Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality.
Sherman Eagles is partner at SoftwareCPR, lead instructor for the AAMI Safety Assurance Cases for Medical Devices course, and former technical fellow at Medtronic. Email: seagles@ softwarecpr.com The need for effective cybersecurity to ensure safety and functionality of networks used for healthcare has become more important with increased use of wireless communication, Internetand network connected medical devices, and the frequent electronic exchange of medical device related health information. It is well understood that responsibility for cybersecurity must be shared between medical device manufacturers and the organizations that control and manage networks. Manufacturers are expected to provide information, such as the Manufacturer Disclosure Statement for Medical Device Security, to healthcare organizations (e.g. hospitals) and conduct cybersecurity risk analysis per Food and Drug Administration (FDA) guidance. Although cybersecurity is a relatively new subject to medical device manufacturers, safety risk management is not. Most medical device manufacturers have established safety risk management practices in compliance with applicable regulations and/or ANSI/ AAMI/ISO 14971:2007. How can manufacturers conduct cybersecurity risk analysis by leveraging their familiarity with the existing risk management framework? What cybersecurity documentation is needed to meet premarket submission requirements per the FDA guidance? Using examples, the current work illustrates how cybersecurity risk analysis can be performed by device manufacturers in leveraging safety risk analysis practices and how the cybersecurity risk analysis results can be documented to meet the premarket submission requirements and to communicate with other stakeholders. The methods are not meant to be exclusive. The examples are based on an insulin pump system (Figure 1) and previous research. Also of note, the examples are based on highly abstract information and are meant to illustrate the cybersecurity analysis methods rather than the completeness and accuracy of the technical analysis results. Furthermore, for the examples used in this article, the insulin pump system is defined as consisting of a pump that can deliver insulin programmatically and a meter remote. The meter remote is a combined device consist
Biomedical instrumentation technology