The Biden administration has rejected a proposal to ease artificial intelligence regulations that radiology advocates had previously labeled as “extraordinarily concerning” for patient safety, officials announced Thursday.
Alex M. Azar, immediate-past secretary of the U.S. Department of Health and Human Services, proposed a plan just before leaving office that would have exempt many class II medical devices from Food and Drug Administration premarket requirements.
While the FDA temporarily waived review for these devices during the pandemic, the “midnight” proposal would have permanently eliminated 510(k) stipulations for seven class I devices and possibly 83 class II devices. The latter would have included radiology products, such as AI and machine learning software used for triage, detection and diagnosis.
Imaging groups sent a March 5 letter to federal officials warning that permanently tossing oversight requirements would jeopardize care, among other concerns. Of note, the American College of Radiology, RSNA, and Society for Imaging Informatics in Medicine never anticipated the current administration would implement the changes.
HHS shared a notice, set to be published Friday, explaining “fundamental flaws” with the data and rationale used by the former HHS secretary fueled its decision to withdraw the proposal. The agency further noted that the FDA had never been consulted when the document was developed.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.