Expert Analysis

• Unpacking NIST's Guidance On Genomic Data Cybersecurity

  

  The National Institute of Standards and Technology's final internal report on cybersecurity of genomic data highlights unique concerns associated with the use of such data and provides strong recommendations for risk management, though one area of the report may cause some confusion, say attorneys at Ropes & Gray.

• Key Legal Trends For Healthcare And Life Sciences In 2024

  

  Due to the impact of contentious legal battles over drug pricing negotiations, the growing integration of artificial intelligence into drug development and manufacturing, and the publication of industry segment-specific guidance, the year ahead promises to be a dynamic period of changes and challenges, say Xin Tao and Lois Liu at Baker McKenzie.

• What To Know About FCA Cybersecurity Enforcement

  

  Now is a good time for practitioners, government contractors and potential relators to review recent developments in cybersecurity-related False Claims Act enforcement, and consider best practices for navigating this space in the new year, say Ellen London at London & Stout, and Li Yu and Molly Knobler at DiCello Levitt.

• 8 Privacy Law Predictions For 2024

  

  As the new year begins, looking back to several of last year's privacy law developments may help companies forecast what to focus on when updating their privacy programs, including children's privacy, so-called dark patterns and the collection of data by connected cars, say attorneys at Sheppard Mullin.

• Series

  ESG Around The World: South Africa

  

  While South Africa has yet to mandate the reporting of nonfinancial and environmental, social, and corporate governance issues, policy documents and recent legislative developments are likely to have a material impact in the country's transition to a low-carbon economy and in meeting its international obligations, say Glynn Kent at Eversheds Sutherland.

• FOIA Exemption Questions On Redacted HHS Cannabis Letter

  

  The U.S. Department of Health and Human Services' recent recommendation letter concerning the rescheduling of cannabis was heavily redacted, and based on an analysis on the applicability of Freedom of Information Act Exemption 5 to the letter, it's likely that we will see successful legal challenges to those redactions, say attorneys at Troutman Pepper.

• Evaluating Retroactivity Of Mich. Drugmaker Immunity Repeal

  

  In assessing whether a new Michigan law lifting drugmakers' blanket immunity from product liability suits will apply retroactively, there are four key factors that Michigan courts will likely consider, say Sherry Knutson and Brenda Sweet at Tucker Ellis.

• 4 Legal Ethics Considerations For The New Year

  

  As attorneys and clients reset for a new year, now is a good time to take a step back and review some core ethical issues that attorneys should keep front of mind in 2024, including approaching generative artificial intelligence with caution and care, and avoiding pitfalls in outside counsel guidelines, say attorneys at HWG.

• Bribery Settlement Gives Insight On DOJ Policies

  

  Chemical company Albemarle’s recent $218 million settlement with the government to resolve foreign bribery claims provides valuable data points for companies on the U.S. Department of Justice’s voluntary self-disclosure policy and its clawback pilot program, say Michael DeBernardis and Tiauna Mathieu at Hughes Hubbard.

• A Primer On New Calif. Health Transaction Reporting Rules

  

  New California regulations regarding the reporting of certain transactions involving healthcare entities, which took effect on Jan. 1, address some industry feedback about overly broad requirements but still leave several areas of concern, says Andrew Demetriou at Husch Blackwell.

• Opinion

  Waiving COVID-19 IP Protections Would Harm US Industry

  

  President Joe Biden should turn down a World Trade Organization proposal to waive crucial intellectual property protections behind COVID-19 tests and diagnostics — protections that allow U.S. companies to sustain millions of jobs and develop life-saving treatments that benefit patients in every country, says former U.S. Circuit Judge Paul Michel, now at the Council for Innovation Promotion.

• Series

  In The CFPB Playbook: Rulemaking Rush Before Election Year

  

  In this quarterly Consumer Financial Protection Bureau activity recap by former bureau personnel, attorneys at McGuireWoods explain the regulator's recent push to finalize new rules about data aggregators, digital payment apps and more before the election-year Congressional Review Act window opens.

• What The Law Firm Of The Future Will Look Like

  

  As the legal landscape shifts, it’s become increasingly clear that the BigLaw business model must adapt in four key ways to remain viable, from fostering workplace flexibility to embracing technology, say Kevin Henderson and Eric Pacifici at SMB Law Group.

• 4 PR Pointers When Your Case Is In The News

  

  Media coverage of new lawsuits exploded last year, demonstrating why defense attorneys should devise a public relations plan that complements their legal strategy, incorporating several objectives to balance ethical obligations and advocacy, say Nathan Burchfiel at Pinkston and Ryan June at Castañeda + Heidelman.

• Digging Into The Debate On FDA's Proposed Lab Test Rule

  

  A proposed 10-word amendment from the U.S. Food and Drug Administration represents a sea change in device regulation as it would summarily end decades of FDA enforcement discretion for laboratory developed tests, and the public comments offer some insight into the future of this long-running saga, say attorneys at Mintz.