Historically, the FDA was used to approving material health products and medical devices. But with the rise of health technology, including generative AI, the department must approach regulations differently to ensure that digital products remain safe and effective once they’re on the market.
So, how does the FDA think about monitoring digital health products and diagnostics? How do they assess the risks associated with innovations in the healthcare space?
On this episode of The Beat, Troy joins hosts Dr. Jessica Shepherd and Dr. Gautam Gulati to discuss the role of the FDA in the regulatory oversight and safety of digital health products and diagnostics. Troy explains how losing his wife to cancer informs his work and shares the risk management framework the FDA uses to keep up with the speed of health innovation.
Listen in for Troy’s insight on prioritizing technology that addresses labor shortages that delay care and learn how the FDA develops policy around emerging technologies in healthcare.
About Troy Tazbaz:
Troy Tazbaz is Director of the Digital Health Center of Excellence at the FDA, where he's responsible for envisioning a future of safe and effective healthcare delivery with a focus on advancing public health goals with the use of technology.
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