a CRL won't show them this. Publishing only FDA's side of the conversation feels like releasing the prosecutor’s closing argument without hearing the defense’s case. It risks misleading the public and oversimplifying a complex process. I’d love to hear other perspectives. Do you see this transparency push as a net positive for the industry, or do you feel it risks creating more confusion than clarity? (Links to the FDA press release and the CRL database are in the comments.)

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I was having similar thoughts. I think many companies think “we did enough” without understanding the laws. Or the expectations of the public. Or just plain common decency.

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Sick of 101 rejections tanking your clients’ patents? It’s not the courts; like everything else in patents "the name of the game is the claim." You’ve probably cursed the USPTO (or PTAB or CAFC for that matter), thinking they’re out to squash inventors or kill innovation. I get it—101 rejections sting, especially for after grinding through the patent application process. But let’s be real: the courts aren’t anti-patent. They’re just following the law. Most patents getting axed under 35 USC 101 are functionally claimed, describing what the invention does without showing how. That’s a recipe for rejection during prosecution and invalidation later on. Look at the data: over half of software and biotech patents face 101 challenges. Cases like Alice, Electric Power Group, Yu, and American Axle scream one thing—claims need technical grit. Datzov and Rantanen’s Predictable Unpredictability nails it: vague, outcome-focused claims don’t cut it. Sure, the courts mess up sometimes, but they’re otherwise consistent. If your claims read like a a list of verbs that produce outcomes, they’re toast...even if allowed by an Examiner. I’ve seen it firsthand—a how rejections can be flipped by rewriting claims to feature an algorithm’s technical leap. Quickly approved, and ready for use IRL. Stop blaming the system. Check your claims. Do they claim technology or outcomes? If only outcomes, rewrite them. Care to share your worst 101 rejection headache below? Let’s trade tips to draft claims that stick!

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After two appeals of class certification in the BIPA context where the Illinois Appellate Court, First District affirmed certification, the court in Brewer v. Pepperidge Farm reversed. But do not think this decision will have broad application. Plaintiff Tyrone Brewer, who worked for a week at Pepperidge Farm’s Downers Grove bakery, alleged that use of a “HandKey” scanner violated BIPA by collecting hand geometry without consent and without a retention policy. He sought to represent a class of nearly 900 workers. The circuit court granted class certification, finding numerosity, commonality, and predominance satisfied, and holding Brewer was an adequate representative. It disqualified Brewer’s daughter, an attorney at Community Lawyers, from serving as class counsel due to a conflict of interest, but allowed her firm and other affiliated attorneys to remain. On appeal under Rule 306(a)(8), the First District disagreed. The court held that once the trial court recognized the conflict posed by Brewer’s familial tie to counsel, it was unreasonable to leave her partner and other close colleagues in place as class counsel. The court further found that Brewer could not serve as the sole class representative under these circumstances. Reversing certification, the panel remanded for the trial court to evaluate whether other counsel can adequately represent the class and to require appointment of additional, conflict-free representatives The decision is below. Dan Cotter and I discussed the case in the BIPA segment of Episode 274 of the Podium and Panel Podcast that is linked in the comments. #law #lawyers #appeals #attorneys #civilprocedure #BIPA

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Last month, the U.S. District Court for the Northern District of Illinois dismissed antitrust claims brought by a proposed class of health plans alleging that Biogen had harmed competition by paying Pharmacy Benefit Managers not to promote generic alternatives to its treatment for multiple sclerosis. The case provides useful guidance for how manufacturers of branded pharmaceuticals can defend against claims of competitive foreclosure by manufacturers of generic drugs. Read all about it in a post I co-authored with Alex C. on Covington & Burling LLP’s Inside Class Actions blog. 

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🛑 Reproductive Health Privacy Rule Vacated – Immediate Implications for Medical and Healthcare Practices A federal court in Texas has vacated nearly all provisions of the 2024 #HIPAA Privacy Rule intended to protect reproductive health information, including PHI relating to abortion and gender-affirming care. The ruling, issued on June 18, 2025, applies nationwide and is effective immediately. 📍 The now-vacated rule had restricted how HIPAA-covered entities—including #medical#practices, clinics, and healthcare providers—could respond to requests for PHI related to lawful reproductive care in the context of investigations or legal proceedings. The court held that the regulation exceeded the U.S. Department of Health and Human Services’ (HHS) authority and conflicted with existing federal and state laws—particularly state-level reporting requirements in Texas, including those related to child abuse and public health enforcement. ⚖️ HHS has not yet stated whether it will appeal, and other legal challenges are still pending. This remains a fast-moving and evolving area of law. 💡 For clinics, #physician practices, and healthcare providers, this ruling is significant. The reproductive health privacy rule took effect in June 2024, with a compliance deadline of December 23, 2024, for most provisions. While the Notice of Privacy Practices (NPP) updates were not required until February 2026, many organizations had already begun implementing policy and training changes. With the rule now vacated and HHS not yet having announced whether it will appeal, covered entities should reassess their HIPAA #policies and #compliance programs in light of the current ruling, while staying alert for potential legal developments. 📌 Key implications for Texas and other providers: – The enhanced HIPAA restrictions on disclosing reproductive health information are no longer enforceable (with limited exceptions for NPP updates). – Covered entities should review privacy protocols, staff training, and disclosure practices to ensure alignment with the current legal framework. 📄 Full opinion (June 18, 2025): https://lnkd.in/gNHhY4TQ #HIPAA #HealthcareCompliance #TexasLaw #MedicalPractice #PrivacyLaw #ReproductiveHealth #HealthLaw #PetersLaw

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About 1,500 federally funded community #healthcenters that serve 34 million low-income patients face closures and staff cuts as the #shutdown halts funding and #Medicaid cuts loom. Advocates warn this could overwhelm hospitals and are pushing for at least $5.8B in stable, multiyear funding to keep services afloat.

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Minnesota's Paid Leave law is in effect. Samuel Kavalier gives us more details on when leave can be taken, for how long, and in what forms. https://lnkd.in/gcVhXHt6

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If your company uses or plans to use AI in the Digital Mental Health space, this article is worth reading: https://lnkd.in/gqHs-qvE?

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