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Unlocking the Potential of Digital Health Therapeutics: FDA-Approved Solutions for Modern Healthcare

ByJackie Orabone

Digital health therapeutics (DTx), applications increasingly powered by AI and/or machine learning, are on the rise and promise to increase access to healthcare, provide real-time monitoring of health data, improve patient engagement and adherence to treatment, and reduce healthcare costs. What Are Digital Health Therapeutics? DTx are evidence-based therapeutic interventions driven by software and technology…

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From Pilot to Policy: The FDA’s Rapid March Toward AI-Powered Drug Reviews

ByAaron Csicseri

When FDA reviewers discovered that a generative-AI pilot could slash a 3-day document review task to mere minutes—a time-savings of 99%!—it became clear that artificial intelligence is no longer an aspirational tool but a present-day catalyst for regulatory transformation. That single statistic captures why FDA is fast-tracking AI: the volume and complexity of regulatory submissions…

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Regulating Generative AI: Insights From the FDA’s First DHAC Meeting

ByAaron Csicseri

The FDA’s new Digital Health Advisory Committee (DHAC) convened for the first time on November 20-21, 2024. The topic of discussion was medical devices that rely on generative AI (GenAI) models, which hold transformative potential for healthcare but pose unique regulatory challenges. For example, how to define the device’s intended use, manage errors like hallucinations…