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

Journal of the American College of Radiology : JACR
Y Tony Yang, Bradley Merrill Thompson

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.

References

Jul 7, 2011·JAMA : the Journal of the American Medical Association·Michael Greenberg, M Susan Ridgely
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Dec 26, 2012·International Journal of Medical Informatics·Farah MagrabiEnrico Coiera
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Citations

Jan 19, 2017·Anesthesia and Analgesia·Bala G NairMaxime Cannesson

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