Resource Library

This blog explores the U.S. Food & Drug Administration (FDA) two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19 Public Health Emergency (PHE), and (ii) that were issued emergency use authorizations (EUAs). These guidance documents finalize the corresponding draft guidance documents that were issued on December 23, 2021.

This blog focuses on U.S. Food and Drug Administration (FDA) published framework to guide regulatory decision-making on the use of digital health technologies (DHT) in clinical drug trials. DHTs include a wide array of technologies, including software applications that run on a phone, wearables, and environmental sensors, among others. As DHT becomes more sophisticated, the technologies have the potential to play an even larger role in health care, including clinical research.

This article focuses on the Centers for Medicare & Medicaid Services (CMS) massive rule (Final Rule)2 amending regulations for Medicare Advantage (MA or Part C), Medicare Cost Plan, the Medicare Prescription Drug Benefit (Part D) programs, and Programs of All-Inclusive Care for the Elderly (PACE).

This article focuses on the changes to the Medicare Advantage (MA) and Part D programs marketing rules at 42 C.F.R. parts 422 and 423, which are applicable for all contract year 2024 marketing and communications beginning September 30, 2023.

This blog explores physician recapitalization transactions and how complex they are and their myriad issues. At Foley, in our representation of both investors in, and sellers of, physician practices, we note how often tax issues become gating items that drive the structural aspects of the transaction.

This blog post focuses on health care companies who are increasingly using artificial intelligence (AI) to create innovations, set prices, and compete with rivals. At the same time, federal and state antitrust enforcers are finding new ways to apply antitrust law to the modern, data-driven economy. Amid these myriad changes in technology and the law, the time is ripe to consider what the growth of AI in health care means for antitrust compliance.

This blog focuses on the Biden Administration’s announcement on its intention to end the COVID-19 public health emergency (PHE) on May 11, 2023. For Federally Qualified Health Centers (FQHCs), flexibilities offered under the PHE expanded opportunities to be paid for telehealth services, particularly for Medicare patients. Any FQHC relying on PHE flexibilities should begin preparing for the end of the PHE to ensure its service offerings are in compliance with post-pandemic requirements.

In this multi-jurisdictional guide, explore an overview of key legal issues, rules and developments regarding pharmaceutical advertising across a range of jurisdictions.

The presence of private equity (PE) investment has exploded in recent years in all areas of the health care sector. PE in health care is a good thing when done right: It can pave the way for much needed innovation, efficiency, and nontraditional care delivery models. However, government regulators, media journalists, some health care practitioners, and private parties are watching PE investment with growing suspicion that profit-driven goals may conflict with the quality of care for patients.

Although use of telehealth in clinical trials is not new, the modality was not popularized until social distancing efforts brought about by COVID-19 forced the issue. Companies interested in providing clinical trial services via telehealth have to deal with whether the carrying out the clinical aspects of a clinical trial is part of the practice of medicine.