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

February 24, 2021
Companies leveraging AI to innovate in the healthcare space will soon face a new regulatory landscape.

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.

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