"Hospital Medical Devices Could Be Vulnerable to Malware, Experts Say," reported iHealthBeat on Thursday, October 18, 2012.
"Kevin Fu,a member of the medical device panel and a computer scientist at the University of Michigan and the University ofMassachusetts-Amherst, said, "Conventional malware is rampant in hospitals because of medical devices using unpatched operating systems. There's little recourse for hospitals when a manufacturer refuses to allow OS updates or security patches.'"
Defying logic, "Brian Fitzgerald, a deputy director at FDA, said that visits to hospitals around the country indicate that many of them are struggling with malware issues."
"He said that FDA is reviewing its regulatory stance on medical device software, adding, 'This will have to be a gradual process, because it involves changing the culture, changing the technology, bringing in new staff and making a systematic approach to this [address the issues].'"
In other words, providers can waste time and money fighting malware-induced computer failures in devices that could lead to higher patient death rates because medical device malware is not high on the FDA's "to-do" list.
Is the deputy director oblivious to the HITECH Act and CMS' "meaningful use"? Is the deputy unconcerned that billions of taxpayer dollars (oh, that's it- somebody else is "paying the freight") are being lost while FDA is "changing the culture, changing the technology, bringing in new staff and making a systematic approach" to address the issues"?
FDA's "slothful approach" tells the tale. No lions, no tigers, no bears. Oh my, a sloth.