Healthcare AI
In our first installment, we explored the rapidly evolving world of digital health therapeutics (DTx),1 which are innovative, evidence-based software solutions that go far beyond wellness apps to deliver clinically meaningful outcomes for patients. We discussed the distinctions between prescription and non-prescription DTx, highlighted real-world examples, and discussed the significant benefits DTx offer in terms…
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…
Artificial Intelligence (AI) is significantly transforming pharmaceutical regulatory affairs. Rather than replacing regulatory professionals, AI enhances their capabilities and allows them more time for strategic activities. This blog post explores how AI is revolutionizing the regulatory submission process, the challenges posed by the rapidly evolving AI regulatory landscape, and what regulatory affairs professionals need to…
