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 "CDS Software Regulation Is A Sticking Point At Tri-Agency HIT Meeting."
Following is an excerpt:
FDA, Office of the National Coordinator for Health Information Technology and Federal Communications Commission recently issued a report proposing a risk-based framework for HIT that would categorize some CDS software as "health management" -- a category that would not be overseen by FDA. Brad Thompson, an attorney with Epstein, Becker & Green that works with stakeholders on the issue, said the confusion over CDS regulation highlights flaws in the report which provided few examples of the kinds of CDS software that would be considered health management. The three agencies offered a high-level view of HIT regulation that has only emboldened proponents of legislation to codify HIT categories, he said. ?...
"Other than provide a laundry list of eight or something software functionalities that would be included, they really didn't provide any way to extrapolate beyond that," Thompson told FDA Week. "So if yours is one of the eight great...but for the vast majority of people they weren't addressed by the eight and there were no rules in there that you could say 'Ah, that's where I belong under this scheme.' And so that's the anxiety and that anxiety is going to remain all the way up until we get some clarity around exactly where they're divided."
The Clinical Decision Support Coalition, which Thompson leads, has suggested determinations about categorizing CDS software rest on the extent of the user's reliance on the device. For example, any device that does not provide information about how it reached its conclusion, is used in a setting where there is not enough time to reevaluate the recommendation or makes recommendations that the user is not independently capable of making should be classified as high risk, CDS Coalition has said.
