Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in HealthTech Magazine, titled “Why New Guidelines Are the Best Way to Address Medium-Risk CDS Software.”
Following is an excerpt:
Clinical decision support (CDS) software can help doctors more effectively wade through mountains of data to find the best treatment options for each patient. Despite the fact that CDS only produces recommendations to clinicians, bad information can produce bad outcomes.
While defective CDS software can be harmful, this does not mean that that U.S. Food and Drug Administration should regulate all CDS software. Low-risk CDS should be left alone, and the CDS Coalition recently released industry guidelines for medium-risk CDS that aim to protect patients. …
The guidelines do not simply track the new statute, though. In developing them, the coalition also considered liability issues and best practices in the design and marketing of CDS software.
In the end, for medium-risk CDS, these guidelines identify approaches that will help ensure the ability of the clinician to stay in control of the decision-making, instead of asking the clinician to rely on a black box.
