Paths Forward for Clinicians Amidst the Rise of Unregulated Clinical Decision Support Software: Our Perspective on...

Amidst the US overdose epidemic, policymakers, law enforcement agencies, and healthcare institutions have contributed to a decrease in opioid prescribing, assuming reduced mortality would result-an assumption we now understand was oversimplified. At this intersection between public health and public safety domains as they relate to opioid prescribing, unregulated and proprietary clinical decision support tools have emerged without rigorous external validation or public data sharing. In the following piece, we discuss challenges facing clinicians practicing medicine amidst unregulated clinical decision support tools, using the case of Bamboo Health's NarxCare-a prescription drug monitoring program-based analytics platform marketed as a clinical decision support tool-that is already positioned to impact over 1 billion patient encounters annually. We argue that sufficient evidence does not yet exist to support NarxCare's wide implementation, and that clinical decision support tools like NarxCare have flourished in recent years due to a lack of federal regulatory oversight and shielding by their proprietary formulas, which have facilitated their unchecked and outsized influence on patient care. Finally, we suggest specific actions by federal regulatory agencies, healthcare institutions, individual clinicians, and researchers, as well as academic journals, to mitigate potential harms associated with unregulated clinical decision support tools.