Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
Stay on top of developments in healthcare research compliance - Whether you missed the 2024 in-person Higher Education & Healthcare Research Compliance Conference in New Orleans, or are looking for additional insights...more
Background on Indiana’s “Baby HSR” Law - Indiana passed Senate Bill 9 in March 2024, which requires an Indiana healthcare entity involved in a merger or acquisition with another healthcare entity with a value of at least...more
As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more
Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more
In early May 2024, the New Civil Liberties Alliance (NCLA) notified the U.S. Consumer Product Safety Commission (CPSC) that it intended to file suit against CPSC and CPSC Commissioner Richard Trumka for allegedly violating...more
On June 14, House Energy and Commerce Committee (E&C) Chair Cathy McMorris Rodgers published a “framework for discussion” proposing reforms to the National Institutes of Health (NIH)....more
The term ‘repetitive stress injury’ covers a wide variety of conditions. A Repetitive stress or strain injury happens when too much stress is placed on a given body part and can result in pain, swelling, muscle strains, and...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more
On June 14, 2024, the Chair of the House Energy and Commerce Committee Cathy McMorris Rogers (R-WA) released a framework for changes within National Institutes of Health (NIH) and asked for public input....more
Attorney Peter Zeidenberg was surprised to learn that NIH had successfully clawed back $3.6 million—plus a nearly 100% penalty—from Cleveland Clinic. The Department of Justice (DOJ) claimed the award funds were ill-gotten...more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
The federal government awards billions of dollars each year in sponsored research funding to institutions of higher education, academic research institutions, non-profit organizations, and companies—making federal grants an...more
The Situation: The National Institutes of Health ("NIH") proposed a new policy requiring entities that receive licenses from the NIH to certain taxpayer-funded inventions to submit Access Plans for ensuring broader patient...more
Key Points - GLP-1 agonists have ushered in a new era in anti-obesity medication policy considerations against the backdrop of a continued focus by policymakers on both drug access and pricing. CMS has taken steps to clarify...more
New York Medical College (NYMC) officials thought the HHS Office of Inspector General’s (OIG) audit was wrapping up in December 2021, based on what “the original senior auditor” told them. But the auditor retired and work...more
Some funding applications submitted to NIH beginning Jan. 25 will face new requirements and undergo a revised peer review process. To prepare investigators and institutions, NIH launched a dedicated website with details about...more
In 2022, the United States Department of Justice (“DOJ”) announced its decision to shut down the “China Initiative”—the controversial program used to investigate and prosecute academics, health care workers, and...more
A group of four bipartisan senators known as the Bipartisan Senate Artificial Intelligence (AI) Working Group (Working Group) on May 15, 2024, released "Driving U.S. Innovation in Artificial Intelligence: A Roadmap for...more
Let's talk about releases and, in particular, the leading Federal Circuit case regarding releases that involve delay and cumulative impact. Bell BCI v. United States, 570 F.3d 1337 (Fed. Cir. 2009), involved the...more