News & Analysis as of August 4, 2025

Healthcare

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The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on 5/22/2025

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

MoFo Life Sciences on 4/29/2025

Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more

AI Regulation and Legal Trends in the U.S and Abroad

Gardner Law on 2/28/2025

The Evolving Role of AI/ML in Healthcare - The use of artificial intelligence/machine learning (AI/ML) in healthcare is evolving rapidly and introducing new challenges. Not only are medical devices using AI for diagnostics,...more

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

Rothwell, Figg, Ernst & Manbeck, P.C. on 1/14/2025

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Akin Intelligence - June 2024

Akin Gump Strauss Hauer & Feld LLP on 7/15/2024

Welcome to the June edition of Akin Intelligence. This month, the General Services Administration (GSA) launched its first AI-focused cohort of Presidential Innovation Fellows (PIF), bringing together experts from across the...more

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

Spilman Thomas & Battle, PLLC on 3/8/2024

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

Recent Healthcare-Related Artificial Intelligence Developments

Sheppard Mullin Richter & Hampton LLP on 2/27/2024

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

5 Major Drug and Device Developments of 2022

Faegre Drinker Biddle & Reath LLP on 12/23/2022

As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...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

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