medical devices

A warning letter from the FDA to St. Jude Medical said the firm ignored warnings that its implantable medical devices and related software were vulnerable to hacking or unexpected failure.

Update: FDA says St. Jude Medical knew about Device Flaws 2 Years Before Muddy Waters Report

In-brief: In a damning report, the FDA said that St. Jude Medical* knew about serious security flaws in its implantable medical devices as early as 2014, but failed to address them with software updates or other mitigations, or by replacing those devices. (Editor’s note: updated to include a statement from Abbott and comment from Dr. Kevin Fu. – PFR April 14, 2017)

Data theft long ago reached epidemic proportions in the U.S. So why don't policy makers act?

Silent Epidemic: Data Theft has become a Public Health Crisis | Digital Guardian

In-brief: One in four Americans was the victim of data theft, but policy makers can’t find the spirit to act. What if I said that there was a disease that affected one in four adults in the U.S.? This disease caused pain and hardship and the costs of curing it were considerable – ranging to thousands of dollars per patient? And, again: one in four people contacted this disease – 25% of the adult population?Most epidemiologists would consider a disease that widely spread to be an “epidemic.” After all, the CDC considers an influenza outbreak to be an “epidemic” when around 7% of morbidity (deaths) in a given observation period are due to the flu. Here in the U.S., however, there’s a long-standing affliction bearing down on a quarter of the population, but nary a mention of the words “epidemic.” In fact, officials who monitor this disease are loath to […]