- An industry coalition has finalized guidelines on the design and development of medium-risk clinical decision support software that aren’t subject to Food and Drug Administration review.
- The aim of the Clinical Decision Support Coalition’s voluntary guideline is to encourage software designs that allow clinicians to independently review the basis for a CDS product’s recommendations. It also provides a framework for software developers to determine if additional validation is needed.
- “These guidelines reflect the view that taking over, in any substantial way, the healthcare decision-making carries with it heightened responsibility for validation,” the document says.
Under the guidelines, developers should consider two questions: Can clinicians independently review the software’s recommendations? And will clinicians not need to rely primarily on the software for their clinical decision-making?
To answer those questions, developers should use the following criteria:
- Does the software provide sufficient transparency for the user to grasp and assess the clinical basis of the software recommendation?
- Is the intended user competent to make the clinical decision without the software?
- Will the user have adequate time to reflect on the software recommendation before making a decision?
The 21st Century Cures Act, passed late last year, removes clinical decision support software and certain other categories of software from FDA regulation. That helps manufacturers in planning their strategies, Bradley Merrill Thompson, a partner at Epstein Becker Green, told Healthcare Dive last December.
The FDA plans to publish draft guidance clarifying when CDS software falls outside its purview.