Expert Analysis

• A Road Map To Modernizing Clinical Lab Regulations

  

  The Centers for Medicare & Medicaid Services' recent request for comments on potential changes to the Clinical Laboratory Improvement Amendments provides an early indication of where CLIA is headed, and the operational, compliance, reimbursement and enforcement issues those changes will create, says Jose Vela at Clark Hill.

• Where AI Patent Risk Begins And How Records Can Help

  

  The Federal Circuit's recent decision in Dental Monitoring v. Align highlights the importance of documenting how artificial intelligence-assisted inventions work, and how humans contributed, as such records can support inventorship, written description, eligibility and definiteness requirements, say attorneys at Sterne Kessler.

• 2nd Circ. Tylenol MDL Ruling Clarifies Court Gatekeeper Role

  

  The Second Circuit’s recent decision in multidistrict litigation over alleged links between Tylenol and developmental disorders, holding that the trial court improperly excluded expert witnesses, preserves meaningful judicial gatekeeping while making clear that judges may not resolve legitimate scientific disputes themselves, say attorneys at Lowenstein Sandler.

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  Law School's Missed Lessons: Cultivating Good Judgment

  

  Law schools generally overlook the role that solid judgment skills play in real-world practice, but attorneys can bridge the gap by strengthening their abilities to assess a case’s strengths and weaknesses, develop and execute effective strategies, and provide clear recommendations to clients, says Manny Caixeiro at Venable.

• CMS Rule, DOJ Probes Deepen Gender Care Compliance Risk

  

  The Centers for Medicare & Medicaid Services' final rule restricting Medicaid funding for hospitals that provide gender-affirming care is likely to face immediate litigation, but the CMS rulemaking is already working alongside U.S. Department of Justice's enforcement campaign to create operational risk for providers, say attorneys at Arnall Golden.

• 2 Cases Shed Light On Invoking The 5th Before Congress

  

  Given the anticipated increase in congressional investigations following the midterm elections, those who anticipate being in Congress' spotlight can draw valuable Fifth Amendment lessons from the ongoing case involving Dr. Anthony Fauci's testimony and the D.C. Circuit’s recent ruling in de la Torre v. Cassidy, say attorneys at King & Spalding.

• Loper Bright Unlikely To Upend DEA Rescheduling Challenges

  

  As cannabis industry stakeholders await a U.S. Drug Enforcement Administration ruling on broader cannabis rescheduling, the U.S. Supreme Court's 2024 decision in Loper Bright to eliminate judicial deference to agency decisions should not dramatically affect cannabis rescheduling litigation risk, but it could marginally strengthen proponents' hand if the DEA denies rescheduling, say attorneys at Dentons.

• Vanda Ruling Offers New Guide To Generic Labeling Disputes

  

  The D.C. Circuit's recent decision in Vanda Pharmaceuticals v. U.S. Food and Drug Administration is significant for its guidance on when generic-drug labeling remains sufficiently similar to brand labeling and when a difference requires a statutory exception, says Shashank Upadhye at Upadhye Tang.

• Attorneys Using AI May Have Ethical Duty To Redact Docs

  

  The trajectory of legal ethics guidance in recent years strongly suggests that as redaction technology becomes more accessible, the failure to use it when uploading highly confidential materials into artificial intelligence tools will become increasingly difficult to defend as reasonable, say attorneys at Lewis Brisbois.

• Cannabis, Psychedelics Boom Raises IP Hurdles

  

  Recent data regarding patent filing activity and litigation in the cannabis and psychedelics markets indicates that as commercial interest accelerates, the scope of publicly accessible prior art is also expanding, setting a higher bar for novelty and nonobviousness in patent applications, say attorneys at Sterne Kessler.

• State AI Safety Laws Raise New Liabilities For Healthcare Cos.

  

  Healthcare and life science companies using third-party artificial intelligence tools should pay particular attention to the changing state-level legal landscape, where the rollout of multiple AI safety laws is introducing both new compliance obligations and potential consumer protection liabilities, say attorneys at McDermott.

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  Juggling And Unicycling Make Me A Better Lawyer

  

  Because I juggle (sometimes with fire) and ride the unicycle, friends and family used to joke that I should join the circus, but I pursued the practice of law instead and learned that my hobbies benefit my profession in several important ways, says Morgan Eddy at Smith Currie.

• AI Note-Taking Suits May Fill Gap In Privacy Law Structure

  

  A recent class action against Granola joins other pending lawsuits against AI note-taking providers, highlighting the legal uncertainty surrounding these tools, but there are practical steps companies using "invisible" AI services can take to mitigate risk, including conducting inventories and reviewing access permissions, say attorneys at Barnes & Thornburg.

• FDA Closeout Letter Suggests Relaxing Stance On Wearables

  

  The U.S. Food and Drug Administration's recent decision not to pursue enforcement action against Whoop's wearable blood pressure tracker, read together with guidance released earlier this year, suggests a softer shift in the FDA's approach to regulating wearables, say attorneys at Arnold & Porter.

• Fed. Circ. Dental IP Ruling Reinforces Prior Art Framework

  

  The Federal Circuit's recent decision in Dental Monitoring v. Align Technology reaffirms the necessity of substantive written description support for establishing an earlier effective prior art date under the America Invents Act, and aligns Patent Trial and Appeal Board practice with district court litigation, say attorneys at Morgan Lewis.