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Showing posts tagged with medical device security
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Axel Wirth | 23 Oct 2014 | 1 comment

Like with my previous post on this topic, I am using a quote from one of the presenters to report on Day 2 of the public FDA workshop on “Collaborative Approaches for Medical Device and Healthcare Cybersecurity”. And like with my previous post, this quote is a good indicator of the spirit of the day. It is time to move - and we are.

It was reported that the workshop had 200 registrants, requiring the creation of an overflow room, and that Day 1 drew 1100 remote participants!

In his opening keynote Michael Daniel, Special Assistant to the president and White House Cybersecurity Coordinator, called cybersecurity one of the defining challenges of the 21st century and referred to it as a “wicked” problem (drawing applause from the Bostonians in the audience) due to its complex nature: technical, scientific, economical, political, and human. He pointed out that we don’t really...

Axel Wirth | 02 Oct 2014 | 1 comment
On Oct. 1st, the FDA released final guidance on “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”  The document had previously been published as a draft version (June 2013), after public comment this final version has been issued. Symantec had submitted review comments and we applaud the FDA on finalizing this important document.
 
 
What does the document address?
 
Overall, the FDA maintained the approach of the initial draft, laying out how manufacturers should consider cybersecurity in the design of network-connected medical devices and that they should make cybersecurity documentation a part of their premarket submission. The document has become more specific in some areas, for example by referencing a list of FDA-recognized standards, but also by specifically referring to patient safety as one of the main drivers behind this guidance.
...
Karalee Serra | 06 Jun 2014 | 0 comments
Increasingly, medical devices are being networked to improve efficiency, enhance clinical value, and support patient safety initiatives. Yet, this increasing integration results in higher exposure to cyber threats like hacker attacks and malware, and increasingly creates dependency and reliance on the complex interaction of all components. 
 
It is, in a sense, a “system of systems” problem and hospitals’ BioMedical Engineering and IT Departments are challenged to protect this complex and critical part of their infrastructure against an exponentially growing and increasingly sophisticated threat landscape.
 
In this webinar, you will:
  • Develop an understanding of the underlying and complex medical device cybersecurity challenges we are facing
  • Learn how to minimize risks
  • Be introduced to available best practices and resources. 

...

Axel Wirth | 11 Nov 2013 | 0 comments

Granted, there are easier to decipher acronyms than the one describing the Manufacturer Disclosure Statement for Medical Device Security, short MDS2. The initial version was developed in 2008 through a cooperation of NEMA (National Electrical Manufacturers Association) and HIMSS’ (Health Information and Management Systems Society) Medical Device Security Task Force, in collaboration with multiple industry associations, government agencies and other stakeholders. It provided a basic, 3-page form allowing medical device manufacturers to describe to their customers, i.e. the hospitals, the basic security and privacy properties of a specific medical device; things like the operating system and version, type of network connection, the ability of the operator to install antivirus software, or what PHI (Protected Health Information) is stored on the device and whether it is transient or permanent.

Although the form fulfilled its purpose, there was also some criticism on this...

Karalee Serra | 27 Sep 2013 | 2 comments

Learn what you can do today to protect your medical devices from attacks and malware while manufacturers start to provide devices with improved security posture. If you missed our recent webinar, click here to view the archived edition.

Karalee Serra | 27 Sep 2013 | 0 comments

mHealth security panelists wonder, can a hacked medical device kill you?
The depiction of a U.S. vice president killed by his hacked pacemaker on the Showtime series "Homeland" may be a bit too fantastic for those in the mHealth industry to take seriously, but the potential exists. Continue reading the full article >>