Update February 2024 on Commission Plans Liberalization of New Genomic Techniques (NGTS) in the EU
- Research assistant Sarah Baumann substantially contributed to this article. On February 7, 2024, the European Parliament approved the draft regulating plants obtained by certain new genomic techniques (NGT) like CRISPR-Cas. The members of the European Parliament (MEPs) voted to divide NGT plants into two... ›
2024 Regulatory, Compliance, and Enforcement Predictions for Life Sciences Companies
By: Adam L. Braverman, Kate Driscoll, Nathaniel R. Mendell, Stacy Cline Amin and Brigid DeCoursey Bondoc
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 and Enforcement Group for a 2024 preview, and here is... ›How To Operate In The AI Compliance Vacuum
By: Brigid DeCoursey Bondoc and Melissa M. Crespo
The use of artificial intelligence (AI) in healthcare has grown significantly in recent years. The global market estimate for AI in healthcare was over $15 billion in 2022, and that market is expected to grow exponentially. The COVID-19 pandemic accelerated this global demand 167%... ›New Regulations Rooted in Evidence: Looking Back on How EPA and USDA Updated Engineered Plant Regulations and Labeling in 2023
By: Abby C. Burrus Ph.D., Deborah A. Pohlmann Ph.D., Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc, William F. Tarantino and Michael Ward Ph.D.
Alongside rapid advances in biotechnology that are improving fine-tuned genetic engineering in plants, regulation for such plants is also rapidly evolving, including several important updates in the past year. The year 2023 witnessed dramatic shifts in this regulation around the world. Within the U.S.,... ›Top 10 Considerations in Licensing Cleantech Innovations
By: Matthew A. Ferry, Anita Choi and Emily Jane Roberts Ph.D.
Spurred by both planetary and economic needs, the industry commonly referred to as “cleantech”—short for “clean technology”—has been on the rise. Current estimates predict clean energy technologies could dominate oil and gas by as early as 2030 (Global cleantech market size by country 2030 |... ›5 Questions About Generative AI in Healthcare
By: Brigid DeCoursey Bondoc
Brigid Bondoc and Wendy Chow authored an article for HealthTech about what the recent growth of generative artificial intelligence (AI) tools means for providers and patients. “In the absence of a clear legal and ethical framework that promotes the complete scope of the benefits... ›Commission Plans Liberalization of New Genomic Techniques (NGTs) in the EU
By: Wolfgang Schönig
After undergoing an extensive three-year consultation process, the EU Commission’s proposal for a regulation on plants obtained by certain new genomic techniques like CRISPR-Cas (the “Proposal”) is finally available for consideration (see Proposal ). Although the official presentation is scheduled for July 5, 2023,... ›The EU’s New Proposal for Plants Developed Using New Genomic Techniques: How Does it Compare to U.S. Regulation?
By: Liz Freeman Rosenzweig Ph.D., Brigid DeCoursey Bondoc and Michael Ward Ph.D.
After much anticipation, the EU Commission’s proposal for a regulation on plants developed using New Genomic Techniques (NGTs) is now under consideration. For an overview of the EU proposal, please see MoFo’s recent post. Here, we provide a brief overview of U.S. regulation of... ›- - AI + Robotics, Digital Health, FDA, Intellectual Property, Medical Devices + Diagnostics, Privacy + Data Security, Regulatory
The Legal and Regulatory Landscape Evolving with AI in Life Sciences
By: Brigid DeCoursey Bondoc and Anna Yuan
Morrison Foerster sponsored and spoke at the Association of Corporate Counsel’s 2023 Life Sciences Conference on May 11, 2023, on the topic of “Artificial Intelligence in Life Sciences: The Evolving Legal and Regulatory Landscape.” Eric Elting of TransPerfect Legal Solutions reported on the discussion.... › New York Enacts Material Healthcare Transactions Notice Requirements: Four Key Takeaways
On May 3, 2023, New York Governor Kathy Hochul signed into law an amendment to the New York Public Health Law that will require certain healthcare entities to provide the State Department of Health (DOH) with written notice and supporting documentation of “material transactions”... ›