Expert Analysis

• Opinion

  Life Sciences Regulators Must Write Cloud-Specific Guidance

  

  As cloud services continue to revolutionize the life sciences industry's ability to conduct regulated activities, the U.S. Food and Drug Administration and other regulators should update their data management policies to clearly support and encourage use of cloud technology, say Nate Brown and Marlee Gallant at Akin.

• Attorneys, Law Schools Must Adapt To New Era Of Evidence

  

  Technological advancements mean more direct evidence is being created than ever before, and attorneys as well as law schools must modify their methods to account for new challenges in how this evidence is collected and used to try cases, says Reuben Guttman at Guttman Buschner.

• The Self-Funded Plan's Guide To Gender-Affirming Coverage

  

  Self-funded group health plans face complicated legal risks when determining whether to cover gender-affirming health benefits for their transgender participants, so plan sponsors should carefully weigh how federal nondiscrimination laws and state penalties for providing care for trans minors could affect their decision to offer coverage, say Tim Kennedy and Anne Tyler Hall at Hall Benefits Law.

• Series

  ESG Around The World: The UK

  

  Following Brexit, the U.K. has adopted a different approach to regulating environmental, social and governance factors from the European Union — an approach that focuses on climate disclosures by U.K.-regulated entities, while steering clear of the more ambitious objectives pursued by the EU, say attorneys at Dechert.

• 3 Tips For Defending Against Data Breach Litigation

  

  As cyberattacks become more prevalent, companies responding to data breaches must consider several strategies to better position themselves in the event of litigation even during their preliminary investigations and breach notifications, say attorneys at Davis Wright.

• Tips For Litigating Against Pro Se Parties In Complex Disputes

  

  Litigating against self-represented parties in complex cases can pose unique challenges for attorneys, but for the most part, it requires the same skills that are useful in other cases — from documenting everything to understanding one’s ethical duties, says Bryan Ketroser at Alto Litigation.

• What Pharma Cos. Must Know About FDA Off-Label Guidance

  

  The U.S. Food and Drug Administration recently issued draft guidance on how pharmaceutical companies should share research on off-label use of medical devices, outlining how firms could avoid enforcement action — especially when disseminating self-created content about their own products, say Jacqueline Berman and Maarika Kimbrell at Morgan Lewis.

• It's Time To Prescribe Frameworks For AI-Driven Health Care

  

  As health care providers begin to adopt artificial intelligence in clinical settings, new legal and regulatory challenges are emerging, with the critical issue being balancing AI's benefits and innovations in health care while ensuring patient safety and provider accountability, say attorneys at Kirkland.

• Opinion

  Air Ambulance Ch. 11s Show Dispute Program Must Resume

  

  Air Methods’ recent bankruptcy filing highlights the urgent need to reopen the No Surprises Act’s independent dispute resolution program for air ambulances, whose shutdown benefits insurance companies and hurts providers, says Adam Schramek at Norton Rose.

• Preparing For Higher Health Transaction Standards In Calif.

  

  The California Office of Health Care Affordability's revised draft regulations on the reporting of health care transactions incorporate useful improvements to the regulatory scheme, but also contain provisions that may cause concerns for parties contemplating covered transactions, says Andrew Demetriou at Husch Blackwell.

• How Ill. Supreme Court Could Shape Statutory Violation Cases

  

  In Fausett v. Walgreens, the Illinois Supreme Court will take up the question of whether a violation of the Fair and Accurate Credit Transactions Act satisfies the injury-in-fact requirement, and any outcome could significantly change the litigation landscape in Illinois, say Donald Patrick Eckler and Joshua Zhao at Freeman Mathis.

• Class Action Defense: Don't Give Up On Bristol-Myers Squibb

  

  Federal appellate court decisions in the six years since the U.S. Supreme Court decided Bristol-Myers Squibb show that it's anyone's ballgame in class action jurisdictional arguments, so defendants are encouraged to consider carefully whether, where and when arguing lack of specific personal jurisdiction may be advantageous, say attorneys at K&L Gates.

• Pro Bono Work Is Powerful Self-Help For Attorneys

  

  Oct. 22-28 is Pro Bono Week, serving as a useful reminder that offering free legal help to the public can help attorneys expand their legal toolbox, forge community relationships and create human connections, despite the challenges of this kind of work, says Orlando Lopez at Culhane Meadows.

• FDA Proposals Clarify Rules For Devices With Predicates

  

  As medical devices continue to grow in complexity, U.S. Food and Drug Administration policies surrounding premarket submissions for devices with existing predicates have fallen behind, but new draft guidances from the agency help fill in some gaps, say attorneys at Hogan Lovells.

• State Regs Sow Discord Between Cannabis, Hemp Industries

  

  Connecticut, Maryland and Washington are the latest states choosing to require intoxicating hemp products to comply with the states' recreational marijuana laws, resulting in a widening rift between cannabis and hemp as Congress works on crafting new hemp legislation within the upcoming 2023 Farm Bill, say attorneys at Wilson Elser.