Policy & Compliance

Expert Analysis

• What 2024 Tells Us About Calif. Health Transaction Reviews

  

  Looking back at the California Office of Health Care Affordability's first year accepting notices for material healthcare transactions reveals critical lessons on what the OHCA's review process may mean for the future of covered transactions in the state, say attorneys at Ropes & Gray.

• Updated HIPAA Rule Is A Necessary Step For Data Protection

  

  The U.S. Department of Health and Human Services' updated rules addressing cybersecurity threats in healthcare will necessitate significant investment in technology, training and compliance infrastructure, but are an essential evolution in safeguarding data in an increasingly digital world, say attorneys at Clark Hill.

• Courts Must Curb The Drug Price Negotiation Program

  

  The Inflation Reduction Act's drug price negotiation program upends incentive structures that drive medical innovation, and courts must act appropriately to avoid devastating consequences for American healthcare and the pharmaceutical industry, says Jeff Stier at the Consumer Choice Center.

• The OIG Report: Preparing For Oversight In 2025

  

  Across sectors, Office of Inspector General work plans and challenge reports for 2025 provide a trove of information on the issues and industries that will likely be the focus of government oversight in the year to come, says Diana Shaw at Wiley.

• 5 Drug And Device Developments That Shaped 2024

  

  The last year saw significant legal developments affecting drug and device manufacturers, with landmark decisions and regulatory changes that require vigilance and agility from the industry, say attorneys at Faegre Drinker.

• How New Fraud Enforcement Tool Affects Gov't Contractors

  

  Government contractors will likely face greater scrutiny under the recently enacted Administrative False Claims Act, which broadens federal agencies' authority to pursue low-dollar fraud claims, but contractors may also find the act makes settlement of such claims easier to negotiate, say attorneys at Wiley.

• Consultants Should Be Aware Of DOJ's Potential New Reach

  

  The U.S. Department of Justice's recent first-of-its-kind settlement with McKinsey & Co. indicates not only the DOJ's more aggressive stance toward businesses' potential criminal wrongdoings, but also the benefits of self-disclosure and cooperation when wrongdoing becomes apparent, says Dom Caamano at Kibler Fowler.

• Health Tech Regulatory Trends To Watch In 2025

  

  With an upcoming change in administration and the release of some long-awaited rules, the healthcare industry should prepare for shifting trends, including a growing focus on health data and interest in technology-enabled delivery of healthcare, say attorneys at Orrick.

• 10 Noteworthy CFPB Developments From 2024

  

  In a banner year for consumer finance regulation, the Consumer Financial Protection Bureau made significant strides in its efforts to rein in Big Tech and nonbank financial firms, including via rules regarding open banking, credit card late fees, and buy now, pay later products, say attorneys at Wiley.

• The Future Of GLP-1 Policy After Drug Shortage Ends

  

  If and when the U.S. Food and Drug Administration determines that GLP-1 RA drugs are no longer in short supply, regulators will face questions of how to balance access to GLP-1 RAs with statutory and policy considerations applicable to compounded drugs, say attorneys at Skadden.

• Top 10 Whistleblowing And Retaliation Events Of 2024

  

  From a Florida federal court’s ruling that the False Claims Act’s qui tam provision is unconstitutional to a record-breaking number of whistleblower tips filed with the U.S. Commodity Futures Trading Commission, employers saw significant developments in the federal and state whistleblower landscapes this year, say attorneys at Proskauer.

• How White Collar Defense Attys Can Use Summary Witnesses

  

  Few criminal defense attorneys have successfully utilized summary witnesses in the past, but several recent success stories show that it can be a worthwhile trial tactic to help juries understand the complex decision-making at issue, says Jonathan Porter at Husch Blackwell.

• Nutraceutical Patent Insights As Market Heats Up

  

  Companies entering the expanding nutraceutical market and seeking patents to protect their innovations should evaluate successful nutraceutical claim language and common patent challenges in this field, say attorneys at Sterne Kessler.