Kulkarni S. et al, in an Academic Radiology article on state-level AI regulation.

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Artificial Intelligence

Could States Take Over AI Regulation from the FDA?

Could states take over AI regulation from the FDA as a possible solution to the growing workforce shortage in radiology? It may seem like a wild idea at first, but it’s a question proposed in a special edition of Academic Radiology focusing on radiology and the law. 

Healthcare’s workforce shortage is no secret, and in radiology it’s manifested itself with tight supplies of both radiologists and radiologic technologists. 

• AI has been touted as a potential solution to lighten the workload, such as by triaging images mostly likely to be normal from requiring immediate radiologist review. 

And autonomous AI – algorithms that operate without human oversight – are already nibbling at radiology’s fringes, with at least one company claiming its solution can produce full radiology reports without human intervention.

• But the FDA is notoriously conservative when it comes to authorizing new technologies, and AI is no exception. So what’s to stop a state facing a severe radiologist shortage from adopting autonomous AI on its own to help out? 

The new article reviews the legal landscape behind both constitutional and state law, finding examples in which some states have successfully defied federal regulation – such as by legalizing marijuana use – if the issue has broad public support. 

• States are already eyeing their own more vigorous AI legislation, such as California adopting more stringent rules on automated decision-making technology, while Georgia has given permission for assessment mechanisms (including AI) to generate optometry prescriptions.

But the authors eventually answer their own question in the negative, stating that it’s not likely states will usurp the FDA’s role regulating AI because…

• The U.S. Constitution’s Supremacy and Commerce clauses ensure federal law will always supersede state law.
• If AI made an error, malpractice regulation would be murky given a lack of legal precedent at the state level. 
• Teleradiologists could opt out of providing care to a state if AI regulations were too burdensome – which could exacerbate the workforce crisis. 

The Takeaway

Ultimately, it’s not likely states will take over AI regulation from the FDA, even if the healthcare workforce shortage worsens significantly. But the Academic Radiology article is an interesting thought experiment that – in an environment in which U.S. healthcare policies have already been turned upside down – may not be so unthinkable after all. 

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