Dark Reading is part of the Informa Tech Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them.Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Perimeter

7/26/2010
06:19 AM
Gadi Evron
Gadi Evron
Commentary
Connect Directly
Twitter
LinkedIn
RSS
E-Mail
50%
50%

Killed By Code: The FDA And Implantable Devices Security

A new report from the Software Freedom Law Center deals with the security implications of bionic medical devices being implanted into the human body.

A new report from the Software Freedom Law Center deals with the security implications of bionic medical devices being implanted into the human body.The report, called "Killed by Code: Software Transparency in Implantable Medical Devices," was written by researchers Karen Sandler, Lysandra Ohrstrom, Laura Moy, and Robert McVay. They have done a superb job, and I am very excited about it.

A choice quote from the abstract:

"The Food and Drug Administration (FDA) is responsible for evaluating the risks of new devices and monitoring the safety and efficacy of those currently on market. However, the agency is unlikely to scrutinize the software operating on devices during any phase of the regulatory process unless a model that has already been surgically implanted repeatedly malfunctions or is recalled. The FDA has issued 23 recalls of defective devices during the first half of 2010, all of which are categorized as Class I, meaning there is 'reasonable probability that use of these products will cause serious adverse health consequences or death.' At least six of the recalls were likely caused by software defects."

Not by design -- although I am not complaining -- I am considered the father of the field of what I refer to as Bionic Hacking (others prefer cybernetic hacking). Having evangelized the subject matter for some years now, this is why I am especially happy to see this research released.

The four researchers warn that the FDA's lack of regulation and flexibility are creating potentially immense future liability; issues such as a vendor not being there to correct a future vulnerability is a main concern:

"At the very least, we urge the FDA to establish a repository of medical device software running on implanted IMDs in order to ensure continued access to source code in the event of a catastrophic failure, such as the bankruptcy of a device manufacturer"

While I am happy this realm of security is getting more attention, I hope the FDA is more serious than the security industry. I can't help but be skeptical that before some sort of disaster happens, whether to us or someone else, the controls put in place will be inadequate, to say the least.

Follow Gadi Evron on Twitter: http://twitter.com/gadievron.

Gadi Evron is an independent security strategist based in Israel. Special to Dark Reading. Gadi is CEO and founder of Cymmetria, a cyber deception startup and chairman of the Israeli CERT. Previously, he was vice president of cybersecurity strategy for Kaspersky Lab and led PwC's Cyber Security Center of Excellence, located in Israel. He is widely recognized for ... View Full Bio

Comment  | 
Print  | 
More Insights
Comments
Newest First  |  Oldest First  |  Threaded View
COVID-19: Latest Security News & Commentary
Dark Reading Staff 9/21/2020
Hacking Yourself: Marie Moe and Pacemaker Security
Gary McGraw Ph.D., Co-founder Berryville Institute of Machine Learning,  9/21/2020
Startup Aims to Map and Track All the IT and Security Things
Kelly Jackson Higgins, Executive Editor at Dark Reading,  9/22/2020
Register for Dark Reading Newsletters
White Papers
Video
Cartoon
Current Issue
Special Report: Computing's New Normal
This special report examines how IT security organizations have adapted to the "new normal" of computing and what the long-term effects will be. Read it and get a unique set of perspectives on issues ranging from new threats & vulnerabilities as a result of remote working to how enterprise security strategy will be affected long term.
Flash Poll
How IT Security Organizations are Attacking the Cybersecurity Problem
How IT Security Organizations are Attacking the Cybersecurity Problem
The COVID-19 pandemic turned the world -- and enterprise computing -- on end. Here's a look at how cybersecurity teams are retrenching their defense strategies, rebuilding their teams, and selecting new technologies to stop the oncoming rise of online attacks.
Twitter Feed
Dark Reading - Bug Report
Bug Report
Enterprise Vulnerabilities
From DHS/US-CERT's National Vulnerability Database
CVE-2015-4719
PUBLISHED: 2020-09-24
The client API authentication mechanism in Pexip Infinity before 10 allows remote attackers to gain privileges via a crafted request.
CVE-2020-15604
PUBLISHED: 2020-09-24
An incomplete SSL server certification validation vulnerability in the Trend Micro Security 2019 (v15) consumer family of products could allow an attacker to combine this vulnerability with another attack to trick an affected client into downloading a malicious update instead of the expected one. CW...
CVE-2020-24560
PUBLISHED: 2020-09-24
An incomplete SSL server certification validation vulnerability in the Trend Micro Security 2019 (v15) consumer family of products could allow an attacker to combine this vulnerability with another attack to trick an affected client into downloading a malicious update instead of the expected one. CW...
CVE-2020-25596
PUBLISHED: 2020-09-23
An issue was discovered in Xen through 4.14.x. x86 PV guest kernels can experience denial of service via SYSENTER. The SYSENTER instruction leaves various state sanitization activities to software. One of Xen's sanitization paths injects a #GP fault, and incorrectly delivers it twice to the guest. T...
CVE-2020-25597
PUBLISHED: 2020-09-23
An issue was discovered in Xen through 4.14.x. There is mishandling of the constraint that once-valid event channels may not turn invalid. Logic in the handling of event channel operations in Xen assumes that an event channel, once valid, will not become invalid over the life time of a guest. Howeve...