The Law
The Corporate Transparency Act (the CTA), a law enacted by Congress requiring certain business entities to disclose beneficial ownership information (a BOI Report) to FinCEN, went into effect on January 1, 2024, and obligates reporting companies formed before
On November 28, 2024, China’s National Medical Products Administration (NMPA, 国家药品监督管理局), China’s equivalent of the U.S. Food and Drug Administration, issued the Draft Administrative Measures for Management of Medical Representatives for public comment (the Draft Management Measures, 医药代表管理办法) in conjunction
The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced on December 3 that it imposed a $1.19 million penalty on Gulf Coast Pain Consultants, a pain management practice in Florida, following a security breach that
In our blog post from May this year, we set out what you need to know about the U.S. Food and Drug Administration (FDA) final rule, revising the regulatory definition of an in vitro diagnostic (IVD) to explicitly capture
Frazier Healthcare Partners has announced the closing of a new fund with $2.3 billion of commitments.
The fund, Frazier Healthcare Growth Buyout Fund XI, was oversubscribed and hit its hard cap in six months. The fund will focus on acquiring
Where Physician Burnout and Value-Based Care Intersect
This series explores legal issues related to physician burnout and potential solutions, and here we explore the potential impact of value-based care (“VBC”). Our first post addressed how healthcare organizations can foster the
Following the implementation of the Windsor Agreement, a new framework is coming into effect in the new year affecting the UK licensing regime for medicinal products, giving the Medicines and Healthcare products Regulatory Agency (MHRA) the exclusive authority to licence
In the final 2025 Medicare Physician Fee Schedule, which is set to be published in the Federal Register on December 9, the Centers for Medicare and Medicaid Services (CMS) included substantive changes to the regulations governing when a provider must
The Department of Justice recently announced a landmark Penn State cybersecurity fraud settlement, with the university agreeing to pay $1.25 million to resolve False Claims Act allegations. This October 2024 settlement, which awarded the whistleblower $250,000, highlights two critical
