Regulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition

Journal of the American College of Radiology

Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, co-authored an article in the Journal of the American College of Radiology, titled “Regulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition.” (See the abstract and license terms.)

Following is an excerpt:

US regulators have been slow to provide meaningful guidance to industry participants on the issue of clinical decision support (CDS) software. It is crucial that regulators soon clarify the differences between regulated medical devices and unregulated health management software that nevertheless has the potential to affect patient care. Future CDS regulation in the United States should aim to reduce ambiguity by establishing detailed and simple criteria for manufacturers to use in deciding if a CDS product will be regulated. Clear standards will help ensure the safety of CDS that is brought to market. In addition, clarification will facilitate technological innovation, delivering clinical benefits to needy patients. To this end, the regulatory framework implemented in the United States with respect to CDS should consider the “substantial dependence” standard.