In a decision joined by all nine justices, the Supreme Court preserved the Food and Drug Administration’s (“FDA’s”) regulatory approval of mifepristone, ensuring continued access to the widely-used abortion medication across the country. Food and Drug Administration, et al. v. Alliance for Hippocratic Medicine et al., No. 23-235 and Danco Laboratories, L.L.C. v. Alliance for Hippocratic Medicine, et al., No. 23-236. The Court ultimately decided the case on procedural grounds, holding that the plaintiffs lacked standing to bring suit.Continue Reading Supreme Court Unanimously Preserves Access to Mifepristone

Only two months after California’s cost and market impact review (CMIR) regime began to require notice of certain healthcare-related transactions, the Office of Health Care Affordability (OHCA) has already proposed several amendments (Amendments) to the regulations. To recap, the CMIR regulations as currently in effect require that health care entities (HCEs) notify OHCA of transactions meeting certain materiality thresholds at least ninety days prior to closing, as discussed in depth in our previous blog series.[1] Public comments to the Amendments will be accepted until June 20, 2024 and the Amendments are scheduled for discussion at an OHCA board meeting on June 26, 2024. OHCA has not yet announced when the Amendments would take effect, if passed.Continue Reading OHCA Proposes Amendments to its Cost and Market Impact Review Program

On June 6, 2024, California Attorney General Rob Bonta announced that he led a multistate coalition of eleven (11) state attorneys general in in submitting a comment letter (the “Comment Letter”) in response to the Federal Trade Commission, the U.S. Department of Justice, and the U.S. Department of Health and Human Services’ (together the “Agencies”) request for information regarding consolidation in healthcare by private equity. On March 5, 2024, the Agencies issued a “Request for Information on Consolidation in Healthcare Markets,” on the same day the Agencies hosted a public workshop regarding the impact of private equity investment in the healthcare system. Continue Reading California Attorney General Advocates for Greater Antitrust Enforcement in Private Equity in Healthcare

On May 17, 2024, Colorado Governor signed into law, Senate Bill 24-205, the Colorado Artificial Intelligence (AI) Act (the “Act”). The law will take effect on February 1, 2026 and the Colorado Attorney General will have exclusive enforcement authority. As previewed in our prior blog post, the Act focuses on consumer protection issues when companies develop AI tools and imposes obligations on developers (i.e., creators) and deployers (i.e., users) of “high risk” AI systems. “High-Risk” AI systems (“HRAIS”) are defined as any AI system that “makes, or is a substantial factor in making, a consequential decision.” A substantial factor means one that (1) “assists in making a consequential decision”; (2) “is capable of altering the outcome of a consequential decision”; and (3) “is generated by an artificial intelligence system.” A consequential decision is a decision that has a material legal or similarly significant effect on matters related to education, employment, financial lending services, an essential government service, healthcare services, housing, insurance, or legal services. This article specifically reviews the impact the Act has on healthcare services.Continue Reading Colorado’s Artificial Intelligence Act Impact on Healthcare Decisions

At last week’s America’s Physician Groups Spring conference in San Diego, California, we listened as physicians and health system leaders described the ways in which they are responding to short and long term challenges to the sustainability of America’s healthcare system in its current form. It now stands at a critical juncture, facing challenges such as provider shortages and burnout, increasing concerns around access and cost for pharmaceutical products and other supplies, the increasing burden of managing chronic diseases, rising demand for services across the spectrum from an aging population, and balancing the transition to value-based care models in a predominantly fee-for-service environment.Continue Reading Acting Now to Sustain and Improve America’s Healthcare System: Advice from Innovative Physicians and Health System Leaders

At last week’s America’s Physician Group Spring conference in San Diego, California, our team heard firsthand how physicians are leading efforts to integrate Artificial Intelligence (AI) applications in ambulatory and inpatient settings in major healthcare systems across the nation. Physician and IT leaders described in detail their organizations’ efforts to identify safe, cost-effective, desirable ways to leverage AI to enhance the efficiency and quality of patient care and reduce physicians’ administrative workload. Here, we highlight key approaches that have generated early success for various health systems and physician groups, as well as key pitfalls that participants looking to adopt these technologies need to account for in their planning.Continue Reading How Physicians are Pioneering Use of AI Applications in Ambulatory and Inpatient Care

If your organization has not updated its policies to comply with Utah’s Artificial Intelligence Policy Act (the “Act”), now is the time. As we noted in a prior blog post, this law took effect on May 1st. While it imposes certain AI-related disclosure obligations on businesses and individuals as a whole, the obligations for regulated occupations (which include those licensed by the Utah Division of Professional Licensing, such as clinical services provided by a licensed healthcare provider, including a physician or nurse), are stricter.Continue Reading Utah Providers – Are You Complying with the AI Policy Act?

Almost 40 years after its passing, the Emergency Medical Treatment and Active Labor Act (EMTALA) remains not only a key consideration for hospitals with emergency departments, but also a significant federal enforcement priority. EMTALA requires hospitals with emergency departments that participate in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, stabilizing treatment and transfer for patients with emergency medical conditions (EMCs) and women in labor.Continue Reading EMTALA: In the Spotlight

The healthcare sector is undergoing a transformative phase due in large part to the integration of digital technologies into every-day care. At the forefront of this revolution is Remote Patient Monitoring (“RPM”), a technology that appears poised to redefine the industry’s approach to care. In the ninth episode of Sheppard Mullin’s Health-e Law Podcast, Vipul Kella, M.D., Chief Medical Officer at Physio AI, sheds light on how RPM is revolutionizing the healthcare landscape, with Sheppard Mullin’s Digital Health Team co-chairs, Sara Shanti and Phil Kim.Continue Reading Remote Patient Monitoring Innovating Health Tech: A Discussion with Dr. Vipul Kella

On May 16, 2024, the Subcommittee on Health of the House Committee on Energy and Commerce (the “Subcommittee”) announced that it advanced the Telehealth Modernization Act of 2024 (H.R. 7623) as amended (the “Bill”) during a markup session. The Bill is meant to extend a number of telehealth flexibilities under Medicare through 2026. This corresponded with 22 other bills advanced by the Subcommittee to strengthen access to healthcare.Continue Reading Congress Seeks to Extend COVID-19 Telehealth Flexibilities Through 2026 and Expand Reimbursement

California’s AB 3129, which would require private equity firms and hedge funds to obtain prior approval to consummate certain healthcare-related transactions, is now one step closer to becoming law following the State Assembly’s May 22, 2024 passage of the pending legislation. The legislation is now being considered by the California State Senate, where approval must be obtained prior to the end of the legislative session in August if it is to be enacted into law this year.Continue Reading Update: California State Assembly Passes AB 3129 Requiring State Approval of Private Equity Healthcare Deals