Startup Roadshow: FDA Regulation of Artificial Intelligence Used in Healthcare

Join Fast Forward Medical Innovation and the U-M Office of Tech Transfer for the Startup Roadshow – AI in Healthcare, a unique program that focuses on entrepreneurs and experienced developers of artificial intelligence for the health care industry. You will hear from experts in the medical software community who are already subject to FDA regulation, including experienced medical software executives and Epstein Becker Green attorneys. The main program concludes with a panel discussion featuring Tom Shehab, M.D., Managing Partner, Arboretum Ventures, and Don Bauman, CEO, Isabel Healthcare


January 24, 2019
Biomedical Science Research Building (BSRB)
Kahn Auditorium
109 Zina Pitcher PL


Following the main session, Entrepreneur Office Hours will be available from 12:30pm-2:30pm for you to ask questions and learn more about specific interest areas. Sign up for these 20-minute individual sessions during the 11:00am break. 

Track #1
Is my software regulated?
BSRB • Room 2008

Track #2
What is my best pitch to market? (and other questions associated with regulated software
BSRB • Room 4008)

Startup Roadshow

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  • In December 2017, the FDA published a draft guidance building on that legislation, providing the agency’s perspective on the clinical decision support software that the FDA should regulate and what it should not. That guidance has profound implications for artificial intelligence used to guide healthcare decision-making.
  • Throughout 2018, the FDA will be engaging in a year-long process of completely revamping the agency’s approach to regulating software. The FDA calls its new program the “Precertification Program.”

The Startup Roadshow will cover a wide range of topics relating to AI in healthcare, including:

  • What uses of artificial intelligence in healthcare does the FDA regulate?
  • How does the FDA regulate devices that include artificial intelligence?
  • Panel discussion on the pros and cons of participating in the FDA’s new Precertification Program

The Startup Roadshow is FREE for all U-M faculty and staff. Please enter the discount code roadshowfree when filling out the registration. ID will be required onsite to confirm the complimentary rate. If you have any questions, please contact Jon Servoss, FFMI Director of Commerciaization Education, at or 734-764-2692.

This CME event is open to all U-M faculty, staff, and students.

 The University of Michigan Medical School is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

The University of Michigan Medical School designates this live activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

The speakers have no commercial relationship relevant to this presentation. The faculty planner, has no commercial relationship relevant to this activity.


Questions?  Please contact Jon Servoss, M.S., FFMI Director of Commercialization Education, at or 734-764-2692.

January 15, 2019