Rulings & Guidance
Discover the pivotal court rulings and regulatory updates from this year that continue to define and reshape the legal landscape.
RULING Chevron Overturned
Amid a wave of important opinions issued in the U.S. Supreme Court’s 2023–2024 term, perhaps the most consequential to the ongoing state of federal administrative law was in Loper Bright Enterprises v. Raimondo. Notably, the decision empowers employers, giving them more say to ensure that agencies—and their actions—stay within their proper boundaries when exercising rulemaking authority.
RULING Federal Trade Commission's Non-Compete Ban
In April 2024, the Federal Trade Commission announced a highly controversial rule that would have banned most non-compete agreements between employers and employees nationwide—with few exceptions. The new rule was heavily contested, notably by Epstein Becker Green attorneys, who proved successful on appeal when a federal court issued a nationwide injunction against the rule shortly before it was scheduled to go into effect.
RULING The U.S. Food and Drug Administration’s Final Rule on Regulation of Laboratory Developed Tests
The landscape of laboratory testing in the United States is changing. On April 29, 2024, following more than a decade of discourse, the Food and Drug Administration released its long-awaited “Medical Devices; Laboratory Developed Tests” final rule formalizing the agency’s authority to regulate laboratory developed tests as medical devices.
UPDATE Final Mental Health Parity Rules
On September 23, 2024, the U.S. Departments of Labor, the Treasury, and Health and Human Services released final rules that implement requirements under the Mental Health Parity and Addiction Equity Act (MHPAEA). Three aspects of the final rules are noteworthy for employers: (i) the elimination of quantitative testing for non-quantitative treatment limits, (ii) the application of MHPAEA to intellectual and developmental disabilities, and (iii) a new plan fiduciary certification requirement.
GUIDANCE The Food and Drug Administration's Draft Guidance on Clinical Trial Diversity Guidelines
In June 2024, the Food and Drug Administration issued its long-anticipated draft guidance titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies Guidance for Industry.” The landmark document set forth recommendations for sponsors of clinical studies to create and implement Diversity Action Plans aimed at recruiting and enrolling participants from underrepresented groups.
Trends
Explore the most significant industry trends of the year, uncovering the forces shaping current strategies and driving the future of the field.
Applying Artificial Intelligence & Legal Developments
In 2024, the enthusiasm around artificial intelligence (AI) continued to grow, expanding AI’s use across industries while introducing new regulatory challenges.
The Food and Drug Administration updated guidance on AI-based clinical devices, focusing on stricter data transparency and real-time monitoring to ensure safety and effectiveness. New standards also emerged to address bias in AI hiring tools, aiming to tackle discrimination concerns. Meanwhile, Colorado’s Artificial Intelligence Act set the stage for similar legislation in states like California, New York, and Illinois.
Transforming the Future of Health Care Investment
State-imposed legislation requiring prior approval or transparency in health care transactions is reshaping how private equity firms and management companies operate with patient-facing organizations. These changes, coupled with increased federal scrutiny of health care deals, are creating a more complex regulatory environment for transactions.
Epstein Becker Green leverages its extensive experience in health care law to help clients navigate these challenges with confidence. The firm provides strategic counsel to ensure seamless transactions while mitigating compliance risks and addressing both state regulations and federal oversight. With a deep understanding of industry trends and evolving laws, we support clients in successfully growing or selling their businesses despite the increasing regulatory pressures.
Unionization and Decision-Making at the National Labor Relations Board
The National Labor Relations Board (NLRB) is under increased scrutiny as legal challenges arise from its expansive interpretation of enforcement authority under the National Labor Relations Act. Coupled with the potential implications of the U.S. Supreme Court’s Loper Bright decision, these developments may significantly impact the NLRB’s structure. Meanwhile, shifts in unionization trends, court rulings, and evolving worker demands highlight a dynamic labor landscape.
New Administration, New Outlook
What does a new presidential administration mean for your organization? Each administration brings its own priorities, altering regulations, legislation, and enforcement. What worked yesterday may not work tomorrow. For decision-makers, shifts in federal or state power reshape the rules, disrupting strategies while creating new opportunities. The stakes? Business and compliance strategies that can drive growth—or expose vulnerabilities. This constant challenge demands agility and foresight.
Change isn’t optional. Leading through it is.
Innovations
Discover our cutting-edge solutions and forward-thinking strategies, which are designed to adapt to the evolving legal landscape and meet our clients’ needs with precision and innovation.
Agency Action Challenges Team
Certain 2024 U.S. Supreme Court decisions, such as Loper Bright, Corner Post, and Jarkesy have altered federal administrative law dramatically. In response to these landmark decisions, which will compel administrative agencies to exercise greater caution in their actions, Epstein Becker Green formed the Agency Action Challenges Team to advise clients on the implications of new rules and regulations and represent those clients who need to challenge agency rules and regulations. When agencies act unreasonably, our clients and stakeholders will have more avenues available to challenge those rules and regulations.
EBG Advisors Selected to Help Launch NIST’s U.S. AI Safety Institute Consortium
EBG Advisors, the consulting arm of national law firm Epstein Becker Green, has been selected by the National Institute of Standards and Technology (NIST) to serve as an inaugural participant in the organization’s U.S. AI Safety Institute Consortium (AISIC). The AISIC is tasked with developing guidelines for red-teaming, capability evaluations, risk management, safety, and security, and watermarking synthetic content.
Telemental Health Laws App
Since 2016, Epstein Becker Green attorneys have researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services.
We are pleased to once again release our latest update to Epstein Becker Green’s Telemental Health Laws app, an extensive compilation of laws, policies, and other state guidance for practitioners supporting the mental/behavioral health practice disciplines.
Wage & Hour Guide for Employers App
Many professionals depend on mobile devices to access information at work. Rather than plodding through search engine results or cumbersome government websites on a mobile device, users can swiftly navigate through the Wage & Hour Guide for Employers app (“Wage & Hour App”), which contains a directory of laws and regulations for each U.S. jurisdiction.
As the laws and regulations have changed, so too has the Wage & Hour App, which is regularly updated to reflect those developments.
Innovation at Every Corner
In 2023, we proudly expanded upon our commitment to providing clients with innovative solutions, technologies, and other offerings. Building on our legacy of focused excellence, we launched the Speaking of Litigation podcast series, where Epstein Becker Green litigators pull back the curtain to provide an inside look at the various stages of litigation and the key strategic issues businesses face along the way. We hosted the Health Care Construction Conference in Nashville, Tennessee, for real estate investment trusts, for-profit and nonprofit providers, rural public hospital authorities, other inpatient or outpatient systems, and related investors operating diverse health care facilities. We were also pleased to launch substantial updates to our two cutting-edge apps: the Wage & Hour Guide for Employers app and the Telemental Health Laws app.