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
On May 14, 2024, the United States Trade Representative (USTR) released its Final Report relating to the four-year review of actions taken in the Section 301 investigation. Within the Report, the USTR confirmed that it...more
As reported in our previous client alert, on May 14, 2024, President Biden announced that he directed his Trade Representative to increase tariffs under Section 301 of the Trade Act of 1974 (Section 301) on a wide range of...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
On March 15, 2024, four of the US Food and Drug Administration’s (FDA) medical products centers released a joint paper, titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,”...more
GAO’s recent decision in Marathon Medical Corporation provides a cautionary tale for government contractors seeking to protest the terms by which an agency conducts a procurement. Specifically, Marathon reinforces a...more
On February 5, 2024, Judge Arun Subramanian of the United States District Court for the Southern District of New York largely declined to dismiss a putative class action asserting claims under the Securities Exchange Act of...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On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more
Revised Draft FDA Guidance Expands Scope of Permissible Proactive Off-Label Communications This week, FDA published new revised draft guidance, Communications From Firms to Health Care Providers Regarding Scientific...more
On August 15, 2023, the Food and Drug Administration (FDA) issued its updated guidance on informed consent for clinical investigations. The FDA’s updated guidance is titled Informed Consent Guidance for IRBs, Clinical...more
Medical Supplier Agrees to Pay $29 Million for FCA Violations - Earlier this month, the US Department of Justice (DOJ) and medical supplier Lincare Holdings Inc. reached an agreement to settle claims that Lincare violated...more
The FDA has updated its Medical Device Shortages List to remove Specimen Collection, Laboratory Reagents and Testing Supplies, Transport Media Device, Saline Vascular Access Flush, and Certain Ventilation-Related Products....more
Pennsylvania Medical Supply Company Agrees to $5 Million Settlement - A Pennsylvania medical supply company, AdaptHealth LLC, formerly known as QMES LLC, agreed to a $5.3 million settlement to resolve allegations that it...more
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more
Massachusetts AG Andrea Joy Campbell settled with Regional Home Care, Inc., a medical equipment supplier and service provider, to resolve allegations that the company’s billing and debt collection practices violated the...more
The United States Trade Representative (USTR) is likely to reinstate Section 301 tariffs on 81 COVID pandemic-related products. The 81 health care products that will be affected include, but are not limited to, these items: ...more
The Medicines and Healthcare products Regulatory Agency has extended the EC Decision reliance procedure (EC DRP) to apply until 31 December 2023....more
Auterion, a drone software company, commissioned a survey from market research company, Propeller Insights, of 1,022 adults, gender-balanced and distributed across age groups from 18 to 65+, living in rural, suburban, and...more
On June 30, 2022, California Governor Gavin Newsom signed into law SB 54, putting into place some of the nation’s strictest, far-reaching regulations on packaging materials. The legislation mandates significantly reduced use...more
This week, North Carolina announced that it will begin long-range health care deliveries by drone in an effort to expand on-demand health care and improve the patient experience in the state. A distribution center will be set...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
The sun is shining, children are out of school, families are headed off on summer vacations, and the SEC is … bringing enforcement actions against companies for 2020 fraud related to COVID-19 products. One such action was...more
On May 27, 2022, the Office of the US Trade Representative (USTR) published a Federal Register notice extending Section 301 tariff exclusions for certain China-origin medical products needed to address the COVID-19 pandemic....more