Episode 20 – Healthcare Tech: How Will the FDA Regulatory Framework Adapt to AI?

By Latham & Watkins

Artificial intelligence (AI) is a burgeoning sector for investors and companies alike, but the unclear regulatory landscape for the use of AI in healthcare may cause headwinds that prevent it from achieving its full potential. The US Food and Drug Administration (FDA) asserts broad authority over medical devices, from toothbrushes to high-tech implants, under a decades-old regulatory framework. Recent advances in medical technology, including use of AI and machine learning, which are becoming increasingly integrated into traditional products and have accelerated the creation of novel devices that have the potential to revolutionize healthcare, but are nonetheless subject to a dated regulatory regime that in some ways is ill-suited to this cutting-edge technology. How must the FDA evolve its regulatory framework to realize the untapped potential of AI and machine learning, and what actions has it taken to date to support these technological advances? In this episode of Connected With Latham, Bay Area partner Luke Bergstrom, Global Vice Chair of the Mergers & Acquisitions Practice and the Technology Industry Group, discusses the future of FDA regulation of AI machine learning and the key considerations for investors and companies with Washington, D.C. partners Ben Haas and Elizabeth Richards, members of the Healthcare and Life Sciences Practice.   This podcast is provided as a service of Latham & Watkins LLP. Listening to this podcast does not create an attorney client relationship between you and Latham & Watkins LLP, and you should not send confidential information to Latham & Watkins LLP. While we make every effort to assure that the content of this podcast is accurate, comprehensive, and current, we do not warrant or guarantee any of those things and you may not rely on this podcast as a substitute for legal research and/or consulting a qualified attorney. Listening to this podcast is not a substitute for engaging a lawyer to advise on your individual needs. Should you require legal advice on the issues covered in this podcast, please consult a qualified attorney. Under New York’s Code of Professional Responsibility, portions of this communication contain attorney advertising. Prior results do not guarantee a similar outcome. Results depend upon a variety of factors unique to each representation. Please direct all inquiries regarding the conduct of Latham and Watkins attorneys under New York’s Disciplinary Rules to Latham & Watkins LLP, 885 Third Avenue, New York, NY 10022-4834, Phone: 1.212.906.1200

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