The Food and Drug Administration has proposed that health information technology products should be classified into three categories based on their potential risks to patient safety, rather than by their technology platform.
The federal agency released its proposal in a report that offers recommendations for how health IT products should be regulated.
“We believe a limited, narrowly tailored approach that primarily relies on (Office of the National Coordinator for Health Information Technology)-coordinated activities and private sector capabilities is prudent,” the report stated. “We also recommend that no new or additional areas of FDA oversight are needed.”
Administrative HIT products such as billing and claims software and inventory management systems would fall into a low-risk category.