Print“As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records there is a growing expectation that they will be interoperable—and that the data they transmit will be secure.”
The U.S. Food and Drug Administration is advancing an updated list of “plug and play” interoperability standards for medical devices in an effort to improve patient care, reduce medical errors, and lower costs.
The voluntary guidelines are intended to help manufactures create devices that are both secure and work well together, wrote FDA senior policy advisor Bakul Patel, who announced the standards on the agency’s FDA Voice blog.
“As medical devices become increasingly connected to other medical devices, hospital information systems and electronic health records,” wrote Patel, “there is a growing expectation that they will be interoperable—and that the data they transmit will be secure.”
Interoperability between medical devices from unrelated manufacturers has become increasingly important as common devices, such as glucometers and electrocardiographs, have moved from standalone to wirelessly networked, creating new conveniences but new security vulnerabilities too.
Among the new entries, the FDA introduced standards for how to manage risks to computer networks that incorporate medical devices and how to establish industrial automation and control system security programs.
Patel is widely known for his role in developing the FDA’s draft guidance for mobile medical apps, a high-interest area for developers of digital health products. But the new standards are more important to the realm of premarket reviews, evaluations of high-risk medical devices for which interoperability errors could injure or even kill patients, such as infusion pumps or ventilators. An infusion pump could, for example, administer the wrong amount of medication to a patient at the wrong time if it was not fully interoperable with an electronic medical records system containing instructions for treatment.
“This is a very good day for medical device interoperability,” says Carol Hermann, a senior vice president at the Association for the Advancement of Medical Instrumentation, a group that helped shape the new standards. “Just five years ago we couldn’t fill a small conference room with the people who cared about interoperability.”
She says that there’s still a long way to go, but that existing momentum will make future progress easier.
August 07, 2013
http://www.burrillreport.com/article-fda_updates_%e2%80%98plug_and_play%e2%80%99_standards.html
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