Blog

40,000 Unregulated Health Apps, And Counting

June 24, 2014

Are healthcare apps written for mobile devices regulated?

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NCCIC Urges Medical Device Security Review

June 24, 2014

The National Cybersecurity and Communications Integration Center (NCCIC) is urging federal agencies to better monitor medical device security after documented cases of cybersecurity issues.

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New Bi-Partisan Medical Device Legislation Announced

June 24, 2014

In Washington, Senators Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wisc.) co-authored legislation that would better regulate the fast-growing medical device industry.

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Robot Surgeries Get Hacked ... For Good

June 24, 2014

Robotic surgeries are designed to help emerging countries deal with complicated healthcare issues. But so far only one product, Intuitive Surgical's da Vinci system, is available and deployed worldwide. Now US National Science Foundation hopes that students hacking open-source surgical robots at universities in the U.S will spur more competition.

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Johnson & Johnson Warned By FDA Over Insulin Pump Failures

June 24, 2014

In late December, the Food and Drug Administration (FDA) sent the pharmaceutical company Johnson & Johnson a letter warning of possible penalties for not reporting life-threatening vulnerabilities with its OneTouch Ping and 2020 insulin pumps. It is unclear whether the vulnerabilities are outright device failures or from interference or manipulation from outside sources.

After an inspection at Johnson & Johnson's subsidiary plant in West Chester, Pa., the FDA discovered one complaint about series patient injury and two other incidents never reported. According to the FDA one patient was hospitalized with diabetic ketoacidosis, a condition where the body does not have enough insulin. Another received high doses of insulin. And a third patient suffered serious injury, which could include coma, respiratory failure, and hypoglycemia as a result of user error.

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