Startup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare

Register for the Startup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare

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. For example:

• 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• In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not.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 engaged in a year-long process of completely revamping the agency’s approach to regulating software. FDA calls its new program the “Precertification Program.”

In assembling our speakers for the Startup Roadshow, we drew heavily from the medical software community already subject to FDA regulation. You will hear directly from experts as well as experienced medical software executives and Epstein Becker Green attorneys. For more information on the agenda, click here.

Dates/Locations

The Startup Roadshow will be held at the following locations:

• January 24, 2019: University of Michigan

• February 21, 2019: University of California, San Diego

• February 28, 2019: Georgia Tech

• March 26, 2019: Carnegie Mellon University

• April 12, 2019: Johns Hopkins University

• April 16, 2019: Rutgers University

• April 25, 2019: University of California Berkeley

• May 2, 2019: MATTER, in Chicago

For more information, please contact Wesley Hayden at whayden@ebglaw.com

Hosts

Sponsors

Additional Sponsors

Download the Presentation PDFs

• Brad Thompson:  What Uses of Artificial Intelligence in Healthcare Does FDA Regulate?

• Scott Thiel:  Startup Roadshow: Background Information