Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in RAPS Regulatory Focus, in “Convergence: Experts Offer Advice on Leveraging AI in Regulatory,” by Ferdous Al-Faruque.
Following is an excerpt:
As the world grapples with the proliferation of artificial intelligence (AI) tools, including generative AI, experts urged regulatory professionals not to lose sight of the human element. While such tools can be incredibly valuable, they also require human oversight and interpretation to realize their full potential.
Experts who spoke at the opening plenary session discussed how AI can be leveraged across industries, the promise of the technology, and the challenges in realizing those possibilities. The panelists included Ryan Kurtzman, technology partnerships officer for the City of Long Beach; Bradley Thompson, an attorney at Epstein Becker Green; Michelle Jump, CEO of MedSec; and Jay Mashburn, director of regulatory policy at Recursion Pharmaceuticals. The panel was moderated by Megha Iyer, director of global strategic regulatory affairs at Thermo Fisher Scientific.
Thompson noted that he uses AI to build databases from publicly available US Food and Drug Administration (FDA) documents, including 510(k) summaries. He also said that he has created an AI algorithm that can predict whether FDA will require a clinical trial for a medical device mased on its intended use with a high level of accuracy.
"A lot of what I do is what would be referred to as natural language processing because, as a lawyer, I focus on words quite a bit, and there's so much information locked in unstructured texts, like within [medical device reports] MDRs, the narrative description of what went wrong with the device," said Thompson. "These days, there are millions of MDRs, and there is no feasible way for humans to read those.”
"Creating a natural language processing algorithm to extract meaning, trends, and other information out of large unstructured texts is another example [of AI's potential]," he added.
Thompson said that lawyers often use AI for legal research, and that some tools are capable of writing legal memos. Such tools can save lawyers up to a quarter of the time they would spend writing memos themselves, he said, adding that AI-written memos must still be checked for accuracy.
“A lot of these algorithms might have 95% accuracy, which means you have to disagree with them at least 1 out of 20 times if you want to be right,” said Thompson. “You have to take your logic and apply it to [the AI].”
