FDA signals increasing focus on cybersecurity requirements

With the continued explosion of software and software-controlled medical devices, including the growing use of machine learning and artificial intelligence, the FDA (the Agency) Medical Device Safety Action Plan (the Plan) released last week highlights the Agency's increasing focus on cybersecurity. In announcing the plan, FDA Commissioner Scott Gottlieb emphasized the importance of cybersecurity in ensuring patient safety. The Plan recognizes that the increased interconnectedness of medical devices of all types can lead to safer, more effective technologies, but also introduces increased potential for security breaches and exploitation of device vulnerabilities. While progress has been made in this area, the Agency maintains that additional efforts are needed to prevent, detect, and respond to threats such as hacking and cyber attacks. Accordingly, the Agency's fiscal year (FY) 2019 budget request asks for authority and appropriations to impose new obligations on device manufacturers, as well as to enhance FDA's ability to assess these issues as they arise.

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