Hardware Podcasts

#350: The Evolving Landscape of AI in MedTech

Global Medical Device Podcast · 4 Jan 2024 · 49m · Episode 350

What this episode covers

Eric Henry, a regulatory expert at King & Spalding and strategic committee member for the AI Global Health Initiative, discusses the evolving regulatory landscape for AI in medical devices with host Etienne Nichols. They explore the distinction between 'locked' algorithms, which are currently supported by the FDA, and 'adaptive' algorithms that modify themselves in the field, noting that the FDA's Predetermined Change Control Plan (PCCP) still requires human intervention for changes. Henry emphasizes the critical role of the Federal Trade Commission (FTC) and its 'algorithmic disgorgement' power, while advising companies to focus on robust design controls and engage with public-private partnerships like the Coalition for Health AI to navigate harmonization challenges.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Greenlight Guru, King & Spalding, FDA, FTC, AI Global Health Initiative, Coalition for Health AI
Also
PCCP, ISO 13485, QMSR

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