FDA Regulation of Digital Health: Software-Related Recalls Can Negatively Influence Medical Care

September 12, 2017

Medical software has become an increasingly critical component of health care, with the hacking of medical devices a growing concern.  And yet the regulatory landscape for digital health is inconsistent and controversial. In a new study in The Milbank Quarterly, Jay G. Ronquillo of Western Michigan University Homer Stryker M.D. School of Medicine and Diana M. Zuckerman of the National Center for Health Research have found that software problems in medical devices are not rare and have the potential to negatively influence medical care.

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