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 “New Coalition Will Attempt to Unite Stakeholders on Clinical Software Regulation.”
Following is an excerpt:
A new industry coalition, The CDS Coalition, will attempt to unite different stakeholders to ensure that the Food and Drug Administration does not overregulate clinical decision support (CDS) software.
According to Thompson, FDA has initiated a process to develop a guidance document to define the types of clinical decision support (CDS) software that FDA will regulate. The agency kicked off that initiative with a hearing in September and is now actively working on drafting guidance, he said. It is expected to be published sometime early in 2012.
Thompson said stakeholders have been expressing concern that FDA might be too restrictive when it decides to regulate CDS software. Over the years, FDA has been regulating many software packages that perform decision support functions, but the precise rules have never been clear, Thompson said.
Thompson said the coalition would exist only temporarily, with a focus on proactively developing an industry proposal for how to draw the line between regulated and unregulated CDS software.
“The timing is up in the air,” Thompson told BNA. Even if FDA comes out with its draft guidance before the coalition develops its proposal, he said the group will still submit its thoughts on the best regulatory path for CDS software.
The coalition would broadly address two questions: what types of CDS software should be regulated, and to what level should the types be regulated?