A first-of-its-kind pilot program in Utah developed by a health-technology startup company uses artificial intelligence to automatically renew certain prescriptions for patients with chronic conditions such as hypertension and diabetes. But according to a new paper co-written by a University of Illinois Urbana-Champaign expert in legal issues surrounding cutting-edge medical technology, autonomous AI-based drug prescribing raises important clinical and legal issues.
With AI rapidly being deployed in health care, a “move fast and break things” mentality has permeated the industry, raising complex questions about the role of the U.S. Food and Drug Administration in regulating these technologies, says Sara Gerke, the Richard W. & Marie L. Corman Scholar at the College of Law.
“The big issue here is the relationship between state and federal law, which we’re seeing in Utah, where the state has become a testing ground for so-called AI sandboxes that companies can use to experiment,” said Gerke, also a professor at the European Union Center at Illinois. “The idea behind it is to test these AI medical tools before they are completely developed. But even that is legally questionable. The existence of mitigation agreements and waivers under state law doesn’t automatically render the use of unproven medical technology lawful at the federal level.”