Episódios
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On this episode of Ropes & Gray’s podcast series, Decoding Digital Health, host Kellie Combs, a partner in the life sciences regulatory and compliance group and co-chair of the firm’s cross-practice digital health group, is joined by Greg Levine, chair of the firm's global life sciences regulatory and compliance practice, and Lincoln Tsang, head of the European life sciences practice. They unpack some key insights from a recent webinar on regulatory issues surrounding artificial intelligence (“AI”) and machine learning (“ML”) devices, hosted by Ropes & Gray and HLTH. The conversation covers the boundaries of AI and ML regulation as a medical device, the evolving regulatory frameworks in the U.S. and Europe, and upcoming guidance and developments in the field.
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The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. In this episode, Digital Health Initiative co-lead and health care partner, Christine Moundas, interviews health care partner and member of the digital health group, David Peloquin. They discuss the legal challenges and potential solutions that health care and life sciences companies face when transferring health data from Europe to the U.S.
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The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. On this episode, Digital Health Initiative co-lead and IP transactions partner, Megan Baca, is joined by Verily Life Sciences Lead Product Counsel, John Vaughan, to continue their discussion on Verily’s innovative partnerships in digital health, the challenges Verily has faced as well as the rewarding solutions that Verily and its partnerships have created.
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The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. On this episode, Digital Health Initiative co-lead and IP transactions partner, Megan Baca, is joined by Verily Life Sciences Lead Product Counsel, John Vaughan, for a two-part discussion on digital health dealmaking. Megan and John dive into topics related to partnership strategies between biopharma and tech companies, as well as the key opportunities and challenges associated with digital health innovation deals.
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The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. On this episode, IP transactions partner Regina Sam Penti joins the Digital Health Initiative co-leads, Kellie Combs, Christine Moundas and Megan Baca, to discuss the increasing prominence of artificial intelligence (“AI”) and machine learning technology in the health care and life sciences industry. The discussion reviews key applications of AI, the IP protections around machine-learning, transactional and licensing issues that arise in the context of AI, as well as the health care and FDA regulatory issues to consider.
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The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. In this inaugural episode, the co-leads of the Ropes & Gray Digital Health Initiative, Megan Baca, Kellie Combs and Christine Moundas, take a multidisciplinary approach to exploring trends and hot topics for 2021 related to their transactional, FDA regulatory and health care practices. Many of the topics covered in this initial episode will be further discussed and explored throughout the series, including developments in artificial intelligence, big data and interoperability considerations, as well as regulations and guidance around telehealth, software as a medical device, and use of real-world evidence.
