title: Regulatory Framework for Clinical Decision Support Software: Present Uncertainty and Prospective Proposition.
abstract: 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.
authors.affiliation: Department of Health Administration and Policy, George Mason University, Fairfax, Virginia. Electronic address: ytyang@gmu.edu.
authors.forename: Y Tony
authors.initials: YT
authors.lastname: Yang
authors.affiliation: Epstein Becker & Green, P.C., Washington, DC.
authors.forename: Bradley Merrill
authors.initials: BM
authors.lastname: Thompson
mesh_terms: D020000:Decision Support Systems, Clinical / Q000331:legislation & jurisprudence*; D018795:Device Approval; D006801:Humans; D012984:Software / Q000331:legislation & jurisprudence*; D014481:United States; D014486:United States Food and Drug Administration
keywords: Clinical decision support; Food and Drug Administration; medical device; regulations