Devices

Managing Legacy Device Cyber Risks

A Mitre Corp. report, “Next Steps Toward Managing Legacy Medical Device Cybersecurity Risks,” prepared under a contract with FDA, makes recommendations for protecting legacy medical devices that “cannot be reasonably protected against current cybersecurity threats.” The report says that because of the long lifetimes of medical devices and the lack of harmonization between medical device manufacturer and healthcare delivery organization practices for supporting and replacing devices, what may have been effective cybersecurity controls present at the point of purchase may no longer adequately defend against current cyber threats.

At the same time, it says, legacy medical devices may still be broadly in use and providing needed healthcare, and simple removal of them may present risks to patient safety and clinical operations, as well as fiscal challenges. “Since legacy risks likely cannot be mitigated sufficiently through patching and updating due to outdated technology and compatibility issues, other approaches to managing these risks may be required,” Mitre says.

Mitre used stakeholder interviews and working group discussions to make these recommendations:

secure legacy medical devices by implementing regular software updates, establishing firewalls, and ensuring compatibility with modern security protocols, among other controls;
improve manufacturing and develop transparency among developers and users;
improve the turnaround time for security updates and patches;
increase the adoption and rigor of the secure development lifecycle in the development of medical devices;
require strong authentication to improve identity and access to medical devices; and
employ strategic and architectural approaches to reduce attack surfaces.

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

Read more

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