AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
Health + Tech - How Digital Health Tools Help Create Greater Consumer Focus in Healthcare
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Episode 132: Dr. Ehsan Jabbarzadeh, Co-Founder, Obsidio, and Professor, USC
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Healthcare Headlines: Episode 8 – Healthcare Lending Deal Landscape Trends and Forecasts for the Future
Healthcare Headlines: Episode 7 — Evolving Landscape of Healthcare Provider & Medical Product Liability
Medical device manufacturer, Medtronic, began its second trial on June 14 in the US Tax Court in a $1.36 billion transfer pricing dispute with the IRS. The trial concluded on June 25 and is among the most significant transfer...more
DOJ’s 2020 False Claims Act Recoveries Lowest Since 2008 - On January 14, 2021, the Department of Justice (DOJ) announced that it obtained more than $2.2 billion in settlements and judgments from civil cases involving...more
A state appeals court in California has preempted Uber and Lyft’s threatened state-wide shutdown over a new state law ordering them to reclassify their drivers as employees by “allowing them to continue operating [under their...more
...On Monday, House Speaker Nancy Pelosi, Majority Whip James Clyburn, Transportation & Infrastructure Committee Chairman Peter DeFazio, and Energy & Commerce Committee Chairman Frank Pallone held a press conference on a...more
Highlights: ..Unless Congress acts in the next three weeks, effective as of January 1, 2020, a 2.3% excise tax (the “Medical Device Tax”) generally will be imposed on the price at which a “taxable medical device” is sold...more
On January 22, 2018, President Trump signed into law H.R. 195 (hereinafter referred to as the “2018 Budget Deal”) which ended the federal government shutdown and funds the federal government through February 8, 2018. In...more
Addressing whether certain intercompany technology license agreements were negotiated at arm’s length, the US Tax Court rejected the Internal Revenue Service’s (IRS’s) alleged $1.36 billion tax deficiency and determined that...more
I. REGULATIONS, NOTICES, & GUIDANCE - On April 15, 2016, the Food and Drug Administration (FDA) issued a proposed rule entitled, “Applications for Approval and Combinations of Active Ingredients Under Consideration for...more
Guidance eases tax filing burdens on medical device manufacturers. On February 24, 2016, the Internal Revenue Service (IRS) published informal guidance on the suspension of the Medical Device Excise Tax through an update...more
On Oct. 8, the House Republican caucus did not select a candidate for Speaker of the House and selection has been delayed. The current Speaker, John Boehner (R-OH), had announced that he would step down and retire from...more
In This Issue: - King v. Burwell before the Supreme Court and the Potential Congressional Response - Implementation of the Affordable Care Act - Other Federal Regulatory Initiatives - Congressional...more
In Private Letter Ruling 201420004 (released May 16, 2014), the Internal Revenue Service (IRS) has ruled on the question of which party in a contract manufacturing arrangement is the "manufacturer" for purposes of the medical...more
In This Issue: A Primer on the Medical Device Excise Tax; FATCA Registration Begins; In re Downey Financial Corp. (U.S. Bankr. Court Dist. of Delaware 10/8/2013); In re NetBank (11th Cir. 9/10/2013); and In re...more
Foley Hoag and the Advanced Medical Technology Association (AdvaMed) collaborated on an important resource guiding manufacturers, importers, and producers of taxable medical devices through the newly released Internal Revenue...more
Last week, the IRS and the Treasury Department published final regulations regarding the medical device excise tax under § 4191 of the Internal Revenue Code (IRC). IRC § 4191, which was enacted by the Health Care and...more
Beginning January 1, 2013, manufacturers, producers, and importers of medical devices must report and pay a 2.3% excise tax on the sales price of taxable medical device pursuant to Section 4191 of the Internal Revenue Code...more
The U.S. Department of the Treasury and the Internal Revenue Service (IRS) recently issued much-anticipated final regulations under Section 4191 of the Internal Revenue Code (Code), which imposes a 2.3% tax on sales of any...more
Pending the January 1 effective date, final regulations and interim guidance on the medical device excise tax provide some clarity but leave many questions unanswered. On December 7, the Internal Revenue Service (IRS)...more
On December 5, 2012, the Internal Revenue Service (IRS) published final regulations regarding the implementation of the excise tax applicable to the sale of certain medical devices, enacted by the Patient Protection and...more
The Internal Revenue Service (IRS) released final regulations and other guidance on the excise tax applicable to the sale of certain medical devices under the Affordable Care Act. Beginning January 1, 2013, a tax of 2.3...more