In December of 2016, the US Food and Drug Administration (FDA) issued its second Cyber Security guidance entitled “Postmarket Management of Cybersecurity in Medical Devices.” This document was preceded by “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” which was published in October of 2014. The FDA – as part of the presidential Executive Order on Improving Critical Infrastructure Cybersecurity, and in recognition of the risk involved with the exploitation of networked medical devices – suggests very specific recommendations for device manufacturers to consider. These guidelines serve a dual purpose of protecting patients (first and foremost) AND protecting your reputation as a manufacturer.
With every new guidance or FDA regulatory initiative for Medical Devices, it becomes important to understand how these new information streams will affect organizations and their ability to stay compliant while driving their business. While the FDA clearly stresses the serious nature of the risks involved, it is natural to contemplate how critical it will be to start merging these guidelines in to standard business operations. With Cyber Security not being the primary driver behind the development of Medical Devices, it is also natural that the terminology, suggested practices, and path to securing medical devices may seem foreign to many. With the FDA suggesting both pre and post market focus on Cyber Security, how will companies know where to begin?
This interactive 60- minute webinar will provide direction and information on the following topics…
- An introduction and overview of the FDA Medical Device Cyber Security Guidance
- Making sense of the terminology – and filtering out the noise
- A discussion on the projected enforceability of the guidance and those who will be looking out for program existence
- Aligning the technical guidance to actual business risk in your program
- Which comes first: Evaluating the current program or building Cyber Security into the business process?
- How to build Cyber Security into the process from pre-development to deployment and maintenance
- Evaluating the current program and building a roadmap to meet guidance requirements