Discussion: Changes to FDA regulation of digital health products, Sept. 26

When is software a medical device?FDA Regulation of Digital Health Products: Exploring the recent changesDoernbecher Children’s Hospital
Vey Auditorium
Wednesday, Sept. 26, 2018, 3 to 5 p.m. 

Digital health care is an explosive area of innovation, and significant actions by the FDA and Congress have changed the regulatory landscape for digital health products. It is critical for innovators to know early in the development cycle whether their software is or is not a medical device and, if so, what regulatory requirements apply so they can plan the time and cost to market.

During this one-hour discussion, Carol Pratt, Ph.D., J.D., FDA regulatory attorney and partner at Lee & Hayes Law, will provide a tutorial on FDA regulation of medical devices. She also will discuss how software can meet the definition of a medical device, either as a standalone software or as a component or accessory.

Pratt will discuss the 21st Century Cures Act on the FDA’s current regulatory framework for digital health products.

Carol Pratt PhD JD
Carol Pratt’s practice focuses on regulatory issues associated with the research, development and FDA requirements that apply to bio-medical and health products.

She also will address products including wearables, mobile medical apps, clinical and patient decision support software, and artificial intelligence.

The event, hosted by Technology Transfer and Business Development, is free and open to all OHSU faculty, staff, post-docs, students and fellows. Register today to attend.

Questions? Contact Karen Boren at borenk@ohsu.edu.