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Life Sciences Risk Management Today's Popular Updates

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Woodruff Sawyer

Life Sciences Insurance: Navigating Risk from Lab to IPO

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In our new webinar series, Risk Management for Your Life Sciences Company, we discuss the insurance and risk management milestones life science companies should prepare for as they move from early funding through clinical...more

White & Case LLP

Life Science Private Equity Risk

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Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

Mintz - Intellectual Property Viewpoints

Patenting AI/ML Life Sciences and TechBio Innovations – How Much Disclosure is Sufficient?

In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

FDA Issues Draft Guidance Documents on Artificial Intelligence for Medical Devices, Drugs, and Biological Products

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support a regulatory decision about a drug or biological product’s safety, effectiveness, or...more

Ropes & Gray LLP

New Year, New Data Breach Notification Requirements in New York: Impactful Changes for Life Sciences and Consumer Health Care...

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In December 2024, New York Governor Kathy Hochul signed into law two bills (A8872A and S2376B; collectively, the “Bills”) that amend New York’s Data Breach Notification Law. The Bills introduce a maximum thirty-day timeframe...more

American Conference Institute (ACI)

How Can Companies Tackle Europe’s AI and Data Protection Rules?

Life science companies will have to grapple with unique questions in complying with the European Artificial Intelligence Act, including the scope of the law’s research exemption and the use of AI in personalized medicine and...more

Jones Day

Vital Signs: Digital Health Law Update | Winter 2024

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on HHS' recent final rule on the confidentiality of substance use disorder patient...more

Spilman Thomas & Battle, PLLC

Decoded: Technology Law Insights - V 4, Issue 9, September 2023

Are Automakers Making Sufficient Efforts to Protect Customer Data? With the ever-expanding Internet of Things, data privacy is a growing concern in today’s digital age. The automotive industry is no exception. The National...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Rothwell, Figg, Ernst & Manbeck, P.C.

[Webinar] Artificial Intelligence Litigation Risks for the Medical Technology Industry - August 29th, 2:00 pm ET

Partners Jenny Colgate and Jennifer Maisel will present a webinar titled "Artificial Intelligence Litigation Risks for the Medical Technology Industry" for Medmarc, the leading expert in the products liability risks facing...more

Goodwin

Antitrust & Competition Life Sciences 2022 Year In Review

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M&A activity in the life sciences space proceeded largely as usual in 2022, with most transactions receiving expected levels of agency scrutiny and closing in the normal course despite aggressive rhetoric from new leadership...more

Gardner Law

FDA’s New Draft Guidance on Cybersecurity

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The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - July 21st - 22nd, Boston, MA

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

McDermott Will & Schulte

[Event] 2019 Healthcare Litigation, Compliance & Investigations Forum - November 5th, Washington, DC

Healthcare industry business, legal and compliance executives and investors will learn strategies for proactively managing and effectively responding to compliance risks, investigations and litigation at our fourth annual...more

Hogan Lovells

French legal and regulatory update - July/August 2019

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The Paris office of Hogan Lovells is pleased to provide this English language edition of our monthly e - newsletter, which offers a legal and regulatory update covering France and Europe for April 2018. ...more

Hogan Lovells

[Event] Privacy and Cybersecurity KnowledgeShare – September 19th, London, UK

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Join us on Thursday 19 September for the Hogan Lovells Privacy and Cybersecurity KnowledgeShare in London. We will share our latest thinking on the key privacy and cybersecurity issues faced by those with data protection...more

Hogan Lovells

Best practices for managing cybersecurity risks related to IoT-connected medical devices

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Connected medical devices deliver numerous benefits not available before, including improved monitoring of patient welfare and a wealth of vital data. But for all the advantages available through these devices, their...more

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