04 Dec '14, 4pm

the fda is looking into medtech device security guidelines:

the fda is looking into medtech device security guidelines:

SAN JOSE -- Regulators are playing catchup with the rise of digital health products, working to define and rationalize guidelines in areas such as security and software, a senior policy adviser for the US Food and Drug Administration said at the BioMeDevice event here. "The world of connected health is evolving very quickly," said Bakul Patel of the FDA's Center for Device and Radiological Health. "We believe prevention-based healthcare will lead to better outcomes, and this next healthcare paradigm is emerging right in front of us." The FDA published initial guidelines for making security a part of the design process for medtech devices. It also held a workshop recently as a first step toward finding a way to monitor and respond to cyber attacks. "It's a work in progress," he said. "We want to get ahead of the problems." Separately, the FDA is cooperating with other agenc...

Full article: http://www.eetimes.com/document.asp?doc_id=1324861

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