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  • In December 2017, FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that FDA should regulate and what it should not.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. 


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


Who Should Attend: The Startup Roadshow is focused on entrepreneurs and experienced developers of artificial intelligence for the health care industry.

Cost: Admission is $100.

To register for the Startup Roadshow, click here now.

For more information, please contact Lisa Blackburn at


Hosts of the Startup Roadshow: University of Michigan, UC San Diego, Georgia Tech, Carnegie Mellon, Johns Hopkins, Rutgers, UC Berkeley, MATTER (Chicago)


Epstein Becker Green is pleased to sponsor the Startup Roadshow.

Sponsors of the Startup Roadshow: ACT - The App Association, Clinical Decision Support Coalition, AMIA (American Medical Informatics Association), EBG Advisors, Epstein Becker Green, PATH (Partnership for Artificial Intelligence and Automation in Healthcare), RAPS (Regulatory Affairs Professionals Society)

Additional Sponsors

Additional Sponsors of the Startup Roadshow: BNY Mellon Wealth Management, Fast Forward Medical Innovation, University of Michigan Tech Transfer, Pittsburgh Life Sciences Greenhouse, Innovation Works, Big Idea Center

Event Detail

Rutgers University
Jump to Page

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.