The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
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In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more
The health care industry has utilized artificial intelligence for decades, but the recent expansion of AI’s capabilities into generative AI models is raising questions about how and to what extent to regulate the technology....more
The Texas Attorney General is once again signaling the office’s intent to enforce the state’s privacy and consumer protection laws. According to a June 2024 press release, Texas Attorney General Ken Paxton “launched a major...more
Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more