Digital Health & Technology

Expert Analysis

• Health Policy Legislative Landscape May Remain Frozen

  

  With Congress again delaying the full resolution of fiscal year 2024 federal spending legislation, there is now an additional window in which Congress could work through several priority issues for healthcare stakeholders, though these issues are unlikely to be resolved in time, say attorneys at Faegre Drinker.

• What Businesses Should Know About NJ Privacy Bill

  

  New Jersey’s recently passed comprehensive privacy bill S.B. 332 presents businesses with a nuanced framework and compliance obligations, including opt-in consent requirements for sensitive data, with recommendations for businesses to organize data, review consent requirements and more, says Trisha Sircar at Katten.

• Staying Ahead Of The AI Policymaking Curve

  

  With artificial intelligence poised to be the hottest legislative and regulatory topic in 2024, expect the AI policymaking toolbox to continue to expand and evolve as stakeholders in the U.S. and abroad develop, deploy, use and learn more about these technologies, say attorneys at Hogan Lovells.

• The 7th Circ.'s Top 10 Civil Opinions Of 2023

  

  Attorneys at Jenner & Block examine the most significant decisions issued by the Seventh Circuit in 2023, and explain how they may affect issues related to antitrust, constitutional law, federal jurisdiction and more.

• DOJ's Biopharma Settlement Raises Anti-Kickback Questions

  

  In the aftermath of the U.S. Department of Justice's settlement with Ultragenyx over genetic testing programs, it may be prudent to reevaluate genetic tests through the lens of the Anti-Kickback Statute and reconsider whether it is proper for free testing programs to be treated like patient assistance programs, says Mary Kohler at Kohler Health Law.

• Uncharted Waters Ahead For FCA Litigation In 2024

  

  Following a year of significant court decisions, settlements, recoveries and proposed amendments, 2024 promises to be a lively year for False Claims Act actions and litigation, and one that will hopefully provide more clarity as FCA jurisprudence evolves, say attorneys at Crowell & Moring.

• Healthcare Industry Must Prepare For Greater AI Regulation

  

  Healthcare entities that use even basic machine-based systems should pay close attention to a recent executive order and a proposed bill, both of which focus on artificial intelligence safety and security, and signal the government's intent to establish a regulatory framework for AI-enabled technology, says Kristen Petry at Spencer Fane.

• 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.

• 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.

• AI Executive Order's Life Science, Healthcare Industry Effects

  

  The recent White House executive order to manage risks associated with artificial intelligence includes provisions specific to healthcare and life sciences that merit special attention, including transparency, human oversight of AI output, and real world performance monitoring, say attorneys at Ropes & Gray.

• 5 Most Notable Class Action Standing Cases Of 2023

  

  Key appellate class action decisions this past year continued the trend of a more demanding approach to the threshold issue of standing during each phase of litigation, say attorneys at MoFo.

• How SEC And NY Cyber Reporting Rules Affect Key Industries

  

  The new U.S. Securities and Exchange Commission and New York State Department of Financial Services cybersecurity disclosure requirements, and their competing obligations, reveal the increasing complexity for organizations evaluating and reacting to cybersecurity incidents — particularly those in the healthcare and financial services industries, say attorneys at Manatt.

• In The World Of Legal Ethics, 10 Trends To Note From 2023

  

  Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.