DOTmed December 2, 2019
Sean Ruck

In October’s issue of HCB News, we looked at the history of AI and the fundamentals behind the technology. Rik Primo, the principal of Primo Medical Imaging Informatics Inc., is again with us for part two of our two-part piece to look at the FDA’s efforts to regulate healthcare AI software.

According to Primo, the FDA has a challenge. “The FDA has very clear rules for the approval of medical devices. If you have an X-ray device for example, you submit the device to the FDA. They will test it; you help them with the testing.” But Primo points out, the intended usage is straightforward — producing an image using radiation. The term to be familiar with here is “software as...