In an era where artificial intelligence (AI) is reshaping landscapes in the healthcare industry and beyond, understanding the governance of AI technologies is paramount for organizations seeking to utilize AI systems and tools. AI governance encompasses the policies, practices, and frameworks that guide the responsible development, deployment, and operation of AI systems and tools within an organization. By adhering to established governance principles and frameworks, organizations can ensure their AI initiatives align with ethical standards and applicable law, respect human rights, and contribute positively to society. Various international organizations have set forth AI governance principles that provide organizations with a solid foundation to develop organizational AI governance based on widely shared values and goals.Continue Reading Navigating the Complex Landscape of AI Governance: Principles and Frameworks for Responsible Innovation
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Election 2024 Coverage: Examining the Future of Healthcare and Antitrust
Leading up to the U.S. presidential election this November, our Antitrust & Competition team will offer thoughts and insights into what antitrust enforcement will look like under the next presidential administration. While there is at least some uncertainty regarding antitrust enforcement under either a Harris or Trump administration, there is no doubt that the current Biden administration has been extraordinarily active.Continue Reading Election 2024 Coverage: Examining the Future of Healthcare and Antitrust
Update: OHCA Approves Amendments to Cost and Market Impact Review (CMIR) Regulations
California’s Office of Health Care Affordability (OHCA) has officially approved amendments (“Amendments”) to the cost and market impact review (CMIR) regulations, effective August 22, 2024. Most significantly, these Amendments expand the scope of health care entities (HCEs) subject to a CMIR, among other notable changes discussed below.Continue Reading Update: OHCA Approves Amendments to Cost and Market Impact Review (CMIR) Regulations
Attention Maryland Providers: Are You Availing Yourselves of Regulatory Flexibilities under the TCOC Model?
An April 2024 independent[1] report (“Report”) analyzed the results of the first four years following implementation of the Maryland Total Cost of Care Model (the “TCOC Model”), finding that between 2019 and 2022 (the “TCOC Measuring Period”), the TCOC Model reduced Medicare spending, hospital admissions, and health disparities. CMS also distributed a summary of the Report’s findings.Continue Reading Attention Maryland Providers: Are You Availing Yourselves of Regulatory Flexibilities under the TCOC Model?
There Are Limits! Reining In FCA Penalties Pursuant to the Excessive Fines Clause
In the high-stakes realm of False Claims Act (FCA) litigation, per-claim penalties can reach daunting levels that dwarf even treble damages. A recent ruling from the Eighth Circuit Court of Appeals provides valuable guidance on the limits of penalties under the Constitution’s Excessive Fines Clause (Clause). In Grant ex rel. United States v. Zorn, the Eighth Circuit applies the Clause in FCA litigation to identify when a penalty for purely economic loss offenses might be considered excessive. Specifically, the Court held that:Continue Reading There Are Limits! Reining In FCA Penalties Pursuant to the Excessive Fines Clause
Massachusetts Senate Passes Bill to Increase Oversight of Private Equity Healthcare Transactions
On July 18, 2024, the Massachusetts Senate passed S. 2871, An Act Enhancing the Health Care Market Review Process (the Bill), to increase oversight of healthcare transactions involving private equity firms, real estate investment trusts, and management services organizations (MSOs). The Bill is another example of the increasing trend towards curbing private equity influence in health care, as highlighted in our previous blog series on California’s Assembly Bill 3129.[1] In Massachusetts, 51% of all healthcare provider transactions in the past decade have involved private equity firms,[2] and the Bill targets such involvement with the goals of expanding care and medication access and improving transparency and affordability, particularly in the primary care space.Continue Reading Massachusetts Senate Passes Bill to Increase Oversight of Private Equity Healthcare Transactions
California Attorney General Advocates for Greater Antitrust Enforcement in Private Equity in Healthcare
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
Colorado’s Artificial Intelligence Act Impact on Healthcare Decisions
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
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 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
Update: California State Assembly Passes AB 3129 Requiring State Approval of Private Equity Healthcare Deals
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
California’s Minimum Wage Increase for Health Care Workers is on the Horizon
On June 1, 2024, nearly all health care facilities in California will be required to increase the minimum wage paid to health care workers, ranging anywhere from $18 per hour up to $23 per hour depending on the type of health care facility. Below we address the key questions these facilities should be asking to evaluate their current and future compliance with this new law.Continue Reading California’s Minimum Wage Increase for Health Care Workers is on the Horizon