Day: November 30, 2005

Daylight Savings Time

Remember the Y2k "bug"? A while back, a reader asked about the potential impact when daylight-savings time starts earlier than usual in the US come 2007. I remember the stories about the pending legislation, but haven't really heard anything about it from vendors or anyone else. Of course, any medical device that generates data for a clinical record, either via printing or into a computerized record will have to be patched. Much like the Y2k situation, vendors will provide current products with upgrades and older products will have to be replaced. Hopefully I am not being a "chicken little" but I have drawn attention within our IT shop to this issue (finally). It took about 3 conversations with our CTO and subsequent discussions with the VP of Applications and our Director of Departmental Applications where I showed them the notifications from Microsoft on the subject. Finally, we have a project chartered for 2006 but no targeted funds for remediations. Those that are at-risk (NT4 Server-based) are the usual one-off, "well-architected", vendor "dream" solutions that are prevalent in healthcare. Well aren't all device vendor's systems "well-architected, dream solutions?" The rub for this reader is their plans to implement an EMR and automatically capture data from medical devices - a messy (and potentially expensive) proposition in the best of circumstances. The upside is that pending changes to daylight-savings may provide an...

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Cisco Touts Medical Grade Network Site

Cisco is touting Sweden's largest hospital as medical grade network showcase. So far Karolinska University Hospital has simply hooked up remote sites and deployed a WLAN (800 access points). No advanced features are reported, but they mention plans for video conferencing, and VoIP wireless phones. Karolinska, which is a world leader in cancer research and treatment, is using the Cisco Medical-Grade Network to connect as many as 14,000 users in sites around Stockholm. Two thousand of the users will access the network via more than 800 Cisco wireless access points. Karolinska has already started to deploy applications such as real-time video conferencing over the Cisco network. It is developing an e-enabled operating room which will broadcast operations and support real-time interaction world wide. Other future applications include Cisco Internet Protocol communications and replacing doctors' bleepers with handheld devices and mobile phones so that they can be alerted and can access information from a hospital site or...

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Medical Device Software Patch Problems in Decline

Paul Kelly on the Biomed Listserv pointed out this article in NetworkWorld on medical device software patches. For years, manufacturers had been telling customers that they couldn't provide timely patches because the U.S. regulatory body in charge of medical-device safety, the Food and Drug Administration (FDA), had to approve the software fixes first in a lengthy inspection process. But inquiries last year to the FDA division in charge, the Center for Devices and Radiological Health, revealed that the FDA had no such rules. This shattered a myth that had been at best a misunderstanding and at worst a deceit. Since then, much of the change in the dialogue among manufacturers and hospital IT staff can be attributed to FDA guidance. The agency has made clear it isn't opposed on principle to customers patching medical devices. "There is no FDA legal requirement that would prevent the user from installing patches without prior approval from the device manufacturer," says John Murray, the FDA's software and electronic-records compliance expert. In its "Guidance for Industry: Cybersecurity for Networked Medical Devices Containing Off-the-Shelf Software," the FDA told manufacturers that they "bear the responsibility for the continued safe and effective performance of the medical device, including the performance of the off-the-shelf software that is part of the device." The article also provides links (also found in Important Reference Web Links on this site) to some...

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VCs Ready to Fund Home Patient Monitoring Business Plan

The Healthcare IT Guy, Shahid Shah, has an interesting post on a story in Business 2.0 magazine. In this story, the writer interviewed a variety of venture capitalists about, "business ideas they're dying to bankroll." The business idea that caught Shahid's attention was the one on home patient monitoring network for recuperating hospital patients (for which the VC is willing to throw in $8 million). No one likes extended hospital stays. Not patients, not hospitals, and not insurance companies paying bills that can exceed $5,000 a day. For the critically ill, there's no way around lengthy visits. But thousands of other patients could be sent home early if they could be monitored at home or at a lower-cost facility. Badawi and Aslin envision a wireless transmitter that would attach to existing hardware such as portable ECG machines and heart-rate and blood-pressure monitors. The device would send data through a wireless router to a cluster of back-office servers. The servers would function like a call center, routing a patient's vital signs to the right nursing station or on-call physician. Trimming just two days off the typical 10-day hospital stay for stroke victims would be a service worth $2.7 billion. Any patient that is sucking up $5,000 per day in charges is probably too acute to be a candidate for early discharge and home monitoring. Typical high volume and high cost...

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