News & Analysis as of June 1, 2025

Cybersecurity › Department of Justice (DOJ) › Food and Drug Administration (FDA)

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Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk... more +

Follow this channel for advisories on one of the biggest threats to businesses today. Read a morning brief of fresh guidance and commentary by leading lawyers on security, privacy, risk management, global regulations, data protection, leaks, hacking, cyber insurance, compliance, HIPAA, and every other aspect of cybersecurity of import to corporate readers right now. less -

Security Requirements and Compliance Obligations in DOJ's Final Rule on Data Transactions

Akin Gump Strauss Hauer & Feld LLP on 2/24/2025

The Department of Justice’s (DOJ) final rule implements President Biden’s Executive Order 14117 of February 28, 2024, on “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States Government-Related Data...more

2024 Healthcare Fraud Enforcement Year in Review

Morrison & Foerster LLP on 1/28/2025

In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the False Claims Act (FCA) alone resulted in $1.67 billion in settlements and judgments...more

Drug Pricing and Health Care Fraud Remain Key Issues

Skadden, Arps, Slate, Meagher & Flom LLP on 1/21/2025

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

[Hybrid Event] Due Diligence Decoded: M&A Success in FDA-Regulated Industries - September 20th, Boston, MA

Gardner Law on 8/20/2024

Join Gardner Law for a half-day CLE event in person at Loft on Two in Boston, MA or attend virtually. Industry experts will decode the intricacies of regulatory scrutiny and strategic decision-making in acquisitions. Gain...more

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on 7/22/2024

Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more

Holland & Knight Health Dose: June 11, 2024

Holland & Knight LLP on 6/13/2024

Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include:...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Skadden, Arps, Slate, Meagher & Flom LLP on 3/25/2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies

Morrison & Foerster LLP on 1/10/2024

The year 2023 was a busy one for regulatory, compliance, and enforcement developments in the healthcare and life sciences industries, and 2024 promises to be even busier. We tapped MoFo’s Life Sciences + Healthcare Compliance...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates

Skadden, Arps, Slate, Meagher & Flom LLP on 11/3/2023

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Legal Insights for Manufacturing: Outlook for 2024

Husch Blackwell LLP on 11/2/2023

Our downloadable report, Legal Insights for Manufacturing, explores how the business, legal, and regulatory framework is evolving—and will evolve—to address the large generational shifts taking place. This year, our report...more

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on 12/2/2022

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Prevent A Clinical Trial From Turning Into A Criminal Trial

MoFo Life Sciences on 11/16/2022

On November 2, 2022, Stacy Cline Amin, former Chief Counsel of the U.S. Food and Drug Administration (FDA) and Deputy General Counsel of the Department of Health and Human Services (HHS), moderated the panel “Compliance and...more

The DOJ’s Focus on Clinical Trial Enforcement: An Ounce of Prevention Is Better Than an Enforcement Action Cure

Orrick, Herrington & Sutcliffe LLP on 4/27/2022

In early April, the U.S. Department of Justice (DOJ) Civil Division’s Consumer Protection Branch (CPB) published its first-ever “Recent Highlights” report. The report provides background on the CPB, highlights from its recent...more

DOJ Announces First Settlement Under New Civil Cyber-Fraud Initiative

Dorsey & Whitney LLP on 3/29/2022

In October 2021, the Department of Justice (“DOJ”) announced its new Civil Cyber-Fraud Initiative, led by the Civil Division’s Fraud Section, to enhance its ongoing efforts to address cybersecurity threats. The initiative...more

Window On Washington - Vol. 4, Issue 7

Clark Hill PLC on 2/18/2020

Outlook for This Week in the Nation’s Capital - Recess. Both the House and Senate are in recess this week....more

Window On Washington - Vol. 3, Issue 38

Clark Hill PLC on 10/15/2019

Outlook for This Week in the Nation's Capital - Congress Returns. The House and Senate return on Tuesday from a two week recess that included multiple House committee meetings related to the impeachment inquiry....more

Weekly Update Newsletter - May 2019 #3

PilieroMazza PLLC on 5/20/2019

FALSE CLAIMS ACT / LITIGATION - U.S. Supreme Court – According to Law360, the U.S. Supreme Court ruled unanimously that the “government knowledge” statute of limitations applies in False Claims Act cases regardless of...more

2019 Health Care Predictions

Saul Ewing LLP on 2/1/2019

INTRODUCTION - The Saul Ewing Arnstein & Lehr, LLP health care practice group includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery...more

Window On Washington - Vol. 2, Issue 29

Clark Hill PLC on 7/23/2018

Outlook for This Week in the Nation's Capital - Minibus on Senate Floor. The Senate is expected to take up a four-bill spending package next week. ...more

Window On Washington - Vol. 2, Issue 25

Clark Hill PLC on 6/26/2018

Outlook for This Week in the Nation's Capital - Senate Floor. The Senate is schedule to finish its work this evening on the minibus appropriations bill, a three-bill spending package that includes Energy and Water...more

Window On Washington - Vol. 2, Issue 22

Clark Hill PLC on 6/5/2018

Outlook for This Week in the Nation's Capital - Minibus Appropriations Strategy. The House and Senate are planning to move appropriations bills in small packages of two or three bills in order to avoid a significantly delayed...more

Holland & Knight's Israel Practice Newsletter - Winter 2017

Holland & Knight LLP on 12/12/2017

Holland & Knight invites you to read our Winter 2017 Israel Practice newsletter, in which our authors discuss pertinent American-Israeli topics. As Israel has been a crossroads and a prolific source of new ideas for more than...more

Global Privacy & Cybersecurity Update Vol. 15

Jones Day on 9/15/2017

UNITED STATES - Regulatory—Policy, Best Practices, and Standards - FTC Comments on Improvements to IoT Device Security - On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the...more

Window on Washington - This Week in the Nation's Capital - Vol. 1, Issue 24

Clark Hill PLC on 9/5/2017

Hurricane Harvey Could be the Most Expensive Natural Disaster in US History: Republican House members from Texas and Louisiana are pressing congressional leaders and top Trump administration officials for immediate federal...more

King & Spalding Lawyers Discuss The Regulatory Landscape At Medical Device Cybersecurity Risk Mitigation Conference

King & Spalding on 8/9/2016

On July 25 and 26, 2016, industry stakeholders assembled in Arlington, Virginia, to participate in the Medical Device Cybersecurity Risk Mitigation Conference sponsored by Q1 Productions. The conference focused on the...more

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