The U.S. Food and Drug Administration's lack of policy on clinical decision support is leading to confusion and delays for developers, according to a white paper out today from the CDS Coalition.
The coalition, within the white paper, includes the results of a survey of 48 companies conducted this past December and January focusing on how such "regulatory uncertainty" by the FDA impacts their efforts. Thirty-six percent of 41 respondents to a question on that uncertainty said not knowing if regulation was coming made securing funding for product development a challenge. Sixty-two percent of 39 respondents to a question about delays said their product development efforts had been delayed as a result of such uncertainty; 20 percent of those respondents (13 people) said they had to abandon development of a CDS product because of the uncertainty.
"Prompt legislative and/or regulatory action is needed to clarify the scope of CDS software that will be subject to FDA regulation, as well as the specific regulatory requirements that will apply to any software that is regulated," the coalition says. "Until the regulatory playing field for CDS software is better defined, it is likely that powerful and potentially life-saving CDS tools will be kept out of clinicians' and patients' hands."
Bradley Merrill Thompson, an attorney with Epstein Becker Green who serves as general counsel for the CDS Coalition, tells FierceHealthIT in an email that the group is working to develop a policy proposal that deals with the regulatory uncertainty head on. The coalition, he says, wants to blend international standards and other consensus approaches with innovative ideas.
"We may not try to fully bake the ideas ourselves, but rather get them in decent enough shape to release them for public discussion and comment," Thompson says. "I would love to get feedback from all the different stakeholders because the issues are complex, and there is risk of unintended consequences if it isn't well vetted."
Thompson adds it "breaks his heart" that useful CDS software isn't being deployed as a result of a lack of FDA policy, especially since the agency labeled it as a top priority at the beginning of 2015.
"Right now confusion reigns, and that quite literally is sand in the gears of commerce," Thompson says. "[I]t means that venture capital and other sources of investment are simply unwilling to fund certain projects, if they are in the gray area defined by the uncertainty."
Language in a revamped version of the Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act, unveiled in August, could provide some clarity for developers. Thompson, following the unveiling of the bill, said language around clinical decision support strikes the right balance between how to approach software that helps a doctor vs. software a doctor is not dependent on to make a patient care determination. The bill is set to be discussed during a Senate Health committee hearing on March 9.
To learn more:
- here's the white paper (.pdf)