FDA Medical Device Guidance
Last week the US Food and Drug Administration (FDA) finally released a couple of important documents. The first being their guidance on using radio frequency wireless technology in medical devices (replacing a draft from January 3,2007), and a second being their new (draft) guidance on premarket submission for management of cybersecurity in medical devices. The wireless technology guidance document seeks to address many of the risks and vulnerabilities that have been disclosed in medical devices (embedded or otherwise) in recent years – in particular those with embedded RF wireless functionality…
Las Vegas 2013
Again, that time of the year is approaching; thousands of people from the security community are preparing to head to Las Vegas for the most important hacking events: Black Hat USA and DefCon. IOActive will (as we do every year) have an important presence at these conferences. We have some great researchers from our team presenting at Black Hat USA and DefCon. At Black Hat USA, Barnaby Jack will be presenting “Implantable medical devices: hacking humans”, and Lucas Apa and Carlos Mario Panagos will be presenting “Compromising industrial…
FDA Safety Communication for Medical Devices
The US Food and Drug Agency (FDA) released an important safety communication targeted at medical device manufacturers, hospitals, medical device user facilities, health care IT and procurements staff, along with biomedical engineers in which they warn of risk of failure due to cyberattack – such as through malware or unauthorized access to configuration settings in medical devices and hospital networks. Have you ever been to view a much anticipated movie based upon an exciting book you happened to have read when you were younger, only to be sorely disappointed…
“Broken Hearts”: How plausible was the Homeland pacemaker hack?
[1] I watched the TV show Homeland for the first time a few months ago. This particular episode had a plot twist that involved a terrorist remotely hacking into the pacemaker of the Vice President of the United States. People follow this show religiously, and there were articles questioning the plausibility of the pacemaker hack. Physicians were questioned as to the validity of the hack and were quoted saying that this is not possible in the real world [2]. In my professional opinion, the episode…