3rd Annual Archimedes Workshop on Medical Device Security

Dozens of medical device and security experts
converge in Ann Arbor each summer.

Engineers from medical device manufacturers, safety and security officers from health care providers, Archimedes members, and special guests will converge in Ann Arbor, Michigan for the 3rd Annual Archimedes Workshop on Medical Device Security May 4-5, 2015. This invitation-only event brings together solution-oriented experts in medical device manufacturing and computer security to discuss the new FDA cybersecurity guidance and how to improve information security.

EHR software and ebola, what could possibly go wrong?

Forget malware on medical devices. Try ebola. The Atlantic is reporting that software flaws in the exchange of Electronic Health Records (EHRs) is partly to blame for an ebola patient being sent home from Texas Health Dallas.  More information appears on the hospital's website.

According to Bloomberg news, the EHR software at Texas Health Dallas is made by Epic Systems Corp.

FDA issues final version of long-awaited cybersecurity guidance

The long-awaited guidance will help resolve past
uncertainties about expectations of cybersecurity
in the pre-market review of medical devices.

Today, FDA issued its long-awaited cybersecurity guidance for pre-market review of medical devices.  This is a document years in the making.

A PDF of the actual guidance document appears here.

A second draft cybersecurity guidance document on post-market practices (e.g., vulnerability and incident reporting) is expected later this year.