Three Key Takeaways from FDLI’s Panel Discussion on FDA’s Digital Health Center of Excellence and Working with the FDA in the Digital Health Space

FDLI hosted a virtual conference November 9-10, 2021, titled Digital Health Technology and Regulation During COVID-19 and Beyond. One of the keynote events was the panel on “FDA’s Digital Health Center of Excellence: Working with the FDA on Digital Health.” The panel featured Bakul …›

Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference

The Food and Drug Law Institute (FDLI) hosted the virtual conference Digital Health Technology and Regulation During COVID-19 and Beyond, November 9-10, 2021. Morrison & Foerster’s Stacy Cline Amin and Bethany Hills led panel discussions during the two-day conference. Stacy Cline Amin, who …›

Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop

On October 14, 2021, the Food and Drug Administration (FDA) held a virtual public workshop on transparency surrounding Artificial Intelligence/Machine Learning (AI/ML) enabled medical devices. The workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML technology …›

May 6, 2021 - AI + Robotics, FDA

CTA Publishes New Standard for Healthcare AI

In February, the Consumer Technology Association (CTA) announced a voluntary standard for healthcare products that use Artificial Intelligence (AI). This standard follows the Food and Drug Administration’s (FDA) recently published action plan for regulatory oversight of AI and machine learning-based medical software. FDA ultimately …›

FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS

U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory oversight. The FDA recently published an AI/ML SaMD action plan, developed in direct response to …›

Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations

In this second of a four-part podcast series on the science, regulatory framework, commercial transactions, and privacy and data security considerations of each unique aspect of the current health crisis, Michael Ward, MoFo partner and global head of the firm’s Life Sciences Group and …›

The New ABC's: Artificial Intelligence, Blockchain and How Each Compliments the Other

Artificial intelligence (AI) and blockchain technology are two novel innovations that offer the opportunity for us to move beyond our legacy systems and streamline enterprise management and compliance in ways previously unimaginable. Each technology augments the strengths and tempers the weaknesses of the other. …›