Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "International Regulators Coalition Weighs in on Medical Software Regulation"

Following is an excerpt:

A recently proposed medical software risk categorization framework from the International Medical Device Regulators Forum is a "mixed bag" that discusses health information technology in areas where FDA has been remiss, but does not address how to classify software on which patients are more dependent -- an area where clinical decision support software stakeholder have pressed for more clarity -- an industry attorney said. The international proposal comes amid regulatory and legislative efforts to establish health information technology regulatory boundaries, but the international effort is not legally binding upon countries participating in the forum.

IMDRF -- a global coalition of regulators that includes the United States, Europe and Australia, among others -- released "Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Controls" March 26. The framework creates four risk categories for software used as a medical device (SaMD): class I (very high impact), class II (high impact), class III (medium impact) and class IV (low impact). ?...

Bradley Merrill Thompson, an attorney with Epstein, Becker and Green who also leads several industry coalitions, applauded IMDRF for going further than FDA and other foreign regulators by contrasting software as a medical device with software that actually controls medical device hardware. The document also specifies that software risk categorization should consider the seriousness of the disease or condition the software is intended to address, but also be based on the role the software is intended to play, not just the disease, he noted. ?...

Yet, Thompson called the framework a "mixed bag" that identifies some important factors for classifying software but fails to address nuanced issues related to user dependence on software -- an area where one industry groups have pushed for more clarity.

"Unfortunately, it's just a structured, high level definition -- it's not guidance like FDA provided for mobile medical apps in which it spent 20 some pages explaining the nuances of which apps qualify as a medical device and which do not," he said. "The IMDRF simply did not take that challenge."

The outstanding question is whether software on which users are dependent should be classified as high risk. The Clinical Decision Support Coalition, headed by Thompson, has said that user dependence can be forced through three circumstances: software that does not explain data or how it arrives at conclusions; intended care settings that do not allow the user time to reevaluate software recommendations; and an intended user that is not independently capable of making the decision the software is designed to make. IMDRF's proposed framework does not address this factor at all, he said.

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