Podcast: President Biden's Use of the Defense Production Act - Diagnosing Health Care
Supporting Health Through Supply Chain Management
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
Blakes Continuity Podcast: Life Sciences: Liability and Immunity During COVID-19
K&L Gates Triage: Using Drones in Medicine
Misinformation shared by independent third parties presents a significant public health concern because it can lead patients and healthcare providers to forgo treatments that are safe and effective or choose treatments that...more
News Briefs - Biden Places New Tariffs on Chinese Medtech Product Imports - The Biden administration announced its plan to increase tariffs on Chinese-made medical supplies as part of a broader push to tax imports from the...more
The value of private equity (PE) deals in the healthcare sector has grown from <$2B in 2001 to $151 billion in deals in 2021. Barring government intervention, PE in healthcare is here to stay....more
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more
On June 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-13, approving an arrangement under which a durable medical equipment (DME) manufacturer...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more
Alere Inc. and Alere San Diego Inc. (collectively “Alere”) have come under fire recently by the U.S. Department of Justice (“DOJ”) and other government agencies, agreeing to settle several rounds of accusations of False...more
In the past week, President Biden revealed a new plan to share COVID-19 vaccines with other countries, and the CDC allowed vaccination sites to prioritize vaccinations over minimizing waste; both actions reflect the...more
When the COVID-19 crisis struck in early 2020, the immediate need for mass quantities of personal protective equipment (PPE) resulted in major supply shortages that made headlines across the country. As suppliers scrambled to...more
On December 3, 2020, the U.S. Department of Health and Human Services (HHS) issued another groundbreaking amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act). ...more
On this episode of Leaders Moving 2020 Forward, Chaun Powell, Group Vice President, Strategic Supplier Engagement with Premier, Inc. is interviewed by Jennifer Geetter, a partner in McDermott Will & Emery’s Health practice....more
On November, 10, 2020, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the investigational neutralizing antibody bamlanivimab (Eli Lilly and Company, Indianapolis, IN) for the...more
Medical rationing is not something Americans are accustomed to, but COVID-19 may soon change that. As local hospitals become overwhelmed with COVID-19 patients, they may reach the point where they have to make grim decisions...more
This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more
Greater access to medicines and other health commodities (as well as timely delivery of test results) in remote areas could improve health outcomes and potentially save lives....more
On 9 July 2020 the European Commission adopted a Communication regarding readiness at the end of the transition period between the European Union and the United Kingdom. ...more
In Mitchell v. Blue Cross Blue Shield of N.D., 2020 U.S. App. LEXIS 8818 (8th Cir. Mar. 20, 2020), the Eighth Circuit upheld the payment of 150% of Medicare rates for an out-of-network air ambulance flight, although the...more
Healthcare providers who received or receive payments from the CARES Act Provider Relief Fund (“PRF”) may only use the payment for permissible purposes, must document and report the proper use, and return any excess funds to...more
The current COVID-19 environment has disrupted standard operations in nearly every industry and created fertile grounds for innovation. This is the first of a series of blog posts that will look at how industries have enabled...more
ethikos 34, no. 5 (May 2020) - Doctors around the world are facing choices that no one wants to make. As healthcare facilities run out of beds, supplies, ventilators, and drugs, doctors must “triage”—a term coined during...more
As previously discussed, on April 3, 2020, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a process for inquiries to be submitted to OIG about whether administrative enforcement...more
With the rapid and expansive spread of the COVID-19 pandemic, Alabama health care providers may face a shortage of critical supplies, including ventilators and dialysis machines, which would require difficult decisions...more
The United States is experiencing an unprecedented shutdown affecting almost all aspects of life due to the current pandemic. To speed relief to the economy, on March 27, 2020, Congress enacted the Coronavirus Aid, Relief,...more
Since our last roundup-style blog post on the response of the Food and Drug Administration (FDA) to the COVID-19 public health emergency, the agency has taken a wide variety of additional actions with the goal of getting...more