MoFo Life Sciences

August 02, 2023 - FDA, Regulatory, AI + Robotics, Healthcare
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
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June 15, 2023 - 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.
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May 11, 2023 - AI + Robotics, FDA, Regulatory, Digital Health, United States
FDA on Use of AI/ML in Drug Development: Five Key Takeaways
By: Brigid DeCoursey Bondoc
On Wednesday, May 10, 2023, the Food and Drug Administration (FDA) announced the publication of a new discussion paper titled “ Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products .” The discussion paper aims to facilitate a discussion
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April 27, 2023 - AI + Robotics, Licensing + Commercial, Regulatory, Intellectual Property
10 Considerations When Licensing AI for Drug Discovery
By: Stephanie Lynn Sharron and Wolfgang Schönig
While the traditional process of discovering a new drug is long and expensive, artificial intelligence drug development platforms can help reduce time and money by efficiently analyzing vast data sets within the drug discovery process. Researchers can use such AI platforms for identifying new
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April 26, 2023 - AI + Robotics, FDA, Medical Devices + Diagnostics, Regulatory, United States
FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions
By: Brigid DeCoursey Bondoc and Brandy A. Guarda
On April 3, 2023, FDA released the draft guidance titled “ Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions ” (hereinafter “draft guidance”) proposing an approach to support iterative improvement through modifications to a machine
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December 16, 2022 - AI + Robotics, FDA, Regulatory
AI Trends for 2023 - FDA Regulatory
In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot Program. The new FDA policies move away from prized flexibilities in the previous guidelines governing software products.
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September 09, 2022 - AI + Robotics, Intellectual Property, Medical Devices + Diagnostics
The Importance of Patents for ML-Based Medical Device Inventions
By: Christopher Gloria
The use of machine learning (ML) in the medical device field has greatly expanded in recent years, becoming increasingly important to the product offerings of many medical device companies. The benefits provided by ML are wide-ranging and include providing earlier and more accurate diagnoses
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December 16, 2021 - AI + Robotics, Medical Devices + Diagnostics, Digital Health, Regulatory
AI TRENDS FOR 2022 - FDA REGULATORY
FDA is actively monitoring the use of AI and machine learning (ML) software in medical devices and clinical developments, and has taken a number of first steps in building out a regulatory framework. In 2021, FDA published the AI and Machine Learning Software as
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November 18, 2021 - AI + Robotics, United States, FDA, Digital Health
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
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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
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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Topic Archives: AI + Robotics

5 Questions About Generative AI in Healthcare

By: Brigid DeCoursey Bondoc

The Legal and Regulatory Landscape Evolving with AI in Life Sciences

By: Brigid DeCoursey Bondoc and Anna Yuan

FDA on Use of AI/ML in Drug Development: Five Key Takeaways

By: Brigid DeCoursey Bondoc

10 Considerations When Licensing AI for Drug Discovery

By: Stephanie Lynn Sharron and Wolfgang Schönig

FDA Publishes Draft Guidance for Predetermined Change Control Plan for AI/ML-Enabled Device Software Functions

By: Brigid DeCoursey Bondoc and Brandy A. Guarda

AI Trends for 2023 - FDA Regulatory

The Importance of Patents for ML-Based Medical Device Inventions

By: Christopher Gloria

AI TRENDS FOR 2022 - FDA REGULATORY

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

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