Risk
8/19/2013
11:00 AM
Quick Hits
Quick Hits
Quick Hits
Connect Directly
RSS
E-Mail
50%
50%
Repost This

FDA Issues Guidelines On Wireless Medical Devices

FDA outlines risks such as lost signals and recommends stringent security measures -- but document is not the last regulatory word.

The Food and Drug Administration (FDA) has released final guidelines on the design, testing and use of radio-frequency (RF) wireless medical devices. Although it doesn't promulgate legally enforceable responsibilities, the document is intended to guide both device manufacturers and healthcare providers toward the safe and secure use of wireless medical devices. Covered are devices "that are implanted, worn on the body or other external wireless medical devices intended for use in hospitals, homes, clinics, clinical laboratories, and blood establishments."

The FDA document has no relation to the impending guidance from the agency about how it will regulate apps that turn smartphones and tablets into medical devices. In fact, the draft guidance on RF wireless devices was issued in 2007, before smartphones and tablets became a factor in the industry. The FDA is focusing on the safety aspects of medical devices in hospitals, homes and other fixed-care settings.

For example, the guidance states, "Because there are risks associated with RF wireless systems, we recommend that you carefully consider which device functions should be made wireless and which device functions should employ wired connectivity."

Read the full article here.

Have a comment on this story? Please click "Discuss" below. If you'd like to contact Dark Reading's editors directly, send us a message.

Comment  | 
Print  | 
More Insights
Register for Dark Reading Newsletters
White Papers
Flash Poll
Current Issue
Video
Slideshows
Twitter Feed
Dark Reading - Bug Report
Bug Report
Enterprise Vulnerabilities
From DHS/US-CERT's National Vulnerability Database
CVE-2011-0460
Published: 2014-04-16
The init script in kbd, possibly 1.14.1 and earlier, allows local users to overwrite arbitrary files via a symlink attack on /dev/shm/defkeymap.map.

CVE-2011-0993
Published: 2014-04-16
SUSE Lifecycle Management Server before 1.1 uses world readable postgres credentials, which allows local users to obtain sensitive information via unspecified vectors.

CVE-2011-3180
Published: 2014-04-16
kiwi before 4.98.08, as used in SUSE Studio Onsite 1.2 before 1.2.1 and SUSE Studio Extension for System z 1.2 before 1.2.1, allows attackers to execute arbitrary commands via shell metacharacters in the path of an overlay file, related to chown.

CVE-2011-4089
Published: 2014-04-16
The bzexe command in bzip2 1.0.5 and earlier generates compressed executables that do not properly handle temporary files during extraction, which allows local users to execute arbitrary code by precreating a temporary directory.

CVE-2011-4192
Published: 2014-04-16
kiwi before 4.85.1, as used in SUSE Studio Onsite 1.2 before 1.2.1 and SUSE Studio Extension for System z 1.2 before 1.2.1, allows attackers to execute arbitrary commands as demonstrated by "double quotes in kiwi_oemtitle of .profile."

Best of the Web