Much is changing with regard to how the U.S. Food and Drug Administration (FDA) approaches software generally, and artificial intelligence in particular. Some of that change is driven by the remarkable innovation going on right now at universities and in industry. But some of the change originates with the government.
- In December 2016, Congress enacted the 21st Century Cures Act, which fundamentally changed the scope of FDA regulation of clinical decision support software.
- In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.
- Throughout 2018, FDA will be engaging in a year-long process of completely revamping the agency’s approach to regulating software. FDA calls its new program the “Precertification Program.”
Bradley Merrill Thompson (Chairman of the Board of consulting firm EBG Advisors) and Scott Thiel (Director of Navigant Consulting) will discuss FDA regulation of artificial intelligence in healthcare and methods the FDA uses to regulate devices that include artificial intelligence. This webinar highlights presentations on the same topic from the highly successful in-person roadshow held at eight major engineering schools around the country.
We understand you may have missed the opportunity to join us in-person at the roadshow. Therefore, please join us for this last lecture of the Startup Roadshow – AI in Healthcare. We look forward to you attending this encore webinar!
For more information on the agenda, click here.
Who Should Attend
The webinar is focused on entrepreneurs and experienced developers of artificial intelligence for the health care industry.
Cost: $25 (**Please note this webinar will not be recorded)
Payment must be submitted to confirm registration and receive webinar login instructions.
For questions about the Startup Roadshow, please contact Ohemah Addai at email@example.com.