Dive Brief:

• Two months after the FDA released its initial thoughts on how it plans to regulate certain types of clinical and patient decision support software, the Clinical Decision Support Coalition is sounding the alarm over what it says is a policy that over-regulates "to the detriment of patient care."
• The group, which includes software providers, IT infrastructure manufacturers, providers, medical device makers and pharmaceutical manufacturers, argues the FDA fails to take a risk-based approach in its draft guide.
• The FDA should revise and re-issue the document as another draft guidance, the CDS Coalition argues in its comment. The group says that if implemented, the draft guide would "force many sellers of existing CDS software to remove their products from the market."

Dive Insight:

FDA Commissioner Scott Gottlieb in December said the proposed draft guidance tries to make clear what type of CDS is not defined as a medical device, which would not be regulated by the agency. Generally, CDS that allows a medical provider to "independently review the basis for the recommendations are excluded from the FDA’s regulation," he added.

"We believe our proposals for regulating CDS and [patient decision support software] not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation," Gottlieb previously said in a statement.

But the industry coalition argues that such an approach inadvertently sweeps certain low-risk software into FDA regulation because the underlying basis may not be transparent enough. 

"In the Cures Act, Congress employed transparency not as a way to remove low risk products from FDA regulation, but rather as a means of delineating the dividing line between FDA jurisdiction and oversight by the state boards of medicine. Transparency is not a substitute for a risk-based model of regulation," the group wrote in its comment on the draft guide. 

Brad Thompson, general counsel for the CDS Coalition, told Healthcare Dive that FDA's plan is a let-down. "Given that the guidance was seven years in the development process, we expected much more. FDA had been repeatedly promising to make the guidance risk-based, but then didn't," he said.

The group also raises concern with FDA's view of what level of transparency is needed to be given to doctors, saying the approach would bring many CDS software products that use machine learning under regulation.

"In the Draft Guidance, FDA proposes that software will only be exempt from regulation if the user is 'able to reach the same recommendation on his or her own without relying primarily on the software function.' However, that is radically different from the statutory test, which exempts software if the user is able 'to independently review the basis for such recommendations that such software presents so that it is not the intent that such healthcare professional rely primarily on any of such recommendations,'" the group writes. 

The draft guidance would regulate any software that offers insights that a doctor may not be expected to come up with on their own, precluding any software that conducts "mundane calculations that users could do themselves."

"Under the statute, however, the way it is supposed to work is that software that produces unique insights may be exempt from regulation as long as an informed professional user is able to access all of the underlying data and other information to reach his or her own conclusions; whether they would likely be the same or not is immaterial," the group argues.

FDA's draft guidance says that the sources supporting or underlying a CDS recommendation should be "identified and easily accessible to the intended user, understandable by the intended user, and publicly available." 

A practitioner would be unable to independently evaluate the basis of a recommendation if the recommendation were based on non-public information or information whose meaning could not be expected to be independently understood by the intended health care professional user," the draft guidance states.