Radiology advocates urge HHS to reject ‘extraordinarily concerning’ proposal weakening AI oversight

The American College of Radiology and other industry stakeholders recently urged the U.S. Department of Health and Human Services to strike down a last-minute proposal that would ease artificial intelligence regulations.

Under immediate-past Secretary Alex M. Azar’s “midnight” plan, seven class I devices would be permanently exempt from Food & Drug Administration premarket requirements, and possibly 83 class II devices. The FDA temporarily waived review for devices under the former category due to the COVID-19 public health emergency.

In a letter sent to federal officials on March 5, imaging advocates warned that permanently removing federal oversight for AI-backed software would jeopardize care and go against the agency’s prior plans to enhance the evaluation of tools that incorporate machine learning and AI.

The Radiology Society of North America (RSNA) and Society for Imaging Informatics in Medicine (SIIM) joined the ACR in the request.

“The proposal is extraordinarily concerning from a patient safety perspective,” ACR Board of Chancellors Chair Howard B. Fleishon, MD, MMM, said in the document. “Although we do not anticipate implementation by the current administration, informatics experts must inform regulators of the potentially harmful impacts resulting from this idea in case the proposal resurfaces.”

A number of class II devices are used by physicians and radiologists during imaging-driven care, including a lung CT computer-aided detection system, triage and notification software, imaging processing applications, and cancer-detection tools, among many others.

ACR leadership encouraged the FDA to beef up its artificial intelligence oversight to enhance real-world capabilities. This should include multisite validation, monitoring longitudinal performance, and other measures, the letter writers argued.

“The priority of the FDA in this space must be to ensure safety and effectiveness—effectively doing so will ultimately help establish trust and promote clinical adoption of AI/ML-enabled innovations,” said Bibb Allen Jr., MD, chief medical officer of the ACR Data Science Institute.

Read the entire March 5 letter here.