The Center for Devices and Radiological Health published a new draft guidance, “Postmarket Management of Cybersecurity in Medical Devices,” Covington’s Inside Privacy reports. The guidance encourages the use of a National Institute of Standards and Technology framework, as well as an Information Sharing Analysis Organization membership for manufacturers. This is the second such guidance released by the agency after its premarket recommendations, with the agency maintaining that an “effective cybersecurity risk management program should incorporate both premarket and postmarket lifecycle phases and address cybersecurity from medical device conception to obsolescence,” the report states. The draft is open to public comment until April 21.
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