On December 11, 2024, Paragon’s research paper “Healthcare AI Regulation: Guidelines for Maintaining Public Safety and Innovation,” by Kev Coleman, was referenced in Politico.
From the article:
The Food and Drug Administration needs more artificial intelligence talent to regulate the technology, according to Kev Coleman, a research fellow at the Paragon Health Institute, a think tank founded by a former adviser to President-elect Donald Trump.
In a new report, Coleman laid out a policy agenda for how AI should be regulated in health care. First, he said, no policy should interfere with “the primacy” of the FDA’s medical software safety-evaluation process. That would help avoid regulatory capture, he noted. Second, new policies should ensure they incentivize companies to fix problems with their technology.
Coleman also said policymakers should avoid broad AI legislation because not all AI is the same. For example, generative AI poses different risks and benefits than predictive AI — particularly within health care. And those technologies also pose different risks depending on how they’re used. For example, whether they’re used to take down basic health information or offer up medical advice.
To understand those nuances, the FDA needs to hire people who really get AI, he said.
The full article can be found in Politico.
