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Earlier this month, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) announced that it opened a new investigation into a state health department’s behavioral-health licensing practices. The investigation will examine whether the state’s licensing standards, interpretations, or enforcement activities for behavioral-health facilities and licensed professionals comply with federal conscience and equal-treatment laws.Continue Reading HHS OCR Investigates State Licensing: Enforcement Focus on Federal Conscience and Religious-Liberty Protections

Persistent workforce shortages continue to define the post-pandemic healthcare landscape. Hospitals, health systems, and long-term care providers report enduring deficits in nursing, primary care, and behavioral health staffing, with projections indicating that these shortfalls are likely to persist through the next decade.[1]Continue Reading Navigating Healthcare Workforce Shortages: Evolving Scope-of-Practice and Staffing Regulations

Leaders from across Sheppard Mullin’s national healthcare team gathered in Dana Point, California, for a day-long strategy session led by Co-Leaders, Eric Klein and Amanda Zablocki, to discuss the most impactful trends shaping the future of healthcare and how to best support our clients.Continue Reading A Look Ahead: Major Industry Trends Our Healthcare Team is Tracking

The Executive Order

Earlier this summer, the White House confirmed that President Trump is actively reviewing policy proposals developed in response to his executive order (“EO”) aimed at expanding access to in vitro fertilization (“IVF”).[1] Signed on February 18, 2025, the EO acknowledges the importance of family formation and the high financial barriers to fertility treatments. Accordingly, the EO solicits policy proposals “protecting IVF access and aggressively reducing out-of-pocket and health plan costs for such treatments.” [2] The initial submission deadline passed in May.Continue Reading Shifting Landscapes: How Federal and State Policies are Expanding Access to IVF

With increased consolidation of traditional medical practices and declining reimbursement rates, many physicians are turning to alternative models like concierge medicine to preserve their independence. Concierge medicine allows physicians to offer personalized, high-quality care to patients in exchange for a membership fee. This model is governed by private service agreements that outline the relationship between the patient and healthcare provider, detailing the services provided, terms of access, and financial obligations. Unlike traditional practices, concierge medicine operates with a smaller patient panel, fewer insurance constraints, and a focus on improved patient access. Continue Reading So You Want to Start a Concierge Medicine Practice? Here are Five Key Legal Considerations

The White House announced it is launching a health data tracking system early next year that involves an unprecedented partnership between the federal government, providers, payors, and private sector technology companies. The stated objective is to enable patients to more easily access and share their personal health data and medical records across different platforms, including through apps operated by private technology companies (the “Tracking System”). While the initiative may ultimately aspire to improve patient care through expanded data sharing, it raises notable legal and privacy concerns.Continue Reading White House Announces National Health Data Tracking System of Personal Health Data

In a recent decision with important implications for artificial intelligence (AI) driven innovation, the Patent Trial and Appeal Board (PTAB) denied a patent for an AI-based medical tool.[1] The refusal was not because the invention was not new or inventive. Rather, the refusal was because the invention did not meet a fundamental rule of U.S. patent law. In Ex parte Michalek, the PTAB specifically acknowledged that the patent claims at issue recited new information about the nexus between certain biomarkers and the development of lung cancer as facilitated by machine learning. In fact, prior to appeal, the applicant had successfully refuted all arguments raised by the patent examiner that the invention was not new or nonobvious. That said, based on U.S. Patent Office guidance and a related example from that guidance, the PTAB still determined the claims were flawed based on the legal principle of subject matter eligibility. Although the facts in this decision concern medical health innovation, the decision is helpful to inform patent strategy for AI-enabled inventions across various disciplines and industries.Continue Reading PTAB Rejects AI-Driven Medical Patent – Not for Novelty, But Eligibility

Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act[i] (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with generative AI with heightened requirements on regulated professions, including licensed healthcare professionals.Continue Reading Utah Enacts AI Amendments Targeted at Mental Health Chatbots and Generative AI

The recent U.S. election has had profound implications for the healthcare industry, prompting industry leaders to reexamine their strategies and day-to-day operations. At the Miami Herbert Business School’s annual “The Business of Health Care” conference on January 24, 2025, a pivotal forum brought together stakeholders across key sectors—home care, hospital systems, payors, and others—to assess the election’s impact and chart a path forward. The conference highlighted the need for collaboration, innovative solutions, and strategic leadership in addressing the challenges ahead.Continue Reading Healthcare Industry Leaders Predict Four Areas to Watch After the U.S. Election: Takeaways from the Business of Health Care Conference Hosted by the Miami Herbert Business School

On January 8, 2025, Massachusetts Governor Maura Healey signed House Bill 5159 (“H.5159”) into law, marking a notable expansion of the regulation of private equity investments within the Massachusetts healthcare sector. The legislation, set to take effect on April 8, 2025, introduces new measures to enhance transparency and accountability in healthcare transactions, focusing specifically on private equity firms, real estate investment trusts (“REITs”), and management services organizations (“MSOs”). This development also reflects a broader trend across the nation of increasing scrutiny of healthcare transactions and investments by private equity firms and other investors, as highlighted in our previous blog series on California’s Assembly Bill 3129.[i]Continue Reading Massachusetts Expands Oversight of Private Equity Investment in Healthcare: Key Takeaways from House Bill 5159 Signed into Law by Governor Healey

President Trump was sworn into office on Monday, promising swift action on several fronts. There is already a new Federal Trade Commission (“FTC”) Chair, Andrew Ferguson, with former FTC Chair Lina Khan expected to step down shortly. At the Department of Justice, Antitrust Division (“DOJ”), proposed AAG Gail Slater will need to be confirmed by the Senate before she can take the helm.Continue Reading Looking Back and Looking Forward: Healthcare Antitrust in a New Administration: What Stays the Same and What Changes?