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 In fact, the draft guidance on RF wireless devices was issued in 2007,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:
[...]
--
Find the best InfoSec talent without breaking your
recruiting budget! Post a Job, $99 for 31 days.
Hot InfoSec Jobs - http://www.hotinfosecjobs.com/
