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.

Topics Covered:

• Troy’s 4 areas of focus as Director of Digital Health at the FDA
• How losing his wife to cancer informs Troy’s approach to innovation and regulations in healthcare
• How not being a doctor or lawyer gives Troy a different perspective on digital health regulations
• The risk management framework the FDA uses to keep up with the speed of innovation
• Why it’s the health system’s decision whether to integrate digital health products based on the level of risk they’re comfortable with 
• How Troy thinks about mental health concerns that might arise from generative AI products
• Prioritizing technology that addresses labor shortages that delay care
• Who should be responsible for identifying when things go wrong in digital health products
• The potential to exacerbate the digital divide when health systems must monitor digital health products and diagnostics on their own
• Why prevention is the best way to deal with chronic conditions
• What Troy is most excited about when it comes to innovation in healthcare
• What federal agencies can do to build trust with the public

Resources

• The Continuum Diaries
• FDA Digital Health Center of Excellence
• Troy on LinkedIn