Devices

Medical Device Security Moving in ‘Right Direction’: Article

An online article in Healthcare IT News says FDA and the medical device industry “are moving in the right direction” on medical device security, “fueled by the open dialog and FDA guidance on disclosures.” The article notes that medical device vendors reported 400% more vulnerabilities per quarter since FDA released its 2016 cybersecurity guidance. MedCrypt CEO Mike Kijewski says the increase in disclosures is potentially a sign of growing compliance and may also reflect a maturity in security risk assessments. “This may actually be a good thing, showing that medical device vendors are starting to take cybersecurity seriously,” Kijewski told the newsletter.

When considering whether FDA is doing “enough,” the article says the question is hard to answer definitively. “We’re not there yet, but we’re moving in the right direction,” it says.

Kijewski says that “much progress has been made in the last two to four years and our industry is on a trajectory that suggests we’ll have significantly more secure devices in the future than we did in the past.”

The need to continue to make progress, the article says, was shown by McAfee researchers who demonstrated at DEF CON in Las Vegas how easy it was for them to hack into medical devices and modify patient vitals in real-time by mimicking data sent from medical equipment clients to central monitoring systems.

Kijewski says the FDA guidance could be more detailed to help direct “vendors toward security features that would mitigate more complicated vulnerabilities.” For now, the article says, healthcare organizations need to improve patch management policies to ensure that, at the bare minimum, disclosed vulnerabilities are closed off to unauthorized access

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome