Risk

8/19/2013
11:00 AM
Dark Reading
Dark Reading
Quick Hits
50%
50%

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 In fact, the draft guidance on RF wireless devices was issued in 2007, before smartphones and tablets became a factor in the industry.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
Comments
Newest First  |  Oldest First  |  Threaded View
Valentine's Emails Laced with Gandcrab Ransomware
Kelly Sheridan, Staff Editor, Dark Reading,  2/14/2019
High Stress Levels Impacting CISOs Physically, Mentally
Jai Vijayan, Freelance writer,  2/14/2019
Mozilla, Internet Society and Others Pressure Retailers to Demand Secure IoT Products
Curtis Franklin Jr., Senior Editor at Dark Reading,  2/14/2019
Register for Dark Reading Newsletters
White Papers
Video
Cartoon
Current Issue
5 Emerging Cyber Threats to Watch for in 2019
Online attackers are constantly developing new, innovative ways to break into the enterprise. This Dark Reading Tech Digest gives an in-depth look at five emerging attack trends and exploits your security team should look out for, along with helpful recommendations on how you can prevent your organization from falling victim.
Flash Poll
How Enterprises Are Attacking the Cybersecurity Problem
How Enterprises Are Attacking the Cybersecurity Problem
Data breach fears and the need to comply with regulations such as GDPR are two major drivers increased spending on security products and technologies. But other factors are contributing to the trend as well. Find out more about how enterprises are attacking the cybersecurity problem by reading our report today.
Twitter Feed
Dark Reading - Bug Report
Bug Report
Enterprise Vulnerabilities
From DHS/US-CERT's National Vulnerability Database
CVE-2019-5780
PUBLISHED: 2019-02-19
Insufficient restrictions on what can be done with Apple Events in Google Chrome on macOS prior to 72.0.3626.81 allowed a local attacker to execute JavaScript via Apple Events.
CVE-2019-5781
PUBLISHED: 2019-02-19
Incorrect handling of a confusable character in Omnibox in Google Chrome prior to 72.0.3626.81 allowed a remote attacker to spoof the contents of the Omnibox (URL bar) via a crafted domain name.
CVE-2019-5782
PUBLISHED: 2019-02-19
Incorrect optimization assumptions in V8 in Google Chrome prior to 72.0.3626.81 allowed a remote attacker to execute arbitrary code inside a sandbox via a crafted HTML page.
CVE-2019-5783
PUBLISHED: 2019-02-19
Missing URI encoding of untrusted input in DevTools in Google Chrome prior to 72.0.3626.81 allowed a remote attacker to perform a Dangling Markup Injection attack via a crafted HTML page.
CVE-2019-5766
PUBLISHED: 2019-02-19
Incorrect handling of origin taint checking in Canvas in Google Chrome prior to 72.0.3626.81 allowed a remote attacker to leak cross-origin data via a crafted HTML page.