In an article published in Bloomberg Law, Partner Alexis Cohen, Senior Associate Gilbert Smolenski and Associate Xanadu Halkias explain the potential challenges facing developers of AI-powered medical devices and discuss the risks to IP protection efforts when disclosing too much to the FDA.
Excerpt: “Recognizing that technological advances can happen more quickly than the regulatory approval process allows—including in real time for dynamic or self-taught models—the FDA and Congress have been working toward a new regulatory framework that attempts to account for such advances.”