Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health

The innovation of medical IT has the potential to save lives, but even a small “glitch” can harm patients. Our study found hundreds of recalls of flawed devices that affected millions of patients. Examples include electronic medical records that provide info about the wrong patient and “physician support” devices that miscalculate the dosage of medication. But the FDA is set to deregulate these devices.

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A Major Shortcoming in the Public Health Legacy of the Obama Administration

American Journal of Public Health, December 16, 2016. The Obama Administration has been a strong voice for many public health issues, including tobacco control, childhood obesity, and reproductive health. The Affordable Care Act is also a major accomplishment. But, under the same administration, the FDA caved into political pressure by approving medical products based on lower standards of scientific evidence. What will happen going forward?

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