News & Analysis as of

Regulatory Oversight Healthcare

Troutman Pepper Locke

CFPB Will Not Reissue Medical Debt Advisory Opinion

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On July 14, the Consumer Financial Protection Bureau (CFPB or Bureau) filed a status report announcing its decision not to reissue its Medical Debt Collection Advisory Opinion, which had been issued in 2024 to “remind debt...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces AI Councils Amid Calls for Greater Agency Transparency

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more

Tucker Arensberg, P.C.

New CMS Model Targets Inefficient Medicare Spending Through AI and Clinical Oversight

The Centers for Medicare & Medicaid Services (CMS) has launched the WISeR Model (Wasteful and Inappropriate Service Reduction) to modernize and streamline Medicare’s prior authorization process. ...more

Husch Blackwell LLP

California-Based Healthcare Transaction Subjected to OHCA's First Cost and Market Review

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On June 23, 2025, California’s Office of Health Care Affordability (OHCA) issued a determination that a transaction submitted by Covenant Care California, LLC and its subsidiaries under the Material Change Transaction Notice...more

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

McDermott Will & Emery on

The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more

Epstein Becker & Green

HealthBench: Exploring Its Implications and Future in Health Care

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As we noted in our previous blog post, HealthBench, an open-source benchmark developed by OpenAI, measures model performance across realistic health care conversations, providing a comprehensive assessment of both...more

Benesch

Updates to Ohio State Dental Board’s Position Statement on Treatment of Sleep-Disordered Breathing

Benesch on

Summary The Ohio State Dental Board (the “Board”) recently updated its position statement, “Role of the Dentist in the Treatment of Sleep-disordered Breathing.” ...more

Gardner Law

The Importance of a Clinical Trial Strategy

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Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

ArentFox Schiff

FDA Greenlights Commercialization of Gene-Edited Pig Resistant to Devastating Swine Disease PRRSV

ArentFox Schiff on

On April 30, the US Food and Drug Administration (FDA), approved the use of a gene-edited pig to confer resistance to Porcine Reproductive and Respiratory Syndrome (PRRS), a devastating swine disease....more

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...more

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

Smart & Biggar on

On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

Arnall Golden Gregory LLP

Locked Out: How a Federal Moratorium on AI Regulation Could Reshape Healthcare Oversight

On May 22, 2025, the U.S. House of Representatives passed the “One Big Beautiful Bill Act” (H.R. 1) by a vote of 215-214, which includes a significant provision imposing a 10-year moratorium on state and local regulation of...more

Kerr Russell

What Causes a LARA Investigation?

Kerr Russell on

Question: Over the years, several of my colleagues and I have been the subject of investigations by the Michigan Department of Licensing and Regulatory Affairs. In most of these cases it’s hard to imagine why LARA is...more

Dacheng

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

Mintz - Health Care Viewpoints

Private Equity Group and Hedge Fund Bills Continue Through the California Legislature

California legislative activity focused upon private equity group and hedge fund health care transactions continues notwithstanding California Governor Gavin Newsom’s veto last fall of California Assembly Bill 3129 (AB-3129)....more

Troutman Pepper Locke

Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast

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Join Troutman Pepper Locke Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this episode of The Good Bot, Brett Mason and Emma Trivax delve...more

Ropes & Gray LLP

New York Fails to Pass Expanded Health Care Transaction Notice Requirements Bill

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On May 9, 2025, New York State (“NYS”) Governor Kathy Hochul signed legislation enacting the State Fiscal Year 2025-26 budget into law. Notably omitted from the final budget legislation was Part S of the Health and Mental...more

Pullman & Comley - Connecticut Health Law

Head of Connecticut OHS to Resign

Late last week, Governor Lamont announced that the Commissioner of the Office of Health Strategy (OHS), Deidre Gifford, plans to retire from state service in June. No successor was named. ...more

King & Spalding

CMS Will Likely Stop Funding Certain State Medicaid Programs

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CMS announced this month that it does not anticipate using federal funds to match state funds for designated state health programs (DSHP) and designated state investment programs (DSIP) under its section 1115 demonstration...more

Wiley Rein LLP

[Podcast] Contracting for Success: Key Legal Considerations When Segmenting Pharmacy Benefit Programs

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In this episode of The Wiley Contracting Chronicles, co-hosts Jordan Ross and Brooke DeLoatch take a deeper dive into program segmentation within pharmacy benefit programs. After outlining the concept in their previous...more

McDermott Will & Emery

Beyond Private Equity Transaction Oversight: Mass. H.5159 Includes New Licensing Requirements

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H.5159, An Act Enhancing the Market Review Process, was signed into law in January 2025. The primary focus of H.5159 is to expand the Commonwealth’s healthcare oversight mechanisms, particularly with respect to private equity...more

Akin Gump Strauss Hauer & Feld LLP

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

Jones Day

State Attorneys General Increasing Oversight and Focus on Private Equity in Health Care Industry

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State attorneys general ("AGs") have long had unique police powers over a variety of health care providers in their states. Recently, AGs in several states have used this authority to scrutinize consolidation and corporate...more

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