FDA calls for risk-rating health IT

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.

Medication management, provider order entry, most clinical-decision support software and other health management IT products would go into a second low-risk category.

Medical-device systems, including software for bedside monitor alarms and radiation treatment that pose risks to patient safety, would be put into a third category. The FDA would continue to regulate these products.

The proposed framework seeks to protect patient safety and avoid regulatory duplication and is required by a provision in the FDA Safety and Innovation Act of 2012, HHS said in a news release. The ONC and the Federal Communications Commission also helped develop the report.

“This proposed strategy will facilitate innovation, protect patients and support FDA's focused oversight on higher risk technology, similar to medical devices that are currently regulated,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health.

The report is available for public comment and HHS plans to hold a public meeting on it in May.

Follow Jaimy Lee on Twitter: @MHjlee