Description:
How you manage cyber security issues for medical device software raises serious concerns at FDA. Software is subject to a number of FDA requirements, such as the Quality System Regulation design control requirements. In adequate cyber security measures can lead to a risk to health that prompts other regulatory requirements, such as Medical Device Reports, Reports of Corrections and Removals and potentially to premarket requirements where the redesign of cyber security software results in a significant change to a device. There is an open question about whether any correction of software should be reported to the FDA. The webinar will integrate these issues so you can understand the need for cyber security and develop a comprehensive plan to manage the real possibility of a fatal hack attack.
Cyber Security issues address software vulnerabilities. Exploiting software vulnerabilities, such as with “hacking,” can lead to devastating results. In terms of medical devices, malicious hacking can lead to serious injury or death. When FDA began to regulate medical devices, software had not evolved to a level of pervasive use, as a stand alone device or as a customized platform for institutional use. Even today, FDA struggles to keep up with the evolution of software, its applications and its inherent risks. There are many instances of how cyber security measures are inadequate for commercial and personal use software. What happens when the software malfunctions or fails to perform is a necessary consideration now. For example, someone in a remote location can cause a life sustaining device to stop working. That ability has been proven. The elements of design, operation and correction of corrupted software require rigorous evaluation. As health care technology and cost management increasingly rely on software, the potential for an increased incidence of adverse events related to hacking will follow.
Areas to be Covered:
FDA Draft Guidance entitled, “Content of Premarket Submissions for Management of Cyber Security in Medical Devices.”
FDA Safety Alert entitled, “Cyber Security for Medical Devices and Hospital Networks: FDA Safety Communication
Device regulatory requirements before and after marketing
Risk to health consequences of Cyber Security failure
Off-the-Shelf software Cyber Security
Who will Benefit:
Software specification developers and engineers
Information technology managers
Regulatory affairs senior managers
Risk managers for clinical institutions
Clinical management teams
Patient managers for life supporting/life sustaining devices
Crisis intervention planners
Customer training managers
Manufacturers with a history of software recalls
Devices Manufacturers that use software
FDA device consultants
Third party software designers / engineers
Clinical institutions
Entire staff of a start up device manufacturing firms
