DOJ cracking down on AI tools for clinical decision-making

Editor's Note: 

The U.S. Justice Department is investigating how the healthcare industry is using artificial intelligence (AI) tools to analyze and make decisions using patients’ electronic health records (EHRs), Bloomberg Law reported January 29.

So far, DOJ has served subpoenas related to EHRs to at least three major pharma companies: GSK, AstraZeneca, and Merck & Co. In 2020, the agency received an $8.3 billion criminal settlement from Purdue Pharma over the use of automated pop-up alerts pushing doctors to prescribe addictive painkillers. Purdue, which had worked with EHR provider Practice Fusion to use algorithms to trigger these alerts, paid $8.3 billion. 

While attorneys note that there are potential benefits to utilizing AI to aid clinical decision-making, without proper oversight it can quickly become problematic. The primary basis for legal action is the Anti-Kickback Statute (AKS), a federal law that prohibits payments or incentives for referring patients or generating healthcare business. The law is meant to ensure that clinical decisions are based on need and not the financial considerations of providers.

AI algorithms using EHR records are “very ripe for enforcement,” Kyle Faget, who co-chairs Foley & Lardner’s health care practice, told Bloomberg Law, “because any slight manipulation of the inputs or the outputs of AI that have a consequence for clinical decision making” can be “an absolute boon for you as a manufacturer of pharmaceuticals or medical devices.”