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Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more
Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...more
Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more
Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration (FDA)—are crucial for a company’s ability to bring innovative life sciences products to...more
For early-stage life sciences and health tech companies, raising capital is about more than demonstrating scientific promise. Investors are increasingly focused on regulatory preparedness, reimbursement strategy, and risk...more
Innovation in life sciences isn’t just about scientific breakthroughs—it’s about making the right business decisions. Whether a company is developing AI-driven diagnostics, biotech therapies, connected medical devices, or...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
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
On December 27, 2024, the U.S. Department of Health and Human Services (HHS) issued a Notice of Proposed Rulemaking (NPRM) to modify the HIPAA Security Rule and strengthen cybersecurity protections for electronic protected...more
Artificial intelligence already is positively affecting health, according to Mark Gardner, MBA, Esq., Founder and Managing Partner, Gardner Law, which represents clients subject to Food and Drug Administration regulations....more
The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...more
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
The top legal issues in 2024 for the life sciences field reflect the complex and changing legal landscape that the industry is navigating, encompassing drug pricing, regulatory challenges, and broader societal and governance...more
On October 30, the U.S. government released its long-awaited, sweeping executive order (the AI EO or Order) on artificial intelligence (AI). The Order directs various U.S. government departments and agencies to evaluate AI...more
The life sciences industry faces a wide range of legal, regulatory and business challenges, along with constantly evolving trends that impact leadership priorities. McDermott’s cross-functional team of life sciences...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more