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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

McDermott Will & Emery

Partnering with Legal at the Critical AI/Healthcare Crossroads

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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

Gardner Law

The Importance of a Clinical Trial Strategy

Gardner Law on

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

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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

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

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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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

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

Bass, Berry & Sims PLC

Illinois Board of Pharmacy Adopts New Licensure Requirement for Out-of-State Pharmacists-in-Charge

Beginning January 1, 2026, the Illinois Board of Pharmacy will require “out-of-state” (non-resident) pharmacies licensed or seeking licensure in Illinois to have a pharmacist-in-charge (PIC) who is licensed in Illinois....more

Chambliss, Bahner & Stophel, P.C.

How To Get a Disabled Parking Permit

Disabled parking permits enable individuals with mobility issues to access businesses and public spaces more easily. Different types of disabled parking permits include permanent and temporary placards, license plates,...more

McGuireWoods LLP

Texas House Bill 3749 Proposes Stricter Regulations for Medical Spas

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As the medical spa industry rapidly expands, states are increasing regulatory oversight to ensure patient safety and compliance with medical standards. Texas is the latest state to propose legislation targeting med spas,...more

Ropes & Gray LLP

New York Department of Health Issues Guidance Clarifying the Scope of its Health Care Transaction Law

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This month, nearly two years after the passage of New York’s health care transaction law, N.Y. Pub. Health Law § 4550 et seq. (described in our previous Alert), the New York State Department of Health (“DOH”) released...more

Arnall Golden Gregory LLP

HHS to Close 6 of 10 Regional OGC Offices, With Potentially Significant Impacts on Providers and Suppliers

On Tuesday, March 11, 2025, the U.S. Department of Health and Human Services (“HHS”) announced plans to close six of the nation’s 10 regional offices for the HHS Office of the General Counsel (“OGC”). These closures, which...more

Mintz - Health Care Viewpoints

Health Law Diagnosed – Understanding the New Massachusetts Health Care Market Review Law

In the latest episode of Health Law Diagnosed, host Bridgette Keller discusses the new Massachusetts Health Care Market Review Law and what this means for health care providers, investors, and other key stakeholders. She is...more

McDermott Will & Emery

NIH’s Mandatory 15% Indirect Rate – Next Steps Following Preliminary Injunction

On March 5, 2025, a US district court in Massachusetts issued a preliminary injunction blocking the National Institutes of Health (NIH) from implementing a February 7, 2025, “Supplemental Guidance” notice that would establish...more

Foley & Lardner LLP

California: AB 1415 and Expanded OHCA Oversight — What Providers, MSOs, and Investors Need to Know

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On February 21, 2025, California introduced AB 1415, a bill aimed at expanding the regulatory oversight of the Office of Health Care Affordability (OHCA). As discussed in our previous blog, certain health care entities are...more

Quarles & Brady LLP

Alabama Bill Proposes Rewrite of Pharmacy Practice Act

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The future direction of the Alabama Board of Pharmacy (“the Board”) hangs in the balance following recent legislation that, if passed, would revise many portions of the state Pharmacy Practice Act. House Bill 123, sponsored...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Quarles & Brady LLP

PE in Healthcare – Recent Governmental Commentary Could Indicate Policy Changes on the Horizon and Time for Increased Vigilance

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Recent reports published by the Senate Budget Committee (the “Committee”) and the U.S. Department of Health and Human Services (“HHS”) highlight what the authors characterize as concerns related to private equity (“PE”)...more

Foley Hoag LLP - White Collar Law &...

New Massachusetts Healthcare Law Targets Private Equity, REITs, and MSOs; Expands State False Claims Act

On January 8, 2025, Governor Maura Healey signed House Bill 5159 into law, toughening the rules and increasing the risks for private equity (PE) companies, real estate investment trusts (REITs), and management services...more

IR Global

9th Circuit Finds That Stromal Vascular Fraction (SVF) Procedures Constitute Treatments As Drugs

IR Global on

In United States v. California Stem Cell Treatment Center, Inc.[1], the FDA brought a lawsuit against doctors who create and administer a stem cell mixture called stromal vascular fraction (SVF), alleging violations of the...more

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