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The Milbank quarterly · Sep 2017
Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.
- Jay G Ronquillo and Diana M Zuckerman.
- Western Michigan University Homer Stryker M.D. School of Medicine.
- Milbank Q. 2017 Sep 1; 95 (3): 535-553.
AbstractPolicy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.© 2017 Milbank Memorial Fund.
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