MoFo Life Sciences

November 16, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Digital Health
Morrison & Foerster Partners Speak at FDLI’s Digital Health Technology and Regulation Conference
By: Stacy Cline Amin
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
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October 26, 2021 - AI + Robotics, United States, FDA, Medical Devices + Diagnostics, Healthcare
Five Key Takeaways from FDA’s Transparency of AI/ML-Enabled Medical Devices Virtual Workshop
By: Stacy Cline Amin
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 in
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May 06, 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
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March 03, 2021 - AI + Robotics, United States, FDA, Regulatory
FDA’S PLAN FOR AI/ML-BASED SOFTWARE AS MEDICAL DEVICES: PROGRESS AND CONCERNS
By: Jean Nguyen Ph.D.
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
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October 22, 2020 - AI + Robotics, Licensing + Commercial, FDA, COVID-19, Intellectual Property, Privacy + Data Security
Podcast: Applying AI and Data Science to the Fight Against COVID-19: The Science and Legal Considerations
By: Jean Nguyen Ph.D., Kristen J. Mathews, Matthew Karlyn and Michael Ward Ph.D.
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
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October 01, 2020 - AI + Robotics, United States, Intellectual Property
Special Patents and AI with Janet Xiao and Anna Yuan
By: Janet Xiao Ph.D., Anna Yuan and Michael Ward Ph.D.
In this third installment of a six-part Patent Law Course offered by Morrison & Foerster and GSAS Harvard Biotech Club , MoFo partner and head of the firm’s China Life Sciences Group Janet Xiao taught a class on the value, protection, and legal issues involved
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May 12, 2020 - AI + Robotics, United States, Intellectual Property
The USPTO Says No to Naming AI as a Patent Inventor
By: Anna Yuan and Karen G Potter Ph.D.
The increase in AI-related patent filings in the past few years has given rise to unique questions about the current patent system. In particular, the question of whether an AI system can or should be named as an inventor on a patent application has
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March 12, 2020 - AI + Robotics, Global, Corporate + Venture Capital, Blockchain
The New ABC's: Artificial Intelligence, Blockchain and How Each Compliments the Other
By: Vivian L. Hanson
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.
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March 05, 2020 - AI + Robotics, United States, FDA
February FDA Updates
As we move into 2020, we’re starting a regular blog series highlighting noteworthy FDA updates regarding regulatory compliance, fraud and abuse cases, and product development issues every month. Our February recap is below. 1. Two Owners of Telemedicine Companies Charged for Roles in $56
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February 13, 2020 - AI + Robotics, European Union, Intellectual Property
CAN AI BE AN INVENTOR? NOT AT THE EUROPEAN PATENT OFFICE
By: Alistair Maughan and Anna Yuan
The European Patent Office has denied two patent applications on the grounds that an AI system cannot be listed as the inventor. For the first time, the European Patent Office (EPO) has issued a ruling on its approach to patent applications that designate artificial
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