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FDA publishes guidance on med device cybersecurity

Oct. 01, 2014 10:05 AM ETMedtronic plc (MDT) StockIBB, IXJ, JNJ, ABT, RHHBY, STJ, BSX, MDT, IRY, BIB, BIS, DRGSBy: Douglas W. House, SA News Editor1 Comment
  • In response to the ever-increasing risk of security breaches, the FDA issues final guidance for device makers entitled, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." The agency recommends that device manufacturers consider cybersecurity risks at part of the design and development of their products and submit documentation to the FDA about the risks identified and the controls in place to mitigate them. The agency also recommends that companies submit their plans for patches and upgrades to device operating systems and medical software.
  • The agency will hold a public workshop on October 21, 2014 to discuss how all the constituency groups can work together to improve cybersecurity in medical devices and protect the public health.
  • ETFs: IBB, BIB, IRY, IXJ, BIS, DRGS
  • Some related tickers: (MDT -0.2%)(BSX -0.9%)(STJ -0.3%)(ABT -0.6%)(JNJ -1.4%)(OTCQX:RHHBY +0.1%)

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