Expert Analysis

• AI Rise In Healthcare Demands New Cybersecurity Strategies

  

  As artificial intelligence-related capabilities are increasingly integrated into medical devices and healthcare operations, organizations must adapt their compliance playbook to address evolving cybersecurity needs and implement lifecycle-based risk assessment approaches, say attorneys at Covington.

• Hims & Hers Suit Spotlights Health Data-Sharing Privacy Risks

  

  Regulators' complaint against telehealth company Hims & Hers alleging deceptive practices serves as a reminder that the privacy principles developed under consumer protection laws and predating omnibus statutes remain in force, and sensitive data governance continues to be a crucial component of compliance, say attorneys at Venable.

• How Cannabis Rescheduling Is Reshaping Bankruptcy

  

  As broader cannabis rescheduling awaits a recommended decision, cannabis companies continue to test the boundaries of the Bankruptcy Code, with the recent Cannabist Chapter 15 recognition order suggesting that governmental resistance may be reduced in future filings, say attorneys at Thompson Coburn.

• Opinion

  New CMS Medical Device Pathway May Have Limited Effect

  

  The Centers for Medicare & Medicaid Services' new pathway for giving Medicare beneficiaries earlier access to certain medical devices bears similarities to previous programs that did not advance coverage significantly, and thus may only benefit certain manufacturers, say attorneys at King & Spalding.

• How Cos. Can Avoid Infant Product False Advertising Suits

  

  As lawsuits proliferate over products marketed for infant use and sold at a premium that are identical to cheaper general-use products, manufacturers should review related product lines, and scrutinize contextual cues that may contribute to the overall message received by consumers, say attorneys at Chamberlain Hrdlicka.

• 9th Circ. Ruling Raises Bar For Arbitration Pacts Via Email

  

  The Ninth Circuit's recent holding in Rickes v. Thermo Fisher that the mere delivery of an email doesn't establish an employee's assent to the arbitration agreement underscores that rollout processes should both give employees notice of the agreement and create evidence of their assent, say attorneys at Sullivan & Cromwell.

• 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.

• Series

  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.