FDA Issues Guidelines On Wireless Medical Devices

[InfoSec News <alerts () infosecnews org>]

http://www.informationweek.com/healthcare/mobile-wireless/fda-issues-guidelines-on-wireless-medica/240160104

By Ken Terry
InformationWeek.com
August 19, 2013

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 In fact, the draft guidance on RF wireless devices was issued in 2007, 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." Among the issues that could compromise transmissions from 
wireless devices and potentially endanger patient safety, the FDA guidance 
says, are:

[...]



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