At the recent session sponsored by the National Institute of Standards and Technology's Information Security & Privacy Board in Washington, D.C., the article said, panelists blamed much of the security vulnerability on hospitals' use of older Microsoft operating systems that have not been updated with security patches. In some cases, hospitals have been unable to modify the systems or even add anti-virus software because the software manufacturers were unsure whether such modifications would violate FDA regulations.
The FDA in 2009 issued guidance urging hospitals and medical device manufacturers to work together to eliminate security risks. But in September, the Government Accountability Office issued a report warning that implantable medical devices could be vulnerable to hacking, posing a safety threat, and asked the FDA to address the issue.
There's also evidence that malware interferes with other kinds of devices. For example, malware slowed down fetal monitors in an ICU at Beth Israel Deaconess Medical Center in Boston, according to the MIT Technology Review piece.
The FDA is now reviewing its regulations. But the article quotes Brian Fitzgerald, an FDA deputy director, as saying that the regulatory review would be gradual, "because it involves changing the culture, changing the technology, bringing in new staff, and making a systematic approach to this."
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Medical device software increasingly is interconnected with electronic health records systems in hospitals, which themselves are vulnerable to attack. And the issue has been complicated by the widespread adoption of smartphones and other mobile devices, some of them personal devices that clinicians bring from home.
Ken Kleinberg, a health IT consultant with the Advisory Board Co., told InformationWeek Healthcare that the operating systems of these mobile devices have more robust security features than the legacy Windows systems found in many hospitals. But he agrees that hospitals need strong "bring your own device" (BYOD) security policies, including mobile application management tools. "It's not just that you're going to control the configuration on the device, you're also going to control what application can be loaded on that device," he said.
For example, a hospital can give doctors a list of the applications that it has vetted, noted Kleinberg. If a doctor wants to use a document reader, for instance, the hospital might suggest one. If he wants to use a dosing calculator, it might suggest three apps and make them available on its application server.
The operating systems that hospitals use are an even bigger challenge, he said, partly because computer manufacturers upgrade their OS so often. "You used to be able to go for a long time on an operating system, but those time frames are shortened now, and the releases are coming faster," Kleinberg noted. "Now we've got [Microsoft] Windows 8, which came relatively soon after Windows 7. And you've got these new mobile platforms now--mobility is taking off and people want to support it. How long can healthcare organizations hang out on this older stuff? They're probably waiting for the right time to upgrade, but there is no right time."
On the other hand, he pointed out, upgrading to a new operating system is very expensive. First, Microsoft licenses cost a lot of money, and some organizations are looking at alternatives to Microsoft. Also, a new OS might require new computers capable of running it. Much of the software and interfaces already in use must also be upgraded. And from an operational standpoint, "It's a big effort to make these migrations," he said.
Nevertheless, there is no alternative to upgrading, said Kleinberg. "Organizations have to do it, and there's even more reason to do it now. Because if you really want people to use these applications, you have to run them on the devices that clinicians are willing to carry and utilize. That's why BYOD is something that organizations may want to push back on, but they have to embrace it."
Besides BYOD, the other major driver for hospitals to upgrade their computer OS is the prospect that the FDA will tighten its regulations on medical devices, he said. Moreover, other agencies, including the FCC, might also weigh in with new rules "to help monitor the convergence of EHRs and devices and applications."
InformationWeek Healthcare brought together eight top IT execs to discuss BYOD, Meaningful Use, accountable care, and other contentious issues. Also in the new, all-digital CIO Roundtable issue: Why use IT systems to help cut medical costs if physicians ignore the cost of the care they provide? (Free with registration.)
