News & Analysis as of

Artificial Intelligence Cybersecurity Life Sciences

White & Case LLP

From personalization to supply chain optimization: How AI is shaping deals outside the tech arena

White & Case LLP on

Investors are ramping up AI-related M&A to secure cutting-edge capabilities and market-beating returns, but high valuations and open-source disruption are forcing a rethink on deal strategy - Global M&A saw a year-on-year...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Mass layoffs of federal workers impact NIST and AI Safety Institute, Google unveils AI “co-scientist” system,...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

Skadden, Arps, Slate, Meagher & Flom LLP

Executive Briefing: Latest Updates on Trump Executive Actions

As Trump administration directives emerge, it’s crucial for businesses and other stakeholders to stay informed and adapt their strategies accordingly. We will provide ongoing coverage of these developments and their potential...more

Hogan Lovells

PRODUCT | Products Law Year in Review: Key Developments from 2024 and Future Impacts for 2025

Hogan Lovells on

2024 was a transformative year for the products law landscape, marked by sweeping regulatory shifts, emerging trends, and heightened compliance challenges. These developments are reshaping industries worldwide and will...more

Sheppard Mullin Richter & Hampton LLP

FDA Dumps Trio of Device-Related Guidances Prior to Administration Change

Among the wave of guidance documents issued by the U.S. Food and Drug Administration (“FDA” or the “Agency”) in the first week of 2025 were three notable draft guidance documents pertaining to medical devices (together, the...more

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

BakerHostetler

Healthcare Industry Team 2024 Year in Review

BakerHostetler on

As we begin a year that will once again be transformative for the industry, we are excited to present our comprehensive 2024 year-in-review, highlighting all that has happened and the trends that will shape 2025. ...more

Hogan Lovells

Life Sciences Law Update - Key developments for pharma and medical device companies in EU and Germany, France, UK, Italy and Spain...

Hogan Lovells on

Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more

MoFo Life Sciences

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

MoFo Life Sciences on

This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences....more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

Goodwin

Changes Expected as Trump Administration Continues to Take Shape

Goodwin on

As Washington prepares for new leadership in January 2025, significant policy changes appear on the horizon. The incoming administration’s agenda suggests a substantial shift in US economic and regulatory priorities, with...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 9, November 2024

Welcome to our ninth 2024 issue of Decoded - our technology law insights e-newsletter. How are States Using Generative Artificial Intelligence? and Employee AI Adoption Cools Globally - Why this is important: As...more

Troutman Pepper Locke

Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast

Troutman Pepper Locke on

Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment, Brett is joined by Partner Brent Hoard and Andrea...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2024

Jones Day on

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

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

Jones Day

2023 False Claims Act Enforcement in Health Care and Life Sciences, Part III

Jones Day on

In February 2024, the Department of Justice (“DOJ”) announced the results of its 2023 False Claims Act (“FCA”) enforcement efforts. Through those efforts, it obtained more than $2.6 billion in overall recoveries, and of that...more

Spilman Thomas & Battle, PLLC

Decoded Technology Law Insights, V 5, Issue 4, May 2024

MIT Report Details New Cybersecurity Risks - “Cloud misconfigurations, more sophisticated ransomware, and vendor exploitation attacks are contributing to rising cyberattacks.” Why this is important: Worldwide spending...more

Robinson & Cole LLP

Health Law Diagnosis - April 2024

Robinson & Cole LLP on

Additional States Implement Notice Requirements for Healthcare Transactions - In a prior blog post, we noted the trend of states enacting legislation implementing reporting requirements for certain healthcare transactions....more

McDermott Will & Emery

The Impact of the New EU AI Act on the Medtech and Life Sciences Sector

McDermott Will & Emery on

As technology continues to advance almost every aspect of healthcare, so the use of AI has become an increasing focus for developers and the regulators who are racing to keep pace with rapid advancements in technology. ...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Mintz - Health Care Viewpoints

FDA Needs a New Approach to AI/ML-Enabled Medical Devices

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 2, March 2024

HHS Cybersecurity Performance Goals and the Healthcare Industry - The healthcare industry is a major target for cyberattacks because of all of the personal information collected from patients. Recognizing that the healthcare...more

49 Results
 / 
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide